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The Cervical Standalone Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Cervical Standalone Intervertebral Body Fusion Device implants are to be used with autogenous bone graft and implanted via an anterior approach. The cervical device is to be used in patients who have had six weeks of non-operative treatment. The Cervical Standalone Intervertebral Body Fusion Device is to be used with two titanium alloy screws which accompany the implant.

Device Description

The Cervical Standalone Intervertebral Body Fusion Device is comprised of PEEK-OPTIMA® LT cages which are available in a variety of sizes. The cages include toothed spikes on the top and bottom surfaces to engage with the superior and inferior end plates of neighboring vertebral bodies to resist rotation and migration. The cage shape and open center allow for bony in-growth in and around the implant. A single cage is sufficient to be used at each intervertebral level. Screws are inserted through the anterior titanium face and screwed into the vertebral bodies for bony fixation.

AI/ML Overview

The acceptance criteria for the Cervical Standalone Intervertebral Body Fusion Device are based on demonstrating substantial equivalence to a predicate device, the COALITION™ Spacer Intervertebral Body Fusion Device (K083389). The study proving the device meets these criteria involved mechanical testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Technological Equivalence	Equivalent Indications for Use	Meets: Identical indications for use.
	Equivalent Design Concepts	Meets: Same basic design.
	Equivalent Feature Comparisons	Meets: Similar features.
	Equivalent Biocompatible Materials	Meets: Uses established, known materials (PEEK-OPTIMA LT, Tantalum, Titanium 6AI-4V ELI), which are equivalent to the predicate.
	Equivalent Operating Principle	Meets: Same operating principle.
	Equivalent Manufacturing Environment	Meets: Same manufacturing environment.
	Equivalent Sterilization Process	Meets: Same sterilization process.
	Equivalent Packaging Configurations	Meets: Same packaging configurations.
Mechanical Performance	Static Compression per ASTM F-2077	Performed as designed and met or exceeded all product specifications.
	Static Compression Shear per ASTM F-2077	Performed as designed and met or exceeded all product specifications.
	Static Torsion per ASTM F-2077	Performed as designed and met or exceeded all product specifications.
	Static Load Induced Subsidence per ASTM F-2077	Performed as designed and met or exceeded all product specifications.
	Static Expulsion per ASTM F-2077	Performed as designed and met or exceeded all product specifications.
	Dynamic Compression per ASTM F-2077	Performed as designed and met or exceeded all product specifications.
	Dynamic Compression Shear per ASTM F-2077	Performed as designed and met or exceeded all product specifications.
	Dynamic Torsion per ASTM F-2077	Performed as designed and met or exceeded all product specifications.
Wear Testing	Characteristics of particulate wear debris	The result from the wear testing was found to be substantially equivalent to legally marketed devices.

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

Sample Size for Test Set: The document does not specify a distinct "test set" in terms of patient data or
clinical samples. The testing described is primarily mechanical and wear testing of the device itself.
Data Provenance: Not applicable as the testing is non-clinical, mechanical testing of the device.

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

Not applicable. The ground truth for this device's acceptance is based on adherence to engineering standards (ASTM F-2077 and F-2267) and comparison to a predicate device, not on expert clinical review of test data.

4. Adjudication method for the test set

Not applicable. This was a non-clinical, mechanical testing study against established ASTM standards and
predicate device equivalence.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a
physical implant, not an AI-powered diagnostic or assistive tool.

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. The "standalone" in the device name refers to its design as an intervertebral fusion device that does not require an anterior plate.

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

For the mechanical testing, the ground truth was defined by established engineering standards (ASTM F-2077 and F-2267) and the performance specifications of the device itself, with the aim of demonstrating that the device performed "as designed" and met/exceeded these specifications.
For substantial equivalence, the ground truth was based on the characteristics and performance of the legally marketed predicate device (K083389).

8. The sample size for the training set

Not applicable. This is a physical medical device undergoing mechanical validation, not a machine
learning model requiring a training set.

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

Not applicable, as there was no training set for a machine learning model.

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