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The Momentum Posterior Spinal Fixation System is intended to provide immobilization and stabilization 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, kyphosis, and/or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudoarthrosis and failed previous fusion.

When used in conjunction with G21 V-Steady Bone Cement, the Momentum Posterior Spinal Fixation System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. Momentum™ Posterior Spinal Fixation System Screws augmented with G21 V-Steady Bone Cement are limited for use at spinal levels where the structural integrity of the spine is not severely compromised. Iliac screws are not intended to be used with bone cement.

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

The Momentum® Posterior Spinal Fixation System is a standard pedicle screw and rod systems designed for fixation and correction in the thoracolumbar and sacroiliac spine. This 510(k) submission adds hooks, various connectors, and monoaxial screws to the previously cleared system from K231809 and K191932.

The subject hooks are intended to provide deformity correction according to patient anatomical needs. The subject connectors are intended to provide additional options to improve stability. The subject monoaxial fenestrated screws are identical below the tulip to the previously cleared fenestrated screws with the addition of the option to use G21 V-Steady bone cement. The Momentum® Posterior Spinal Fixation System is manufactured from titanium alloy Ti-6Al-4V ELI per ASTM F136 and ISO 5832-3 and cobalt chromium Co-Cr-28Mo per ASTM F1537 and ISO 5832-12.

This document is a 510(k) premarket notification decision letter for a medical device called the "Momentum® Posterior Spinal Fixation System." It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device.

The letter simply states that the FDA has reviewed the submission and determined the device to be "substantially equivalent" to legally marketed predicate devices. This determination is based on a comparison of the device's indications for use, technological characteristics, and performance data (mechanical strength testing results) to existing predicate devices.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study data for an AI/ML powered device based solely on the provided text. The document concerns a traditional implantable medical device, not an AI/ML product.

To reiterate, the provided text does not contain any of the following information:

1. A table of acceptance criteria and the reported device performance: Not applicable, as this is not an AI/ML device with performance metrics like sensitivity, specificity, etc.
2. Sample sizes used for the test set and the data provenance: Not applicable for an AI/ML model. The "test set" here refers to mechanical testing of physical components, not a data-driven model.
3. Number of experts used to establish the ground truth...: Not applicable, as ground truth is not established in the context of an AI/ML model for this device.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The performance data mentioned (ASTM F1717 Dynamic Compression Bending) refers to mechanical testing of the spinal fixation system components to ensure their structural integrity and durability, not the performance of an AI/ML algorithm.

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The uCerv Flux ™-C 3D Porous Titanium Cervical Interbody is indicated for intervertebral body fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2-T1. The device system is designed for use with supplemental fixation cleared for use in the cervical spine and with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate to facilitate fusion. The hyperlordotic implants (≥ 10°) are required to be used with an anterior cervical plate. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The uCerv Flux™-C 3D Porous Titanium Cervical Interbody implants are additively manufactured interbody fusion devices for cervical implantation. The implants are designed having porous surfaces to provide surgical stabilization of the spine. Each interbody has a central cavity that can be packed with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft material and lateral windows for radiographic visualization. The implants are available in a variety of height, length, width and lordotic angulation combinations to accommodate the patient specific anatomy and clinical circumstances.

The provided FDA document is a 510(k) clearance letter for a medical device, not a study evaluating an AI algorithm's performance. Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for AI algorithms is not present in this document.

The document describes the uCerv Flux™-C 3D Porous Titanium Cervical Interbody, an intervertebral body fusion device. The acceptance criteria and "study" described relate to the mechanical performance of this physical device, not a digital diagnostic or AI-driven system.

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

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

Explanation: The document states that "Mechanical testing of the worst case Flux-C devices was relied upon in support of the original uCerv Flux™-C 3D Porous Titanium Cervical Interbody clearance. The testing included static and dynamic axial compression and static torsion according to ASTM F2077 and subsidence according to ASTM F2267. An engineering rationale was used to demonstrate that the additional cervical interbody sizes did not introduce a new worst case." It further mentions, "Mechanical testing of the worst case subject uCerv Flux™-C 3D Porous Titanium Cervical Interbody implants included dynamic torsion according to ASTM F2077 and expulsion tests. The mechanical test results demonstrate that the uCerv Flux™-C 3D Porous Titanium Cervical Interbody performance is substantially equivalent to the predicate devices." The acceptance criteria are implicit in meeting the standards (ASTM F2077, ASTM F2267) and demonstrating substantial equivalence to predicate devices. Specific numerical thresholds for acceptance are not provided in this summary.

Regarding the remaining points (2-9), the provided document does not contain information about an AI algorithm or a study involving human readers, so these points cannot be addressed. The document is for a physical orthopedic implant.

Here's why the other points are not applicable:

• 2. Sample size used for the test set and the data provenance: Not applicable. This document is about a physical device's mechanical performance, not an AI test set with data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for an AI test set is mentioned.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set for an AI algorithm is mentioned.
• 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: Not applicable. No AI assistance or human reader study is discussed.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm is involved.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for the device is its mechanical integrity and performance as per ASTM standards, compared to predicate devices.
• 8. The sample size for the training set: Not applicable. No AI training set is mentioned.
• 9. How the ground truth for the training set was established: Not applicable. No AI training set is mentioned.

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The uNion MAX Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to T1). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.

uNion MAX is an anterior cervical plate and screw system used to provide mechanical support across implanted level(s) in the cervical spine until fusion is achieved. The components include Ø4.0mm and Ø4.5mm fixed and variable screws having self-tapping, self-drilling or self-drilling/self-tapping tips and one- through four-level plates having lengths from 8mm to 84mm. The plates incorporate a pivoting locking mechanism which functions to block screw backout. The devices are sold non-sterile.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the uNion® MAX Cervical Plate System. It describes the device and its intended use, and importantly, declares that the device is "substantially equivalent" to legally marketed predicate devices based on performance data.

However, the document does not contain any information about acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML performance. This document pertains to the regulatory clearance of a physical medical implant, not a software or AI-driven diagnostic or treatment device.

Therefore, I cannot provide the requested information. The concepts of "acceptance criteria," "reported device performance," "sample size for test set," "data provenance," "experts to establish ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "sample size for training set," and "ground truth for training set" as typically applied to AI/ML devices, are not applicable to this document.

The "Performance Data" section in the 510(k) summary refers to "ASTM F1717 mechanical testing of the worst case uNion MAX constructs included static and dynamic compression bending and static torsion." This testing is for the mechanical properties of the cervical plate system itself, ensuring its structural integrity and safety. It tests the physical attributes of the device, not its analytical or interpretive capabilities.

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