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tezo™ is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and with autograft to facilitate fusion.

The tezo™ Titanium Cage Family is comprised of three principal interbody fusion cages. The tezo-P and tezo-T devices have a basic rectangular shape while the tezo-A device has a basic kidney shape. All implants have a hollow center for placement of autograft. The tezo implants are available in an assortment of height, length, width and anteroposterior angulation combinations to accommodate a variety of anatomic requirements

The provided document is a 510(k) Summary for the tezo™ Titanium Cage Family and a letter from the FDA confirming substantial equivalence. This type of regulatory submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than on proving performance against specific acceptance criteria through a full clinical study with an AI component. Therefore, much of the requested information (related to AI performance, ground truth, expert adjudication, sample sizes for training/test sets, MRMC studies) is not present in this document.

However, I can extract the information that is available regarding the device's characteristics and the performance data that was presented for its clearance.

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

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

The document does not specify a "test set" in the context of clinical data for performance evaluation. The performance data presented refers to mechanical testing of the device. The sample sizes for these mechanical tests are not explicitly stated. The data provenance is derived from the manufacturing and testing of the "worst-case tezo™ device" in Germany and/or the USA, but the specific origins of the test specimens are not detailed.

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

Not applicable. This device is an intervertebral body fusion device (medical implant), not an AI algorithm. Ground truth, expert consensus, and expert qualifications are not relevant to the mechanical testing described in this 510(k) summary.

4. Adjudication method for the test set

Not applicable. This is not an AI study requiring adjudication of expert interpretations.

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. There is no AI component or human reader study described in this 510(k) summary.

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

Not applicable. There is no AI component described in this 510(k) summary.

7. The type of ground truth used

For the mechanical testing, the "ground truth" would be the established performance standards of ASTM F2077 and ASTM F2267, and the comparative performance of the predicate devices. There is no clinical "ground truth" (e.g., pathology, outcomes data) detailed in the context of this 510(k) summary as it relies on substantial equivalence to previously cleared devices based on mechanical properties and design.

8. The sample size for the training set

Not applicable. There is no AI component and therefore no training set.

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

Not applicable. There is no AI component and therefore no training set.

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