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The TENOR™ Spinal System, when used for pedicle screw fixation, is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar – first sacral (LS-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation may be from L3 to sacrum); and (d) who are having the device removed after the development of a solid fusion mass.

TENOR™ Plates are intended for the LS-S I pedicle screw indication described above only.

The TENOR™ Spinal System, when used as a posterior, non-pedicle screw fixation system, is intended for the following indications: 1. Degenerative disc discase (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); 2. Pseudarthrosis; 3. Stenosis; 4. Spondylolisthesis; 5. Spinal deformities: scoliosis, kyphosis; 6. Fracture; 7. Unsuccessful previous attempts at spinal fusion; 8. Tumor resection. When used for posterior non-pedicle screw fixation, the TENOR™ Spinal System is intended for thoracic, lumbar, and sacral (TI - Sacrum) fixation only.

The TENOR™ Spinal System is a spinal device intended to provide temporary, bilateral stabilization and augment the development of a solid spinal fusion. The system comprises a variety of shapes and sizes of clamps, cross-connectors, nuts, washers, plates, and screws made of medical grade titanium alloy or stainless steel. The TENORTM Spinal System may be used in conjunction with GDLH™ 5.5mm rods, TSRH® hooks and connectors, TSRH® Low Profile CROSSLINK® plates, CD HORIZON™ Low Profile MULTI-SPAN™ CROSSLINK® plates, and/or MULTI AXIAL Low Profile MULTI-SPANTM CROSSLINK® plates for attachment to the posterior thoracic and lumbar spine. These components are assembled to fit the patient's specific anatomic needs.

The provided text is a 510(k) summary for the TENOR™ Spinal System. It details the device's description, indications for use, and a claim of substantial equivalence. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

The statement "Documentation was provided which demonstrated the TENOR™ Spinal System to be substantially equivalent to itself" is a very unusual and likely erroneous statement within the context of a 510(k). Typically, substantial equivalence is demonstrated by comparing the new device to a legally marketed predicate device. This implies that the device is either (a) a re-submission of a previously cleared device with minor changes, or (b) the sentence is a typo and refers to a known predicate device that is not explicitly named here. Without further documentation, it's impossible to determine the true basis for substantial equivalence.

Therefore, I cannot fulfill your request for the detailed breakdowns of acceptance criteria, study methodologies, and performance metrics as this information is not present in the provided text.

Here's a breakdown of what is and is not available in the provided document, in relation to your request:

1. Table of acceptance criteria and the reported device performance:

• Not provided. The document states that the system is "substantially equivalent" but does not offer specific performance metrics or acceptance criteria for those metrics.

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

• Not provided. No information about a test set, its sample size, or data provenance is present.

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

• Not provided. There is no mention of a test set, ground truth, or experts establishing it.

4. Adjudication method for the test set:

• Not provided. No information about a test set or adjudication method is present.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable/Not provided. This device is a mechanical spinal system, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human-AI collaboration is irrelevant. No information about any comparative effectiveness study is provided.

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

• Not applicable/Not provided. As stated above, this is a mechanical device, not an algorithm. No standalone performance data is provided for the device in general.

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

• Not provided. No information about ground truth is present.

8. The sample size for the training set:

• Not applicable/Not provided. As a mechanical device, there wouldn't typically be a "training set" in the sense of machine learning. There is no information about any study sample sizes.

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

• Not applicable/Not provided. There is no mention of a training set or its ground truth.

In summary, the provided 510(k) pertains to regulatory clearance based on substantial equivalence, and it does not include the detailed study results or performance data that would typically be found in a clinical study report or a more comprehensive technical document.

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