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The CYLOX® ST implants are interbody fusion devices intended for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies.

The cervical device is to be used in patients who have had at least six (6) weeks of non-operative treatment. The devices are to be used with autograft bone graft composed of cancellous, cortical, and / or corticocancellous bone and implanted via an anterior approach.

When used as a standalone system, CYLOX® ST is intended to be used as an adjunct to spinal fusion procedures at one level (C3-T1) and must be used with the CYLOX® ST bone screw fixation or connecting plate and must be secured with the corresponding locking screw.

When used with supplemental fixation, such as anterior cervical plates, CYLOX® ST is intended to be used as an adjunct to spinal fusion procedures at one or two levels of the cervical spine (C3-T1).

The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system. The system is comprised of interbodies, plates, and screws. The interbody device can be used as a standalone implant with screw holes for integrated fixation, or as a construct fixed with a plate and screws. The interbody implants are additively manufactured from titanium alloy (Ti-6Al-4 V ELI). The plates and screws are traditionally machined from titanium alloy (Ti-6Al-4V).

The SIGNUS CYLOX® ST Interbody System is placed in the C3 – T1 spinal region via the Cloward or Smith-Robinson approach. The interbody is available in four different footprints, with multiple heights and angulations. The standalone interbody contains a central holes angulated for fixation with screws into the cranial and caudal vertebral body. The construct interbody contains a central hole and indentation features to mate with the anterior plate.

The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

The provided text is a 510(k) summary for a medical device (CYLOX® ST) and does not contain information about an AI/ML powered device, nor does it include a study proving a device meets acceptance criteria related to AI/ML performance.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details because these elements are specific to the evaluation of AI/ML devices, which is not the subject of this document.

The document describes the non-clinical performance testing conducted for the CYLOX® ST intervertebral body fusion device to demonstrate substantial equivalence to a predicate device. This testing focused on mechanical properties and structural integrity according to ASTM standards.

Here's the relevant information that could be extracted and how it relates to the request (even though it's not AI/ML related):

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

Notes on the above table: The text states, "Substantial equivalence was supported by the results of verification testing to confirm that features, geometry and performance of the subject device performs as well as the predicate system, including: [list of tests]." This implies that the acceptance criteria were the successful completion and meeting of the requirements stipulated by each listed ASTM standard. The reported performance is that the device met these standards, thus demonstrating "substantial equivalence."

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: Not specified in the provided text. The ASTM standards would define the required sample sizes for each test.
• Data Provenance: Not applicable. These are non-clinical (mechanical) tests, not clinical data or patient data.

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):

• Not applicable as this is not an AI/ML study involving expert ground truth.

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

• Not applicable as this is not an AI/ML study involving 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:

• No. This is a non-clinical evaluation of an interbody fusion device, not an AI/ML 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 not an algorithm.

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

• Not applicable. Ground truth for these non-clinical tests would be the physical measurements and observations of the device's behavior under controlled testing conditions, compared against the specified parameters of the ASTM standards.

8. The sample size for the training set:

• Not applicable. There is no training set mentioned as this is not an AI/ML device.

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

• Not applicable.

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