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The disposable Thermo-Plastic Shaver Blades are for orthopedic use and will be provided sterile for single use applications.

The Thermo-Plastic Shaver Blades, consisting of an inner Thermo-Plastic and stainless steel tube which rotates inside of a stainless steel tube through the use of an electrical motor in a handpiece, is equivalent in intended use, safety and effectiveness to existing Thermo-Plastic shaver blades, used in similar applications, by Linvatec.

The provided document is a Summary of Safety and Effectiveness for Thermo-Plastic Shaver Blades and does not contain information typically found in a study demonstrating acceptance criteria for a new medical device algorithm or AI system. Instead, it is a 510(k) summary for a Class II medical device (Arthroscope and accessories) aiming to demonstrate substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving a device meets them for the following reasons:

• No Acceptance Criteria Defined: The document does not specify any quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, precision, recall, F1-score, AUC, etc.) that the device (Thermo-Plastic Shaver Blades) needs to meet.
• No Performance Study Results: The document describes the device's design, materials, intended use, and equivalence to a predicate device, but it does not present data from a performance study demonstrating its accuracy or effectiveness in a clinical context.
• Focus on Substantial Equivalence: The primary objective of this document is to establish substantial equivalence to a legally marketed predicate device (Linvatec, Merlin Polyblade shaver per K940515) based on comparable intended use, safety, and effectiveness, not to prove performance against predetermined acceptance criteria through a specific study.
• Device Type: This document pertains to a physical surgical instrument (shaver blades), not a software algorithm, AI system, or diagnostic device where the requested metrics (sample size, experts, ground truth, MRMC study, standalone performance) would typically apply.

In summary, none of the requested information (points 1-9) can be extracted from the provided text as it is not a performance study report for an AI/algorithm-based device.

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