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The Vitality® Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (TI-S2/iium), posterior hook fixation (TI-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients.

These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scolosis, Scheuermann's Disease), tumor, stenoss, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vitality Spinal Fixation System is intended to be used with autograft and/or allograft.

In addition the Vitality® Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the LS-S1 vertebra in skeletally mature patients receiving fusionenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fission. Levels of pedicle screw fixation for these patients are L3sacrum/ilium.

When used for posterior non-cervical pediatic patients, the Vitality® System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Vitality® System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The use of the Vitality Spinal Fixation System in skeletally mature patients may include the fixation of the Instinct® JavaTM Spinal Fixation System hooks, Apex Spinal System hooks, or fixation of the Universal Clamp® Spinal Fixation System to the rods of the Vitality Spinal Fixation System. The Vitality Spinal Fixation System may also be used in skeletally immature patients when connected with the Universal Clamp® Spinal Fixation System.

In order to achieve additional levels of fixation in skeletally mature patients, the Vitality Spinal Fixation System may be comected to the Virage® OCT Spinal Fixation System and the Instinct® JavaTM Spinal Fixation System offered by Zimmer Spine, using rod connectors.

The Vitality Spinal Fixation System is a thoracolumbar and sacroiliac fixation system designed to aid in the surgical correction of several types of spinal conditions. The system consists of a variety of spinal rods, pedicle screws, and connectors intended only to provide temporary stabilization during the development of a solid fusion of the spine with bone graft. The system can be rigidly locked into a variety of configurations, with each construct being customized to the patient's anatomy. All implants are single use only and should not be reused under any circumstances. The implant system is intended to be removed after solid fusion has occurred.

The system also includes instrumentation for insertion, securing and removal of the implants. All implants are made from medical grade titanium alloy; select rods are also available in medical grade cobalt chromium alloy.

The provided text is a 510(k) summary for the Vitality® Spinal Fixation System. It focuses on demonstrating substantial equivalence to predicate devices, rather than detailing a specific study proving the device meets acceptance criteria in terms of clinical performance or diagnostic accuracy. Instead, the "acceptance criteria" discussed here refer to a set of non-clinical, mechanical performance standards.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the testing was conducted "appropriately to design controls; i.e. ASTM Standards," and that the device components "were assessed and tested appropriately to design controls." It does not provide specific numerical results or direct comparisons against pre-defined numerical acceptance criteria for each test. Instead, the conclusion is based on an overall assertion of substantial equivalence to predicate devices based on the type of testing performed and the "same mechanical and functional scientific technology."

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

• Test Set Sample Size: Not applicable in the traditional sense for a clinical study. The "test set" here refers to the physical Vitality® Spinal Fixation System implants that underwent mechanical bench testing. The specific number of implants tested per condition is not provided.
• Data Provenance: The tests are non-clinical bench tests, meaning they were conducted in a laboratory setting. There is no information on the country of origin of the data or whether it was retrospective or prospective, as these terms typically apply to clinical data.

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

Not applicable. For mechanical bench testing, "ground truth" is established by adherence to standardized ASTM testing protocols and engineering principles, not by expert medical consensus.

4. Adjudication method for the test set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used in clinical studies to resolve discrepancies in expert opinions for ground truth establishment. This is a non-clinical, mechanical testing scenario.

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 510(k) submission for a spinal fixation system, not an AI/CADe device that involves human readers or diagnostic interpretation.

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

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

7. The type of ground truth used

For the mechanical performance, the "ground truth" is defined by the ASTM standards (ASTM F1717 for Static Torsion, Static and Dynamic Compression Bending, and ASTM F1798 for axial and torsional grip strength). The performance of the device components is compared against the expected performance based on these established engineering standards and, implicitly, against the performance of predicate devices that also comply with these standards.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model that requires a training set.

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

Not applicable (see point 8).

Summary of the Study:

The "study" described in the 510(k) summary is a set of non-clinical bench tests designed to assess the mechanical integrity and performance of the Vitality® Spinal Fixation System implants. These tests were conducted according to established ASTM standards (F1717 and F1798).

The primary purpose of these mechanical performance tests was to demonstrate that the new device has "the same mechanical and functional scientific technology" and "substantially equivalent performance characteristics" to previously cleared predicate devices. The document concludes that the Vitality® Spinal Fixation System is substantially equivalent based on these non-clinical tests and shared technological characteristics, rather than reporting on clinical outcomes or diagnostic accuracy.

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