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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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The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.

The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The subject EXPEDIUM Spine System components consist of designs that interface to 5.5mm and 6.35mm rods and are available in various geometries and sizes.

This document describes a 510(k) premarket notification for the EXPEDIUM Spine System, a medical device for spinal fixation. It is not a traditional AI/ML device approval, therefore much of the requested information about AI model performance, training sets, and ground truth establishment is not applicable.

Here's the relevant information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document states that "Performance data per ASTM F 1798 were submitted to characterize the subject EXPEDIUM Spine System components addressed in this notification." This implies that the acceptance criteria are tied to the standards outlined in ASTM F 1798. However, the specific quantitative acceptance criteria (e.g., maximum deflection, fatigue life, strength) and the reported performance values are not provided in the summary. The document only confirms that data was submitted, not the results themselves.

Note: For medical devices like spinal fixation systems, acceptance criteria typically involve detailed mechanical testing (e.g., static and dynamic compression, bending, torsion), biocompatibility, and material characterization to ensure safety and effectiveness. The ASTM F 1798 standard specifically deals with the fatigue testing of intervertebral body fusion devices.

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

The document describes mechanical performance testing, not data analysis or human subject testing in the traditional sense of a "test set" for an AI model. Therefore, the concept of sample size for a "test set" and "data provenance" (country of origin, retrospective/prospective) as it applies to an AI/ML device is not applicable here. The "test set" for this device would refer to the physical components subjected to mechanical tests. The specific number of components tested is not provided in the summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as this is a physical medical device (spinal fixation system) and not an AI/ML product. The "ground truth" for such a device is established through adherence to engineering specifications, material science principles, and mechanical testing standards (like ASTM F 1798). Experts involved would be engineers, material scientists, and potentially surgeons for clinical relevance, but their role is not in establishing a data "ground truth" as it would be for an AI model.

4. Adjudication Method for the Test Set

This concept is also not applicable as this is a physical medical device. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert labeling or diagnoses for AI/ML training or evaluation datasets.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or image-analysis AI/ML systems where human readers interpret cases with and without AI assistance to measure improved performance. This device is a physical implant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

This question is not applicable as the device is a physical spinal implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering standards and mechanical test results. Specifically, the summary states "Performance data per ASTM F 1798 were submitted." ASTM F 1798 is a standard specification for fatigue test performance of spinal artificial disc prostheses and components. Therefore, the ground truth is derived from objective mechanical testing outcomes compared against established engineering standards.

8. The Sample Size for the Training Set

This information is not applicable as this is a physical medical device, not an AI/ML product. There is no "training set" in the context of machine learning. The design and manufacturing process would involve iterative engineering and testing, but not in the sense of an AI training set.

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

This information is not applicable for the same reasons as #8.

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