The Spinal Concepts, Inc. (SCI) Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following:

Degenerative disc disease (DDD) as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies;
Trauma (including fractures);
Tumor;
Spondylolisthesis;
Spinal stenosis;
Deformity (i.e., scoliosis, kyphosis, lordosis);
Pseudarthrosis; and
Failed previous fusions.

Device Description

The Spinal Concepts, Inc. (SCI) Anterior Cervical Plate System components are temporary implants that are used to stabilize the cervical spine during the development of a solid spinal fusion. The SCI Anterior Cervical Plate System consists of single and multi-segmented titanium bone plates of various sizes and lengths, titanium bone screws in two diameters of various lengths, and associated instrumentation. Fixation is provided by the insertion of bone screws through the two openings at each end of a plate segment into the vertebral bodies of the cervical spine. Additional screws may be inserted into the variable-distance holes at the center of each plate segment, if needed, i.e., for multi-level interbody fusions or long strut graft reconstructions.

AI/ML Overview

The provided text describes the Spinal Concepts, Inc. (SCI) Anterior Cervical Plate System. This is a medical device submission, and the content focuses on establishing substantial equivalence to previously approved devices rather than detailing acceptance criteria and performance studies in the way you'd typically find for an AI/software device.

Therefore, many of the requested categories for AI device studies (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or specific ground truth types) are not applicable or cannot be extracted from this document, as it falls outside of the scope of an AI device submission.

However, I can extract the relevant information regarding the performance and the study that supports it, tailored to the context of this device.

Acceptance Criteria and Device Performance for SCI Anterior Cervical Plate System

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Mechanical Integrity	Must be able to withstand clinical loading and maintain mechanical integrity for its intended use.	Static and fatigue testing demonstrated that the SCI Anterior Cervical Plate System is able to withstand clinical loading and maintain mechanical integrity.
Material Equivalence	Materials must be substantially equivalent to predicate devices.	Stated to be substantially equivalent in material to SOFAMOR DANEK ORION™ Anterior Cervical Plate System and SYNTHES Cervical Locking Plate System.
Design Equivalence	Design must be substantially equivalent to predicate devices.	Stated to be substantially equivalent in design to SOFAMOR DANEK ORION™ Anterior Cervical Plate System and SYNTHES Cervical Locking Plate System.
Function Equivalence	Function must be substantially equivalent to predicate devices.	Stated to be substantially equivalent in function to SOFAMOR DANEK ORION™ Anterior Cervical Plate System and SYNTHES Cervical Locking Plate System.
Intended Use Equivalence	Intended Use must be substantially equivalent to predicate devices.	Stated to be substantially equivalent in intended use to SOFAMOR DANEK ORION™ Anterior Cervical Plate System and SYNTHES Cervical Locking Plate System.

2. Sample size 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 provided in this document. The submission pertains to a physical medical implant (Anterior Cervical Plate System) and its mechanical performance, not a software or AI device that would typically involve test sets of patient data. The "study" here refers to mechanical testing.

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 provided. Ground truth in the context of AI/software devices typically refers to expert annotations of data. For a mechanical device, performance is assessed through engineering tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. Adjudication methods are relevant for human-based evaluations of AI/software output, not for mechanical 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

This information is not applicable and not provided. MRMC studies are specific to evaluating the clinical impact of AI systems on human readers, which is not relevant for a spinal implant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable and not provided. This concept applies to standalone AI algorithms, not physical medical devices.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the mechanical testing, the "ground truth" would be the physical properties and behavior of the device under defined loads, measured by established engineering standards and instruments (e.g., load cells, displacement sensors, cycle counters). This is not expert consensus or pathology in the clinical sense. The document states: "Static and fatigue testing was performed on the SCI Anterior Cervical Plate System."

8. The sample size for the training set

This information is not applicable and not provided. This device is a physical implant, not an AI model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable and not provided. As there is no training set for a physical device, this question is not relevant.

Summary of the Study:

The "study" used to prove the device meets its acceptance criteria was Mechanical Testing, specifically "Static and fatigue testing." This testing was performed on the SCI Anterior Cervical Plate System itself. The results demonstrated that the device "is able to withstand clinical loading and maintain mechanical integrity and is, therefore, suited for its intended use." This conclusion supports the substantial equivalence claim by demonstrating that the device performs mechanically at least as well as its predicate devices, which are already deemed safe and effective. The FDA's 510(k) clearance process relies heavily on demonstrating substantial equivalence to already marketed devices.

Summary

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2/12/95

SUMMARY OF SAFETY AND EFFECTIVENESS Spinal Concepts, Inc. (SCI) Anterior Cervical Plate System

I. General Information

Device Trade Name:	Spinal Concepts, Inc. (SCI) Anterior Cervical PlateSystem
Common Name:	Anterior Cervical Plate
Classification Name:	Spinal Intervertebral Body Fixation Orthosis
Classification Code:	87 Orthopedics - Class II as described in 21 CFR888.3060 (product code KWQ).
Submitter's Name & Address:	Spinal Concepts, Inc.8200 Cameron Road, Suite B-160Austin, Texas 78754 U.S.A.Tel: (512) 339-4800Fax: (512) 339-4878
Establishment Registration No.	1649384

Establishment Registration No: 1049584

Contact Person: Pepper A. Chastain, Technical Specialist, Department of Clinical and Regulatory Affairs

Summary Preparation Date: December 31, 1998

II. Predicate Device

The Spinal Concepts, Inc. (SCI) Anterior Cervical Plate System is claimed to be substantially equivalent in material, design, function, and intended use to the SOF AMOR DANEK ORION™ Anterior Cervical Plate System (K973854 and K922087) and to the SYNTHES Cervical Locking Plate System (K945700 and K926453).

III. Device Description

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IV. Sterilization

The SCI Anterior Cervical Plate System implants may be provided sterile or non-sterile. Both implants and instrumentation must be sterilized prior to use in accordance with recommended sterilization parameters described in the package insert in order to achieve a sterility assurance level of 10-6.

V. Indications for Use

The SCI Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following:

Degenerative disc disease (DDD) as defined by neck pain of discogenic origin 1. with degeneration of the disc confirmed by patient history and radiographic studies;
Trauma (including fractures); 2.
Tumor; 3.
Spondylolisthesis; 4.
રું. Spinal stenosis;
ર. Deformity (i.e., scoliosis, kyphosis, lordosis);
Pscudarthrosis; and 7.
Failed previous fusions. 8.

Substantial Equivalence VI.

Spinal Concepts, Inc. believes that the SCI Anterior Cervical Plate System is substantially equivalent in design, materials, function and indications for use to the SOFAMOR DANEK ORION™ Anterior Cervical Plate System (K973854 and K922087) and the SYNTHES Cervical Locking Plate System (K945700 and K926453).

VII. Mechanical Testing

Static and fatigue testing was performed on the SCI Anterior Cervical Plate System. The results of the static tension and fatigue strength testing demonstrated that the SCI Anterior Cervical Plate System is able to withstand clinical loading and maintain mechanical integrity and is, therefore, suited for its intended use. Based upon the static tensile and fatigue strength testing, the Anterior Cervical Plate.

Conclusion VIII.

The Anterior Cervical Plate System is considered to be substantially equivalent in design, material, function, and intended use to the SOFAMOR DANEK ORION™ Anterior Cervical Plate System (K973854 and K922087) and the SYNTHES Cervical Locking Plate System (K945700 and K926453).

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 1999

Ms. Pepper A. Chastain Technical Specialist Requlatory and Clinical Affairs Spinal Concepts, Inc. 8200 Cameron Road, Suite B-160 78754 Austin, Texas

K990005 Re: Spinal Concepts, Inc. (SCI) Anterior Trade Name: Cervical Plate System Regulatory Class: II Product Code: KWO December 31, 1998 Dated: Received: January 4, 1999

Dear Ms. Chastain:

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 qeneral 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 Requlations, 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 Requlation (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. Pepper A. Chastain

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 requlation (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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page I

Spinal Concepts, Inc. Spinal Concepts, Inc.
SCI Anterior Cervical Plate System Premarket Notification December 31, 1998

INDICATION FOR USE STATEMENT

Page 1 of 1

510(k) Number (if known): K990005

Spinal Concepts, Inc. (SCI) Anterior Cervical Plate System Device Name:

The Spinal Concepts, Inc. (SCI) Anterior Cervical Plate System is Indications for Use: indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following:

Degenerative disc disease (DDD) as defined by neck pain of 1. discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies;
Trauma (including fractures); 2.
Tumor; 3.
Spondylolisthesis; 4.
న. Spinal stenosis;
Deformity (i.e., scoliosis, kyphosis, lordosis); ર.
1. Pseudarthrosis; and
Failed previous fusions. 8.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: _ X (Per 21 CFR 801.109) Or

Over-The-Counter (Optional Format 1-2-96)

tosee

Jivision Sigh

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.