SIS System (Version 5.1.0)

K210071

Surgical Information Sciences, Inc. · cleared 2021-03-31 · product code LLZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“The SIS System version 5.1.0, a software only device based on machine learning and image processing, is designed to enhance standard clinical images for the visualization of structures in the basal ganglia area of the brain, specifically the subthalamic nucleus (STN) and globus pallidus externa and interna (GPe/GPi).”
Algorithmmachine learning and image processing, pre-trained deep learning neural network models, deep learning Convolutional Neural Network models
source quote (p.5)
“The SIS System version 5.1.0, a software only device based on machine learning and image processing, is designed to enhance standard clinical images for the visualization of structures in the basal ganglia area of the brain, specifically the subthalamic nucleus (STN) and globus pallidus externa and interna (GPe/GPi).The SIS System version 5.1.0 provides a patient-specific, 3D anatomical model of specific brain structures based on the patient's own clinical MR image using pre-trained deep learning neural network models.The proposed device is a modification to the SIS Software version 3.6.0 that was cleared under K192304. The changes made to the SIS System include (1) an updated algorithm that is based on deep learning Convolutional Neural Network models that were architected and optimized for brain image segmentation;”
Adaptive (vs locked)No
source quote (p.5)
“These pre-trained deep learning neural network models are then applied to a patient's clinical image to predict the shape and position of the patient's specific brain structures of interest.The subject device employs an updated version of the algorithm based on deep learning Convolutional Neural Network Models, which were trained to identify the region of interest and individually predict the location and size of the anatomical structures of interest.”
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Retrospective clinical

sample size not stated

endpoints: visualization accuracy

Standalone

n=55 other

endpoints: probability of a trusted detection being accurate (within ± 30° of the ground truth); probability of an untrusted detection being accurate

Reported performance (2 observations)

accuracyas written: “Accuracy of trusted lead detection”0.91
source quote (p.6)
“When the software trusted the lead detection, it was correct in 91% of cases.”
accuracyas written: “Accuracy of orientations presented to the user”0.9
source quote (p.6)
“This testing demonstrated that greater than 90% of orientations presented to the user are accurate within ± 30°.”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

48
recalls in product code, 24mo
295
MAUDE reports in code, 12mo
+683%
vs code's own 3-yr baseline
29
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K241083 (decision 2024-06-14) from Surgical Information Sciences, Inc. for a matching device line ("SIS System") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K241083

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K230977 (decision 2023-05-02) from Surgical Information Sciences, Inc. for a matching device line ("SIS System") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K230977

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K223032 (decision 2022-11-21) from Surgical Information Sciences, Inc. for a matching device line ("SIS System (Version 5.6.0)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K223032

  • adverse_event_inflection

    MAUDE adverse-event reports for product code LLZ: 295 in the 12 months ending 2026-06, vs a 37.7/12mo average over the prior 3 windows (+683%). Code-level count — reports are not attributed to this specific device.

    first seen 2026-07-08 · openFDA /device/event.json count=date_received product_code=LLZ

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (GE Medical Systems SCS, initiated 2026-05-08): "GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:99042

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2026-03-05): "Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98520

  • …and 23 more.

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K210071