(247 days)
Pall Donor ® Pre-evacuated Post-Operative Autologous Blood Reinfusion System is indicated for the post-operative collection of blood from an orthopedic surgerv patient's wounds and body cavities, filtration of that blood, and reinfusion of the blood into the same patient. Pall Donor ® Pre-evacuated Post-Operative Autologous Blood Reinfusion System significantly reduces lipids, leucocytes, and C3a from the blood before reinfusing it.
The DONOR. HemoVac, Orthofusor, Solocotrans, and ConstaVac are intended to be use to collect, filter, and reinfuse blood lost by the patient due to surgery.
The provided text describes a medical device called "PALL's DONOR® Pre-evacuated Post-Operative Autologous Blood Transfusion System" and its performance data. However, the text does not contain detailed acceptance criteria or a comprehensive study description that directly matches all the requested information for analyzing an AI/ML device.
It's important to note that this document is a 510(k) summary for a traditional medical device (an autotransfusion system), not an AI/ML diagnostic tool. Therefore, many of the requested fields, such as "sample size used for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "training set size," and "ground truth for the training set" are not applicable or not provided in the context of this device's regulatory submission.
The "Performance Data" section mentions "Bench data" which substantiates claims, but it does not detail the methodology, sample sizes, or a formal study comparing performance against acceptance criteria in the way an AI/ML device would be evaluated.
Given this context, here's an attempt to answer your questions based only on the provided text, while acknowledging the limitations:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the claims made and the compliance with a standard. The reported performance is the "reduction" of certain components. Specific numerical thresholds for "significant reduction" are not provided in this summary.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ANSI/AAMI/AT-6 (1991) | Found to comply with ANSI/AAMI/AT-6 (1991) |
| Significant reduction of lipids | Significantly reduces lipids (bench data substantiates) |
| Significant reduction of leukocytes | Significantly reduces leukocytes (bench data substantiates) |
| Significant reduction of C3a | Significantly reduces C3a (bench data substantiates) |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. The document only mentions "Bench data" without detailing the number of samples or experimental runs.
- Data provenance: Not specified. As "Bench data," it implies laboratory testing, but the country of origin or whether it was retrospective/prospective is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not specified. For this type of device (autotransfusion system), the "ground truth" would likely be based on objective analytical measurements (e.g., laboratory assays for lipids, leukocytes, C3a) rather than expert consensus on images or clinical assessments.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable/Not specified. Adjudication methods are typically used for expert reviews in diagnostic studies, which is not the case here.
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/ML diagnostic device, and thus no MRMC study involving human readers with/without AI assistance would have been conducted or is reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm. Its performance is inherent to its design and function. The "bench data" would represent the "standalone" performance of the device in a laboratory setting.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document mentions "Bench data substantiates each of these claims." This implies that the ground truth for reduction claims (lipids, leukocytes, C3a) would be established through objective laboratory analytical methods (chemical assays, cell counts, immunological assays, etc.) that measure the levels of these components before and after filtration by the device. It would not be expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set, this question is not relevant.
§ 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).