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The D100 devices are indicated for use for neonatal patients undergoing surgical procedures requiring cardiopulmonary bypass. The oxygenator is intended to be used for six hours or less.

The D101 devices are indicated for use for infant patients undergoing surgical procedures requiring cardiopulmonary bypass The oxygenator is intended to be used for six hours or less

The D100 KIDS and D101 KIDS oxygenators (hereinafter identified as KIDS) consist of an oxygenator with an integrated heat exchanger and hard-shell cardiotomy venous reservoir.
The KIDS consist of the following main components
• a heat exchanger consisting of a grooved and pleated stainless steel that is placed into a polycarbonate housing with integrated Hansen connectors and is sealed with resin potting at both ends. it controls blood temperature and allows the use of hypothermia or aids in the maintenance of normothermia during surgery.
• an oxygenating module element made of a coiled bundle of polypropylene microporous hollow fibers rolled on the heat exchanger sub assembly. The hollow fiber membrane provides oxygenation and carbon dioxide removal from venous blood or suction blood.
• a hard shell cardiotomy/venous reservoir attached to the top of the oxygenator by means of a molded fitting joint. It is a single chamber reservoir comprised of a rigid polycarbonate housing with an internal hollow support. The filtering system surrounds the internal hollow support and work as a cardiotomy section in the upper part and as a venous reservoir in the bottom part. It collects and filter blood coming from suckers and from the venous return.

The provided document is a 510(k) premarket notification for D100 KIDS and D101 KIDS cardiopulmonary bypass oxygenators. It's a regulatory submission and not a research paper detailing an AI/ML device study. Therefore, most of the requested information regarding acceptance criteria and study details for AI/ML performance (such as sample size for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance) is not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices by evaluating the impact of modified materials through non-clinical in vitro testing.

Here's the relevant information that can be extracted:

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

The document states that "The modified device successfully met all acceptance criteria." However, it does not provide a specific table or list of quantitative acceptance criteria and corresponding performance metrics. It only lists the types of tests performed:

The document also notes that these tests were conducted on "sterile aged devices; accelerated aging for a period of time equivalent to at least 3 years as per device labeling."

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: Not specified. The document only mentions "in vitro testing" without detailing the number of devices or test repetitions.
• Data provenance: In vitro testing; likely performed in Italy (country of the applicant, Sorin Group Italia S.R.L.). The document does not specify if the data is retrospective or prospective, as it's not a clinical study on patient data.

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

• This is not applicable. The device is an oxygenator, and the testing involves physical and mechanical performance metrics (pull strength, pressure resistance, flow rates), not a subjective assessment like expert reads of medical images. Ground truth would be established by validated measurement equipment and protocols, not by human experts in this context.

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

• This is not applicable. As it's in vitro physical testing, there's no need for adjudication among human readers/experts.

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

• No. This is not applicable. The device is a medical device (cardiopulmonary bypass oxygenator), not an AI/ML software. No MRMC study was performed.

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

• No. This is not applicable. The device is a physical medical device, not an AI/ML algorithm.

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

• The "ground truth" for this type of in vitro testing would be established by physical measurements using calibrated instruments, adhering to engineering and performance specifications. For example, a "pull test" would have a specified force threshold, and the device either meets or fails that. There is no biological or clinical "ground truth" in the sense of a diagnosis or outcome.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. There is no "training set" as this is not an AI/ML device.

In summary: This document is a regulatory submission for a physical medical device (oxygenator) demonstrating substantial equivalence based on in vitro performance testing of material modifications. It does not involve AI/ML technology or clinical studies with patient data, and therefore, most of the questions relating to AI/ML device performance evaluation are not relevant to this document.

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