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, 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.

Device Description

The T-PLATE Anterior Fixation System 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 T-PLATE Anterior Fixation System is a supplemental fixation device consisting of a variety of sizes of plates, and screws, as well as ancillary products and instrument sets. The T-PLATE Anterior Fixation System 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 grad titanium alloy. Stainless steel and titanium components must not be used together in a construct.

AI/ML Overview

The provided text describes a medical device, the T-PLATE Anterior Fixation System, and its regulatory approval process, specifically a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a full clinical study with acceptance criteria and performance metrics in the way one might for a novel AI device or a drug.

Therefore, many of the requested categories for a study proving device meets acceptance criteria are not applicable to this document. The "study" mentioned is mechanical testing to demonstrate substantial equivalence, not a clinical trial with human subjects, AI algorithms, or ground truth established by experts.

Here's an breakdown based on the provided text, indicating which information is available and which is not:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to PYRAMID™ ANTERIOR PLATE FIXATION SYSTEM (K013665)	Mechanical testing determined it to be substantially equivalent.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified (refers to mechanical testing, not a patient test set).
Data Provenance: Not specified. It's mechanical testing of the device itself, not human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth in the context of expert consensus on medical images or diagnoses is not relevant for mechanical testing of a spinal fixation system. Substantial equivalence is based on engineering principles and comparison to a predicate device.

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

Not applicable. There was no "test set" of patient data requiring adjudication in a clinical or diagnostic sense.

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. This document describes a physical medical device (spinal implant), not an AI system.

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

Not applicable. This device is a physical implant, not an algorithm.

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

Not applicable. The "ground truth" for substantial equivalence under 510(k) is the performance and characteristics of the legally marketed predicate device (PYRAMID™ ANTERIOR PLATE FIXATION SYSTEM). The new device is evaluated against engineering benchmarks to ensure it is similar enough to the predicate.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. There is no "training set" for this type of device.

Summary based on the document:

The T-PLATE Anterior Fixation System gained regulatory clearance through a 510(k) premarket notification. This process determines substantial equivalence to an existing legally marketed device (the PYRAMID™ ANTERIOR PLATE FIXATION SYSTEM, K013665). The evidence provided for this equivalence was mechanical testing of the device. The document does not describe clinical studies involving human subjects, AI performance, or ground truth established by medical experts for a diagnostic task.

Summary

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JUL 1 3 2005

T-PLATE Anterior Fixation System Summary of Safety and Effectiveness April 2005

ESM Technologies Company: l. 403 Farwell Drive Madison, WI 53704
Cliff Tribus, MD Contact: President, ESM Technologies Telephone: 608 241-5881
Proposed Proprietary Trade Name: T-PLATE Anterior Fixation System II.
Classification Name: Spinal Intervertebral Body Fixation Orthosis (per 21 CFR Section 888.3060 Product Codes: KWQ

Product Description III.

IV. Indications

Page 1.t 2

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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.

V. Substantial Equivalence

Mechanical testing was performed on the Anterior T-Plate fixation system, which determined it to be substantially equivalent to the PYRAMID™ ANTERIOR PLATE FLXATION SYSTEM.(K013665, SE 01/29/02).

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a staff with two snakes entwined around it, which is a common symbol associated with medicine and healthcare. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 3 2005

Dr. Cliff T. Tribus President ESM Technologies, LLC 403 Farewell Drive Madison, Wisconsin 53704

Re: K051764

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: June 29, 2005 Received: June 30, 2005

Dear Dr. Tribus:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosaly is trgms and ment date of the Medical Device Amendments, or to conninered pror to 1118) 2011-04-11 accordance with the provisions of the Federal Food, Drug, de vices mat have been recidential in avire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelere, mains of the Act include requirements for annual registration, listing of general controls proficering 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 If your device to such additional controls. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations affect may be subject to basil adderal 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 r rease be actived a determination that your device complies with other requirements of the Act that I Dr has Intactions and regulations administered by other Federal agencies. You must of any i cach statuted and reguirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K Fart 6077, laboring (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic form in the qualisy byevel provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Dr. Cliff T. Tribus

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ogin maneting of substantial equivalence of your device to a legally prematication. The PDF interessification 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 If you desire specific arrant an (240) 276-0120. Also, please note the regulation entitled, coniact the Office of Compilation of the time the motification" (21CFR Part 807.97). You may obtain Milsoranding of Terefores to presensibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or 11/11/443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Stip Klurda

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Enclosure

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KOSITCH

Page __ of __ l April 2005

510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hpt. Rurla
(Division Sign-Off)

Sign-Off) Division of General, Restorative. and Neurological Devices

510(k) Number Ko51764

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.