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Solstice CCI 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 (C1to 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 CCI 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 CCI may be connected to the titanium Life Spine NAUTILUS Spine System using the 3.5mm/5.5mm titanium parallel connectors.

The Solstice CCI 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, hooks, connectors, rods, and locking caps.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Solstice CCI components with components from any other system or manufacturer. The components should never be reused under any circumstances.

The provided FDA 510(k) clearance letter and summary for the Solstice CCI device primarily focus on mechanical and material equivalency to predicate devices, rather than an AI/ML-driven diagnostic or assistive technology. Therefore, the typical acceptance criteria and study designs associated with AI performance (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by expert consensus) are not applicable to this device submission.

The "Performance Data" section explicitly states:

"The Solstice CCI was tested according to ASTM F2706 which included Static & Dynamic Axial Compression Bending and Torsion."

This indicates that the performance evaluation was primarily mechanical testing to ensure the device's structural integrity and ability to function as intended, rather than its diagnostic accuracy or impact on human reading performance.

Given this, I cannot extract the information requested in your prompt regarding acceptance criteria and study design for an AI/ML medical device.

If this were an AI/ML device submission, the requested information would typically look like this (illustrative example based on common AI/ML diagnostic device submissions):

Hypothetical Example for an AI/ML Device (NOT based on the provided document)

Let's imagine, for the sake of demonstrating the requested output, that the Solstice CCI was an AI-driven system designed to detect spinal fractures from medical images.

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

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: 1500 medical images (e.g., CT scans of the spine).
• Data Provenance: Retrospective data collected from multiple institutions across the United States (e.g., university hospitals, large medical centers). Data diversity included varying scanner types, patient demographics, and image acquisition protocols.

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

• Number of Experts: 3 board-certified radiologists.
• Qualifications: Each radiologist had at least 10 years of experience specializing in musculoskeletal or neuroradiology and had previously participated in consensus reading studies.

4. Adjudication method for the test set

• Adjudication Method: 2+1; All cases were independently reviewed by two primary radiologists. In cases of disagreement between the two primary readers, a third, senior radiologist acted as an arbiter to establish the final ground truth.

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

• MRMC Study: Yes, an observer performance study was conducted.
• Effect Size: Human readers demonstrated a statistically significant improvement in fracture detection accuracy (measured by AUROC) when assisted by the AI algorithm compared to reading without AI assistance. The average AUROC for human readers increased from 0.85 (without AI) to 0.91 (with AI assistance), representing an improvement of 0.06 AUROC points (p < 0.001). This translated to a 15% reduction in missed fractures and a 10% reduction in false positives.

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

• Standalone Performance: Yes, the standalone performance of the AI algorithm was evaluated independently against the established ground truth on the test set. (See table in section 1 for metrics).

7. The type of ground truth used

• Type of Ground Truth: Expert Consensus (Radiologist Consensus). In some challenging cases, correlation with pathology reports (e.g., for surgical samples from confirmed fractures) or follow-up clinical outcomes (e.g., imaging at later time points) was used to support consensus.

8. The sample size for the training set

• Training Set Sample Size: 50,000 medical images (CT scans).

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

• Ground Truth for Training Set: Ground truth for the training set was primarily established through a combination of radiological reports and labels provided by a team of experienced radiologists (different from the test set readers). A subset of these images (e.g., 5-10%) underwent a more rigorous internal consensus review process (e.g., by 2-3 radiologists) to ensure high-quality labeling for critical cases or ambiguous findings. Automated methods, where clinically robust (e.g., based on structured reports or PACS annotations), might also be used to augment initial labeling.

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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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