(30 days)
The Stryker Total Performance (TPS) System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone, teeth and other bone related tissue in a variety of surgical procedures, including but not limited to Dental, ENT Neuro and Endoscopic. It is also usable in the placement of cutting of screws, wires, pins, and other fixation devices. It can also be used to cut metal.
The device description of the Stryker System includes drills, shavers, shields, guards, motors, attachments, saws, wire drivers, collets, console, irrigation pump, cords, footswitch, handswitch, clips, tubing, cutting accessories, and sterilization cases. The scope of this modification is limited to the console of the system.
This 510(k) premarket notification for the Stryker Total Performance (TPS) System does not contain the information requested regarding acceptance criteria and studies proving device performance.
Here's why and what the document does provide:
This document is a 510(k) Summary, which is a high-level overview submitted to the FDA to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. The core purpose of a 510(k) is to show that a new device is as safe and effective as a previously cleared device, not to present detailed performance studies and acceptance criteria as one would find for a more novel or higher-risk device.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment. The document focuses on:
- Device Identification: Trade name, common name, classification, and predicate devices.
- Intended Use: What the device is designed to do.
- Device Description: A general overview of the system's components (drills, motors, console, etc.).
- Technological Comparison: Stating that the technological characteristics are the same as previously cleared predicate devices. This is the crucial part for a 510(k) – proving substantial equivalence rather than novel performance.
- Regulatory Decision: The FDA's letter confirming substantial equivalence and allowing the device to be marketed.
If such detailed performance data and acceptance criteria were required, it would likely be for a premarket approval (PMA) application, or if the device represented a significant change compared to its predicates, which is not the case here according to the submission.
§ 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.