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Indications for use of the SE5 Small Joint Shaver in the wrist are any need for morselization of tissue within the joint. Cutters will be used to debride synovitis, articular cartilage flaps, or torn ligaments when surgeons deem resection appropriate. Burs are indicated for management of osseous lesions such as eburnated articular surfaces or osteophytes.

The SE5 Arthroscopy and Small Joint Debrider Systems are electrically powered instrumentation specifically designed for intra-articular debridement. A common control console powers the SE5 Shaver Handpiece. The SE5 Arthroscopy System is intended to be used by surgeons in orthopedic joints, including the knee, shoulder, ankle, elbow, wrist, hip and tempomandibular joint. It will be used to resect tissue and bur bone. The voice activation system is substantially equal to AESOP voice activation system. With this upgrade there are no new issues of safety and effectiveness.

The provided text is a 510(k) summary for the Stryker SE5 Arthroscopy System with HERMES OR Control Center System. This document describes a medical device, specifically a surgical instrument, and its intended use, rather than an AI/ML powered medical device.

Therefore, the information requested for acceptance criteria and study details (like sample size, ground truth, expert qualifications, MRMC studies, standalone performance, training set details) is not applicable to this submission as it focuses on the performance and safety of a physical surgical system with a voice control component, and not on the diagnostic or predictive capabilities of an algorithm.

The document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant electrical and medical device standards (e.g., IEC 601-1, UL 2601-1, EMC Directive). The "HERMES Voice control System Functional Test Requirements" are mentioned, indicating that the voice control aspect was functionally tested, but no specifics about acceptance criteria or study results for this component are provided in the summary.

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