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OTC:
StatSeal Disc is intended for OTC use as a topical dressing for bleeding control associated with minor wounds, for temporary external control of minor bleeding from minor wounds, minor cuts, minor lacerations and minor burns.

Rx:
StatSeal Disc is intended under the care of a health care professional for external temporary control of bleeding from percutaneous needle access, vascular access sites and percutaneous catheters.

Components - StatSeal Disc is composed of two main components: Potassium ferrate, and hydrophilic polymer.

Mechanism of Action - StatSeal Disc achieves its principle intended action (hemostasis) by creating a physical barrier or seal to the blood flow.

The provided document is a 510(k) premarket notification for the StatSeal Disc, which aims to demonstrate its substantial equivalence to predicate devices. It does not contain acceptance criteria for specific performance metrics nor a detailed study proving the device meets acceptance criteria in the manner typically described for AI/ML medical devices.

The document focuses on:

• Substantial Equivalence: Arguing that the StatSeal Disc is substantially equivalent to existing predicate devices (Biolife, L.L.C.; PRO QR (Quick Relief) ® Powder (K080210) and Hemaderm (K021678)) based on identical claims, mechanism of action, and composition.
• Performance Testing Summary: Briefly listing types of tests performed (biocompatibility, in vitro, in vivo) without providing acceptance criteria or detailed results.

Therefore, most of the requested information regarding acceptance criteria, performance metrics, sample sizes, ground truth, expert involvement, and comparative effectiveness studies (typical for AI/ML device evaluations) cannot be extracted from this document.

However, I can provide the available information:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself. The primary criterion is "substantial equivalence" to predicate devices, implying similar safety and effectiveness.
• Reported Device Performance:
  • Biocompatibility: "All required biocompatibility testing was conducted on PRO QR Powder (K080520) with no adverse results." Since StatSeal Disc and PRO QR Powder have identical composition, "no change in biocompatibility is expected."
  • In vitro Testing: Studies performed include "Absorption Study, Scanning Electron Microscopy (SEM) Comparison, Hemostatic Properties of StatSeal Disc, Disintegration Study, Friability Study." No specific performance results or acceptance criteria are provided.
  • In-vivo Testing: "A comparative Study Evaluating Vascular Access Hemostasis Properties of StatSeal Disc in GottinGen Minipigs." No specific performance results or acceptance criteria are provided. The conclusion states "StatSeal Disc induces hemostasis by fluid dehydration, protein coagulation and agglomeration."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not specified for any of the studies listed.
• Data Provenance: Not specified. The in-vivo study involved "GottinGen Minipigs," which are laboratory animals.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided. The studies conducted are laboratory and animal studies, not human clinical trials requiring expert ground truth for diagnostic or prognostic purposes, and no mention is made of human expert review as a ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is a medical device for hemostasis, not an AI/ML diagnostic or prognostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a medical device, not an algorithm. The in-vivo study assessed the device's performance in minipigs, which can be considered "standalone" in the sense that the device's intrinsic function was evaluated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the in-vivo study in minipigs, the ground truth would inherently be physiological measurements of hemostasis (e.g., time to hemostasis, blood loss) directly observed and quantified in the animals, rather than expert consensus or pathology in the human diagnostic sense. Specific metrics are not detailed in this summary.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that uses training sets.

9. How the ground truth for the training set was established

• Not applicable. This is not an AI/ML device.

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