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The Premium Surgiclip™ III clip application in many types of surgical procedures to occlude vessels and other tubular structures and for vagotomy, sympathectomy, and radiographic markings.

The Premium Surgiclip™ III clip applier consists of an applier shaft with attached handles and integrated cartridge containing 20 titanium clips. The clip applier jaw is placed around a vessel or other tubular structure. As the handles of the appler are brought together, the clip is closed around the vessel or structure. The device contains a ratchet mechanism to ensure that a clip is not allowed to release until a full handle squeeze is applied. As the handles are released, a new clip is automatically loaded into the clip applier jaw. After the last clip is used, the device is designed to lockout which prevents the hands from being closed.

This document describes the Premium Surgiclip™ III, an implantable clip device, and its substantial equivalence to a predicate device. However, it does not contain information about an AI/ML powered device, nor does it detail a study with acceptance criteria in the typical sense of diagnostic performance metrics like sensitivity, specificity, etc.

The document is a 510(k) premarket notification excerpt from the FDA, focusing on demonstrating substantial equivalence to a previously cleared device. The "performance data" mentioned refers to engineering and biocompatibility tests, not clinical performance metrics for a diagnostic or AI-driven system.

Therefore, many of the requested sections about acceptance criteria and study details for an AI device cannot be filled from the provided text.

Here is what can be extracted and inferred based on the provided text, and what cannot:

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

• This is generally not applicable in the context of an implantable clip device's 510(k) submission as it would be for an AI diagnostic device. The "performance" here relates to physical characteristics and function of the clip, not diagnostic accuracy.
• Acceptance Criteria (Implied by testing): The device (Premium Surgiclip™ III) must perform comparably to the predicate device (Premium Surgiclip™ Small 9.0" Clip Applier [K853650]) in a series of bench and in-vivo tests to demonstrate substantial equivalence.
• Reported Device Performance:
  • Bench Tests (In-vitro): Clip over clip, Jaw side load, Jaw deflection, Clip twist resistance, Firing force, Clip formation, Clip security.
  • In-vivo Tests: Hemostasis, Clip security, Clip removal, Jaw twist deflection resistance.
  • Conclusion: The document states that "The results of the performance and comparative testing described above demonstrate that the Premium Surgiclip™ III clip applier is substantially equivalent to the predicate device..." This is the broad performance outcome. Specific quantitative metrics for each test are not provided in this summary.

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

• Sample Size: Not specified for any of the bench or in-vivo tests.
• Data Provenance: Not specified, but likely internal testing by Covidien. The type of tests (bench, in-vivo) suggests a prospective testing approach for these engineering and functional evaluations.

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. This device is an implantable clip, not a diagnostic AI device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for its performance would be defined by engineering specifications and biological outcomes (e.g., successful occlusion, hemostasis).

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

• Not Applicable. No adjudication method is mentioned or relevant for these types of tests.

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 an AI-powered device, and therefore no MRMC study involving human readers with or without AI assistance was conducted.

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

• No. This is not an algorithm or AI device.

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

• Not Applicable/Inferred: The ground truth for performance in this context would be based on established engineering and biocompatibility standards, and observable outcomes in the in-vivo tests (e.g., successful hemostasis, absence of clip migration/removal issues). It's not a diagnostic "ground truth."

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. This is not an AI/ML device.

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