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The Oral Max System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures including but not limited to, dental and oral surgery. It is also usable in the placement of screws.

The Stryker Oral Max System, consisting of electrically powered surgical instruments, controls, power source, and other system accessories.

This document describes a 510(k) premarket notification for the Stryker Oral Max System, a device intended for surgical procedures involving bone and bone-related tissue. The provided text is a summary of safety and effectiveness for a medical device and does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in an AI/ML device submission.

The document states that the Stryker Oral Max System is "equivalent in intended use, safety, and effectiveness to powered instruments, controls, and associated accessories that were marketed by Stryker prior to the 1976 Medical Devices Amendment" and to devices distributed by Aeseptico. This indicates a substantial equivalence (SE) claim, which is a regulatory pathway for devices that are as safe and effective as legally marketed predicate devices.

Therefore, I cannot fulfill the request to provide acceptance criteria and study details because the provided text does not describe an AI/ML device or a study designed to establish detailed performance metrics against pre-defined acceptance criteria. It relies on the substantial equivalence principle rather than demonstrating de novo performance.

To reiterate, the provided text does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies, as it describes a traditional medical device submission based on substantial equivalence, not an AI/ML device with performance studies.

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