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The Spinal Innovations REVOLUTION ™ Spinal Fixation System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the LS-S1 joint; b) who are receiving fusion using autogenous graft only; c) who are having the device fixed or attached to the lumbar or sacral spine; and d) who are having the device removed after the development of a solid fusion mass. When used for this indication, the fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum.

The Spinal Innovations REVOLUTION ™ Spinal Fixation System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as a hook and sacral screw system (other than pedicle screw fixation system for high grade spondylolisthesis), the Spinal Innovations REVOLUTION ™ Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with the degencration of the disc confirmed by a history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal surgery/fusion. When used for this indication, screws of the Spinal Innovations REVOLUTION ™ Spinal Fixation System are intended for sacral/iliac attachment only. Hooks and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. The levels of use for hook and sacral screw fixation of this system are TI to the sacrum.

The Spinal Innovations REVOLUTION ™ Spinal Fixation System is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. Implants of this system consist of hooks and/or screws connected to rods and are intended to be removed after solid fusion has occurred. This system includes fixed and polyaxial screws of varying diameters and lengths, and hooks in varying designs and lengths, curved and straight rods and transverse connectors.

Here's a breakdown of the acceptance criteria and study information for the Spinal Innovations REVOLUTION™ Spinal Fixation System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "various system components" being tested, implying a range of components were subjected to the biomechanical tests.
• Data Provenance: Not explicitly stated. However, given that it's a 510(k) submission for a spinal fixation system, the testing would be conducted in a laboratory setting, likely in the country of origin of the manufacturer (Tennessee, USA). The study is prospective in the sense that the device was manufactured and then tested to demonstrate its performance.

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

• This is not applicable to this type of study. The ground truth for this device's acceptance is established through objective, quantitative biomechanical testing against established ASTM standards and comparison to predicate devices, not through expert consensus on qualitative data.

4. Adjudication Method for the Test Set

• Not applicable. See point 3. Biomechanical testing results are objective measurements and do not require adjudication in the same way clinical or imaging studies might.

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

• No, an MRMC comparative effectiveness study was not done. This document describes a biomechanical performance study of a physical medical device (spinal fixation system), not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable. This device is a physical implant, not a software algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• The ground truth used for this device's acceptance is based on objective biomechanical measurements and established engineering standards (ASTM F 1798-97). The device's performance is compared directly against the performance of legally marketed predicate devices, implying that their established performance serves as the "ground truth" for what is considered safe and effective in this context.

8. The Sample Size for the Training Set

• Not applicable. This is a biomechanical study, not a machine learning study. There is no "training set" in the context of device performance testing through physical measurements.

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

• Not applicable. See point 8.

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