SMISSON STABILIZATION SYSTEM by SMISSON-CARTLEDGE

The Smisson Stabilization 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 (C2-T1) 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), pseudarthrosis, and/or failed previous fusions.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA to Smisson-Cartledge Biomedical, LLC, for the "Smisson Stabilization System." This document primarily indicates the FDA's "substantial equivalence" determination for the device, which is a regulatory classification, not a study evaluating its direct performance against acceptance criteria in the way medical software or AI devices are often assessed.

Therefore, the information requested regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present in the provided document. The letter focuses on the regulatory approval process based on comparison to a legally marketed predicate device, rather than detailed performance metrics from a specific study.

What is present and can be inferred:

Device Name: Smisson Stabilization System
Intended Use: Anterior interbody screw fixation of the cervical spine (C2-T1) for temporary stabilization during cervical spine fusions in patients with several conditions (degenerative disc disease, trauma, tumors, deformity, pseudarthrosis, failed previous fusions).
Regulatory Classification: Class II, product code KWQ.
Predicate Device: The approval is based on substantial equivalence to legally marketed predicate devices, implying that its design and intended use are similar to devices already on the market prior to May 28, 1976, or reclassified devices. The specific predicate device(s) are not named.

Regarding the requested information, here's why it cannot be extracted from this document:

Acceptance Criteria and Reported Device Performance: This document does not contain a table of performance metrics or specific acceptance criteria (e.g., accuracy, sensitivity, specificity, mechanical strength tolerances) that would be a result of a direct device performance study. The "acceptance" here relates to regulatory clearance of substantial equivalence, not a direct performance benchmark.
Sample Sizes and Data Provenance for Test Set: No information about a test set, sample size, or data provenance is provided.
Number and Qualifications of Experts for Ground Truth: The concept of "ground truth" established by experts in an evaluation study is not discussed, as this document is a regulatory clearance letter.
Adjudication Method: Not applicable or discussed.
MRMC Comparative Effectiveness Study: There is no mention of a Multi-Reader Multi-Case (MRMC) study, nor is there any discussion of AI assistance or human reader improvement. This device is a physical spinal fixation system, not an AI software device.
Standalone Performance Study: While the device would have undergone various mechanical and biocompatibility tests (not detailed here but implied by regulatory requirements), a "standalone" performance in the context of an algorithm's output is not relevant for this type of physical implant.
Type of Ground Truth: The concept of "ground truth" (expert consensus, pathology, outcomes data) typical for diagnostic or AI-driven devices isn't explicitly used here. The basis for approval is substantial equivalence to a predicate, meaning its design principles and intended use are considered safe and effective because similar devices are already approved.
Sample Size for Training Set: Not applicable or discussed.
How Ground Truth for Training Set was Established: Not applicable or discussed.

In summary, the provided document is a 510(k) clearance letter for a physical medical device (spinal stabilization system), not a study report for a diagnostic or AI-powered device. Therefore, the specific details requested about performance studies, acceptance criteria, and ground truth establishment are not present in this regulatory correspondence.

Summary

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Public Health Service

JUN 2 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kristi Price Project Manager Smisson-Cartledge Biomedical, LLC 840 Pine Street. Suite 880 Macon, Georgia 31201

K021979 Re:

Trade Name: Smisson Stabilization System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: June 16, 2003 Received: June 17, 2003

Dear Ms. Price:

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 - Ms. Kristi Price

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 levice on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Mark M. Milkease

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): __K021979

Device Name: ___ Smisson Stabilization System_

Indications for Use:

"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 (ODE)

Prescription Use (Per 21 CFR 801.109)

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

for Mark N. Munson
(Division Sign-Off)

(Division Sign-Off) Di ision of General, Restorative and Neurological Devices

510(k) Number _KO21979

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.