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Hemosorb is intended as a topical dressing for the local management of bleeding wounds such as minor cuts, lacerations, and abrasions.

Hemosorb is a bulk granular hemostatic agent, which is placed on or into a wound to effect adsorption, and coagulation of same. The effect of Hemosorb is purely physical, not chemical in nature. Hemosorb has an unusually high adsorptive effect on liquid. This rapid adsorption of water as a blood component serves to concentrate platelets, and increase the speed and effect of their clotting capabilities. This rapid adsorption also diminishes the volume of the liquid present in the wound as a sponge effect, to facilitate clotting.

The provided document is a 510(k) summary for the device Hemosorb, a topical dressing for managing bleeding wounds. It addresses the device's substantial equivalence to a predicate device, Sorbastace.

Here's an analysis of the acceptance criteria and the study descriptions, organized by your requested information:

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

The document does not explicitly state formal "acceptance criteria" in a quantitative manner as might be seen for a new, de novo device. Instead, it focuses on demonstrating "substantial equivalence" to a predicate device, Sorbastace. The performance is reported in terms of efficacy in stopping bleeding and biocompatibility.

2. Sample size used for the test set and the data provenance

The document provides details of several tests, but specific sample sizes for each animal study are often not explicitly stated.

• In vitro and In vivo (rats, rabbits, larger mammals) at the University of Connecticut: "In Invitro and Invivo testing on rats, rabbits and larger mammals at the University of Connecticut." No specific numbers mentioned, but indicates multiple types of animals.
• VAMC (rats and pigs): "Tests by the Chief of Surgery at VAMC. Newington, CT, conducted at Hartford Hospital on rats and pigs' livers and skin." No specific numbers mentioned.
• USUHS and Office of Naval Research (large mammals): This study clearly states a mortality rate for "No Dressing," "Standard Dressing," and "Standard Dressing with Hemosorb," implying a cohort for each. However, the exact sample size (number of large mammals) in each group is not provided.
• Biocompatibility testing (MicroTest Laboratories, Inc.): These are laboratory tests on samples of the device material, not on a "test set" of patient data.

Data Provenance: The studies were conducted in the USA (University of Connecticut, Hartford Hospital, VAMC Newington CT, USUHS, MicroTest Laboratories, Inc. of Agawam, Mass.). All studies appear to be retrospective data collected for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not detail the use of "experts" to establish a ground truth for a test set in the way a clinical study for diagnostic devices might. Instead, the "ground truth" for efficacy was based on measurable physiological outcomes (coagulation rate, bleeding time, blood loss, mortality) observed in animal models. Toxicity was assessed through histopathology and standard biocompatibility tests.

The studies were conducted by:

• University of Connecticut researchers
• UConn Chemistry Department
• Chief of Surgery at VAMC, Newington, CT (conducted at Hartford Hospital)
• USUHS (Uniformed Services University of the Health Sciences) and Office of Naval Research
• ISO 17025 Certified MicroTest Laboratories, Inc.

The qualifications mentioned are "Chief of Surgery" and "UConn Chemistry Department," which imply relevant expertise but specific years of experience or board certifications are not provided.

4. Adjudication method for the test set

Not applicable. The studies described are preclinical animal studies and laboratory tests, not clinical trials involving human readers or subjective assessments that would require an adjudication method. The outcomes measured are objective (e.g., mortality, blood loss, lab test results).

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 local management of bleeding, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI assistance comparison was performed.

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

Not applicable. The device is a physical hemostatic agent, not an algorithm. Therefore, no standalone algorithm performance was evaluated.

7. The type of ground truth used

The ground truth used was based on objective physiological measurements and standardized laboratory results:

• Efficacy: Coagulation rate, bleeding time, reduction in blood loss, and survival/mortality rates in various animal models (rats, rabbits, pigs, large mammals).
• Toxicity/Biocompatibility: Histopathology scores in rats and results from standard ISO biocompatibility tests (cytotoxicity, sensitization, irritation, implant reactions).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device, so there is no "training set" in that context. The development of the device would have involved iterative testing and refinement, but not in the sense of a data-driven training set for an algorithm.

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

Not applicable, as there is no training set for an algorithm.

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