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The Solanas® Posterior OCT Fixation System is intended to provide immobilization of spinal segments as an adjunct into fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability of deformity; failed previous fusions (e.g., pseudoarthorsis); tumors involving the cervical 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 Solanas Posterior OCT Fixation 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 advance stage turnors 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 Solanas Posterior OCT Fixation System may be connected to the components in the Zodiac® Polyaxial Spinal Fixation System, the Arsenal® Spinal Fixation System, or the Invictus™ Spinal Fixation System offered by Alphatec Spine using the Rod Connectors or Transitional Rods.

The Solanas Posterior OCT Fixation System is a spinal fixation system intended to improve stability of the occipital, cervical, and thoracolumbar areas of the spine (Occiput-T3). The Solanas Posterior OCT Fixation System is comprised of two sub-systems: a cervical thoracic system (Solanas®) and an occipital cervical thoracic system (Solanas® Avalon®) which share many of the same implants and instruments. The implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, and cobalt chromium (Co-28Cr-6Mo) alloy 1 (annealed and cold worked) and alloy 2 (warm worked) per ASTM F1537. The Solanas Posterior OCT System consists of a variety of shapes and sizes of screws, rods, hooks, bridges, connectors and general surgical instruments that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The implants are provided non-sterile to be steam sterilized by the end user. The Class I general instruments are made of stainless steel and other materials, and are provided nonsterile to be cleaned and sterilized by the end user.

The provided text is a 510(k) summary for the Alphatec Spine, Inc. Solanas® Posterior OCT Fixation System. This document focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance data and technological comparisons, rather than AI/ML device performance or clinical studies with human readers.

Therefore, most of the requested information regarding acceptance criteria for AI/ML performance, study details for AI/ML models, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth for training sets is not applicable to this submission.

Here's a breakdown of what can be extracted from the document:

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

The document does not provide specific acceptance criteria or reported device performance in the format of a table as it pertains to AI decision-making. Instead, it refers to performance testing and engineering analysis for mechanical properties, demonstrating substantial equivalence to predicate devices. The "performance data" section states:

• Acceptance Criteria (Implied / Mechanical): The previously presented mechanical testing data in predicate K173522 is sufficient to support the expanded indications for the Solanas system. This implies that the device must meet the mechanical performance standards established by the predicate device for:
  • Static and Dynamic Compression Bending
  • Static and Dynamic Torsion
  • Axial Grip
• Reported Device Performance: "Since no new device designs and no new worst case sizes are being introduced to the Solanas system, the previously presented mechanical testing data in predicate K 173522 is sufficient to support the expanded indications for the Solanas system." This indicates that the subject device's mechanical performance is considered equivalent to that demonstrated by the predicate and meets those established benchmarks without requiring new tests.

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

Not applicable. This is not an AI/ML device. The "test set" would refer to the mechanical testing conducted on the physical device components, not a dataset of images or patient information. The document does not specify sample sizes for mechanical testing, but confirms that prior testing on the predicate device (K173522) is relied upon.

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)

Not applicable. This is not an AI/ML device. "Ground truth" in this context would relate to engineering standards and measurements from mechanical testing, not clinical expert consensus.

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

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

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. The document explicitly states: "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

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)

Not applicable. The "ground truth" for this medical device's clearance is based on engineering standards and mechanical testing results (Static and Dynamic Compression Bending, Static and Dynamic Torsion, Axial Grip) as compared to a legally marketed predicate device.

8. The sample size for the training set

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

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

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

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