The T-PLATE ANTERIOR PLATE FIXATION SYSTEM is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures. When properly used this system will help provide temporary stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2) Pseudoarthrosis; 3) Spondylolysis; 4) Spondylolisthesis; 5) Fracture; 6) Neoplastic disease; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity.

Device Description

The modified T-PLATE Anterior Fixation System (The Translation Plate Phase 1 (T-1 plate) and The Translation Plate Phase 2 (T-2 plate)) is a temporary implant used for the correction and stabilization of the spine. The system is also intended to help provide temporary stabilization and to help augment the development of a solid spinal fusion. The modified T-PLATE Anterior Fixation System (The Translation Plate Phase 1 (T-1 plate) and the Translation Plate Phase 2 (T-2 plate)) is a supplemental fixation device consisting of a variety of sizes of plates, and screws, as well as ancillary products and instrument sets. The modified T-PLATE Anterior Fixation System (The Translation Plate Phase 1 (T-1 plate) and the Translation Plate Phase 2 (T-2 plate)) components can be locked into a variety of configurations, with each construct being tailor-made for the individual case. The implant components are made from medical grade titanium alloy. Stainless steel and titanium components must not be used together in a construct.

AI/ML Overview

Here is an analysis of the provided information, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Device (K051764)	The modified T-PLATE Anterior Fixation System (T-1 plate and T-2 plate) was determined to be "substantially equivalent" to the predicate device (T-PLATE ANTERIOR PLATE FIXATION SYSTEM, K051764) based on mechanical testing. This implies that its performance met the accepted standards established by the predicate.
Maintenance of Spinal Stabilization	The device is intended to "help provide temporary stabilization until a solid spinal fusion develops." The mechanical testing is expected to demonstrate its ability to fulfill this function.
Appropriateness for Indicated Use Cases (e.g., Degenerative disc disease, Fracture, Spondylolisthesis)	The substantial equivalence determination, based on mechanical testing, suggests that the device performs adequately across the stated indications.
Material Compatibility and Safety (Medical Grade Titanium Alloy)	Implied by the predicate device's prior clearance and the explicit mention of using medical-grade titanium alloy. Mechanical testing would also confirm the structural integrity of this material for the intended use.

2. Sample Size Used for the Test Set and Data Provenance

The document states that "Mechanical testing was performed" but does not specify the sample size used for this testing. It also does not provide any information regarding data provenance (e.g., country of origin, retrospective or prospective). Given that this is a 510(k) for a mechanical device, the "test set" would refer to the mechanical specimens tested, not patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this submission. For a mechanical device, "ground truth" is established through engineering standards, test methods, and quantitative measurements of mechanical properties, not through expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable. Mechanical testing does not involve adjudication in the way clinical studies or expert reviews do. Standardized test methods (e.g., ASTM, ISO) typically dictate how results are measured and interpreted.

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

No MRMC comparative effectiveness study was mentioned or performed. This submission is for a physical medical device (an anterior fixation system), not an AI-powered diagnostic or assistive tool. Therefore, the concepts of human readers or AI assistance are not relevant.

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

Not applicable. As stated above, this is for a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is based on mechanical engineering standards and quantitative measurements of the device's physical properties and performance under various loads and conditions (e.g., fatigue, static strength, stiffness). The comparison is made against the performance of the legally marketed predicate device.

8. The Sample Size for the Training Set

There is no concept of a "training set" in this type of 510(k) submission for a mechanical device. The device is designed, manufactured, and then tested, not "trained."

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no training set, there is no ground truth established for it.

Summary of Acceptance Criteria and Study for K072231:

The primary acceptance criterion for the T-PLATE Anterior Fixation System in this 510(k) submission (K072231) was demonstrating substantial equivalence to a previously cleared predicate device (K051764).

The study that proves the device meets this acceptance criterion was "mechanical testing." This testing compared the performance of the modified T-PLATE system (T-1 plate and T-2 plate) to the predicate device. The nature of this testing would involve evaluating properties like strength, fatigue resistance, and construct stability, ensuring that the modified device performs comparably to the predicate for its intended use as a spinal fixation system. While specific details of the tests (e.g., specific loads, cycles, failure modes) and the number of samples are not provided in this summary, the FDA's clearance indicates that these mechanical tests were sufficient to demonstrate substantial equivalence, thus meeting the regulatory acceptance criteria for market authorization.

Summary

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K072231

T-PLATE Anterior Fixation System 510(K) Summary August 2007

ESM Technologies, LLC. I. Company: 403 Farwell Drive Madison, WI 53704

DEC 2 & 2007

Cliff Tribus, MD Contact: President, ESM Technologies Telephone: 608 467-8324 Cell: 608 332-8521 e-mail: ctribus@esmtech.com
II. Proprietary Trade Name: T-PLATE Anterior Fixation System Proposed Name of Modified Devices: The T-PLATE ANTERIOR PLATE Fixation System: 1. The Translation Plate Phase 1 (T-1 plate) 2. The Translation Plate Phase 2 (T-2 plate) Classification Name: Spinal Intervertebral Body Fixation Orthosis (per 21 CFR

Section 888.3060 Product Codes: KWO

Predicate (unmodified) Device: The T-PLATE ANTERIOR PLATE Fixation System K051764, July 13, 2005

III. Product Description

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each construct being tailor-made for the individual case. The implant components are made from medical grade titanium alloy. Stainless steel and titanium components must not be used together in a construct.

IV. Indications

V. Substantial Equivalence

Mechanical testing was performed on the The modified T-PLATE Anterior Fixation System (The Translation Plate Phase 1 (T-1 plate) and The Translation Plate Phase 2 (T-2 plate)), which determined it to be substantially equivalent to the T-PLATE ANTERIOR PLATE FIXATION SYSTEM. (K051764, July 13, 2005)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter.

Public Health Service

DEC 2 € 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ESM Technologies, LLC % Cliff Tribus. M.D. President, ESM Technologies 403 Farwell Drive Madison, WI 53704

Re: K072231

Trade/Device Name: T-PLATE Anterior Fixation System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: December 10, 2007 Received: December 12, 2007

Dear Dr. Tribus:

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 - Cliff Tribus, M.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 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 Reporting (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 N Mulkerson

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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Indications for Use

510(k) Number (if known): K072231

Device Name:

T-PLATE Anterior Fixation System

1. The Translational Plate Phase 1 (T-1 plate)
1. The Translational Plate Phase 2 (T-2 plate)

Indications For Use:

The T-PLATE ANTERIOR PLATE FIXATION SYSTEM is indicated for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures. When properly used this system will help provide stabilization until a solid spinal fusion develops. Specific indications include: 1) Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); 2) Pseudoarthrosis; 3) Spondylolysis; 4) Spondylolisthesis; 5) Fracture; 6) Neoplastic disease; 7) Unsuccessful previous fusion surgery; 8) Lordotic deformities of the spine; 9) Idiopathic thoracolumbar or lumbar scoliosis; 10) Deformity (i.e., scoliosis, lordosis, and/or kyphosis) associated with deficient posterior elements such as that resulting from laminectomy, spina bifida, or myelomenigocele; and/or 11) Neuromuscular deformity (i.e., scoliosis, lordosis, and / or kyphosis) associated with pelvic obliquity.

Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Boubane Buelup
Division Sign Off

Division of General, Rest . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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August 2007

510(k) Number K0722631

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.