(314 days)
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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NG 20 199
K954690
stryker®
INSTRUMENIS
4100 East Milham Avenue Kalamazoo, MI 49001-6197 (616) 323-7700 (800) 253-3210
Device Name:
| Classification Names: | Drill, Bone, Powered; 21 CFR 872.4120, Class IIBur, Dental; 21CFR 872.3240, Class IController, Foot, Handpiece and Cord; 21 CFR 872.4200, Class I | |
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| Common/Usual Name: | Electrical Powered Surgical Instruments andAccessories/Attachments | |
| Proprietary Name: | Stryker Oral Max System | |
| Device Sponsor: | Stryker CorporationInstruments Division4100 E. Milham AvenueKalamazoo, MI 49001Registration No: 1811755 | Stryker Puerto RicoLas Palmas Industrial ParkHighway 3, 130.2Arroyo, Puerto Rico 00615Registration No.: 2648666 |
Regulatory Classification: Class II
Summary of Safety and Effectiveness:
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, 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.
The cutting accessories available to be used with the Oral Max System will be provided sterile. The materials of construction, cutting action, and cutting surface configuration are equivalent to devices distributed by Stryker prior to the 1976 Medical Devices Amendment. As proven in surgical procedures, these designs offer the required precision required for controlling the location and extent of the surgical contact.
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The power source/console described in this submission is equivalent to power sources distributed by Aeseptico. Intended use, function, and safety risks are all substantially equivalent. Safety warnings and operating duty cycles are listed in the Oral Max Operator's Manual. In addition, the Stryker Oral Max System is designed to meet the following Standards: CSA 22.2; UL 544.
The Stryker Oral Max System does not raise any new safety and efficacy concerns when compared to similar devices already being marketed. Therefore, the Stryker Oral Max System is substantially equivalent to these existing devices.
Jimmy Founds
Tammy Lounds Supervisor, Regulatory Affairs Stryker Instruments
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.