(85 days)
The MicroAire® 1000E System is indicated for use in cutting, sawing, drilling, reaming, wire driving, pinning, screw driving, decorticating, shaping and manipulation of bone and other bone related tissue in a variety surgical procedures. The applications include ENT, maxilliofacial, neurological, oral, orthopedic, plastic, podiatric and spinal surgery.
The MicroAire® 1000E System consists of an electric power supply, powerconnecting cable(s), a foot and/or hand lever power activation control, modular and unitized handpieces, modular head assemblies and accessories.
The provided text from K014060 is a 510(k) summary for a medical device and does not contain information about acceptance criteria or a study proving the device meets said criteria.
This document is a premarket notification for fundamental equivalence to an existing device, the Stryker® HERMES-Ready™ Total Performance System (TPS™). The 510(k) process primarily focuses on demonstrating that a new device is "substantially equivalent" to a predicate device already on the market, meaning it has the same intended use and similar technological characteristics, or if there are differences, those differences do not raise new questions of safety or effectiveness.
Therefore, I cannot extract the requested information from the provided text because it is not present. The document focuses on:
- Identification of the device and manufacturer.
- Identification of a predicate device (Stryker® HERMES-Ready™ Total Performance System).
- Assertion of substantial equivalence based on intended use, design, energy, materials, performance, safety, effectiveness, labeling, biocompatibility, and applicable standards.
- Description of the technological characteristics of the new device and a comparison to the predicate device.
- The FDA's decision letter granting substantial equivalence.
- Indications for use.
None of these sections discuss specific acceptance criteria or details of a study that would quantify the device's clinical performance against such criteria.
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).