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These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery.

The Medtronic DLP Malleable Single Stage Venous Cannulae represent modified versions of existing Medtronic Single Stage Venous Cannulae. The proposed change involves the incorporation of a malleable wire/tube assembly embedded within the wall of the cannula. This malleable wire/tube assembly allows the cannula body to be shaped into a surgeon preferred position.

The provided document, KO22272 for the Medtronic DLP Malleable Single Stage Venous Cannula, is a 510(k) summary for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than establishing completely new performance criteria. Therefore, the document does not contain detailed acceptance criteria in the form of specific performance metrics or a study that rigorously "proves" the device meets them in the same way a de novo or PMA submission might.

Instead, the acceptance criteria are implicitly met by demonstrating that the new device is as safe and effective as the predicate device, which is already on the market. The study described focuses on non-clinical tests to support this substantial equivalence.

Here's an analysis based on the provided text, addressing the requested points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation of "Acceptance Criteria" in this context: For a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as a device already cleared by the FDA. The specific performance metrics are often derived from the predicate device's established safety and effectiveness. Here, the key performance aspect is the biocompatibility of the materials used in the modified device.

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

• Sample Size: The document does not specify a numerical sample size for the non-clinical tests. "Material biocompatibility was conducted in accordance with the ISO 10993-1 standard," which typically involves various in vitro and in vivo tests, but the number of samples or specimens used is not detailed.
• Data Provenance: The data is from "non-clinical tests" conducted by Medtronic. The country of origin is not explicitly stated, but Medtronic is a US-based company, and the submission is to the FDA. The tests are "non-clinical," meaning they are laboratory or bench tests, not involving human subjects.

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

• This information is not provided in the document. For non-clinical, biocompatibility testing, "ground truth" is established through standardized laboratory procedures and scientific protocols rather than expert consensus on individual cases.

4. Adjudication method for the test set:

• This concept is not applicable to the type of non-clinical, biocompatibility testing described. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies when multiple human readers/reviewers assess images or clinical outcomes.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a cardiovascular cannula, a physical medical device, not an AI or imaging diagnostic tool. Therefore, the concept of "human readers improving with AI assistance" is not relevant here.

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

• No, a standalone (algorithm only) performance study was not done. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• For the non-clinical biocompatibility tests, the "ground truth" is derived from the results of the specific standardized tests themselves (e.g., cytotoxicity assays, sensitization tests, irritation tests, hemocompatibility tests as defined by ISO 10993-1). The pass/fail criteria for these tests, based on established biological responses, serve as the ground truth.

8. The sample size for the training set:

• This device is not an AI/ML algorithm, so there is no "training set" in that sense. The concept of a training set is not applicable.

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

• As there is no training set for an AI/ML algorithm, this question is not applicable.

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