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The HEMOVAC® Blood Reinfusion System is a closed system intended for post operative collection, filtration, and reinfusion of autologous blood. It is the responsibility of the physician to determine if this therapy is appropriate for a specific procedure.

The HEMOVAC® Blood Reinfusion System is a sterile, single patient use, closed, disposable system intended for post operative collection, filtration, and reinfusion of autologous blood. The system consists of a wound drain and trocars, blood lines, graduated 800ml blood collection reservoir (contains pre-filter, air filter, fat retention valve), Hemovac® evacuator, anticoagulant port, transfer tube, and blood reinfusion bag.

This document describes the HEMOVAC® Blood Reinfusion System for post-operative collection, filtration, and reinfusion of autologous blood. The study presented is a non-clinical performance evaluation, not an AI or imaging-based study. As such, many of the requested categories related to AI/imaging studies are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in the provided text. The study was non-clinical (device testing in a lab setting), not involving human subjects or clinical data in the context of a "test set" as understood for AI/imaging.
• Data Provenance: Not applicable. The study was non-clinical, evaluating device performance against established standards.

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

• Not applicable. This was a non-clinical device performance study against established engineering and biological standards, not an AI/imaging study requiring expert ground truth for a test set.

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

• Not applicable. This was a non-clinical device performance study.

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 not an AI-assisted device.

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

• Not applicable. This is not an AI algorithm.

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

• For this non-clinical study, the "ground truth" was defined by the requirements and test methodologies outlined in the specified industry standards (ANSI/AAMI AT6-1991, ANSI/AAMI/ISO 10993-1:1997, and AAMI/ANSI/ISO 10993-4:2002). Compliance with these standards served as the benchmark for device performance.

8. The sample size for the training set

• Not applicable. This is not an AI model, and thus there is no "training set."

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

• Not applicable. This is not an AI model, and thus there is no "training set" or "ground truth for the training set."

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