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The Power Circular Stapler Digital Loading Units® have applications throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.

Power Circular Stapler Digital Loading Units® are single use, disposable, surgical stapling devices designed for creating a circular anastomosis between two tubular structures and/or tissue layers.

This document describes a Special 510(k) Pre-Market Notification for a device called "Power Circular Stapler Digital Loading Units®". This is a surgical stapling device, and the submission is for a modification to an existing, cleared device (SurgASSIST® Circular Stapler Digital Loading Units®, K003277).

Due to the nature of this submission being a Special 510(k) for a surgical stapler device modification, the provided text does not contain information related to software-driven acceptance criteria or the type of study typically conducted for AI/ML-driven medical devices. The description focuses on mechanical device modifications and their functional equivalence to the predicate device.

Therefore, I cannot populate the requested table and answer the specific questions about AI/ML device studies (sample sizes, expert ground truth, MRMC studies, standalone performance, training set details) because this information is not present in the provided text. The device is a mechanical surgical stapler, not an AI/ML diagnostic or predictive tool.

Here's a breakdown of what can be extracted and why the other information is absent:

1. Table of acceptance criteria and the reported device performance:

Explanation for Inferred Criteria and Performance:
The document states, "The Power Circular Stapler Digital Loading Units® cut and staple identically to the predicate device, Circular Stapler Digital Loading Units® (K003277)." It also confirms, "The Power Circular Stapler Digital Loading Units® have the same indications for use and the same functionality as the previously cleared predicate Circular Stapler Digital Loading Units® (K003277)." In a Special 510(k) for a device modification, the primary "acceptance criterion" is typically demonstrating substantial equivalence in performance and safety to the predicate device, especially when the core mechanism and indications remain unchanged.

Missing Information (and why it's missing for this type of device):

• 2. Sample sized used for the test set and the data provenance: Not applicable. There isn't a "test set" in the context of an AI/ML algorithm. Testing for a mechanical device modification would typically involve bench testing, animal studies, or cadaver studies, but the specifics are not detailed in this high-level summary.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML diagnostic device requiring expert interpretation for ground truth.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device, not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a surgical stapler is its mechanical performance (e.g., staple formation, tissue approximation, leak testing) and clinical outcome (e.g., successful anastomosis), but these details are not provided in the summary.
• 8. The sample size for the training set: Not applicable. There is no AI model being trained.
• 9. How the ground truth for the training set was established: Not applicable. There is no AI model being trained.

Summary of the Study for Substantial Equivalence:

The study proving the device meets the acceptance criteria (i.e., substantial equivalence) is implicitly a comparison study against its predicate device (K003277). The modifications made (reduced rigid length, relocated gearing, redesigned anvil clamping mechanism) are presented as not altering the fundamental stapling mechanism or the indications for use.

The statement, "The Power Circular Stapler Digital Loading Units® cut and staple identically to the predicate device," serves as the primary evidence presented in this summary for meeting the performance criteria. The "Predicate Comparison Chart in Section J" (not provided in this excerpt) would have contained the detailed technical comparison data. Such a comparison would typically involve engineering analysis, bench testing, and potentially some form of in-vitro or ex-vivo testing to demonstrate equivalent staple formation, strength, and sealing characteristics. However, these specific study details are not expanded upon in the provided K061649 summary.

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