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The Endoskeleton® TCS System is an anterior cervical intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies) at one disc level from C2 to T1. Patients should have received 6 weeks of non-operative treatment prior to treatment with the device is indicated to be used with autograft bone. The device is a stand-alone system when used with Endoskeleton® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared for the cervical spine.

The Endoskeleton® TCS Interbody Fusion Device (IBD) implants are available in a variety of sizes with a variety of lordotic angles, to accommodate patient anatomy. Endoskeleton® TCS IBD implants are intended for treatment in Cervical Interbody Fusion used in single placement treatment placed across the disc space, and are designed with a large hollow region in the center to house bone graft material. The purpose of this submission is to change the surface treatment. The device is a stand-alone system when used with Endoskeleton® TCS integrated screws and when used without the integrated screws it requires additional supplemental fixation cleared in the cervical spine. All implantable components are manufactured from medical grade titanium alloy (Ti-6AI-4V-ELI). The only modification being made in this submission is the change to a new surface treatment which was previously cleared by the FDA for the Endoskeleton® System in K141953.

This document is a 510(k) premarket notification decision letter from the FDA regarding the Endoskeleton® TCS System, an intervertebral body fusion device. The focus of the submission is a change to the surface treatment of the device.

Since this document is a regulatory approval and not a study report, it does not contain the detailed information required to describe acceptance criteria, device performance, and study specifics in the format requested. The document states that the modified device is substantially equivalent to previously cleared devices based on a new surface treatment that was already validated. It explicitly says "no additional testing is needed."

Therefore, I cannot provide the requested information in the same way it would be presented for a study. However, I can extract the relevant statements from the document to answer some of your questions, and indicate where the information is not applicable or not provided.

Here's a breakdown of what can be extracted based on the document:

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

• Acceptance Criteria: The document implies that the acceptance criterion for this submission is "substantial equivalence" to previously cleared predicate devices. Specifically, the key acceptance criterion is that the new surface treatment modification and the overall device "does not raise new questions regarding safety and effectiveness."
• Reported Device Performance: The document states that the performance is considered substantially equivalent to the predicate devices and that the modification "presents no additional risk during implantation." The performance related to the surface treatment was previously validated with the Endoskeleton® System (K141953).

A table cannot be fully constructed as specific, quantifiable performance metrics for this particular submission are not provided, nor are explicit acceptance criteria beyond "substantial equivalence."

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

• Sample size for the test set: Not applicable and not provided. The document states that "no additional testing is needed" for this submission because the modification (surface treatment) was previously cleared and validated.
• Data provenance: Not applicable.

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

• Not applicable and not provided. This submission relies on the prior validation of the surface treatment and a comparison to predicate devices, not a new clinical test set requiring expert ground truth establishment.

4. Adjudication method for the test set

• Not applicable and not provided.

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

• Not applicable. This is a medical device for spinal fusion, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI performance metrics are irrelevant to this submission.

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

• Not applicable. This is a physical medical implant, not an algorithm.

7. The type of ground truth used

• For this specific submission (K153122), the "ground truth" for demonstrating safety and effectiveness relies on the prior validation of the new surface treatment (NanoFIX™) in a previous submission (K141953) and comparative analysis to predicate devices. It also states that "all original design validations were supported" by the addition of the surface treatment.

8. The sample size for the training set

• Not applicable and not provided. This is not an AI/machine learning device. The validation mentioned refers to engineering and biocompatibility testing for the surface treatment, not a "training set" in the context of data science.

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

• Not applicable. As noted above, this is not an AI/machine learning device. The "ground truth" for the previously validated surface treatment (K141953) would have been established through relevant in-vitro and potentially in-vivo non-clinical studies to assess its mechanical properties, biocompatibility, and intended biological response, following established regulatory guidelines for medical device components and surface modifications. The document does not detail these prior studies.

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