PMD-200

DEN210022

Medasense Biometrics Ltd. · granted 2023-02-17 · product code QVE · Anesthesiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.1)
“An adjunctive pain measurement device for anesthesiology is a prescription device that includes software algorithms to analyze physiological sensor data and measure response to painful stimuli in patients under general anesthesia. The device may be software-only or it may include hardware such as physiological sensors.”
Algorithmsoftware algorithms to analyze physiological sensor data and measure response to painful stimuli; Calculation of the NOL index based on physiological parameters extracted from raw data signals.
source quote (p.1)
“An adjunctive pain measurement device for anesthesiology is a prescription device that includes software algorithms to analyze physiological sensor data and measure response to painful stimuli in patients under general anesthesia. The device may be software-only or it may include hardware such as physiological sensors. Software includes two main components: Calculation of the NOL index based on physiological parameters extracted from raw data signals.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.4)
“Software documentation including management of cybersecurity was provided in accordance with the FDA Guidance Document, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,” (issued May 11, 2005) for a Moderate Level of Concern (LOC).”

Validation studies (4)

Bench

n=604 other

endpoints: sensitivity; specificity; nociception / no nociception levels

Retrospective clinical

n=500 patients

endpoints: Algorithm overall predictability; AUC; Specificity; Sensitivity; Accuracy; Characterization of NOL values at times of no noxious stimulus; NOL ability to correctly grade various nociceptive intensities

Prospective clinical

n=75 patients · 1 site(s)

endpoints: Reduction of pain score in the PACU; Reduction in the frequency of inadequate analgesia/anesthesia events; Total intraoperative fentanyl consumption; Use of vasoactive medication; Time to the first administration of morphine and/or non-opioid systematically administered analgesics; Post-operative opioid consumption from arrival to discharge; Readiness to discharge from PACU; Post-operative sedation scores; Respiratory Depression; Nausea and vomiting incidence; Pruritis requiring treatment; Pain scores (VAS or NRS Scale); 24 hours post-operative opioid consumption; PONV medication consumption

Prospective clinical

n=50 patients · 2 site(s)

endpoints: Postoperative pain scores in the post anesthetic care unit (PACU); Postoperative opioid consumption; Fentanyl use during anesthesia; Sevoflurane consumption during anesthesia; Inadequate hemodynamic events; Time between reversal of neuromuscular block and extubation /eyes open; Occurrence of awareness; Anesthesia and surgery times/PACU stay time; Blood ACTH and cortisol levels during and following the procedure

Reported performance (4 observations)

sensitivity0.85CI 0.75 for low 95% CI
source quote (p.7)
“Sensitivity 0.85 (0.75 for low 95% CI)”
specificity0.85CI 0.75 for low 95% CI
source quote (p.7)
“Specificity 0.85 (0.75 for low 95% CI)”
aurocas written: “auc”0.85CI 0.8 for low 95% CI
source quote (p.7)
“AUC 0.85 (0.8 for low 95% CI)”
accuracyas written: “Accuracy”stated without value
source quote (p.7)
“Accuracy > 0.85”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: De Novo decision summary PDF.

Predicate network

Postmarket — what happened after clearance

Not yet tracked — the weekly postmarket refresh hasn't snapshotted this device.

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 De Novo AI/ML devices in the Anesthesiology 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/DEN210022