The CETRA Anterior Cervical Plate System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:

a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);

b) Spondylolisthesis;

c) Fracture;

d) Spinal Stenosis;

e) Deformities (i.e., scoliosis, kyphosis, and/or lordosis);

f) Tumor;

g) Pseudoarthrosis;

h) Revision of previous surgery

Device Description

The CETRA Anterior Cervical Plate System consists of an assortment of non- sterile, single use, titanium alloy (Ti6Al4V ELI per ASTM F136) plates and screws that allow a surgeon to build a temporary anterior cervical implant construct. The plate is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device called the "CETRA Anterior Cervical Plate System". The context of the document is a submission to the FDA (Food and Drug Administration) for substantial equivalence to existing predicate devices.

Here's an analysis based on the provided text:

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

Based on the document, the acceptance criteria and device performance are demonstrated through non-clinical mechanical testing rather than clinical performance metrics. The core argument for substantial equivalence relies on the device's technological characteristics being similar to already approved predicate devices.

Acceptance Criteria (Stated Goal)	Reported Device Performance (Summary)
Meet ASTM F1717 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model.	Mechanical testing conducted in accordance to ASTM F1717, including: - Static Axial Compression Test - Dynamic Axial Compression Test - Static Torsion Test
Ability of the locking mechanism to retain screws after implantation.	Screw push-out test conducted, which served to mechanically evaluate the CETRA Anterior Cervical Plate System locking mechanism's ability to retain screws after being implanted.

The document concludes that the "new CETRA Anterior Cervical Plate System has the same intended use, the same indications for use, the same technological characteristics and design, same materials and the same principles of operation as the predicate Hallmark Anterior Cervical Plate System (K100614) and the additional predicate devices..." This implies that the performance in these mechanical tests was found to be comparable and acceptable, establishing substantial equivalence.

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

The document does not specify exact sample sizes for each mechanical test performed (e.g., number of plates or screws tested). It simply states that "Mechanical testing... were conducted" and "Additional mechanical testing included a screw push-out test."

Data provenance: This is a pre-market notification for a new device. The data is non-clinical (mechanical testing), not human clinical trial data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" don't directly apply in the usual sense of clinical studies. The testing was conducted by the device manufacturer, Orthofix Inc.

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

This question is not applicable in the context of this document. The "ground truth" for mechanical testing is based on established engineering standards (ASTM F1717) and physical measurements, not expert human interpretation (like in medical imaging). There's no mention of experts establishing ground truth in the way it would be done for, say, a diagnostic AI.

4. Adjudication method for the test set

Not applicable. Adjudication methods are relevant for clinical studies where human interpretation or consensus is required (e.g., in MRMC studies). For mechanical testing, the results are quantitative and objective based on defined standards.

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 device is a spinal implant, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and analysis of AI assistance is irrelevant to this submission.

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

Not applicable. This is a physical medical device, not a software algorithm.

7. The type of ground truth used

The "ground truth" for demonstrating the device's performance is based on established engineering standards and physical durability/functionality measurements as defined by ASTM F1717 and the screw push-out test. This is an objective, quantitative ground truth for mechanical properties.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" for physical product evaluation in this context.

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

Not applicable, as there is no training set mentioned or implied for this physical device.

Summary

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

December 16, 2016

Orthofix, Inc. Jacki Koch Regulatory Affairs Specialist, II 3451 Plano Parkway Lewisville, Texas 75056

Re: K162638

Trade/Device Name: CETRA Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: December 6, 2016 Received: December 7, 2016

Dear Ms. Koch:

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 devicerelated adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)	K162638
Device Name	CETRA Anterior Cervical Plate System

Indications for Use

Indications for Use (Describe)

The CETRA Anterior Cervical Plate System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:

a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);

b) Spondylolisthesis;

c) Fracture;

d) Spinal Stenosis;

e) Deformities (i.e., scoliosis, kyphosis, and/or lordosis);

f) Tumor;

g) Pseudoarthrosis;

h) Revision of previous surgery

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for Orthofix. The logo consists of a blue, stylized, abstract shape on the left, followed by the word "ORTHOFIX" in black, sans-serif font. The "R" in "ORTHOFIX" is slightly larger than the other letters. There is a trademark symbol after the "X".

K162638 CETRA Anterior Cervical Plate System

510(k) SUMMARY

CETRA Anterior Cervical Plate System

510(k) Owner InformationName:Address:	Orthofix Inc.3451 Plano ParkwayLewisville, TX 75056
Telephone Number:Fax Number:Email:	214.937.2100214-937-3322jackikoch@orthofix.com
Registration Number:	2183449
Contact Person:	Jacki Koch, Regulatory Affairs Specialist, II
Date Prepared:	September 21, 2016
Name of DeviceTrade Name / ProprietaryName:	CETRA Anterior Cervical Plate System
Common Name:	Anterior Cervical Plate System
Product Code:	KWQ
Regulatory Classification:	Class II - 21 CFR § 888.3060
Review Panel:	Orthopedic Device Panel
Primary Predicate:	Hallmark Anterior Cervical Plate System – K100614 - Orthofix
Additional Predicates:	Reliant Anterior Cervical Plate System - K030595 - OrthofixSLIM*LOC Anterior Cervical Plate System - K013877 - DepuyCodman & Shurtleff, Inc.MaxAn Anterior Cervical Plate System - K133518 - Biomet

Reason for 510(k) Submission: Orthofix is submitting this Traditional 510(k) premarket notification for the introduction of a new Anterior Cervical Plate System called CETRA Anterior Cervical Plate System.

Device Description

Intended Use / Indications for Use

The CETRA Anterior Cervical Plate System is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:

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Image /page/4/Picture/1 description: The image shows the logo for Orthofix. The logo consists of a blue abstract shape on the left, followed by the word "ORTHOFIX" in black, sans-serif font. The "®" symbol is present to the right of the word "ORTHOFIX".

K162638 CETRA Anterior Cervical Plate System

a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies);

b) Spondylolisthesis;
c) Fracture:
d) Spinal Stenosis:
e) Deformities (i.e., scoliosis, kyphosis, and/or lordosis);
f) Tumor:
q) Pseudoarthrosis:
h) Revision of previous surgery

Summary of the Technological Characteristics of the Device Compared to the Selected Predicate Devices

The technological characteristics of the CETRA Anterior Cervical Plate System are similar to the predicate device and reference device in terms of design, dimensions, intended use, materials, and performance characteristics. There are no significant differences between the CETRA Anterior Cervical Plate System and the predicate Hallmark Anterior Cervical Plate System (K100614) and the additional predicate devices Reliant Anterior Cervical System (K030595), SLIM*LOC Anterior Cervical Plate System (K013877) and MaxAn Anterior Cervical Plate System (K133518), which would adversely affect the use of the product.

PERFORMANCE DATA - Summary of Non-Clinical Test Conducted for Determination of Substantial Equivalence

Mechanical testing consisting of Static Axial Compression Test, Dynamic Axial Compression Test and Static Torsion Test were conducted in accordance to ASTM F1717. Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model.

Additional mechanical testing included a screw push-out test, which served to mechanically evaluate the CETRA Anterior Cervical Plate System locking mechanism's ability to retain screws after being implanted.

Conclusion

The new CETRA Anterior Cervical Plate System has the same intended use, the same indications for use, the same technological characteristics and design, same materials and the same principles of operation as the predicate Hallmark Anterior Cervical Plate System (K100614) and the additional predicate devices Reliant Anterior Cervical System (K030595), SLIM*LOC Anterior Cervical Plate System (K013877) and MaxAn Anterior Cervical Plate System (K133518).

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.