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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 Spinal 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 Spinal System may be connected to the titanium Life Spine NAUTILUS Spine System using the 3.5mm titanium parallel connectors.

The hooks and rods are also intended to provide stabilization following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

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 text is a 510(k) Pre-market Notification from the FDA regarding the "Solstice OCT System," a spinal implant device. This document details the device's indications for use, its description, and a summary of performance data to demonstrate substantial equivalence to predicate devices.

However, the information provided does not contain any details about AI/ML algorithm performance, acceptance criteria for such an algorithm, or studies proving an algorithm meets those criteria. The performance data mentioned refers to static and dynamic mechanical testing of the physical spinal implant parts (per ASTM F1717), not the performance of a digital diagnostic or AI-powered system.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving a device meets those criteria, as the input document describes a physical medical device (spinal implant) and its mechanical testing, not a device involving AI or software performance.

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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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