(154 days)
The fixation devices are designed to draw two or more bone fragments together in order to facilitate healing. The fixation devices are driven through the bone fragments using a powered rotary device. The fixation devices are typically left implanted in the body to provide fixation while the bone mends.
The subject devices (K-Wires and Steinmann Pins) are stainless steel fixation devices which draw bone fraqments together in order to facilitate healing. They will be supplied both as sterile and non-sterile devices and will be labeled for single use.
This document, K961522, is a 510(k) summary for Kirschner Wires (K-Wires) and Steinmann Pins. It describes the product, its intended use, and claims substantial equivalence to predicate devices.
However, the provided text DOES NOT contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or any details related to AI/algorithm performance.
Therefore, I cannot fulfill the request for information regarding acceptance criteria and the study that proves the device meets them based on the given input. The document is primarily a regulatory submission for a medical device and lacks the scientific study details you are asking for.
{0}------------------------------------------------
SEP 2 3 1996
ATTACHMENT 11
510(k) SUMMARY
| Submitting Company: | SYNVASIVE Technology, Inc.4925 Robert J. Matthews Pkwy.El Dorado Hills, CA 95762 |
|---|---|
| Telephone: | 916-939-3913 |
| Fax: | 916-939-3919 |
| Contact Person: | Michael G. FisherVice President |
| Date Prepared: | April 8, 1996 |
| Common Product Name: | Kirschner Wires (K-Wires) and Steinmann Pins |
| Classification Name: | Smooth or Threaded Metallic Bone FixationFastener (per 21 CFR 888 .3040) |
Product Description: The subject devices (K-Wires and Steinmann Pins) are stainless steel fixation devices which draw bone fraqments together in order to facilitate healing. They will be supplied both as sterile and non-sterile devices and will be labeled for single use.
Intended Use: The fixation devices are designed to draw two or more bone fragments together in order to facilitate healing. The fixation devices are driven through the bone fragments using a powered rotary device. The fixation devices are typically left implanted in the body to provide fixation while the bone mends.
Substantial Equivalence: The fixation devices are substantially equivalent to standard K-Wires and Steinmann Pins legally marketed by many companies including DePuy, Howmedica, MicroAire, and Zimmer.
Technological Characteristics: The fixation devices have the same technological characteristics as all of the predicate devices.
Safety and Effectiveness Testing: All materials used in the fixation devices conform with ASTM specifications for medical device use. Material specifications are tested on a design basis and certificates of conformance to specifications are supplied with each material batch.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.