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ORTHOVITA PEEK SPACER is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-C7. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. ORTHOVITA PEEK SPACER should be used with a commercially available supplemental spinal fixation system. ORTHOVITA PEEK SPACER should also be packed with autograft prior to implantation. Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with ORTHOVITA PEEK SPACER.

ORTHOVITA PEEK SPACER is a cervical interbody fusion device designed to be inserted within the intervertebral disc space in order to provide structural stability and act as an aid in spinal fixation. Machined from medical grade PEEK-OPTIMA®, the device is trapezoidal in shape with a hollow frame to accept autogenous bone graft. ORTHOVITA PEEK SPACER is available in a range of heights and geometries to accommodate individual pathologies and anatomical conditions.

This document describes an intervertebral body fusion device and its pre-clinical testing, not a study evaluating a device's performance against specific acceptance criteria for diagnostic output. Therefore, many of the requested categories related to clinical study design and performance metrics cannot be found in the provided text.

Here is the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the acceptance criteria for all tests were met, but it does not quantitatively define what those criteria were. It refers to the ASTM standards but doesn't detail the specific pass/fail thresholds used.

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

The provided text describes pre-clinical bench testing, not a clinical study involving a test set of data. Therefore, this information is not applicable.

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

This information is not applicable as the document describes pre-clinical bench testing of a physical device, not a diagnostic or AI-driven device requiring expert-established ground truth.

4. Adjudication method for the test set

This information is not applicable as the document describes pre-clinical bench testing of a physical device, not a diagnostic or AI-driven device requiring ground truth 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

This information is not applicable as the document describes pre-clinical bench testing of a physical device, not a diagnostic or AI-driven device involving human readers or AI assistance.

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

This information is not applicable as the document describes pre-clinical bench testing of a physical device, not an algorithm.

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

This information is not applicable. For this device, "ground truth" would be the engineering specifications and performance limits defined by the ASTM standards and the device's design, which were verified through physical testing.

8. The sample size for the training set

This information is not applicable as the document describes pre-clinical bench testing, not a machine learning study.

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

This information is not applicable as the document describes pre-clinical bench testing, not a machine learning study.

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