(82 days)
The Swift Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. These systems are 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 discogenic pain with degeneration of the disc confirmed by history and radiographic studies), reoperation for failed fusion, or instability following surgery for the above indications.
The Swift Anterior Cervical Plate System consists of an assortment of plates and screws.
The Swift Anterior Cervical Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
The provided document is a 510(k) summary for the Swift Anterior Cervical Plate System, a spinal implant. It describes the device, its intended use, and its predicate devices. However, this document does not contain explicit acceptance criteria or details of a study that proves the device meets such criteria in the format requested for AI/algorithm performance.
Instead, it primarily focuses on establishing substantial equivalence to previously cleared predicate devices for regulatory clearance. The "Performance Data" section merely states: "Performance data were submitted to characterize the Swift Anterior Cervical Plate System." This is a very general statement and does not provide specifics about the nature of the data, the tests performed, or the results against any defined acceptance criteria, as would be expected for evaluating an AI-based medical device.
Therefore, I cannot populate the requested table and answer the specific questions about "acceptance criteria," "reported device performance," "sample size," "experts," "adjudication," "MRMC study," "standalone performance," "ground truth," and "training set" based solely on the information provided in this document.
This document is for a mechanical implant and the regulatory review process primarily relies on manufacturing standards, material testing, and comparison to predicate devices, rather than clinical performance studies with specific statistical endpoints and ground truth determinations that are typical for AI/algorithmic devices.
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| IX. 510(k) Summary | JUN - 2 2004 K040655Page 1 of 2 |
|---|---|
| SUBMITTER: | DePuy Spine, Inc.325 Paramount DriveRaynham, MA 02780 |
| CONTACT PERSON: | Lisa A. Gilman |
| DATE PREPARED: | March 5, 2004 |
| CLASSIFICATION NAME: | Spinal Intervertebral Body Fixation Orthosis |
| PROPRIETARY NAME: | Swift Anterior Cervical Plate System |
| PREDICATE DEVICES: | Peak Polyaxial Anterior Cervical Plate System(K971730)Codman SLIM-LOC Anterior Plating System(K013877) |
| DEVICE DESCRIPTION: | The Swift Anterior Cervical Plate System consists ofan assortment of plates and screws.The Swift 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 Peak Polyaxial Anterior Cervical Plate System(K971730). The indications are as follows:The Swift Anterior Cervical Plate System is intendedfor anterior cervical intervertebral body fixation.These systems are 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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discogenic pain with degeneration of the disc 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 theSwift Anterior Cervical Plate System. |
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of a bird-like figure, which is the department's symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
UN - 2 2004
Ms. Sharon Starowicz Director, Regulatory Affairs DePuy Spine, Inc. 325 Paramount Drive Raynham, MA 02767-0350
Re: K040655
Trade/Device Name: Swift Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 8, 2004 Received: March 12, 2004
Dear Ms. Starowicz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Ms. Sharon Starowicz
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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111. Indications for Use
Page 1 of 1
510(k) Number (if known): __ Koyo G55
Swift Anterior Cervical Plate System Device Name:
Indications For Use:
The Swift Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. These systems are 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, posttraumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), re-operation for failed fusion, or instability following surgery for the above indications.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use: (Per 21 CFR 801.109) | X |
|---|---|
| OR Over-The-Counter Use: | ____________________ |
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
§ 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.