The CITADEL™ Anterior Lumbar Plate System is intended for use in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolysis, spondylolisthesis, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery.

Device Description

The CITADEL™ Anterior Lumbar Plate System consists of plates of various lengths with variable or fixed bone screws for spinal fixation of the anterior or anterolateral vertebral bodies of the lumbar or lumbosacral spine (L1-S1). The implants are composed of titanium alloy, as specified in ASTM F136, F1295.

AI/ML Overview

The provided text describes a medical device, the "CITADEL™ Anterior Lumbar Plate System," and its 510(k) submission to the FDA. The submission focuses on establishing substantial equivalence to predicate devices through mechanical testing. However, the document does not contain the specific information requested in the prompt regarding acceptance criteria and a study that proves the device meets those criteria, particularly in the context of an AI/algorithm-based device.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

Not found: The document states that "Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal Systems 510(k)s', May 3, 2004 is presented." However, it does not provide a table of specific acceptance criteria (e.g., minimum tensile strength, fatigue life cycles) or the explicit performance results of the CITADEL™ device against these criteria. It only asserts that the device is "similar" to predicate devices in "technical characteristics, performance, and intended use."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not found: This device is a mechanical orthopedic implant, not an AI or algorithm-based diagnostic tool. Therefore, concepts like a "test set" with data provenance (country, retrospective/prospective) are not relevant in the context of the device described here. Mechanical testing typically uses physical samples of the device components. The document does not specify the number of samples used for the mechanical tests.

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)

Not applicable: Ground truth using expert consensus is relevant for diagnostic performance studies, not for the mechanical testing of an implant.

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

Not applicable: Adjudication methods are relevant for expert review in diagnostic studies, 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

Not applicable: This is a mechanical implant, not an AI-assisted diagnostic tool.

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

Not applicable: This is a mechanical implant, not an algorithm.

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

Not applicable: For mechanical devices, performance is typically measured against established engineering standards (e.g., ASTM standards) rather than clinical ground truth types like pathology or outcomes data in the context of an AI model's performance. The "ground truth" here would be the physical properties and mechanical behavior of the device under test, compared to relevant standards or predicate devices.

8. The sample size for the training set

Not applicable: This device is a mechanical implant and does not involve a "training set" in the sense of machine learning.

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

Not applicable: As above, this concept does not apply to a mechanical implant.

In summary, the provided document relates to a 510(k) submission for a mechanical spinal implant. It confirms that mechanical testing was performed according to a guidance document for spinal systems. However, it does not offer the detailed information requested about acceptance criteria and a study design that would be relevant for an AI/algorithm-based medical device.

Summary

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Image /page/0/Picture/0 description: The image shows the alphanumeric string "K062836" in a handwritten style. Below this string, there is the text "510(k) - CITADEL™ System". The text is underlined, suggesting it is a title or label associated with the alphanumeric string above.

비. 510(k) Summary

SUBMITTED BY:

DEC 1 9 2006

Globus Medical Inc. Valley Forge Business Center 2560 General Armistead Ave. Audubon, PA 19403 (610) 415-9000 Contact: Kelly J. Baker

DEVICE NAME:

CITADEL™ Anterior Lumbar Plate System

CLASSIFICATION:

21 CFR §888.3060 Spinal Intervertebral Body Fixation Orthosis Product Codes KWQ. Regulatory Class II. Panel code 87.

PREDICATE DEVICES:

REVERE™ Stabilization System K061202 (SE July 20, 2006) GATEWAY™ Thoracolumbar Plate System K062407 (SE Sept 6, 2006) Medtronic Sofamor Danek Pyramid Plate K013665 (SE Jan 29,2002) Synthes Anterior Tension Band K022791 (SE Nov 13, 2002) Product code KWQ. Regulatory Class II.

DEVICE DESCRIPTION:

INTENDED USE:

PERFORMANCE DATA:

Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal Systems 510(k)s", May 3, 2004 is presented.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The CITADEL™ Anterior Lumbar Plate System implants are similar to the predicate devices with respect to technical characteristics, performance, and intended use.

CONFIDENTIAL

GLOBUS MEDICAL

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Globus Medical Inc. % Kelly J. Baker, Ph.D Director, Regulatory and Clinical Affairs Valley Forge Business Center 2560 General Armistead Avenue Audubon, Pennsylvania 19403

DEC 1 9 2006

Re: K062836

Trade/Device Name: CITADEL™ Anterior Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: November 15, 2006 Received: November 16, 2006

Dear Dr. Baker:

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, EDA over 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. Your 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 set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the elections product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Kelly J. Baker, Ph.D

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 logally 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Harbare Buchemp

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ll. Indications for Use Statement

510(k) Number: K062836

Device Name: CITADEL™ Anterior Lumbar Plate System

Indications:

The CITADEL™ Anterior Lumbar Plate System is intended for use by an anterior or anterolateral approach in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), turnor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery.

Prescription Use OR Over-The-Counter Use ______________________________________________________________________________________________________________________________________________________ X (Per 21 CFR §801.109) ·

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Bouchard

Division Sign-O Division of General, Restorative, and Neurological Devices.

510(k) Number K062836

CONFIDENTIAL

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.