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When used as a cervical intervertebral fusion device, the Coveris Cage is indicated for use at one level in the cervical spine, from C3-C7, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems (such as anterior cervical plating systems, or posterior systems) cleared for use in the cervical spine.

The Camber Spine Coveris Cage series of intervertebral body fusion devices are used to maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The series is comprised of cages of various fixed heights and shapes for placement in the cervical spine. Each cage has a hollow center to allow placement of graft material inside of the cage. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion. The Coveris Cage of intervertebral body fusion devices are made from the PEEK radiolucent material with embedded tantalum x-ray markers as specified in ASTM F2026 and ASTM F560, respectively.

Here's an analysis of the acceptance criteria and study information for the Camber Spine Coveris Cage (K133529) based on the provided text:

Acceptance Criteria and Device Performance (Non-Clinical Study)

The provided document describes physical and mechanical tests demonstrating the device's substantial equivalence to predicate devices. It states that "The results of these studies showed that the Coveris Cage met the acceptance criteria." However, the exact numerical acceptance criteria for each test are not specified in the provided text. The table below lists the tests performed and the general statement about meeting acceptance criteria.

Study Details:

1. Sample size used for the test set and the data provenance:

   • The document describes non-clinical (mechanical) testing, not a study involving human or animal subjects that would typically have a "test set" and "data provenance" in the traditional sense of a clinical or AI study.
   • The tests were performed on the Camber Spine Coveris Cage device itself to evaluate its mechanical properties and compare them to predicate devices. The sample size for these mechanical tests (e.g., number of cages subjected to each test) is not specified.
   • Data provenance (country of origin, retrospective/prospective) is not applicable as this was a device's physical characteristic testing, not patient data.

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

   • This is not applicable as the study involved mechanical testing of a medical device, not a diagnostic or AI-driven assessment requiring expert-established ground truth. The "ground truth" for these tests would be the physical and mechanical properties measured and compared against established ASTM standards and predicate device performance.

3. Adjudication method for the test set:

   • This is not applicable given the nature of the mechanical testing performed.

4. 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, an MRMC comparative effectiveness study was not performed, nor is it relevant for this type of device (intervertebral body fusion cage). This device is a physical implant, not an AI diagnostic tool.

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

   • No, this is not applicable as the device is not an algorithm or AI system.

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

   • The "ground truth" here is the established performance standards for intervertebral body fusion devices, as defined by ASTM international standards (e.g., ASTM F2077, ASTM F2267, ASTM F1877) and the performance characteristics of legally marketed predicate devices. The device's performance was measured against these mechanical and material benchmarks.

7. The sample size for the training set:

   • This is not applicable. There was no "training set" as this was not an AI or machine learning study.

8. How the ground truth for the training set was established:

   • This is not applicable as there was no training set. The "ground truth" for assessing device performance was based on recognized engineering standards and comparison to predicate devices, as elaborated in point 6.

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