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The Performa Adult Hollow Fiber Membrane Oxygenator is intended for use in adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.

The Performa Adult Hollow Fiber Oxygenator is a cardiopulmonary bypass blood oxygenator with an integral heat exchanger.

This document describes the Performa Adult Hollow Fiber Membrane Oxygenator, a medical device, and its evaluation for substantial equivalence to a predicate device. The information provided outlines the non-clinical and in vitro testing conducted. It is important to note that this document is a 510(k) summary, which typically focuses on demonstrating equivalence to an already approved device rather than a comprehensive de novo submission requiring extensive proof of safety and effectiveness from scratch.

Here's an analysis of the provided text in the context of acceptance criteria and a study:

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

The document does not provide a specific table of acceptance criteria with numerical targets. Instead, it states that the tests "met established specifications." The "established specifications" likely refer to the requirements outlined in ISO 7199 and the FDA Guidance for Cardiopulmonary Bypass Oxygenators.

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

• Sample Size: The document does not explicitly state the sample size (number of devices) used for the non-clinical and in vitro tests. It refers to "Applicable tests" and "The Performa Oxygenator aged to 3 years was tested," implying that a certain number of devices underwent these evaluations. Without specific numbers, it's impossible to quantify the sample size.
• Data Provenance: The tests seem to have been conducted by Dideco S.r.l., which is based in Mirandola (MO), Italy. The data is in vitro and non-clinical, meaning it's from laboratory testing rather than human subjects. It is prospective testing, as the device was manufactured and then subjected to these tests to assess its performance.

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)

This section is not applicable to the provided document. The study described is an in vitro and non-clinical engineering and performance evaluation of a device. It does not involve human subjects, expert review of images, or clinical outcomes that would require "ground truth" established by medical experts in the way that, for example, an AI diagnostic device would. The "ground truth" here is the established scientific and engineering principles and the specifications outlined in ISO and FDA guidance documents.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies where there are subjective interpretations of data (e.g., medical images, patient symptoms) that require consensus among multiple experts. The tests described are objective, measurable physical and chemical properties of the device, assessed against predefined quantitative specifications.

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

This section is not applicable. An MRMC study is relevant for diagnostic or screening devices where human readers (e.g., radiologists) interpret cases (e.g., medical images) with and without the assistance of an AI algorithm. The Performa Adult Hollow Fiber Membrane Oxygenator is a therapeutic device (for cardiopulmonary bypass), not a diagnostic tool, and its evaluation does not involve human readers interpreting cases or AI assistance in that context.

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

This section is not applicable. "Standalone performance" in this context typically refers to the performance of an AI algorithm independent of human intervention. The Performa device is a physical medical device, not an AI algorithm. Its performance is evaluated mechanically, chemically, and biologically through in vitro tests.

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

As mentioned in point 3, the concept of "ground truth" for this type of device evaluation differs from clinical studies involving diagnostic accuracy. The "ground truth" or reference standards used are:

• Established specifications/standards: Primarily the requirements from ISO 10993-1:1997 (for biocompatibility) and ISO 7199 (for in vitro performance characteristics such as gas transfer, pressure drop, plasma leakage, heat exchange, hemolysis, operating blood volume, and mechanical integrity).
• FDA Guidance: The FDA May 1, 1995 Memorandum (for biocompatibility) and the Guidance for Cardiopulmonary Bypass Oxygenators 510(k) submissions -- Final Guidance for industry and FDA Staff November 13, 2000 provided the framework and specific criteria for the in vitro testing.

These standards serve as the objective "ground truth" against which the device's performance is measured.

8. The sample size for the training set

This section is not applicable. A "training set" refers to data used to train a machine learning or AI model. The Performa oxygenator is a physical medical device, not an AI algorithm, and therefore does not have a "training set."

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

This section is not applicable. As there is no training set for an AI algorithm, the concept of establishing ground truth for it does not apply here.

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