(17 days)
The VENTURE™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.
The VENTURE™ Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates, screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The implant components will be made from titanium alloy and may be supplied either sterile. The locking plate is manufactured from shape memory metal (Nitinol). The purpose of the application is to add modified fixed and variable angle screws to the system.
This document is a 510(k) summary for the Venture™ Anterior Cervical Plate System, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo safety and effectiveness studies with detailed acceptance criteria and performance data.
Therefore, the requested information regarding acceptance criteria, specific study details, sample sizes, expert involvement, and ground truth establishment cannot be fully provided from the given text alone. The document does not describe the types of performance studies typically associated with such detailed acceptance criteria.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state acceptance criteria in a quantitative manner, nor does it present specific performance data against such criteria. The primary "performance" reported is its substantial equivalence to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated (likely implied to be similar performance and safety profile to the predicate device) | Demonstrated substantial equivalence to the predicate VENTURE™ Anterior Cervical Plate screw and plate components cleared in K042922. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not applicable or not specified. This document discusses a comparison to a predicate device, not a new clinical or performance study with a "test set" in the traditional sense of a clinical trial for a new device.
- Data provenance: Not applicable or not specified. The comparison is made to a previously cleared device (K042922), implying the existing data/performance of that predicate device is being leveraged.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The document does not describe a study involving expert-established ground truth for a test set of this new iteration of the device.
4. Adjudication method for the test set:
Not applicable. No "test set" requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a spinal implant, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used:
Not applicable in the context of a new performance study. The "ground truth" for the device's indications and safety is implicitly tied to the established safety and effectiveness of the predicate device (K042922).
8. The sample size for the training set:
Not applicable. The document describes an implant system, not a software or AI device that would require a "training set."
9. How the ground truth for the training set was established:
Not applicable. As above, no training set for an AI/software device is involved.
Summary of what the document does communicate:
The primary "study" or demonstration presented in this 510(k) summary is the assertion of substantial equivalence to a previously cleared device (K042922). This means that the FDA determined that the new components (modified fixed and variable angle screws) of the VENTURE™ Anterior Cervical Plate System are as safe and effective as the predicate device. This determination is made based on comparing indications for use, technological characteristics, and performance data if necessary (though not detailed here) to the predicate device. For such a device, in vitro biomechanical testing or material characterization is common to support equivalence, rather than large-scale clinical trials with specific acceptance criteria and ground truth as might be seen for a diagnostic or AI device.
{0}------------------------------------------------
K0611274
VENTURE™ Anterior Cervical Plate System Special 510(k) Summary May 3, 2006
MAY 2 5 2006
| I. | Company: | Medtronic Sofamor Danek USA, Inc.1800 Pyramid PlaceMemphis, Tennessee 38132(901) 396-3133 |
|---|---|---|
| Contact: | Richard W. Treharne, Ph.D.Senior Vice President, Regulatory Affairs | |
| II. | Product Name: | VENTURE™ Anterior Cervical Plate System |
| Classification Name: | Spinal intervertebral body fixation orthosis | |
| Regulation Number: | 888.3060 | |
| Code: | KWQ |
III. Description:
The VENTURE™ Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates, screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The implant components will be made from titanium alloy and may be supplied either sterile. The locking plate is manufactured from shape memory metal (Nitinol). The purpose of the application is to add modified fixed and variable angle screws to the system.
IV Indications
The VENTURE™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
{1}------------------------------------------------
IV. Substantial Equivalence:
The subject VENTURE™ Anterior Cervical Plate System components were demonstrated to be substantially equivalent to the predicate VENTURE™ Anterior Cervical Plate screw and plate components cleared in K042922.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 5 2006
Medtronic Sofamor Danek USA, Inc. % Richard W. Treharne, Ph.D. Senior VP, Regulatory Affairs 1800 Pyramid Place Memphis. Tennessee 38132
Re: K061274
Trade/Device Name: VENTURE™ 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: May 3, 2006 Received: May 8, 2006
Dear Dr. Treharne:
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.
{3}------------------------------------------------
Page 2 - Richard W. Treharne, Ph.D.
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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/industry/support/index.html.
Sincerely yours,
Helmut Lener nos
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Page _1 of
May 2006
510(k) Number (if known): 1506 127 VENTURETM Anterior Cervical Plate System Device Name:
Indications For Use:
The VENTURE™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.
Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hebert Lemond
Division of General, Restorative, and Neurological Devices
510(k) Number K061274
§ 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.