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The ARx® Spinal System implants are non-cervical spinal fixation devices intended for posterior spine (T1 to S2/ilium) and posterior hook fixation (T1-L5) in skeletally mature patients and for pediatric patients to treat adolescent idiopathic scoliosis. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

When used as a posterior spine thoracic/lumbar system, the ARx® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures and spinal deformity (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (pseudarthrosis), (6) spinal stenosis, (7) spondylolisthesis.

In order to achieve additional levels of fixation in skeletally mature patients, the ARx® Spinal System 5.5/6.0 rod system may be connected to the Solstice OccipitoCervicoThoracic Fixation System's 3.5mm rod.

The ARX® Spinal System consists of screws and longitudinal rods intended to provide temporary stabilization and immobilization following surgery to fuse a portion of the thoracic, lumbar, and/or sacral spine. The ARX® Spinal System consists of an assortment of connectors, cross connectors, rods, hooks and screws. The bone screw, head, and taper lock are assembled together during manufacturing to create the ARX® Spinal System screw assembly component. The ARX® Spinal System implant components are made from titanium alloy (Ti- 6AI-4V ELI) as described by ASTM F136 and Cobalt Chrome (Co-28Cr-6Mo) as described by ASTM F1537. Do not use any of the ARX® Spinal System components with the components from any other system or manufacturer.

This document is a 510(k) premarket notification for the ARx Spinal System, a spinal fixation device. It is important to note that this document is for a medical device (spinal implant components), not an AI/ML-driven device or diagnostic tool. Therefore, many of the requested criteria, such as acceptance criteria based on metrics like sensitivity, specificity, or AUC, sample size for AI test and training sets, expert ground truthing, and MRMC studies, are not applicable.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the mechanical performance testing of the physical implant components.

Here's a breakdown of the applicable information:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document only states that testing was performed according to these standards and that the results "demonstrate the substantial equivalency" to the predicate devices. It does not provide specific numerical results or define explicit pass/fail criteria for these mechanical tests within this summary. Such detailed results would typically be found in the full submission, not in this 510(k) summary.

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

• Sample size for test set: The document does not specify the number of physical samples (implants) used for each mechanical test. Mechanical testing typically involves a statistically relevant number of samples, but the exact count is not provided in this summary.
• Data provenance: Not applicable in the context of mechanical testing of physical implant components. The tests are performed in a lab setting, not on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The "ground truth" for mechanical testing is established by the test standards (ASTM F1717, F1798) themselves and the physical measurements taken during the tests. There are no human experts "establishing ground truth" in the way it would be for an AI diagnostic.

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

• Not applicable. Adjudication methods are relevant for human interpretation of data, typically in diagnostic or clinical studies. Mechanical testing results are objective measurements.

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. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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

• For mechanical performance, the "ground truth" is defined by the objective physical properties and performance characteristics as measured against established ASTM standards and compared to legally marketed predicate devices.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no "training set."

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

• Not applicable. As there is no training set for an AI/ML model, no ground truth needed to be established in this context.

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The SOLSTICE OCT System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 to T3): Traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The SOLSTICE OCT System is also 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 cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, The SOLSTICE OCT System may be connected to the titanium Life Spine NAUTILUS Spine System using the 3.5mm/5.5mm titanium parallel connectors.

The SOLSTICE OCT System is a temporary, titanium alloy (6AL-4V-ELI per ASTM F 136), multiple component system comprised of a variety of non-sterile, single use implantable components. The system consists of an assortment of occipital plates, occipital bone screws, polyaxial screws, hooks, connectors, rods, and locking caps.

The provided document states that the Solstice OCT System is "substantially equivalent" to predicate devices based on technological characteristics and performance data. Specific acceptance criteria and a study proving the device meets those criteria, as typically understood in a clinical efficacy or accuracy study for AI/software, are not explicitly present in this 510(k) summary.

This document describes a premarket notification for a medical device (spinal system) which, under Section 510(k) of the Food, Drug, and Cosmetic Act, aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device. The focus here is on mechanical and material equivalence, not clinical performance as evaluated by diagnostic accuracy or outcomes.

Therefore, many of the requested information points, particularly those related to AI/software performance studies (e.g., sample size for test set, ground truth experts, MRMC studies, standalone performance, training set details), are not applicable or not provided in this type of submission.

Here's a breakdown of what can be extracted and what is not available:

Acceptance Criteria and Reported Device Performance:

The document states equivalence to predicate devices based on mechanical testing. The "acceptance criteria" are implied by meeting the performance of the predicate device as described in the ASTM standards.

Information Not Applicable or Not Provided for this Device Type and Submission:

This submission is for a physical implantable device, not an AI/software device. Therefore, the following are not relevant or described:

1. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to mechanical testing of physical samples, not a dataset for algorithm evaluation.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is typically based on physical measurements and engineering specifications, not expert consensus on medical images or diagnoses.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
4. 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. This type of study relates to software/AI performance in a diagnostic context.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical testing, the ground truth is often defined by physical properties and engineering standards. Clinical outcomes data would be part of a larger clinical trial, which is generally not required for 510(k) unless substantial equivalence cannot be established through other means.
7. The sample size for the training set: Not applicable. This document does not describe an AI/ML algorithm.
8. How the ground truth for the training set was established: Not applicable.

In summary: The document establishes "substantial equivalence" of the Solstice OCT System to a predicate device primarily through mechanical testing and comparison of design, materials, and indications for use. It does not provide information about clinical performance studies, diagnostic accuracy, or AI/software validation, as those are not the focus of this particular 510(k) submission for this type of device.

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