CHLOE BLAST

K243851

Fairtility Ltd. · cleared 2025-08-15 · product code PBH · Obstetrics and Gynecology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“CHLOE BLAST is a cloud-based software as a medical device (SaMD) that uses a convolutional neural network (CNN) to analyze TLI videos from insemination to Day 3.”
Algorithmconvolutional neural network (CNN)
source quote (p.5)
“CHLOE BLAST is a cloud-based software as a medical device (SaMD) that uses a convolutional neural network (CNN) to analyze TLI videos from insemination to Day 3.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedFDA source did not state this

Validation studies (3)

Standalone

n=1,094 images · 2 site(s)

endpoints: accuracy of the morphokinetic event detection; overall performance of the algorithm in predicting blastocyst formation

Standalone

n=1,726 images · 2 site(s)

endpoints: overall performance of the algorithm in predicting blastocyst formation

Reader study (MRMC)

n=703 images · 3 site(s)

endpoints: Association between the adjunct prediction using CHLOE BLAST of blastocyst outcome and the actual blastocyst outcome for Good/Fair embryos, measured by an Odds Ratio (OR) greater than 1; OR for predicting blastocyst formation based on adjunct prediction with CHLOE for all embryos; OR for predicting blastocyst formation using traditional morphology only, for all embryos as well as the subset of embryos graded as Good/Fair; OR for Good/Fair embryos predicting blastocyst formation for each individual embryologist, using traditional morphology only and using morphology plus CHLOE; Embryo-level diagnostic performance measures: Specificity, Sensitivity, Negative predictive value (NPV), Positive predictive value (PPV), Negative likelihood ratio, Positive likelihood ratio; Subgroup analyses (Good/Fair embryos) were conducted for several factors, including age group, BMI category, Race and Ethnicity categories, and clinical site (with CHLOE score); Subject-level analysis: a subject-level performance of CHLOE; Top 2 embryo analysis: analysis of embryos that were selected as one of the top two by at least one panelist based on morphology alone

Reported performance (5 observations)

sensitivity0.846
source quote (p.13)
“Sensitivity: 0.846 / 0.893”
specificity0.444
source quote (p.13)
“Specificity" 0.444 / 0.246”
aurocas written: “auc”0.88CI 0.86, 0.90
source quote (p.9)
“The AUC of the overall performance of the Blast prediction was 0.88 (95% CI: 0.86, 0.90)”
ppvas written: “Positive Predictive Value (PPV)”0.629
source quote (p.13)
“PPV (Positive Predictive Value): 0.629 / 0.569”
npvas written: “Negative Predictive Value (NPV)”0.721
source quote (p.13)
“NPV (Negative predictive Value): 0.721 / 0.675”

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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

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 Obstetrics and Gynecology 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/K243851