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The Surgical Image Laboratories Laparoscope is equivalent in materials, intended use, safety and effectiveness to the Dyonics 8000 Laparoscope. The outer tube is fabricated from 304 stainless steel. The block and light adapter are made from plated brass and the I.D. ring from anodized aluminum. The distal end tip is fabricated from optical glass which may be coated with an anti-reflective coating. The optic tube which fits within the outer tube is fabricated from stainless steel. The distal fiber which transmits light from the light source through the fiber cone, around the optic tube, and on to the surgical area is fabricated from optical fibers and sealed at the distal end with adhesive. The eye shield or camera connection adapter is made from acetal plastic or an FDA accepted equivalent. All surfaces are smooth and polished or bead blasted. The end of the instrument that is inserted into the human body through an incision is blunt or rounded with no sharp edges.

The provided text describes a 510(k) summary for the Surgical Image Laboratories Laparoscope, asserting its equivalence to existing laparoscopes, specifically mentioning the Dyonics 8000 Laparoscope. This document focuses on material composition, intended use, safety, and effectiveness. However, it does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance metrics in the way you've outlined for an AI-powered diagnostic device.

Therefore, I cannot fulfill your request for:

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

The provided text is for a traditional medical device (a laparoscope), outlining its physical properties and claiming substantial equivalence to other devices on the market based on its design, materials, and intended use, rather than a performance study with specific acceptance criteria as would be typical for a diagnostic AI.

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