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The tangoRS™ is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and sacral spine (T1-S2). When used as a posterior spine thoracic/lumbar system, the tangoRS 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, spinal tumor, pseudarthrosis and failed previous fusion.

The tangoRS™ consists of rods, polyaxial pedicle screws and crosslinks 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. Polyaxial screws are available in a variety of diameter-length combinations. Crosslinks are offered in four lengths. The purpose of this submission is to add components (a screw size and crosslink options) and two indications for use.

The provided 510(k) summary for the tangoRS™ multifunctional posterior system describes its performance through mechanical testing. Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a "sample size" in terms of individual patients or clinical cases for a test set. The performance evaluation is based on mechanical testing of "worst case tangoRS™ constructs." The exact number of constructs tested is not provided, but it would typically involve multiple samples for each test condition to ensure reproducibility.
• Data Provenance: The data is generated from in-vitro (benchtop) mechanical testing, not from patient-derived data. Therefore, there's no country of origin for clinical data, and it is not retrospective or prospective in the clinical sense.

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

This information is not applicable to this type of submission. Mechanical testing does not involve human experts establishing "ground truth" on patient data. The "ground truth" for mechanical testing is established by the specified ASTM F1717 standard and the performance of predicate devices.

4. Adjudication Method for the Test Set

This is not applicable as the study is mechanical testing, not a clinical study involving human judgment that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This submission relies on mechanical bench testing, not clinical studies involving human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable. The device is a physical medical implant (pedicle screw system), not an algorithm or software. Therefore, there's no concept of "standalone performance" in the context of an algorithm. The performance described is inherent to the device's physical and mechanical properties.

7. Type of Ground Truth Used

The "ground truth" used for this type of device and submission is based on:

• ASTM F1717 standards: These provide the accepted methodology and criteria for testing spinal implant constructs.
• Performance of predicate devices: The tangoRS™ system is compared against the mechanical performance of previously cleared predicate devices (flamenco™ {K102853}, CD HORIZON® {K031655/K041460}, Expedium {K041119/K062196}, tangoRS™ {K052385}). The implicit "ground truth" is that if the new device performs "as well as or better than" these established devices under standardized testing, it is considered safe and effective.

8. Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of mechanical testing for a physical implant. The design of the tangoRS™ system is based on established engineering principles and knowledge gained from predicate devices, but there isn't a "training set" of data in the machine learning sense.

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

This is not applicable as there is no "training set" for this type of device and study. The physical design and materials are chosen based on known biomechanical requirements and historical performance of similar devices.

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