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510(k) Data Aggregation
(95 days)
MODIFICATION TO SOLANAS POSTERIOR STABILIZATION SYSTEM
It is intended that this device, in any system configuration, be removed after the development of solid fusion mass. Hook components are indicated for use at C1-C7. Polyaxial screws are limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. These screws are not intended for placement in the cervical spine. The components in the Solanas Posterior Stabilization 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
- l Degenerative disk disease (DDD), defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
- 트 Spondylolisthesis
- . Spinal Stenosis
- 트 Fracture/Dislocation
- Atlanto/Axial fracture with instability
- 트 Revision of previous cervical spine surgery
- 트 Tumors
The SOLANAS III™ Posterior Stabilization System is a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3).
Acceptance Criteria and Device Performance for SOLANAS™ Posterior Stabilization System
Based on the provided 510(k) summary for the SOLANAS™ Posterior Stabilization System, the device's acceptance criteria and the study proving its performance are primarily based on substantial equivalence through mechanical and dynamic testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical performance similar to legally marketed predicate devices. | Mechanical and dynamic testing of the posterior stabilization system was performed. The test results demonstrate that the mechanical performance of the SOLANAS III™ Posterior Stabilization System is substantially equivalent to the predicate devices (K052201). |
| Dynamic performance similar to legally marketed predicate devices. | Mechanical and dynamic testing of the posterior stabilization system was performed. The test results demonstrate that the mechanical performance of the SOLANAS III™ Posterior Stabilization System is substantially equivalent to the predicate devices (K052201). |
| Meeting established standards for spinal fixation systems. | (Implicit in substantial equivalence and FDA clearance process, but specific standard numbers are not detailed in the provided text.) |
| Biocompatibility (implied for implantable devices). | (Implicit in substantial equivalence and FDA clearance process, but specific test results are not detailed in the provided text.) |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for the "mechanical and dynamic testing." The data provenance is also not explicitly stated beyond the fact that testing was performed. However, for mechanical and dynamic testing of medical devices in a regulatory submission, these tests are typically conducted in a laboratory setting, not with human or animal subjects, and thus "country of origin of the data" or "retrospective/prospective" wouldn't apply in the same way as clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of information is not applicable to the provided performance data. Mechanical and dynamic testing of spinal implants typically involves engineering and material science experts, not medical experts establishing ground truth in the diagnostic sense. The "ground truth" for these tests would be established by validated test methods and established engineering specifications.
4. Adjudication Method for the Test Set
The concept of an "adjudication method" (e.g., 2+1, 3+1) is not applicable to mechanical and dynamic testing of devices. Adjudication methods are used in clinical trials or studies where human interpretation or consensus is required to establish an outcome or 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
No, an MRMC comparative effectiveness study was not done. The device described is a spinal fixation system (hardware); it is not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This device is a physical implant, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the mechanical and dynamic testing would have been established by recognized engineering standards and validated test methodologies used to assess the strength, durability, and functional performance of spinal fixation systems. The comparison is made against the performance of legally marketed predicate devices, implying that the predicate devices also met these types of engineering "ground truths."
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this type of device. Training sets are used in machine learning or AI algorithm development. This device's performance is established through physical testing, not algorithmic learning.
9. How the Ground Truth for the Training Set was Established
As noted above, the concept of a "training set" and its associated "ground truth" is not applicable to this medical device.
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