(128 days)
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
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| American National Standard for Autologous Transfusion Devices (ANSI/AAMI AT6-1991) | Device meets the applicable sections. |
| Biological evaluation of Medical Devices (ANSI/AAMI/ISO 10993-1:1997) | Device meets the applicable sections. |
| Hemocompatibility (AAMI/ANSI/ISO 10993-4:2002) | Hemocompatibility was conducted in accordance with this standard. |
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."
§ 868.5830 Autotransfusion apparatus.
(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).