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The AUTO SUTURE* Occluding Clamp** device is intended for use in those patients undergoing coronary artery bypass surgery when the surgeon determines that it is desirable to temporarily occlude a coronary artery to optimize the exposure during the anastomosis.

The AUTO SUTURE* Occluding Clamp** device is a vascular clamp applier.

The provided documents for the AUTO SUTURE* Occluding Clamp** device (K964251) offer limited details regarding specific acceptance criteria and the comprehensive study that proves the device meets these criteria. The submission states that the device "was tested both in-vitro and in-vivo to evaluate its performance. The results of the testing demonstrate the subject device to be safe and effective." However, it does not provide the detailed information requested in the prompt.

Therefore, much of the requested information cannot be extracted from the given text.

Here is what can be inferred and what is missing:

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

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 (Test Set): Not provided.
• Data Provenance: Not provided (e.g., country of origin, retrospective/prospective).

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)

• Not applicable as this is a medical device (vascular clamp applier) rather than an AI/diagnostic imaging device. No mention of experts establishing a "ground truth" for diagnostic purposes. The evaluation would likely involve surgeons or clinical professionals observing the device's mechanical performance and clinical outcome.

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

• Not applicable/Not provided. The type of device and the information given do not suggest a need for an adjudication method as would be used for subjective interpretations in diagnostic studies.

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 diagnostic device, so an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

• Not applicable. This is not an algorithm-based device.

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

• The document implies that "safety and effectiveness" were evaluated through "in-vitro and in-vivo" testing. For a vascular clamp, "ground truth" would likely be established through:
  • In-vitro: Mechanical testing (e.g., clamp force, durability, material compatibility, sealing capabilities) against engineering specifications.
  • In-vivo: Clinical outcomes data from animal or human studies (e.g., successful temporary occlusion of coronary arteries without damage, ease of use, absence of complications).
  • However, the specific metrics and how ground truth was established are not detailed.

8. The sample size for the training set

• Not applicable. This is not a machine learning/AI device, so there is no concept of a "training set."

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

• Not applicable. As above, there is no training set mentioned or implied.

In summary, the provided 510(k) premarket notification is a high-level summary that confirms the device underwent testing and was found to be safe and effective, leading to substantial equivalence with a predicate device. It does not contain the detailed study protocols, specific acceptance criteria, or performance metrics that would typically be found in a comprehensive clinical or engineering report.

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