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The ANATOMIC PEEK PTC Cervical Fusion System is indicated for 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 intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The ANATOMIC PEEK PTC device is to be used with supplemental fixation. The ANATOMIC PEEK PTC Cervical Fusion System is also required to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, and is to be implanted via an open anterior approach.

The ANATOMIC PEEK PTC Cervical Fusion System consists of PEEK cages of various widths and heights, which can be inserted between two cervical discs to give support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone. The ANATOMIC PEEK PTC Cervical Fusion System will be available in all the same sizes as the predicate system. The only difference between the subject and predicate devices is the subject devices also have a commercially pure titanium (CP Ti) coating.

The provided text describes a 510(k) premarket notification for the ANATOMIC PEEK PTC Cervical Fusion System. The primary purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to prove clinical effectiveness through a study with acceptance criteria in the typical sense of a diagnostic or treatment efficacy study.

Therefore, the requested information categories concerning acceptance criteria, device performance, sample size, ground truth, experts, and comparative effectiveness studies are not fully applicable in the context of this 510(k) summary. Instead, the document focuses on non-clinical (mechanical and material) testing to show that the new device (with a titanium coating) is as safe and effective as its predicate.

Here's an analysis of the provided text in relation to your request:

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

The document does not present a table of specific acceptance criteria with quantitative performance metrics for clinical efficacy. Instead, it details non-clinical testing performed to demonstrate substantial equivalence to a predicate device. The acceptance criterion for a 510(k) submission like this is primarily that the device performs as well as or similarly to the predicate device in its intended use, based on the non-clinical tests.

Summary of "Acceptance Criteria" (Implicit) and Reported "Device Performance" (Non-Clinical Testing):

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not explicitly stated for each test, but standard ASTM methods typically define sample sizes (e.g., number of specimens for mechanical testing). These are laboratory tests, not human trials.
• Data Provenance: The tests are non-clinical, conducted in a laboratory setting according to ASTM standards. Country of origin for data is not specified but would typically be the company's testing facilities or contract labs. This is not retrospective or prospective in the clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. For non-clinical, mechanical testing, "ground truth" is established by adherence to recognized ASTM standards and the measurements obtained during testing. There are no human experts "establishing ground truth" in the clinical sense for this type of submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for non-clinical mechanical testing directly. The ASTM standards themselves often include criteria for valid test runs and data interpretation.

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 is not applicable. This 510(k) submission is for a medical implant (fusion system), not a diagnostic device or an AI-assisted system. No MRMC study was conducted or is relevant here.

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

This is not applicable. The device is a physical implant, not an algorithm.

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

For the non-clinical tests described, the "ground truth" is defined by the physical and mechanical properties measured according to established ASTM standards. For example, for "shear fatigue," the ground truth is the material's failure point under specified cyclical loading as determined by the test method. For animal testing, the "ground truth" would be the observed biological response to the implant in the canine model.

8. The sample size for the training set

This is not applicable. This is a medical implant, not a machine learning algorithm that requires a "training set."

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

This is not applicable, as there is no "training set" for an implant.

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