ORION ANTERIOR CERVICAL PLATE SYSTEM by SOFAMOR DANEK USA,INC.

The ORION® Anterior Cervical Plate System is intended for anterior cervical intervertebral body fusions only. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal 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), pseudarthrosis, and/or failed previous fusions.

Device Description

The ORION® Anterior Cervical Plate System consists of a variety of bone plates and screws. Fixation is provided by the insertion of bone screws through the openings at each end of the plate into the vertebral bodies of the cervical spine. The ORION® Anterior Cervical Plate System features a locking screw which screws into each end of the plate to help secure the positioning of the ORION® screws. The use of the locking screw is not optional. In addition, the central portion of ORION® plates have slots and holes which accommodate 4.35mm diameter ORION® screws. The placement of these central screws is intended to augment fixation by providing additional vertebral body purchase and/or bone graft purchase. The use of the central screws is recommended. Associated instruments are also available to facilitate the implantation of the device. The implant components will be made from titanium alloy as described by ASTM F-136 or ISO 5832-3 and may be supplied either sterile or non-sterile.

AI/ML Overview

The request asks for details about the acceptance criteria and the study that proves the device meets them, based on the provided 510(k) summary for the ORION® Anterior Cervical Plate System.

However, the provided text does not contain acceptance criteria or details of a study with specific performance metrics for the ORION® Anterior Cervical Plate System. Instead, it states:

"The ORION® Anterior Cervical Plate System was claimed to be substantially equivalent to commercially available cervical plating systems."
"Information concerning these devices was supplied in support of establishing equivalence."
"Mechanical test data were provided in support of this notification."

This indicates that the submission relied on demonstrating substantial equivalence to predicate devices and likely included mechanical testing to support the device's physical properties. It does not provide the specific performance criteria or the results of those tests in a format that would allow filling out the requested table.

Therefore, many of the requested fields cannot be answered definitively from the provided text.

Here's an attempt to answer based on the available information, with clear indications of what is not provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Not explicitly stated, inferred from claims of substantial equivalence and mechanical tests)	Reported Device Performance (Not explicitly stated in terms of specific thresholds or results)
Mechanical Strength	The device, including plates and screws, is expected to withstand physiological loads and stresses encountered in the anterior cervical spine without failure (e.g., fracture, loosening, deformation) as demonstrated by mechanical testing.	"Mechanical test data were provided in support of this notification." (Specific results, e.g., bending strength, torsional rigidity, fatigue life, or comparison to predicate values, are not provided). The FDA found the device "substantially equivalent," implying these tests were satisfactory.
Biocompatibility	Materials (titanium alloy as described by ASTM F-136 or ISO 5832-3) are expected to be biocompatible, non-toxic, and non-allergenic when implanted in the human body.	The materials specified (titanium alloy per ASTM F-136 or ISO 5832-3) are commonly accepted as biocompatible for implantable medical devices. (Specific test results are not provided, but adherence to these standards implies they meet acceptance criteria for biocompatibility).
Device Functionality	The system should effectively provide temporary stabilization for anterior cervical intervertebral body fusions, including secure fixation of screws into vertebral bodies and proper functioning of the locking screw mechanism.	Implied by the claim of substantial equivalence to commercially available cervical plating systems. (Specific functional performance metrics, e.g., screw pull-out strength, locking mechanism reliability, are not provided in numerical terms). The device's design, including mandatory locking screws, is described.
Sterilization (if sterile)	For sterile products, the sterilization method must achieve a specified sterility assurance level (SAL).	The device "may be supplied either sterile or non-sterile." (Specific sterilization validation results are not provided).
Indications for Use	The device must meet the specified indications for use: temporary stabilization during cervical spinal fusions for degenerative disc disease, trauma, tumors, deformity, pseudanthrosis, and/or failed previous fusions. It must not be approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.	The FDA cleared the device for the stated indications for use and explicitly prohibited promotion for pedicular screw fixation. This indicates the device met the criteria for its intended use and did not meet the criteria for the prohibited use.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not provided. The documentation mentions "mechanical test data" but does not specify the number of samples tested for each type of component or for the system as a whole.
Data Provenance: The mechanical tests were performed to support the 510(k) submission, likely by the manufacturer (Sofamor Danek USA). The country of origin for the data is implicitly the USA, where Sofamor Danek is based. The nature of mechanical testing makes it inherently prospective data collection for the purpose of the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable / Not provided. For a purely mechanical device tested for substantial equivalence, "ground truth" related to expert assessment in the clinical sense (e.g., radiological interpretation) is not typically established for the mechanical testing itself. The "experts" involved would be engineers and material scientists conducting the tests, and potentially biomechanical experts reviewing the results against established standards or predicate device performance. Their number and specific qualifications are not stated.

4. Adjudication method for the test set

Not applicable / Not provided. Adjudication methods like 2+1 or 3+1 typically refer to clinical endpoint adjudication where multiple experts independently assess cases for a definitive outcome. This is not relevant for the mechanical testing of a spinal implant. The "adjudication" for the mechanical tests would be the review of the raw data, test reports, and compliance with test standards by the manufacturer's internal quality/regulatory team and the FDA reviewers.

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. This is a medical device for spinal fixation, not an AI-powered diagnostic or imaging interpretation tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

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

No. This is a physical, implantable medical device. The concept of an "algorithm only" or "standalone" performance without human interaction is not applicable as there is no algorithm or AI component.

7. The type of ground truth used

For the mechanical testing, the "ground truth" would be the physical properties and performance characteristics of the device measured through standardized biomechanical tests (e.g., ultimate tensile strength, fatigue life, intersegmental ROM, pull-out strength). These measurements are then compared against established standards or the performance of legally marketed predicate devices.
For the claim of substantial equivalence, the "ground truth" is adherence to the design and material specifications, and performance data that is comparable to predicate devices.

8. The sample size for the training set

Not applicable / Not provided. This device does not involve a "training set" in the context of machine learning or AI. While manufacturers gain experience and refine designs over time (which could be metaphorically considered "training"), there is no formalized training set as used in the AI context.

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

Not applicable / Not provided. As there is no "training set" as defined in AI/ML, the establishment of its ground truth is not relevant.

Summary

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ORION® Anterior Cervical Plate System 510(k) Summary K973854 January 1998

l. Company: Sofamor Danek USA 1800 Pvramid Place Memphis, Tennessee 38132 (901) 396-3133
ORION® Anterior Cervical Plate System II. Product Name: Spinal intervertebral body fixation orthosis Classification Name:
The ORION® Anterior Cervical Plate System consists of a variety of bone plates lll. and screws. Fixation is provided by the insertion of bone screws through the openings at each end of the plate into the vertebral bodies of the cervical spine. The ORION® Anterior Cervical Plate System features a locking screw which screws into each end of the plate to help secure the positioning of the ORION® screws. The use of the locking screw is not optional. In addition, the central portion of ORION® plates have slots and holes which accommodate 4.35mm diameter ORION® screws. The placement of these central screws is intended to augment fixation by providing additional vertebral body purchase and/or bone graft purchase. The use of the central screws is recommended. Associated instruments are also available to facilitate the implantation of the device. The implant components will be made from titanium alloy as described by ASTM F-136 or ISO 5832-3 and may be supplied either sterile or non-sterile.
IV. The ORION® Anterior Cervical Plate System is intended for anterior cervical intervertebral body fusions only. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal 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), pseudanthrosis, and/or failed previous fusions.

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

V. The ORION® Anterior Cervical Plate System was claimed to be substantially equivalent to commercially available cervical plating systems. Information concerning these devices was supplied in support of establishing equivalence.
Mechanical test data were provided in support of this notification.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring a symbol that resembles an abstract caduceus or a representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 6 1998

Richard W. Treharne, Ph.D. Vice President Research and Regulatory Affairs Sofamor Danek 1800 Pyramid Place 38132 Memphis, Tennessee

Re: K973854 ORION® Anterior Cervical Plate System Requlatory Class: II Product Code: KWQ Dated: January 8, 1998 Received: January 12, 1998

Dear Dr. Treharne:

We have reviewed your Section 510(k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act You may, therefore, market your device system subject (Act) . . to the general controls provisions of the Act and the limitations identified below.

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. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment would cause the device system to be adulterated under 501(f)(1) of the Act.

FDA identifies that any device system, if intended for use in pedicular screw fixation/attachment, except for some limited indications, would be found not substantially equivalent and would be a class III device under Section 513(f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:

1 . You may not label or in any way promote this device system for pedicular screw attachment to, or fixation of the cervical, thoracic or lumbar vertebral column. Therefore, in order to prevent off-label promotion, the

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package insert must include the following statement, This device system is not approved for screw "WARNING: attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.";

All labeling for this device system, including the 2. package label, must state that there are labeling limitations. The package insert must prominently state that the device system is intended for the specific use (s) described in the enclosure only; and

Pedicular screw fixation/attachment to the cervical, 3. thoracic or lumbar vertebral column, except for limited indications, of any device system is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device system for pedicular screw fixation/attachment must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investigation.
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. ਉੱ 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 requlation (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 In addition, FDA may publish further announcements action. 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.

FDA advises that the use of the subject device system and/or device components with any other device components but those identified in this 510(k) would require submission of a new 510 (k) providing documentation of design, material, and labeling compatibility between the device components. Mechanical testing of a spinal system consisting of the subject device components and other device components, whether yours or other manufacturers', may also be required.

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Page 3 - Richard W. Treharne, Ph.D.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.

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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October, 1997

Page 1 of 1

510(k) Number (if known): _ K973854

ORION® Anterior Cervical Plate System Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The ORION® Anterior Cervical Plate System is intended for anterior interbody screw The system is indicated for use in the temporary fixation of the cervical spine. stabilization of the anterior spine during the development of cervical spinal 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), pseudarthrosis, and/or failed previous fusions.

Warning: This device is 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 (OD)

(Division Sign-Off) Division of General Restorative D 510(k) Number

Prescription Use	X
(Per 21 CFR 801.109)

Over-The-Counter Use _

(Optional Format 1-2-96)

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.