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Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments are intended for use in open or thoracoscopic surgical procedures. They are designed for cutting, manipulating, grasping, clamping, dissecting or suction.

Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments are designed for cutting, manipulating, grasping, clamping, dissecting, or suction during open, or thoracoscopic surgical procedures. The instruments are reusable and are made from Stainless Steel with monopolar capabilities. The instruments are modular, consisting of a jaw insert and insulated outer tube with interchangeable ratcheting and non-ratcheting handles. The instruments are 250mm in length with a 7mm diameter. The instruments can be used interchangeably with either a ratcheting or non-ratcheting handle. The handles are made from PEEK with a HF connection that fits any standard monopolar cable. The instruments can be used with a visualization system to allow for better visibility during the procedure. This is an independent system and is not system specific. No new visualization systems are being introduced by Aesculap® in this submission.

The provided text is related to a 510(k) premarket notification for surgical instruments, specifically "Aesculap® Video Assisted Thoracic Surgery (VATS) Instruments." It describes the device, its intended use, and a comparison to predicate devices, along with performance data.

However, the request asks for information relevant to the acceptance criteria and study that proves a device meets those criteria, particularly for an AI/ML-enabled medical device. The document provided does NOT describe an AI/ML-enabled medical device. It describes traditional surgical instruments and their performance testing (design verification, electrical safety, biocompatibility, cleaning/sterilization).

Therefore, I cannot extract the requested information regarding AI/ML device acceptance criteria and study details from the provided text. The document does not contain:

1. A table of acceptance criteria and reported device performance for an AI/ML device. The performance data tables are for mechanical and electrical properties of surgical instruments.
2. Sample size used for the test set or data provenance for an AI/ML device.
3. Number of experts used to establish ground truth or their qualifications for an AI/ML device.
4. Adjudication method for an AI/ML device.
5. MRMC comparative effectiveness study or human reader improvement for an AI/ML device.
6. Standalone (algorithm only) performance for an AI/ML device.
7. Type of ground truth (expert consensus, pathology, outcomes data) for an AI/ML device.
8. Sample size for the training set of an AI/ML device.
9. How ground truth for the training set was established for an AI/ML device.

The document describes standard engineering and biological safety tests for physical medical devices.

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