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Aesculap's Reposable Instrument System is designed to cut, dissect, manipulate and/or cauterize various tissue during endoscopic/laparoscopic, general, vascular, gynecological, and thoracic surgical procedures.

Aesculap's Reposable Instrument System is comprised of non-sterile, reusable handles which are capable of monopolar electrocautery, via a underside connection terminal, reusable jaw inserts which come in different sizes and one single use endoscopic scissors. The jaw inserts include the blades, shaft and locking nut. The reusable scissors insert is supplied non-sterile, and the single use scissors insert is supplied sterile. The reusable and single use jaw inserts are intended to be use with either the non-ratcheted or ratcheted handle.

The provided text is a 510(k) summary for a medical device (K014207: Reposable Instrument System). It explicitly states: "No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. The Reposable Instrument System, however, conform to the following electromedical standard: IEC/EN 60601-2-2 and IEC/EN 60601-2-18."

This means there are no specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for this device in the traditional sense, as it is a surgical instrument system, not an AI or diagnostic device. The "performance data" section indicates conformance to electromedical standards, which are about electrical safety and basic functionality for electrosurgical devices, rather than clinical performance metrics.

Therefore, many of the requested points are not applicable to this particular 510(k) submission.

Here's an attempt to answer based on the provided information, addressing what is present and noting what is not:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable. This is a surgical instrument device, not a diagnostic or AI device that relies on a test set of data (e.g., images, patient records). The "testing" refers to conformance to engineering standards and comparison to predicate devices, not studies with patient data.

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

• Not Applicable. See point 2. Ground truth, in the context of diagnostic/AI devices, is not relevant here.

4. Adjudication method for the test set

• Not Applicable. See point 2.

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 a surgical instrument, not an AI device or a diagnostic aid for human readers.

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

• Not Applicable. This is a surgical instrument.

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

• Not Applicable. See point 2. The basis for approval is conformance to electromedical standards and substantial equivalence, not a "ground truth" derived from patient data.

8. The sample size for the training set

• Not Applicable. This is a surgical instrument, not an AI device that requires a training set.

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

• Not Applicable. See point 8.

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