The Transcorp Trans-Plate Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7). These implants have been designed to provide stabilization to cervical fusion. Indications for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, or failed previous fusion.

Device Description

The Transcorp Trans-Plate Anterior Cervical Plate System includes The Transoorp Trans Fivical plates and bone screws. The anterior cervical plate system includes a cover plate that covers the bone screws and the "window" of the plate. The cover plate is manufactured from implant grade PEEK conforming to ASTM F2026na. The plates, screws, and cover plate locking blade are manufactured from Titanium Alloy conforming to ASTM F136-08. The plate is fixated by attaching screws through holes in the plate to The plate is fixution of the vertebral body of the cervical spine (C2-C7).

AI/ML Overview

Here's an analysis of the provided information regarding the Transcorp Trans-Plate Anterior Cervical Plate System's acceptance criteria and studies:

Key Takeaway: This 510(k) submission does not involve a study related to AI or any medical imaging device. It is for a mechanical spinal implant (plate and screws) and relies solely on non-clinical mechanical testing to demonstrate substantial equivalence to predicate devices. Therefore, many of the requested points regarding AI/imaging studies, ground truth, expert consensus, and human reader performance are not applicable.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria & Test Name	Metric/Standard	Transcorp Trans-Plate Performance
Static Torsion	ASTM F1717	Performed (results demonstrate equivalence to predicate devices)
Static Bending Compression	ASTM F1717	Performed (results demonstrate equivalence to predicate devices)
Dynamic Bending Compression	ASTM F1717	Performed (results demonstrate equivalence to predicate devices)
Wear Testing Analysis	ASTM F1877	Performed (particulate generation and wear debris collected and analyzed)

The "reported device performance" for this submission is consistently stated as demonstrating equivalence to the predicate devices based on the test results. Specific numerical results are not provided in this summary document.

Further Information (Addressing all points, noting applicability)

Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document. For mechanical testing of medical devices, sample sizes are typically determined by statistical requirements for engineering studies (e.g., to achieve a certain confidence level in material properties or fatigue life) rather than patient data.
- Data Provenance: The testing was "performed on the Transcorp Trans-Plate Anterior Cervical Plate System," implying in-house or contract lab testing. It is not patient data (e.g., country of origin is not applicable). It is not retrospective or prospective clinical data. It is laboratory-based mechanical test data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This submission is for a mechanical implant and relies on standardized engineering tests (ASTM F1717, F1877). "Ground truth" in the context of expert consensus on medical findings is not relevant here. The "truth" is determined by the physical properties and performance measured against the standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are used for resolving disagreements in expert interpretations, typically in clinical studies or when establishing ground truth from imaging. For mechanical testing, the results are typically directly measured and analyzed according to the specified ASTM standards.
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 is not an AI or imaging device. There were no human readers involved in evaluating the performance of this mechanical implant, nor was there any AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. As noted, this is a mechanical device. The "ground truth" for its performance is derived from measurements of physical properties and mechanical behavior compared against accepted engineering standards (ASTM F1717, ASTM F1877) and against the performance of legally marketed predicate devices.
The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
How the ground truth for the training set was established:
- Not Applicable. There is no "training set" for this mechanical device.

Summary of the Study:

The "study" conducted for the Transcorp Trans-Plate Anterior Cervical Plate System was a series of non-clinical performance tests aimed at demonstrating the mechanical equivalence of the new device to established predicate devices already on the market. These tests included:

Static Torsion (per ASTM F1717): Measures the device's resistance to twisting forces.
Static Bending Compression (per ASTM F1717): Measures the device's resistance to forces that would bend and compress it.
Dynamic Bending Compression (per ASTM F1717): Measures the device's fatigue life and performance under repetitive bending and compression forces.
Wear Testing Analysis (per ASTM F1877): Assesses the generation of particulate and wear debris, which can be critical for biocompatibility and long-term implant function.

The fundamental principle behind this 510(k) submission is that if the new device demonstrates similar mechanical properties and performance characteristics to previously approved predicate devices, it can be considered "substantially equivalent" and thus safe and effective for its intended use without requiring new clinical trials or evaluations of diagnostic accuracy.

Summary

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510(k) Summary Pursuant to 21 CFR 807.92c

Submitted By:

Andrew Rodenhouse Transcorp. Inc. 1000 100th St. SW Suite F Byron Center, MI 49315 Ph: 616-877-4177 Fax: 616-877-4522

MAY 21 2010

Date:

May 20, 2010

Device Information:

Trade Name: Common Name: Classification:

Transcorp Trans-Plate Anterior Cervical Plate System Spinal Intervertebral Body Fixation Orthosis 21 CFR Section 888.3060, Product Code KWQ, Class II

Predicate Devices:

K030866 Synthes CSLP K021461 Medtronic Atlantis Cervical Plate System

Device Description:

510(k) Premarket Notifica

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Intended Use:

WARNING: The Transcorp Trans-Plate Anterior Cervical Plate System in not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Performance Data:

Performance testing was performed on the Transcorp Trans-Plate Anterior Cervical Plate System. Static torsion, static bending compression, and dynamic bending compression were performed per ASTM F1717. A wear testing analysis was performed to determine particulate generation and wear debris was collected and analyzed per ASTM F1877. No clinical testing was performed.

Substantial Equivalence:

The Transcorp Trans-Plate Anterior Cervical Plate System is equivalent to the predicate devices in design, function, and indications for use. The results of non-clinical testing and analysis demonstrate that the mechanical performance of the Transcorp Trans-Plate Anterior Cervical Plate System is equivalent to the predicate devices. Thus, the Transcorp Trans-Plate Anterior Cervical Plate System is substantially equivalent to the predicate devices.

510(k) Premarket Notificatio

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an emblem that features a stylized eagle with three lines extending from its wing. The eagle is facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

MAY 2 1 2010

Transcorp, Inc. % Mr. Andrew Rodenhouse Principle Engineer 1000 100th Street SW, Suite F Byron Center, Michigan 49315

Re: K092695

Trade/Device Name: Transcorp Trans-Plate Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: May 18, 2010 Received: May 19, 2010

Dear Mr. Rodenhouse:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Andrew Rodenhouse

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

vards Fees/Resources for Industry Training

Sincerely yours.

Kaubaie Buelund

Mark N. Melke Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

K092695

510(k) Number:

Device Name:

Transcorp Trans-Plate Anterior Cervical Plate System

Indications for Use:

WARNING: The Transcorp Trans-Plate Anterior Cervical Plate System in not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Prescription Use X(per CFR 801.109)	or
------------------------------------------------	----

Over-the-counter use

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and 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.