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The tangoRS Polyaxial System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and sacral spine. When used as a posterior spine thoracic/lumbar system, the tangoRS Polyaxial System is intended for the following indications: degenerative disc disease (as defined by back pain of discogenic with degeneration of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., degenerative scoliosis, kyphosis, and/or lordosis), fracture, and spinal tumor.

The tangoRS Polyaxial System includes screws (preassembled), a locking screw, rod and cross links.

The provided text is a 510(k) summary for the tangoRS Polyaxial System, a pedicle screw spinal fixation system. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of diagnostic or AI-based performance.

The document describes the device, its intended use, and its classification, and confirms that the FDA found it substantially equivalent to predicate devices. It mentions that "Performance data were submitted," but does not detail what that performance data entailed, what the acceptance criteria were, or the results of any specific studies related to its performance characteristics against predefined criteria.

Therefore, I cannot provide the requested information for the following reasons:

1. Acceptance Criteria and Reported Device Performance: This information is not present in the provided text. The document is about regulatory clearance, not a performance evaluation against specific metrics.
2. Sample Size for Test Set and Data Provenance: Not applicable as no diagnostic or AI-based performance study is described.
3. Number of Experts and Qualifications: Not applicable as no ground truth establishment for a test set is described.
4. Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.
6. Standalone Performance Study: Not applicable.
7. Type of Ground Truth Used: Not applicable.
8. Sample Size for Training Set: Not applicable.
9. How Ground Truth for Training Set was Established: Not applicable.

The document focuses on the regulatory approval process (510(k) clearance) for a medical device that provides immobilization and stabilization of spinal segments. The "Performance Data" mentioned likely refers to mechanical testing, biocompatibility, and other engineering-related assessments required for spinal implants, rather than clinical performance data in the way one might evaluate a diagnostic AI device.

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