The 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 a solid spinal fusion in patients with neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies (DDD), trauma (i.e. fractures), tumors, deformities (i.e. kyphosis, lordosis, and scoliosis), pseudoarthrosis, spinal stenosis, and failed previous fusions.

WARNING: These devices are not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Device Description

The Anterior Cervical Plate System consists of multiple sized plates and screws. All components are manufactured from titanium alloy (Ti-6A1-4V) that conform to ASTM F136.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary:

This device (Anterior Cervical Plate System) is a Class II medical device, and the submission is a 510(k) Pre-Market Notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel clinical effectiveness. Therefore, the study details provided will be different from those typically found for AI/software-as-a-medical-device (SaMD) products.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (based on ASTM F1717-96)	Reported Device Performance
Static Compression Testing	Performed
Fatigue Compression Testing	Performed
Static Torsion Testing	Performed

Note: The document states that "The Food and Drug Administration have established no performance standards applicable to anterior cervical plating systems." However, it explicitly mentions that testing was performed according to ASTM F1717-96. This implies that compliance with the methods and expected outcomes of this standard would serve as the de facto acceptance criteria for the mechanical performance of the device. The summary doesn't provide specific numerical results of these tests, only that they were performed.

Study Details

This 510(k) submission primarily relies on mechanical performance testing and substantial equivalence arguments rather than a clinical study evaluating diagnostic accuracy or reader performance typically seen with AI/SaMD.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not applicable in the context of clinical patient data. The "test set" here refers to the actual physical devices (plates and screws) that underwent mechanical testing. The exact number of units tested is not specified in the summary but would be dictated by the ASTM F1717-96 standard.
- Data Provenance: Not applicable for mechanical testing. The testing would have been conducted in a laboratory setting.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Mechanical testing outcomes (e.g., force at failure, cycles to failure) are objectively measured by testing equipment, not established by human experts. The "ground truth" is determined by physical properties and engineering principles.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As noted above, the results are objective measurements from mechanical testing, not subjective human interpretations requiring adjudication.
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 MRMC clinical study was performed or is mentioned. This device is an implantable medical device (anterior cervical plate system), not an AI/SaMD product that assists human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or software. The "standalone performance" is the mechanical performance of the device itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the mechanical testing, the "ground truth" is the physical measurement of material and structural properties under various stress conditions, as defined and measured according to the ASTM F1717-96 standard.
The sample size for the training set:
- Not applicable. There is no AI/machine learning model involved; therefore, no "training set" in the computational sense. The design and manufacturing process for the device would have been developed based on general engineering principles and material science.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI model. For the mechanical device, its design and expected performance are based on established engineering principles, material specifications (titanium alloy (Ti-6A1-4V) conforming to ASTM F136), and prior knowledge of predicate devices.

Summary

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K013439

page 1 of 1

510(k) Summary of Safety and Effectiveness

Submitter's name:	Scient'x
Submitter's address:	Guyancourt, France
Contact telephone number:	(512) 834-6255 JAN 1 4 2002
Contact person:	Joanna Droege
Date summary prepared:	October 8, 2001
Trade or proprietary device name:	Anterior Cervical Plate System
Common or usual name:	Anterior cervical plating system
Classification name:	Class II
Legally marketed predicate device:	Sofamor Danek – Orion SystemDePuy - DePuy Motech PEAK

(4) Subject device description:

The Anterior Cervical Plate System consists of multiple sized plates and screws. All components are manufactured from titanium alloy (Ti-6A1-4V) that conform to ASTM F136.

Subiect device intended use: (5)

WARNING: These devices are not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Performance data: (6)

The Food and Drug Administration have established no performance standards applicable to anterior cervical plating systems. However, static and fatigue compression and static torsion testing of the Anterior Cervical Plate System were performed according to ASTM F1717-96.

Basis for substantial equivalence: (7)

The Anterior Cervical Plate System has similar design characteristics, i.e., material, screw size, and indications, as the Orion (K973854) and PEAK System (K971730) systems distributed by Sofamor Danek and DePuy Motech, respectively.

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 2002

Ms. Joanna Droege Scient'X c/o Encore Orthopaedics 9800 Metric Boulevard Austin Texas 78758

Re: K013439

Trade Name: Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: K WQ Dated: October 15, 2001 Received: October 17, 2001

Dear Ms. Droege:

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 - Ms. Joanna Droege

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, please 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,

Mark M Mullener

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 (if known):

Device Name: __ Anterior Cervical Plate System

Indications For Use:

Anterior Cervical Plate System

Indications For Use

WARNING: These devices are not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ision of General, Restorative and Non Jogical Devices ાર્ડ તાલુકાઓ પૈકીના એક એવા ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં લોકોનો મુખ્ય 510(k) Number -OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use (per 21 CFR 801.109) (Optional Format 1-2-96)_

OK

SK-5

్రాప్ర : :

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Regulation Number and Section

§ 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.