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The Tailored-H Cervical Stand-Alone anterior cervical interbody fusion system indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. The Tailored-H Cervical Stand-Alone System is used to facilitate intervertebral body fusion in the cervical spine and is placed via an anterior approach at one- or two-disc levels (C2-T1) using autograft bone. Patients should have at least six (6) weeks of nonoperative treatment. The Tailored-H Cervical Stand-Alone Interbody Fusion System is intended to be used with the bone screw fixation provided and requires no additional fixation.

The Tailored-H Cervical Stand-Alone System is an internal spinal fixation system consisting of additively manufactured interbody devices and machined titanium bone screws. It is designed to provide mechanical support to the cervical spine while arthrodesis occurs. The Tailored-H Cervical Stand-Alone System is available in a variety of lordosis and footprint options with a porous architecture to offer increased capacity for bone growth and mechanical properties to suit the individual pathology and anatomical conditions of the patient.

The Tailored-H cages are additively manufactured from titanium alloy Ti-6Al-4V ELI per ASTM F3001. The fixation screws and face plates are machined from titanium alloy Ti-6Al-4V ELI per ASTM F136 and ISO 5832-3.

I am unable to find information about acceptance criteria and study detailed in the prompt from the provided document. The document primarily discusses the FDA's 510(k) clearance for the "Tailored-H Cervical Stand-Alone System," focusing on its indications for use, technological characteristics, and a list of mechanical performance tests conducted.

Here's a breakdown of what the document does contain regarding performance testing:

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

The document lists performance tests conducted, but does not provide specific acceptance criteria or quantitative reported device performance values. It only states: "The results of this non-clinical testing show that the strength of the Tailored-H Cervical Stand-Alone System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

The tests performed are:

• Static Axial Compression per ASTM F2077
• Static Compression Shear per ASTM F2077
• Static Torsion per ASTM F2077
• Subsidence per ASTM F2267
• Dynamic Axial Compression per ASTM F2077
• Dynamic Compression Shear per ASTM F2077
• Dynamic Torsion per ASTM F2077

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

This information is not provided in the document. The document describes mechanical tests, not clinical studies with human subjects or data sets.

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 information is not provided. The testing described is mechanical, not involving human interpretation or ground truth establishment by experts in a clinical context.

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

This information is not applicable as the described tests are mechanical and do not involve human 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 provided and is not applicable to an intervertebral body fusion device. The document does not describe any AI component or human reader effectiveness studies.

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

This information is not provided and is not applicable to the device described.

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

This information is not provided and not applicable to the mechanical testing described. The "ground truth" for these tests would be the physical properties and performance measured against established ASTM standards.

8. The sample size for the training set:

This information is not provided. The document describes a medical device undergoing mechanical testing, not an AI or machine learning model that would require a training set.

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

This information is not provided and not applicable.

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