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This instrument is indicated for providing endoscopic access to the posterior lumbar spine by retracting tissues during endoscopic discectomy procedures.

The KSEA ENDOSPINE Operating Tube and Telescope Bridge consists of an operating tube, an obturator for use with the operating tube, and a telescope bridge for use with the operating tube. The telescope bridge contains a working channel, an irrigation channel, and a channel for an endoscope. The body contact portions of the KSEA ENDOSPINE Operating Tube and Telescope Bridge are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

The provided text describes a 510(k) summary for the Karl Storz ENDOSPINE Operating Tube and Telescope Bridge, which is a surgical instrument. It does not include information about acceptance criteria, device performance metrics, or study details typically associated with AI/ML-powered medical devices.

Therefore, I cannot provide the requested information in the format you specified. The document is about a mechanical surgical device and primarily focuses on its substantial equivalence to predicate devices, rather than performance studies with defined acceptance criteria.

Here's why I cannot fulfill your request based on the provided text:

• No AI/ML Component: The device described is an "Arthroscope" (specifically an "Operating Tube and Telescope Bridge") made of surgical grade stainless steel. It is a mechanical instrument for providing endoscopic access and retracting tissues during surgery. There is no mention of any software, algorithm, or AI/ML component.
• No Performance Data: The document states that "minor differences between the KSEA ENDOSPINE Operating Tube and Telescope Bridge and the predicate device raises no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices." This indicates a substantial equivalence pathway, which typically does not require extensive performance studies with acceptance criteria and ground truth as would be needed for novel AI solutions.
• No Study Details: There are no details about any studies conducted, such as sample sizes, data provenance, expert reviews, or MRMC studies. The content focuses on regulatory compliance and equivalence to existing devices.

In essence, the information you're asking for is specific to the evaluation of AI/ML or diagnostic devices, which is not what this 510(k) summary pertains to.

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