The Synthes Anterior Tension Band System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. This system is indicated 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), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.

Device Description

The Synthes Anterior Tension Band System consists of a range of plate sizes and 5.5 mm cancellous screws with a locking head. The plates attach to the anterior or anterolateral aspect of the vertebral body of the lumbar / lumbosacral spine (levels L1-S1) and provide stabilization to permit the biological process of spinal fusion to occur. All components are manufactured from Titanium alloy.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Synthes Anterior Tension Band (ATB) System." It is a regulatory submission for a spinal implant, not an AI/ML medical device. Therefore, the questions related to AI/ML device performance, ground truth, expert adjudication, training/test sets, and MRMC studies are not applicable to this document.

The document focuses on demonstrating substantial equivalence to a legally marketed predicate device, which is the standard for 510(k) submissions for traditional medical devices. The "acceptance criteria" here refers to the FDA's decision criteria for substantial equivalence based on the device's design, materials, indications for use, and performance within the context of established orthopedic standards, rather than AI performance metrics.

Here's an analysis based on the provided document, acknowledging the non-AI nature:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by 510(k) Process)	Reported Device Performance (Implied by FDA Clearance)
Material Composition: Use of biocompatible and mechanically sound materials.	"All components are manufactured from Titanium alloy." (Titanium alloy is a commonly accepted material for orthopedic implants.)
Indications for Use: Alignment with existing predicate devices for spinal fixation.	Indicated for "lumbar and lumbosacral (L1-S1) spine instability" due to various conditions (fracture, tumor, DDD, etc.). This matches the established uses of similar spinal fixation systems.
Surgical Approach: Compatibility with established surgical techniques.	Indicated for "lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels." This covers standard approaches for lumbar/lumbosacral fixation.
Mechanical Performance/Stability: Demonstrated ability to provide stabilization to permit spinal fusion.	The device "provide(s) stabilization to permit the biological process of spinal fusion to occur." (While specific mechanical test data isn't in this summary, it would have been part of the full 510(k) submission, likely showing equivalent mechanical properties to the predicate).
Substantial Equivalence: Demonstrated similarity in principle of operation, indications, and technological characteristics to a legally marketed predicate device.	FDA determined the device is "substantially equivalent... to legally marketed predicate devices." This is the ultimate "acceptance" for a 510(k).

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

Not Applicable. This is a 510(k) submission for a physical medical device (spinal implant), not an AI/ML device. There is no "test set" in the context of an algorithm's performance evaluation. The substantial equivalence determination is based on a comparison to predicate devices, material properties, and manufacturing controls, typically supported by bench testing and sometimes cadaveric studies, not clinical data in the same way an AI model would be tested.

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

Not Applicable. See point 2.

4. Adjudication method for the test set

Not Applicable. See point 2.

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. See point 2. This device is not an AI diagnostic tool.

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

Not Applicable. See point 2. This is a physical implant, not an algorithm.

7. The type of ground truth used

Not Applicable. For a physical implant, the "truth" is established through engineering principles, material science, biomechanical testing, and clinical experience with comparable predicate devices. The ground truth for this type of device relates to its safety and effectiveness for its intended use, typically demonstrated through non-clinical performance data and comparison to predicates.

8. The sample size for the training set

Not Applicable. See point 2.

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

Not Applicable. See point 2.

In summary, the provided document details a regulatory submission for a traditional medical device (a spinal implant) and its clearance by the FDA based on substantial equivalence. It does not provide information relevant to the testing and validation of an Artificial Intelligence or Machine Learning (AI/ML) medical device.

Summary

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KO22791 PAGE 1/1

NOV 1 3 2002

Synthes Spine 510(k) Premarket Notification Anterior Tension Band (ATB) System

11.0 510(K) SUMMARY

DESCRIPTION

INDICATIONS

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, bold line drawing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 13 2002

Vikki M. Hoffman Senior RA Associate Synthes Spine 1690 Russell Road Paoli, Pennsylvania 19301

Re:

K022791 Synthes Anterior Tension Band (ATB) System Trade Name: 21 CFR 888.3060 Regulation Number: Spinal Intervertebral Fixation Orthosis Regulation Name: Regulatory Class: Class II KWQ Product Code: Dated: August 20, 2002 August 22, 2002 Received:

Dear Ms. Hoffman:

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. Vikki M. Hoffman

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 device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 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" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained 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/dsmamain.html.

Sincerely yours,

Sincerely, yours,

L. Mark N. Milikens

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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Synthes Spine 510(k) Premarket Notification Anterior Tension Band (ATB) System

3.0 FDA INDICATIONS FOR USE FORM

510(k) Number (if known): K 022791

Device Name: Synthes Anterior Tension Band (ATB) System

INDICATIONS FOR USE:

(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) OR Over-The-Counter Use

Mark H. Milliken

(Division Sign-Off) Division of General, Restorati and Neurological Devices

510(k) Number KC

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.