(90 days)
The C3™ Anterior Cervical Plate System is intended as a temporary internal fixation device used for the correction and stabilization of the cervical spine. The system is also intended to enhance the development of a solid fusion.
The C3™ Anterior Cervical Plate System is indicated for trauma, deformity (lordosis, kyphosis and scoliosis), pseudoarthrosis, previously failed cervical spine fusion, tumor, degenerative disk disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.) spondylolisthesis, and spinal stenosis.
The C3™ Anterior Cervical Plate System is also indicated for stabilization of the spine from C2 to C7 during the time interval required for arthrodesis.
The C3™ Anterior Cervical Plate System is a titanium alloy anterior cervical plate fixation system. The system consists of a number of plates and screws of varying lengths and a variety of cover plates with locking set screws. Screws are available in different diameters, several lengths, and two different styles: fixed angle and variable angle. Fixed angle screws are used to build a rigid fixation construct. Variable angle screws are used to build a non-rigid construct. Hybrid constructs are possible by combining fixed and variable angle screws.
The provided text describes the "C3™ Anterior Cervical Plate System" and its 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices through performance data. However, the document does not contain specific acceptance criteria, detailed study designs, or results that could be used to fill out the requested table for proving the device meets acceptance criteria.
The information provided only mentions "Non-clinical: Static and fatigue testing was performed. Properties of stiffness, strength, and fatigue life were characterized." This is a general statement about the type of testing conducted, but it lacks specific acceptance thresholds, detailed test parameters, or quantitative results to demonstrate compliance with particular criteria.
Therefore, I cannot provide a detailed response to most of your questions as the necessary information is not present in the provided text.
Here's a breakdown of what can be inferred from the text and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document states that "Static and fatigue testing was performed. Properties of stiffness, strength, and fatigue life were characterized." However, it does not specify what the acceptance criteria were for these properties (e.g., minimum stiffness values, maximum fatigue cycles without failure, specific strength thresholds) or the reported performance in terms of numerical values to compare against those criteria.
2. Sample size used for the test set and the data provenance:
- Cannot be provided. The document does not mention any sample sizes used for the non-clinical testing. It also does not discuss any clinical studies, and thus, there is no information on data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This question pertains to studies involving subjective assessments, often in areas like image analysis or diagnostic performance. The provided text only discusses non-clinical mechanical testing of a medical device, which does not involve "ground truth" derived from expert consensus in the same way.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Similar to point 3, this is relevant for studies involving human assessment and disagreement resolution, not for mechanical device testing.
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:
- Cannot be provided. The device is an anterior cervical plate system, a physical implant. The document describes non-clinical mechanical testing, not a diagnostic or AI-assisted system that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be provided. The device is a physical implant, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable based on the provided text. For mechanical testing, the "ground truth" often refers to the actual mechanical properties measured against engineering specifications or established standards. The text implies standard mechanical testing methodologies for stiffness, strength, and fatigue life, but does not detail the specific "ground truth" definitions or how they were established beyond the characterization through testing.
8. The sample size for the training set:
- Not applicable. The device is a physical implant, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. The device is a physical implant, not an AI model.
In summary: The provided 510(k) summary focuses on general non-clinical performance testing (static and fatigue) to demonstrate substantial equivalence for a physical medical device. It does not contain the detailed study information, acceptance criteria, or performance metrics typically requested for AI/diagnostic devices or comprehensive clinical studies.
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C3" Anterior Cervical Plate System
510 (k) Summary
SpineVision, Inc. Company: 3003 Summit Blvd., Suite 1500 Atlanta, GA 30319
NOV 2 6 2001
C3™ Anterior Cervical Plate System Trade Name:
Classification: KWQ 888.3060. Spinal Intervertebral Body Fixation Orthosis. Class II.
The C3 ... Anterior Cervical Plate System is a titanium alloy anterior cervical plate Description: The system consists of a number of plates and screws of fixation system. varying lengths and a variety of cover plates with locking set screws. Screws are available in different diameters, several lengths, and two different styles: fixed angle and variable angle. Fixed angle screws are used to build a rigid fixation construct. Variable angle screws are used to build a non-rigid construct. Hybrid constructs are possible by combining fixed and variable angle screws.
Performance Data:
Non-clinical:
Static and fatigue testing was performed. Properties of stiffness, strength, and fatique life were characterized.
Intended Use:
The Carn Anterior Cervical Plate System is intended as a temporary internal fixation device used for the correction and stabilization of the cervical spine. The system is also intended to enhance the development of a solid fusion.
The C3™ Anterior Cervical Plate System is indicated for trauma, deformity (lordosis, kyphosis and scoliosis), pseudoarthrosis, previously failed cervical spine fusion, tumor, degenerative disk disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.) spondylolisthesis, and spinal stenosis.
The Call Anterior Cervical Plate System is also indicated for stabilization of the spine from C2 to C7 during the time interval required for arthrodesis.
Substantial Equivalence:
Synthes (USA) Synthes Spine Anterior CSLP (K000742)
Synthes (USA) Titanium Locking Plate System (TILPS) (K970048)
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 6 2001
David W. Mullis, Jr., Ph.D., RAC Consultant for Spine Vision, Inc. Mullis & Associates, Inc .. Box 39 367 Pleasant Valley Road Good Hope, Georgia 30641
Re: K012881
Trade/Device Name: C3™ Anterior Cervical Plate System Regulatory Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: August 27, 2001 Received: August 28, 2001
Dear Dr. Mullis:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - David W. Mullis, Jr., Ph.D., RAC
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, (Jaase contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Susan Walker, us
Image /page/2/Picture/5 description: The image contains what appears to be a signature. The signature is written in cursive and is illegible. The signature is in black ink and is on a white background.
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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510(k) Number: K012881
Device Name: C3™ Anterior Cervical Plate System
Intended Use:
The C3™ Anterior Cervical Plate System is intended as a temporary internal fixation device used for the correction and stabilization of the cervical spine. The system is also intended to enhance the development of a solid fusion.
The C3™ Anterior Cervical Plate System is indicated for trauma, deformity (lordosis, kyphosis and scoliosis), pseudoarthrosis, previously failed cervical spine fusion, tumor, degenerative disk disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.) spondylolisthesis, and spinal stenosis.
The C3™ Anterior Cervical Plate System is also indicated for stabilization of the spine from C2 to C7 during the time interval required for arthrodesis.
(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)
OR
Over-The-Counter Use
(Optional Format 1-1-96)
Susan Walker
Division Sign-Off Division of General. Restorative and Neurological Devices
510(k) Number K012881
§ 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.