The Trinica™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine at levels C2-T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.

Device Description

The Trinica Anterior Cervical Plate System is a fixation device consisting of cervical plates, locking caps, fixed bone screws and variable angle bone screws made from titanium alloy in conformance with ASTM F136. The locking cap is preassembled onto the plate and is designed with tabs that prevent bone screws from backing out. The plates and locking caps are treated with titanium anodization per AMS (Aerospace Material Specification) 2488 Type II. Bone screws are subjected to a color anodizing process to differentiate the screw type and diameter. Plates are offered in one-level, two-level, three-level, and four-level fusion configurations (24 mm through 92 mm). Bone screws are available in lengths from 10mm through 18mm in 1mm increments. The screws have either a 4.2 inch 4.6 inch diameter. Fixed angle and variable angle screws are available.

AI/ML Overview

The provided text describes a 510(k) submission for the Trinica™ Anterior Cervical Plate System, focusing on its substantial equivalence to a predicate device rather than presenting a standalone study of the device's performance against specific acceptance criteria.

Therefore, many of the requested sections about study design, sample sizes, ground truth establishment, and expert involvement cannot be extracted directly from this document.

However, I can provide the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for performance; instead, it relies on demonstrating substantial equivalence to a predicate device. The "performance" assessment is based on non-clinical tests.

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Intended Use	Identical to predicate device (Michelson Anterior Cervical Plate System K974435)	Identical
Anatomical Sites	Identical to predicate device	Identical
Target Population	Identical to predicate device	Identical
Sterilization	Identical to predicate device	Identical
Packaging	Identical to predicate device	Identical
Operating Principle	Identical to predicate device	Identical
Materials	Identical to predicate device (ASTM F136 titanium alloy, AMS 2488 Type II anodization)	Identical
Labeling	Substantially Equivalent to predicate device	Substantially Equivalent
Physical Characteristics (Design)	Substantially Equivalent to predicate device	Substantially Equivalent
Performance Testing	Meets established criteria based on risk analysis; substantially equivalent to predicate device	Meets established criteria and is substantially equivalent
Safety Characteristics	Substantially Equivalent to predicate device; design modifications do not affect safety	Substantially Equivalent; design modifications do not affect safety

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

Not applicable. This document refers to non-clinical tests which are typically bench tests (e.g., mechanical testing) and do not involve patient data or test sets in the context of clinical performance. The data provenance would be laboratory testing.

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

Not applicable. Ground truth in this context would generally refer to a clinical diagnosis or outcome, which is not part of this non-clinical testing summary. Expert involvement would be in the design and interpretation of the non-clinical tests themselves, but this information is not provided.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a "test set" in the sense of clinical data requiring adjudication.

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 is a medical device (spinal plate system), not an AI imaging or diagnostic algorithm.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a medical device, not an algorithm. Performance assessment is based on the physical device itself.

7. The Type of Ground Truth Used

For non-clinical performance testing, the "ground truth" would be established engineering standards, material specifications (e.g., ASTM F136), and biomechanical performance criteria. The document states "appropriate testing was conducted to evaluate the impact of the changes to ensure that the modified device meets established criteria."

8. The Sample Size for the Training Set

Not applicable. This is not a study involving a training set for an algorithm.

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

Not applicable. This is not a study involving a training set for an algorithm.

Summary from the document:

The 510(k) submission for the Trinica™ Anterior Cervical Plate System relies on demonstrating substantial equivalence to a predicate device (Michelson Anterior Cervical Plate System K974435). The "study" referenced is a series of non-clinical tests (likely mechanical, material, and design verification tests) that assessed the impact of design changes. The document explicitly states:

"Results of the testing demonstrated that the modified device meets established criteria."
"Testing of the Trinica Anterior Cervical Plate System demonstrates that the device is substantially equivalent to the predicate Michelson Anterior Cervical Plate System (K974435) and that the design modifications do not affect device safety and effectiveness."

The primary "acceptance criterion" articulated in the document is satisfying the FDA's requirement for substantial equivalence to a legally marketed predicate device, especially regarding safety and effectiveness, which was confirmed through these non-clinical tests.

Summary

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K0/2305

AUG 2 2 2001

510(k) Summary

Submitter's Information

Date:

Name/Address:

Telephone Number: Fax Number:

July 20, 2001

Sulzer Spine-Tech 7375 Bush Lake Road Minneapolis, Minnesota 55439

(952) 830-6205

(952) 832-5620

Janell A. Colley Senior Regulatory Affairs Specialist

Device Information

Trade Name:

Contact:

Trinica™ Anterior Cervical Plate System

Spinal Intervertebral Body Fixation

Common Name: Orthosis

Classification:

Predicate Device:

Class II, KWQ

Michelson Anterior Cervical Plate K974435 concurrence date February 19, 1998

Device Description:

Plates are offered in one-level, two-level, three-level, and four-level fusion configurations (24 mm through 92 mm). Bone screws are available in lengths from 10mm through 18mm in 1mm increments. The screws have either a 4.2 inch 4.6 inch diameter. Fixed angle and variable angle screws are available.

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Intended Use:

The Trinica Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine at levels C2-T1. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Comparison of Required Technological Characteristics

The Trinica Anterior Cervical Plate System is substantially equivalent to the predicate Michelson Anterior Cervical Plate System (K974435). The table below provides a comparison of equivalency characteristics.

Characteristics	Equivalency
Intended Use	Identical
Anatomical Sites	Identical
Target Population	Identical
Sterilization	Identical
Packaging	Identical
Operating Principle	Identical
Materials	Identical
Labeling	Substantially Equivalent
Physical Characteristics (Design)	Substantially Equivalent
Performance Testing	Substantially Equivalent
Safety Characteristics	Substantially Equivalent

Summary of Non-Clinical Tests

Based on risk analysis, appropriate testing was conducted to evaluate the impact of the changes to ensure that the modified device meets established criteria and that identified potential risks were mitigated. Results of the testing demonstrated that the modified device meets established criteria.

Conclusions Drawn From Testing

Testing of the Trinica Anterior Cervical Plate System demonstrates that the device is substantially equivalent to the predicate Michelson Anterior Cervical Plate System (K974435) and that the design modifications do not affect device safety and effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2001

Ms. Janell A. Colley Senior Regulatory Affairs Specialist Sulzer Spine-Tech 7375 Bush Lake Road Minneapolis, MN 55439-2027

Re: 510(K) Number K012305 Trade/Device Name: Trinica™ Anterior Cervical Plate System Regulation Number: 21 CFR § 888.3060 Regulatory Class: II Product Code: KWQ Dated: July 20, 2001 Received: July 23, 2001

Dear Ms. Colley:

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 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). 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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.

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Page 2 - Ms. Janell A. Colley

This letter will allow you to begin marketing your device as described in your 510(k) This iction will anow you to oogin made of substantial equivalence of your device to a premiarket notification: - The PDF 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 and If you desire specific advice to: your cetic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your at (501) 594-4097. Tractionally, et Compliance at (301) 594-4639. Also, please note the device, prease contact the online by reference to premarket notification" (21CFR 807.97). Itegulation chitica, "Misolanding of responsibilities under the Act may be obtained from the Onlici general information of the statunce at its toll-free number (800) 638-2041 or (301) Division of Sinall Marianaolaaress "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

R. Mark M. Melleuson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices

Enclosure

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Indications for Use Statement

510(K) Number:

Device Name: Trinica™ Anterior Cervical Plate System

Indications for Use:

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark N. Milkerson

on Sign-Off Division of General, Restorative and Neurological Devices

510(k) Number K012305

OR Over-

Prescription Use _____________________________________________________________________________________________________________________________________________________________

the-Counter-Use (Per 21 CFR 801.109)

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.