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The device is intended for use in providing access to and visualization of body cavities, organs, and canals to perform various diagnostic and therapeutic surgical procedures.

The device is a line of general and minimally invasive surgical instruments and accessories.

This document is a 510(k) premarket notification decision letter from the FDA for Ackermann Surgical Instruments, classifying it as substantially equivalent to previously marketed devices. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies for any AI/ML-driven medical device.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance study results.
7. Type of ground truth used.
8. Training set sample size.
9. How training set ground truth was established.

The provided text describes a regulatory approval process for conventional surgical instruments, not an AI/ML device.

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