(104 days)
The VERTEBRON SCP™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine 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), pseudoarthriosis, and/or failed previous fusions. The SCP™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.
The Reduced Stature VERTEBRON SCP™ Cervical Plate System is comprised of non-sterile, single-use, titanium alloy components. The VERTEBRON SCP™ Cervical Plate System attaches to the vertebral body by means of self tapping and self drilling cervical screws. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. This submission adds a reduced stature cervical plate.
The provided text describes a medical device, the VERTEBRON SCP™ Cervical Plate System, and its clearance process with the FDA. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics typically associated with AI/ML algorithms (e.g., sensitivity, specificity, accuracy).
The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against quantitative acceptance criteria through a clinical study. The "study" mentioned refers to mechanical testing for equivalence, not a clinical performance study with human subjects, ground truth, or expert readers.
Therefore, most of the requested information cannot be extracted from this document, and the following answers reflect that absence.
Acceptance Criteria and Device Performance Study Information
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Not applicable | Not applicable |
| (The document does not specify quantitative acceptance criteria for clinical or diagnostic performance, nor does it report such performance metrics.) | (The document discusses mechanical testing to demonstrate substantial equivalence to predicate devices, but this is not reported in terms of clinical performance metrics like sensitivity, specificity, or accuracy.) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable (No test set for clinical performance is described).
- Data Provenance: Not applicable (No clinical data provenance is described). The study mentioned is mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable (No experts for establishing ground truth are mentioned as this is not a study assessing diagnostic or clinical performance against ground truth).
4. Adjudication method for the test set
- Not applicable (No adjudication method is mentioned).
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
- No, an MRMC comparative effectiveness study was not done. The device is a cervical plate system, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used
- Not applicable. The document describes mechanical testing for substantial equivalence, not a study requiring clinical or diagnostic ground truth. The "ground truth" for the mechanical testing would be the physical properties and performance of the device under specific loads, as compared to established standards (ASTM F1717) and predicate devices.
8. The sample size for the training set
- Not applicable (No training set is mentioned as this device is not an AI/ML product).
9. How the ground truth for the training set was established
- Not applicable (No training set or associated ground truth establishment is mentioned).
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KD51815
Summary of Safety and Effectiveness VIII.
| SUBMITTER: | VERTEBRON Inc.400 Long Beach Blvd.Stratford, CT 06615(203) 380-9340 |
|---|---|
| CONTACT PERSON: | Luis NespridoRegulatory Affairs, Manager |
| DATE PREPARED: | September 2005 |
| CLASSIFICATION NAME: | Spinal Intervertebral Body Fixation Orthosis (888.3060) |
| COMMON NAME: | Cervical Plating System |
| PROPRIETARY NAME: | VERTEBRON SCP™ Cervical Plate System |
| PREDICATE DEVICES: | VERTEBRON SCP™ Cervical Plate System - K040003 andK043181 |
| DEVICE DESCRIPTION: | The Reduced Stature VERTEBRON SCP™ Cervical Plate Systemis comprised of non-sterile, single-use, titanium alloy components.The VERTEBRON SCP™ Cervical Plate System attaches to thevertebral body by means of self tapping and self drilling cervicalscrews. This system's design is intended to stabilize the spinaloperative site during the fusion process of a bone graft in the discspace. This submission adds a reduced stature cervical plate. |
| INTENDED USE: | The VERTEBRON SCP™ Cervical Plate System is intended fornon pedicle fixation for the following indications: degenerative discdisease (defined as back pain of discogenic origin withdegeneration of the disc confirmed by history and radiographicstudies); spondylolisthesis; trauma (i.e., fracture or dislocation);spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/orlordosis); tumor; pseudoarthrosis; and failed previous fusion inskeletally mature patients. The VERTEBRON SCP™ CervicalPlate System is intended for non cervical pedicle fixation for thefollowing indications: spondylolisthesis; trauma (i.e., fracture ordislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis,and/or lordosis); tumor; pseudoarthrosis; and failed previousfusion in skeletally mature patients. |
| MATERIALS: | The material used is titanium Alloy material that conforms toASTM F136. |
| Substantial Equivalence: | Testing in accordance with ASTM F1717 was performed anddemonstrated that the Reduced Stature VERTEBRON SCP™Cervical Plate System is substantially equivalent to the DOCCervical Stabilization System (K982443), ORION Anterior Cervical |
Page 1 of 2
Plate (K973854), Synthes CSLP (K971883, K000536), ABC
050
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1051815
Cervical Plate (K974706), EBI VueLock Anterioer Cervical Plate (K010003, K023133) and VERTEBRON SCP™ Cervical Plate
System (K040003 and K043181) which have received market clearance by the FDA.
Page E f ?
051
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake entwined around it, representing healing and medicine. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 7 2005
Luis Nesprido Regulatory Affairs Manager Vertebron, Inc. 400 Long Beach Boulevard Stratford, Connecticut 06615
Rc: K051815
Trade/Device Name: VERTEBRON SCP™ Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: September 15, 2005 Received: September 22, 2005
Dear Mr. Nesprido:
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- Luis Nesprido
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/cdrl/industry/support/index.html
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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V. Indications for Use
ર૦રીશોડ 510(k) Number (if known):
Device Name:
VERTEBRON SCP™ Cervical Plate System
Indications For Use:
The VERTEBRON SCP™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine 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), pseudoarthriosis, and/or failed previous fusions. The SCP™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.
× Prescription Use: (Per 21 CFR 801 Subpart D) AND / OR
Over-The-Counter Use: (21 CFR 801 Subpart C)
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_KOS 1815
§ 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.