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The flamenco™ is a spinal fixation system intended to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion.

When used as posterior, pedicle screw fixation, the system is intended for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients. In addition, when used as a pedicle screw fixation system in the non-cervical posterior spine (T1 to S2), the system is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion in skeletally mature patients.

When used as a posterior, non-cervical, hook and/or sacral/iliac fixation system (i.e., nonpedicle screw), the flamenco™ is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (as conformed by patient history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, lordosis, spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.

The flamenco™ consists of rods, monoaxial and polyaxial pedicle screws, hooks and transverse connectors with locking set screws. The components are available in various sizes to accommodate differing patient anatomy. Rods are available in one diameter and a variety of lengths. Monoaxial and polyaxial screws are available in a variety of diameter-length combinations. Hooks are offered in a variety shapes and sizes.

The provided text describes the "flamenco™ spinal fixation system," a Class II medical device. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a comprehensive study report for standalone performance or comparative effectiveness with AI.

Based on the provided information, the following can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The acceptance criteria are implied to be achieving performance at least on par with the predicate devices under the specified ASTM F1717 mechanical tests.

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

The document reports mechanical performance data, not clinical performance data from a test set of patient cases. Therefore, information regarding "sample size used for the test set" (referring to patient data) and "data provenance" (country of origin, retrospective/prospective) is not applicable in this context. The testing was laboratory-based mechanical testing of "worst case" device constructs.

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

As this is a mechanical testing study, there were no human experts involved in establishing "ground truth" in the clinical sense. The "ground truth" for the mechanical tests would be the physical properties and performance measured by standardized mechanical testing equipment.

4. Adjudication Method for the Test Set:

Not applicable, as this was a mechanical test, not a clinical study requiring adjudication of expert interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This device is a spinal fixation system, not an AI diagnostic or therapeutic software that would typically be evaluated with MRMC studies comparing human readers with and without AI assistance.

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

Yes, in spirit, a standalone performance was done for the device's mechanical properties. The mechanical tests were performed on the device "constructs" themselves, independent of human interaction during the test. This is not "standalone algorithm performance" in the context of AI, but rather standalone performance of the physical device.

7. The Type of Ground Truth Used:

The "ground truth" for the mechanical performance study was physical measurements and adherence to engineering standards (ASTM F1717). The performance was compared against the measured performance of predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical implant, not an AI algorithm that requires a "training set."

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

Not applicable, as there is no training set for a physical device.

Summary of Study:

The study described is a mechanical performance study conducted according to ASTM F1717. This standard specifies methods for static and dynamic testing of spinal implant constructs. The "flamenco™" system's "worst case" construct was subjected to static compression bending, torsion, and dynamic compression bending. The objective of the study was to demonstrate that the mechanical performance of the flamenco™ system is equivalent to or superior to that of legally marketed predicate devices. The study concluded that the "flamenco™ performs as well as or better than the predicate devices," thereby meeting the implied acceptance criteria for mechanical equivalence.

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