(24 days)
The UNIPLATE 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-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), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.
The UNIPLATE Anterior Cervical Plate System consists of an assortment of plates and screws. The UNIPLATE Anterior Cervical Plate System also contains Class I manual surgical instruments and cases that are considered exempt from premarket notification. Manufactured from ASTM F 136 implant grade titanium alloy.
The provided text is a 510(k) summary for the UNIPLATE Anterior Cervical Plate System. It describes the device, its intended use, and indicates that performance data were submitted to characterize the device. However, it does not contain detailed information about specific acceptance criteria or the study data proving the device meets those criteria in the way typically expected for an AI/ML device.
This document is for a medical implant (spinal fixation system), not a diagnostic AI/ML device. Therefore, the questions regarding AI/ML performance metrics like sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies are not applicable to this submission.
Here's a breakdown of what can be extracted from the provided text, and where it falls short for an AI/ML device context:
1. A table of acceptance criteria and the reported device performance
The document states: "Performance data were submitted to characterize the subject UNIPLATE Anterior Cervical Plate System components addressed in this notification."
However, it does not provide a table of acceptance criteria or reported device performance in the typical sense of accuracy, sensitivity, specificity, etc., that would be applicable to an AI/ML diagnostic or measurement device. For an implantable device like this, "performance data" likely refers to biomechanical testing (e.g., fatigue, static strength, subsidence testing) to ensure it can withstand the forces in the spine and maintain stability. These specific results and their acceptance criteria are not detailed in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not present as this is a medical implant, not a diagnostic AI/ML device. There is no "test set" in the context of image analysis data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not present as this is a medical implant, not a diagnostic AI/ML device. Ground truth as typically defined for AI/ML (e.g., expert consensus on images) is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not present as this is a medical implant, not a diagnostic AI/ML device.
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
This information is not applicable and not present as this is a medical implant, not a diagnostic AI/ML device. MRMC studies are used for evaluating diagnostic performance of human readers with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not present as this is a medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable and not present directly in the provided text. For an implant, "ground truth" might pertain to established biomechanical standards or clinical outcomes from prior similar devices (often addressed through substantial equivalence).
8. The sample size for the training set
This information is not applicable and not present as this is a medical implant, not a machine learning algorithm.
9. How the ground truth for the training set was established
This information is not applicable and not present as this is a medical implant, not a machine learning algorithm.
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5. 510(K) SUMMARY
Submitter: DePuy Spine, Inc. 325 Paramount Drive Raynham, MA 02767
FEB - 4 2010
Contact Person: Christopher Rogers Manager, Regulatory Affairs Voice: (508) 828-3224 Fax: (508) 828-3797 E-Mail: crogers4@its.jnj.com
Date Prepared: January 8, 2010
Device Class: Class II
Classification Name: Spinal intervertebral body fixation orthosis per 21 CFR §888.3060
Classification Panel: Orthopedics
FDA Panel Number: 87
Product Code(s): KWQ
Proprietary Name: UNIPLATE Anterior Cervical Plate System
Predicate Devices: UNIPLATE Anterior Cervical Plate System (K042544) UNIPLATE Anterior Cervical Plate System (K082273) EAGLE Anterior Cervical Plate System (K040197)
Device Description: The UNIPLATE Anterior Cervical Plate System consists of an assortment of plates and screws
The UNIPLATE Anterior Cervical Plate System also contains Class I manual surgical instruments and cases that are considered exempt from premarket notification.
- Intended Use: The UNIPLATE 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-T1.
DePuy Spine, Inc., a Johnson & Johnson Company
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Special 510(k) Submission - Additions to UNIPLATE Anterior Cervical Plate System
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), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.
Manufactured from ASTM F 136 implant grade titanium Materials: alloy.
Performance Data: Performance data were submitted to characterize the subject UNIPLATE Anterior Cervical Plate System components addressed in this notification.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name arranged in a circular pattern around the perimeter. In the center of the seal is a stylized emblem, which is a modern interpretation of the Public Health Service (PHS) symbol, often referred to as the "Corps Device" or the "Caduceus."
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
DePuy Spine, Inc. % Mr. Christopher Rogers Manager, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767
FEB - 4 2010
Re: K100070
Trade/Device Name: UNIPLATE 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: January 08, 2010 Received: January 11, 2010
Dear Mr. Rogers:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 - Mr. Christopher Rogers
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Barbara Buettner
Mark N. Me Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Special 510(k) Submission - Additions to UNIPLATE Anterior Cervical Plate System
4. INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: UNIPLATE Anterior Cervical Plate System
Indications For Use:
The UNIPLATE 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-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), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.
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)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K100070 510(k) Number_
DePuy Spine, Inc., a Johnson & Johnson Company
Page 4-1
§ 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.