The BodyForm™ Thoracic Fixation System is intended as an adjunct to fusion for treatment of thoracic spinal instability as a result of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, spinal stenosis, deformities or curvatures (scoliosis, kyphosis, and/or lordosis), tumor, and anterior fusion following failed previous fusion operations, including pseudoarthrosis.

The BodyForm™ Thoracic Fixation System is intended for unilateral use to attach to the anterolateral aspect of the vertebral bodies at levels of fixation from T1 to L1.

Device Description

The purpose of this submission is for additional sizes of plates and screws for the BodyForm™ Fixation System. This submission includes smaller sized plates and screws intended for the thoracic region of the spine. All implant components are manufactured from medical grade titanium alloy Ti 6Al-4V (ELI) per ASTM F-136.

AI/ML Overview

This document is a 510(k) summary for the BodyForm™ Thoracic Fixation System. It describes the device, its intended use, and claims substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way you've outlined.

The 510(k) process for devices like this (spinal fixation systems) focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through:

Design Concept Comparison: Showing the new device has a similar design to existing ones.
Material Composition: Verifying the use of established, medical-grade materials (e.g., Ti 6Al-4V (ELI) per ASTM F-136).
Feature Comparisons: Highlighting similar features.
Mechanical Testing: Demonstrating that the device meets relevant mechanical performance standards (though specific results and acceptance criteria are not detailed in this summary document).
Indications for Use: Showing that the intended use is similar to predicate devices.
Engineering Analysis: Providing an engineering rationale for its safety and effectiveness.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study design from the provided text because these types of details are typically not found in the public 510(k) summary, which focuses on the regulatory submission and substantial equivalence claim.

However, I can extract the following relevant information based on the prompt's categories, indicating where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified in document	Not specified in document
(Likely involves mechanical and material standards for spinal implants)	(Evidence of substantial equivalence based on design, materials, feature comparisons, mechanical testing, and engineering analysis.)

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

Sample Size for Test Set: Not applicable or not specified. The submission mentions "mechanical testing" and "engineering analysis" but does not detail a specific "test set" in the context of clinical or performance data for the device. The focus is on comparing to predicate devices and adherence to material/design standards.
Data Provenance: Not applicable or not specified. This document pertains to a regulatory submission demonstrating substantial equivalence, not a clinical study with patient data.

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

Number of Experts: Not applicable. Ground truth for a clinical test set is not discussed.
Qualifications of Experts: Not applicable.

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

Adjudication Method: Not applicable. No clinical test set requiring adjudication is described.

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 versus without AI assistance:

MRMC Study: Not applicable. This is for a mechanical spinal fixation system, not an AI-assisted diagnostic tool involving human readers.

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

Standalone Performance Study: Not applicable. This is for a mechanical spinal fixation system, not an algorithm.

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

Type of Ground Truth: Not applicable in the context of a clinical performance study. For a medical device like this, "ground truth" typically refers to established engineering standards (ASTM, ISO), material properties, and clinical experience with equivalent predicate devices.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable. This document does not describe the development of an AI model or a training set.

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

Ground Truth for Training Set Establishment: Not applicable. No AI model or training set is described.

Summary of Device and Regulatory Status from Document:

Device Name: BodyForm™ Thoracic Fixation System
Manufacturer: Theken Spine, LLC
Regulatory Status: Cleared under 510(k) (K072407) as substantially equivalent to predicate devices.
Intended Use: Adjunct to fusion for treatment of thoracic spinal instability due to various conditions (degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities, tumor, failed fusions including pseudoarthrosis). For unilateral use at T1-L1.
Materials: Implant grade titanium alloy Ti 6Al-4V (ELI) per ASTM F-136 and ISO 5832-3.
Basis for Substantial Equivalence: Design concept, established materials, feature comparisons, mechanical testing, indications for use, and engineering analysis.

Summary

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K072407

Theken Spine, LLC

BodyForm™ Thoracic Fixation System

Page 1 of 1

510(k) Summary (21 CFR Part 807.92)

Submitter Information A. Submitter's Name: Theken Spine, LLC Address: 283 E. Waterloo Akron, Ohio 44319 DEC 2 1 2007 Telephone Number: 330-773-7677 x221 Fax Number: 330-773-7697 Contact Person: Dale Davison Date Prepared: 8/21/07 Device Information B. BodyForm™ Thoracic Fixation System Trade Name: Anterior Spinal Fixation System Common Name: Classification: KWQ 888.3060 - Spinal Intervertebral Body Fixation Orthosis Predicate Device: BodyForm™ Thoraco-Lumbar Fixation System, Theken Spine, LLC (K983622) Thoracolumbar Spine Locking Plate System, Synthes (K020244) Coral Spinal System, Theken Spine, LLC (K041592) The purpose of this submission is for additional sizes of plates and Device Description: screws for the BodyForm™ Fixation System. This submission includes smaller sized plates and screws intended for the thoracic region of the spine. All implant components are manufactured from medical grade titanium alloy Ti 6Al-4V (ELI) per ASTM F-136. The BodyForm™ Thoracic Fixation System is intended as an Intended Use: adjunct to fusion for treatment of thoracic spinal instability as a result of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma, spinal stenosis, deformities or curvatures (scoliosis, kyphosis, and/or lordosis), tumor, and anterior fusion following failed previous fusion operations, including pseudoarthrosis. The BodyForm™ Thoracic Fixation System is intended for unilateral use to attach to the anterolateral aspect of the vertebrah bodies at levels of fixation from T1 to L1. Implant grade titanium alloy Ti 6A1-4V (ELI) per ASTM F-136 Material Composition: and ISO 5832-3.

C. Substantial Equivalence

Theken Spine, LLC believes sufficient evidence exists to reasonably conclude that the BodyForm™ Thoracic Fixation System is substantially equivalent to other legally marketed predicate devices. This is based on the design concept, the use of established known materials, feature comparisons, mechanical testing, indications for use, and engineering analysis.

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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 consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 2007

Theken Spine, LLC % Mr. Dale Davison 283 E. Waterloo Akron. OH 44319

Re: K072407

Trade/Device Name: BodyForm™ Thoracic Fixation System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: December 17, 2007 Received: December 17, 2007

Dear Mr. Davison:

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 – Mr. Dale Davison

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Revorting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 yours,

Mark M. Millman

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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K072407

BodyForm™ Thoracic Fixation System Theken Spine, LLC

Indications for Use

510(k) Number (if known):

The BodyForm™ Thoracic Fixation System is intended for unilateral use to attach to the anterolateral aspect of the vertebral bodies at levels of fixation from T1 to L1.

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Breech

Division of General, Restorative, and Neurologic ... Devices

510(k) Number K072407

Page 1 of 1

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.