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When used as a vertebral body replacement, the MOBIS®, SEMIAL®, and PEEK and Titanium TETRIS™ devices are indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation.

When used as a vertebral body replacement, the KIMBA® and KIMBA® mini devices are indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The devices are intended for use as a vertebral body replacement in the lumbar spine (from L1 to L5) and are intended for use with supplemental internal fixation.

When used as an intervertebral fusion device in skeletally mature patients, the KIMBA® KIMBA® mini, MOBIS®, NOVAL®, SEMIAL®, and PEEK and Titanium TETRIS™ devices are intended for use at one level in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the involved level may be treated with the device. The devices are intended for use with a supplemental internal fixation system and with autograft to facilitate fusion.

The basic shape of the KIMBA®, KIMBA® mini, MOBIS®, NOVAL®, SEMIAL®, PEEK TETRIS™ and Titanium TETRIS™ devices is a hollow structural frame. The upper and lower aspects of the implant are open. Surface spikes assist in the positive anchorage and seating of the implant between the vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anatomical condition.

Here's a breakdown of the acceptance criteria and study information based on the provided text, using the requested structure:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document describes mechanical testing of the "worst-case device (PEEK TETRIS™)". It does not refer to a "test set" in the context of patient data or clinical performance. Therefore, information about a sample size for a test set or data provenance (country of origin, retrospective/prospective) is not applicable here as the study is a benchtop mechanical performance evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the study is a mechanical performance evaluation against established ASTM standards, not a clinical study requiring expert ground truth for patient data.

4. Adjudication Method for the Test Set

This information is not applicable as the study is a mechanical performance evaluation, not a clinical study requiring 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 applicable. The device is an implantable spinal interbody fusion device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is a physical medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the mechanical performance study was established by recognized industry standards (ASTM F2077 and ASTM F2267) and the performance of legally marketed predicate devices. The acceptance criteria were met if the tested device performed "as well as or better than the predicate devices" according to these standards.

8. The Sample Size for the Training Set

This information is not applicable. This is a mechanical performance study, not a machine learning study requiring a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above (not a machine learning study).

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