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The ProMIS™ Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: degenerative disc disease (DDD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The ProMIS™ Fixation System can be used in an open approach or a posterior, percutaneous approach with MIS instrumentation.

The ProMIS™ Fixation System consists of 3 main parts:

• 1. ProMIS™ Fusion Rods: a straight or bent rod with various lengths.
• 2. Polyaxial Pedicle screws.
• 3. Setscrew.

All components are manufactured from Ti6Al4V per ASTM F136.

The provided text describes a medical device called the ProMIS™ Fixation System and its 510(k) summary for FDA clearance. The document focuses on establishing substantial equivalence to a predicate device rather than presenting a study to meet specific acceptance criteria with performance metrics like accuracy, sensitivity, or specificity. Therefore, many of the requested details about acceptance criteria and study design are not present in this document.

However, based on the Performance Data section, the acceptance criteria are implicit in the ASTM F1717 standard for spinal implant constructs. The device's performance is demonstrated by its compliance with this standard.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the system was subjected to these tests, implying it met the criteria, but does not provide specific numerical performance results.

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

Not applicable. This document describes mechanical testing of a physical device, not an AI or diagnostic algorithm that would require a test set of data/images. The "data provenance" mentioned in your template (country of origin, retrospective/prospective) is relevant for clinical or AI studies, which this is not.

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

Not applicable. Ground truth for mechanical testing is established by the physical properties of the materials and the mechanical outcomes measured, not by expert consensus on data interpretation.

4. Adjudication method for the test set

Not applicable. Mechanical testing outcomes are typically objectively measured and do not require expert adjudication in the same way clinical data interpretation would.

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 fixation, not an AI diagnostic tool that assists human readers.

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

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

7. The type of ground truth used

The "ground truth" for the performance data in this context is the results of the mechanical tests performed according to ASTM F1717. These tests directly measure the physical performance and durability of the device under stress conditions, establishing whether it meets the engineering standards for spinal implants.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is physical device testing, not an AI/machine learning application.

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

Not applicable. There is no training set for this type of test.

Summary of the Study:

The "study" described in the document is a pre-clinical mechanical performance assessment. The ProMIS™ Fixation System was subjected to standard mechanical tests: static compression, static torsion, and dynamic compression, as specified by the ASTM F1717 standard. The purpose of these tests was to demonstrate the substantial equivalence of the ProMIS™ System to the predicate devices (THUNDERBOLT™ and LANCER™ Pedicle Screw Systems) in terms of mechanical properties and safety/effectiveness for its intended use. The document concludes that the performance data demonstrates substantial equivalence, indicating that the device met the mechanical acceptance criteria implied by the ASTM F1717 standard.

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