Search Results

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

Not Found

I am sorry, but the provided text from the FDA 510(k) clearance letter for the Pristine Arthroscopic Visualization System does not contain any information about the acceptance criteria or a study proving the device meets those criteria, specifically concerning AI/algorithm performance.

The letter is a general regulatory clearance document that states the device is substantially equivalent to legally marketed predicate devices. It covers:

• Device Name: Pristine Arthroscopic Visualization System
• Regulation Number and Name: 21 CFR 888.1100, Arthroscope
• Regulatory Class: Class II
• Product Code: HRX
• Indications for Use: Provides an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy in hip, knee, and shoulder arthroscopic procedures.
• General Controls: Mentions requirements like annual registration, listing, good manufacturing practice, labeling, etc.

It does not include details about:

• Any specific acceptance criteria for performance, especially for AI or algorithmic components.
• Results of a study proving the device meets performance criteria.
• Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods for any test or training sets.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided document. This type of detailed performance data is typically found in the full 510(k) summary or in test reports submitted as part of the clearance application, which are not included in this FDA clearance letter.

Ask a specific question about this device

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.

Not Found

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.

Ask a specific question about this device

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.

Not Found

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.

Ask a specific question about this device