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The EEA™ Circular Stapler with Tri-Staple™ Technology and OrVil™ transoral circular stapler anvil have application throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.

The EEA™ circular stapler with Tri-Staple™ technology and OrVil™ Transoral Circular Stapler Anvil is a manual, single-use device that places a circular, triple staggered row of titanium staples and resects the excess tissue. It has application throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries. The subject device is to add new product models with OrVil™ transoral circular stapler anvil to EEA™ circular stapler with Tri-Staple™ technology 21mm or 25mm XL purple or black stapler.

This document describes the premarket notification (510(k)) for the EEA™ Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil. It is a medical device, specifically a surgical stapler. The provided text, however, does not contain information about software, AI algorithms, or a study involving human readers' improvement with AI assistance.

Therefore, many of the requested points regarding acceptance criteria and study details for an AI-based device, such as sample sizes for test and training sets, expert qualifications, ground truth establishment for AI models, and MRMC studies, cannot be extracted from this document.

The document primarily focuses on demonstrating the substantial equivalence of this new device to previously cleared predicate devices through non-clinical performance data and usability evaluation.

Here's what can be extracted based on the provided text, while acknowledging the limitations for an AI-related request:

Acceptance Criteria and Reported Device Performance (Non-AI Device)

Given that this is a mechanical surgical stapler and not an AI-driven device, the "acceptance criteria" here refer to the successful completion of various performance and safety tests to demonstrate substantial equivalence to predicate devices, rather than AI performance metrics (e.g., sensitivity, specificity).

Study Details (Relevant to this non-AI medical device submission)

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

   • The document mentions "non-clinical performance data" and a series of "Performance Test (In-Vitro)", "Performance Test (Ex-Vivo)", and "Performance Test (In-Vivo)". No specific sample sizes for these tests are provided.
   • Data provenance (e.g., country of origin, retrospective/prospective) is not specified for these non-clinical tests.

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

   • This is not applicable as the submission describes a mechanical device. The "ground truth" for this device would be engineering specifications and functional performance.
   • For the usability study, "intended users (surgeons, nurses)" evaluated the device, but the number and qualifications beyond their professional roles are not specified.

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

   • Not applicable for this type of device testing. Performance is measured against physical specifications.

4. 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-enabled device.

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

   • No. This is not an AI-enabled device.

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

   • The "ground truth" for this device is based on established engineering specifications, ASTM or ISO standards for medical devices, and successful performance in the described in-vitro, ex-vivo, and in-vivo functional tests. For the usability study, it's based on subjective and objective feedback from intended users against safety and effectiveness criteria.

7. The sample size for the training set:

   • Not applicable. This is not an AI device that undergoes training.

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

   • Not applicable. This is not an AI device that undergoes training.

In summary: The provided document is a 510(k) summary for a traditional mechanical surgical stapler. It does not involve AI or any of the detailed study methodologies typically associated with AI/software medical device submissions. Therefore, most of the questions relating to AI performance, data sets, and expert evaluations cannot be answered from this text.

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