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The Pristine Scope has been designed to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.

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This document is a 510(k) clearance letter for the Pristine Scope, an endoscope and accessories. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria, study details, or performance data for the Pristine Scope device. The document primarily focuses on regulatory clearance, indications for use, and compliance with FDA regulations.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided input.

To answer your questions, I would need access to the 510(k) summary or the full submission for K193161, which would typically contain the design verification and validation testing results.

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The Pristine Scope is an endoscopic device into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy. The Pristine Scope is indicated for use in arthroscopic procedures performed in the hip, knee and shoulder.

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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a device called "Pristine Scope," which is an arthroscope.

The document includes:

• Basic information about the FDA clearance process.
• Device name and regulation details.
• Indications for Use of the device.

However, it does not contain any data regarding:

• Acceptance criteria for device performance.
• Details of studies conducted to prove the device meets acceptance criteria (e.g., sample size, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, ground truth types for training/test sets, or training set size/ground truth establishment).

Therefore, I cannot populate the table or provide detailed answers to your questions based on the provided text.

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