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Sovis Optique's endoscopic light cable is designed to transmit light for illumination purposes from a remote source to an endoscope or similar surgical instrument. It can be adjusted to be compatible with major manufacturers' equipment.

Sovis Optique's endoscopic light cable consists of two metal end fittings connected by a glass fiber bundle and a silicone sheath covering. The sheath is reinforced with a stainless steel spring. The protruding optical end is made from an independent piece of glass bonded to a stainless steel support for ease of replacement.

The provided text is a 510(k) summary for a medical device (endoscopic light cable). It asserts substantial equivalence to a predicate device based on similar intended use, target population, environment of use, design, and materials.

However, the provided document does not contain information about:

• Specific acceptance criteria, performance metrics, or a formal study proving the device meets those criteria.
• Sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods for a study.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• The type of ground truth used in such studies.
• Sample size for training sets or how ground truth for training sets was established.

The summary discusses two minor differences between the proposed and predicate device:

1. Reinforced sheath: The summary claims the reinforcement is molded into the silicone and does not contact human tissues. It also states that "biocompatibility tests performed on the material, the silicone that may potentially contact patients poses no additional safety issues."
2. Independent glass rod at the source end: The summary states "The rod is made from the same components as CUDA or UFR product (i.e., glass, epoxy glue and stainless steel). There is thus no significant adverse effect on safety."

These statements suggest that some form of testing or evaluation was performed for biocompatibility, but details of these tests, their acceptance criteria, or their results are not explicitly provided in the text you've given.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study proving their fulfillment as the necessary information is not present in the provided 510(k) summary. This document focuses on demonstrating substantial equivalence, not on detailed performance study results against specific acceptance criteria.

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