(25 days)
The indications for use for the modified devices described in this submission are the same as those for the previously cleared SWIFT Anterior Cervical Plate System. The indications are as follows:
The SWIFT™ Plus Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.
Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as pain with degeneration of the disc discogenic confirmed by history and radiographic studies), reoperation for failed fusion, or instability following surgery for the above indications.
The SWIFT Plus Anterior Cervical Plate System consists of an assortment of plates and screws.
The SWIFT Plus Anterior Cervical Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
It looks like the text provided is a 510(k) summary for a medical device called the SWIFT™ Plus Anterior Cervical Plate System. This document outlines the device description, intended use, and materials.
However, the provided text does not contain any information regarding acceptance criteria, device performance metrics (numerical or otherwise), sample sizes for testing or training, data provenance, expert information, adjudication methods, or different types of studies (MRMC, standalone).
The "PERFORMANCE DATA:" section is present, but it only states "Performance data were submitted to characterize the SWIFT Plus Anterior Cervical Plate System." without providing any specifics. Medical device submissions like 510(k)s typically include detailed performance data, but this specific excerpt is lacking that information.
Therefore, I cannot fulfill your request for the tables and detailed information about acceptance criteria and study designs based solely on the text provided. To answer your questions, I would need a section that explicitly details the performance testing results, acceptance criteria, test methodologies, and clinical study information.
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IX. 510(k) Summary
| SUBMITTER: | DePuy Spine, Inc.325 Paramount DriveRaynham, MA 02767 |
|---|---|
| CONTACT PERSON: | Frank S. Jurczak |
| DATE PREPARED: | September 5, 2007 |
| CLASSIFICATION NAME: | Spinal Intervertebral Body Fixation Orthosis |
| PROPRIETARY NAME: | SWIFT™ Plus Anterior Cervical Plate System |
| PREDICATE DEVICES: | SWIFT™ Anterior Cervical Plate System(K040655) |
| EAGLE™ Plus Anterior Cervical Plate System(K070994) | |
| DEVICE DESCRIPTION: | The SWIFT Plus Anterior Cervical Plate Systemconsists of an assortment of plates and screws. |
| The SWIFT Plus Anterior Cervical Plate System alsocontains Class 1 manual surgical instruments andcases that are considered exempt from premarketnotification. | |
| INTENDED USE: | The indications for use for the modified devicesdescribed in this submission are the same as thosefor the previously cleared SWIFT Anterior CervicalPlate System. The indications are as follows: |
| The SWIFT™ Plus Anterior Cervical Plate System isintended for anterior cervical intervertebral bodyfixation. This system is indicated for patients in whichstability is desired following anterior cervical fusion forthe indications listed below. The intended levels fortreatment range from C2 to T1. | |
| Indications include symptomatic cervical spondylosis,trauma, fracture, post-traumatic kyphosis or lordosis,tumor, degenerative disc disease (defined as |
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pain with degeneration of the disc discogenic confirmed by history and radiographic studies), reoperation for failed fusion, or instability following surgery for the above indications.
- MATERIALS: Manufactured from ASTM F-136 implant grade titanium alloy.
| PERFORMANCE |
|---|
| DATA: |
Performance data were submitted to characterize the SWIFT Plus Anterior Cervical Plate System.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.