Trauma.
Tumor.
Degenerative Disc Disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Anterior fusion following multiple failed posterior fusion operations, including pseudoarthrosis.
The instrumentation is designed for levels of fixation from T10 to L4.

Device Description

The BodyForm™ Thoraco-Lumbar Fixation System is a construct which consists of one plate, contoured to match the lateral profile of the thoraco-lumbar vertebral bodies, four Morse taper headed screws, and two locking set screws. Plates are designed specifically to particular graft heights, with anatomic limitations in mind.

AI/ML Overview

The provided text describes the "BodyForm™ Thoraco-Lumbar Fixation System," a medical device for spinal instability. However, it does not contain any information about acceptance criteria, device performance metrics, or any specific studies related to clinical or AI/algorithm performance.

The document is a 510(k) summary for regulatory clearance, which primarily focuses on substantial equivalence to predicate devices and describes non-clinical testing for mechanical properties.

Therefore, I cannot provide the requested information. The following points would be "Not Applicable" or "Not Provided in the text":

A table of acceptance criteria and the reported device performance: Not provided. The text mentions "Properties of stiffness, strength, and fatigue life were characterized" according to ASTM F-1717-96, but no specific criteria or reported values are given.
Sample size used for the test set and the data provenance: Not provided. This typically refers to clinical or algorithmic test sets, which are not detailed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
Adjudication method for the test set: Not provided.
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 provided. This is a mechanical device, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided. This is a mechanical device, not an AI diagnostic tool.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
The sample size for the training set: Not provided.
How the ground truth for the training set was established: Not provided.

Summary

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30 1998

K983622

BodyForm™ Thoraco-Lumbar Fixation System

510 (k) Summary

Company: Theken Surgical 1100 Nola Avenue Barberton, Ohio 44203

BodyForm™ Thoraco-Lumbar Fixation System Trade Name:

Classification: Spinal Intervertebral Body Fixation Orthosis. Class II,

The BodyForm™ Thoraco-Lumbar Fixation System is a construct which consists Description: of one plate, contoured to match the lateral profile of the thoraco-lumbar vertebral bodies, four Morse taper headed screws, and two locking set screws. Plates are designed specifically to particular graft heights, with anatomic limitations in mind.

Performance Data:

Non-clinical:

Testing was conducted according to ASTM F-1717-96. Properties of stiffness, strength, and fatique life were characterized.

Intended Use:

The BodyForm Thoraco-Lumbar Fixation System is intended for treatment of anterior thoraco-lumbar spinal instability caused by:

1. Trauma.
1. Tumor.
Degenerative Disc Disease (DDD). DDD is defined as back pain of ల discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
ব Anterior following multiple failed posterior fusion operations, including pseudoarthrosis,

The instrumentation is designed for levels of fixation from T10 to L4.

Substantial Equivalence:

Z-Plate Anterior Fixation System (Sofamor-Danek) University Plate Titanium Anterior System (Acromed) Anterior Thoracolumbar Locking Plate (Synthes)

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human profiles facing right, layered on top of each other, creating a sense of depth and connection.

DEC 30 1998

Mr. Lukas Eisermann Director, Regulatory Affairs Theken Surgical 1100 Nola Avenue Barberton, Ohio 44203

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K983622

Trade Name: BodyForm Thoraco-Lumbar Fixation System Regulatory Class: II Product Code: KWQ Dated: October 13, 1998 Received: October 15, 1998

Dear Mr. Eisermann:

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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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.

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.

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Page 2 - Mr. Eisermann

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

Sincerely vours.

Thurell T. Hayes

C.L.M. Witt, Ph.D., M.D.

In 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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DEC-20-20 00 . DEFFLEFF

510(k) Number K983622. Revision C. Decenber 1998.

510 (k) Number (if known): K983622

Device Name: BodyForm™ Thoraco-Lumbar Fixation System

1. Indications for Use:
  The BodyForm Thoraco-Lumbar Fixation System is intended for treatment of anterior thoraco-lumbar spinal instability caused by:
1. Trauma.
1. Tumor.
1. Degenerative Disc Disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies,
1. Anterior fusion following multiple failed posterior fusion operations, including pseudoarthrosis.

The instrumentation is designed for levels of fixation from T10 to L4.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

Over-The-Counter Use __

(Oplional Format 1/2/96)

Thos. S. Page for Com.

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

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.