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The Momentum™ Posterior Spinal Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracolumbar and sacroiliac spine. When used as a posterior spine system, Momentum is intended for the following indications: degenerative disc disease, spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, and/ or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudoarthrosis and failed previous fusion.

In order to achieve additional levels of fixation, the Momentum Posterior System can also be connected to the neon3® universal OCT spinal stabilization system via transition rods or connectors. Please refer to the neon3 Instructions for Use for a list of indications for use.

The Momentum™ Posterior Spinal Fixation System consists of longitudinal members (rods), anchors (screws), connectors (rod/rod and rod/anchor) and fasteners in a variety of sizes to accommodate differing anatomic requirements.

This document is a 510(k) summary for the Momentum™ Posterior Spinal Fixation System. It describes the device, its intended use, and its substantial equivalence to predicate devices, primarily based on mechanical testing. It does not describe an AI/ML-based medical device. Therefore, the questions related to acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance metrics, ground truth, expert involvement, and sample sizes for AI model training/testing, are not applicable to the provided document.

The document focuses on the mechanical performance of a spinal fixation system. Below is the relevant information from the document related to its performance as a physical medical device, structured as closely as possible to the request, while noting the non-applicability of AI/ML specific criteria.

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• The document mentions "Mechanical testing of worst case Momentum™ System constructs." However, it does not specify the sample size (number of constructs tested) used for these mechanical tests.
• Data Provenance: Not specified, but generally, mechanical testing for medical devices is conducted in a laboratory setting, not typically described by country of origin or retrospective/prospective data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This question is not applicable as the device is a mechanical spinal fixation system, not an AI/ML diagnostic or prognostic tool. "Ground truth" in this context would refer to the physical and mechanical properties measured in a lab, not expert interpretations of medical images or data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This question is not applicable. Mechanical testing typically involves predefined test methods and measurements, not adjudication by human experts.

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

• This question is not applicable as the device is a mechanical spinal fixation system and does not involve human readers or AI assistance.

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

• This question is not applicable as the device is a mechanical spinal fixation system and does not involve algorithms or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this device would be its measured mechanical properties (e.g., strength, stiffness, resistance to pull-off) determined experimentally and compared against established industry standards (ASTM F1717) and the performance of predicate devices. This is not "expert consensus," "pathology," or "outcomes data" in the medical sense.

8. The sample size for the training set

• This question is not applicable as the device is a mechanical spinal fixation system and does not involve AI/ML models with training sets.

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

• This question is not applicable for the same reason mentioned in point 8.

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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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