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Laparoscopic grasping of tissue. Laparoscopic bipolar coagulation. Laparoscopic contraceptive coagulation of the Fallopian tissue and may be used to achieve hemostasis following transection of the Fallopian tube.

The device is a Class III medical device. The Tubal Sterilization device is similar to Everest Medical's current laparoscopic BiCOAG® forceps submitted on 510(k) no. K945975 and the pre-ennactment Tubal sterilization Wolf Kleppinger Forceps.

The provided text does not contain detailed information about specific acceptance criteria or a comprehensive study plan with the granularity required to fill out all the fields in your request for the "BiCOAG Coagulating Forceps" or the "Tubal Sterilization device".

However, based on the information available, here's what can be extracted and inferred:

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

The document mentions "Performance testing has been submitted to support the safety and functional performance of the submitted devices." and "Clinical studies evaluating histological results have been conducted using the same Wolf Bipolar generator to demonstrate equivalent effectiveness to the currently available Tubal sterilization Wolf Kleppinger Forceps."

While specific quantitative acceptance criteria are not detailed, the primary performance criterion appears to be equivalent effectiveness to the predicate device, the "Tubal sterilization Wolf Kleppinger Forceps," as demonstrated by histological results.

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 for Test Set: Not explicitly stated. The document only mentions "Clinical studies evaluating histological results have been conducted."
• Data Provenance: Not explicitly stated. We don't know the country of origin or if the studies were retrospective or 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)

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated.

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

• Adjudication Method: Not specified.

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

• MRMC Study: This is a Class III medical device (tubal sterilization forceps), not an AI-powered diagnostic device for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable in this context. The study focuses on the device's physical performance in a surgical procedure, not its interpretation by human readers.

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

• Standalone Study: This is a surgical instrument, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable. The device's performance is inherently tied to its use by a human surgeon.

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

• Type of Ground Truth: The document explicitly states "Clinical studies evaluating histological results have been conducted." This indicates that histology/pathology was the primary method for determining the effectiveness (e.g., successful tubal occlusion).

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a medical device, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a device would involve engineering design, prototyping, and testing, not data-driven machine learning.

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

• How Ground Truth for Training Set was Established: Not applicable (as explained in point 8).

In Summary:

The provided 510(k) summary focuses on establishing substantial equivalence for a surgical instrument (tubal sterilization forceps). The key evidence presented revolves around performance testing for safety and functional performance, and clinical studies using histological results to demonstrate equivalent effectiveness to a predicate device. The information is very high-level and lacks the granular details typically found in summaries for diagnostic devices or AI algorithms regarding study designs, sample sizes, and expert evaluations.

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