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The SOLANAS AVALON Posterior Fixation System is intended to promote fusion of the cervical spine and the occipito-cervico-thoracic junction (occiput-T3). It is intended that this device, in any system configuration, be removed after development of solid fusion mass. The occipital bone screws are limited to occipital fixation only. Hook components are indicated for use at C1-C7. Polyaxial pedicle screws are intended for placement only in T1-T3 for anchoring of the system. These screws and offset connectors are not intended to be placed in the cervical spine. The components in the Solanas Posterior Fixation System can be linked to the components in the Zodiac Polyaxial spinal fixation system offered by Alphatec Spine using the axial rod connectors, parallel rod connectors or transitional rods. However, the components of the SOLANAS AVALON Posterior Fixation System are not intended to work with the Zodiac System.

It is intended for the following:

1. Degenerative disc disease (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
2. Spondylolisthesis
3. Spinal stenosis
4. Fracture/Dislocation
5. Atlanto/Axial fracture with instability
6. Revision of previous cervical spine surgery
7. Tumors
8. Occipito-cervical dislocation

The Solanas Avalon Posterior Fixation System is a spinal fixation system that consists of a variety of non-sterile, single-use plates and screws. All implants are manufactured from titanium alloy conforming to ASTM F136 or commercially pure titanium conforming to ASTM F67. The system also contains Class I manual instruments. The implants provide stabilization during bone graft healing and/or fusion mass development.

The provided text describes a 510(k) premarket notification for the "Solanas Avalon Posterior Fixation System," a spinal fixation system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance data (mechanical testing) and comparison of technological characteristics. It does not involve a study related to device performance in a clinical setting with human subjects, nor does it typically involve the kind of "acceptance criteria" based on algorithmic performance metrics (like sensitivity, specificity, or AUC) that would necessitate a test set with ground truth established by experts.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding sample sizes, expert-established ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these are not relevant to this type of regulatory submission for a spinal fixation system.

However, I can extract the information relevant to the non-clinical performance data that serves as the "study" proving the device meets the regulatory requirements for substantial equivalence.

Here's a summary of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance: This type of data is not applicable to the provided document. The acceptance criteria here would be satisfying the mechanical testing standards to demonstrate substantial equivalence, not clinical performance metrics.

2. Sample size used for the test set and the data provenance: Not applicable. This document refers to mechanical testing of the device itself, not clinical data.

3. 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 based on objective physical measurements against established standards, not expert consensus on clinical findings.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for mechanical testing.

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 a medical device (spinal fixation system), not an AI-driven diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device.

7. The type of ground truth used: For non-clinical performance, the "ground truth" is defined by the mechanical testing standards (ASTM 2706-08) and the performance of the predicate devices. The device's performance demonstrated substantial equivalence to these established benchmarks.

8. The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Information relevant to the "study" proving the device meets acceptance criteria (for substantial equivalence):

• Acceptance Criteria (implicit for substantial equivalence): The device's mechanical performance must be "substantially equivalent" to predicate devices when tested against recognized standards.
• Study Performed: Non-clinical mechanical testing.
• Study Details:
  • Tests Conducted: In-vitro mechanical testing per ASTM 2706-08.
  • Specific Tests: Axial compression, dynamic compression, static torsion, and dynamic torsion testing of occipital fusion devices.
  • Reported Device Performance: "The test results demonstrate that the mechanical performance of the Solanas Avalon Posterior Fixation System is substantially equivalent to the predicate devices."
  • Comparator (for "ground truth" / equivalence): The predicate devices listed (Vertex Reconstruction System, Ascent POCT System, Solanas Posterior Stabilization System). The benchmark for acceptance is comparison to their performance under the same standards.
  • Data Provenance: In-vitro mechanical testing (laboratory-based, not patient data).
  • Sample Size for Testing: Not explicitly stated in the document (typical for mechanical testing reports, but generally sufficient to meet test standard requirements).

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