(90 days)
The ISOBAR Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
As a pedicle screw system, the ISOBAR Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the ISOBAR Spinal System is intended for hook fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history patient history and radiographic studies), deformities (scoliosis, kyphosis and lordosis), tumor, pseudoarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.
The ISOBAR Spinal System consists of pedicle screws, rods, nuts, crosslink members and hooks. It can be used for single or multiple level fixation. All components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.
The provided text describes a 510(k) summary for the "ISOBAR Spinal System Additional Components." This document focuses on the mechanical performance and substantial equivalence of the device to existing predicate devices, rather than a clinical study evaluating diagnostic accuracy or a human-AI interaction.
Therefore, many of the requested categories for acceptance criteria and study details (like sample size for test set, number of experts, adjudication methods, MRMC study, standalone performance, training set details) are not applicable or not provided in this type of submission. This 510(k) is for a medical device (spinal implant components), not an AI algorithm or a diagnostic tool.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Mechanical Performance | Static and fatigue compression testing according to ASTM F1717-96. | "static and fatigue compression testing was performed according to ASTM F1717-96." (No specific numerical results or pass/fail stated, just that tests were performed.) |
| Material Composition | Conformance to ASTM F136 for titanium alloy (Ti-6Al-4V). | "All components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136." |
2. Sample size used for the test set and the data provenance
- Not applicable/Not provided. This submission is for mechanical device components, not a dataset for an AI algorithm. The performance data refers to material and mechanical testing, not analysis of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. Ground truth, in the context of an AI algorithm, typically refers to expert labels on a dataset. For this medical device, "ground truth" would relate to engineering standards and material properties, not clinical expert consensus on an image or patient outcome.
4. Adjudication method for the test set
- Not applicable/Not provided. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among multiple expert annotators in AI algorithm studies. This is not relevant to the mechanical testing described.
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. This is a mechanical device, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study and human-AI improvement metrics are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is hardware; there is no "algorithm only" performance.
7. The type of ground truth used
- Engineering Standards / Material Specifications. For this device, the "ground truth" for acceptance criteria revolves around established ASTM (American Society for Testing and Materials) standards for materials and mechanical performance (e.g., ASTM F136 for titanium alloy, ASTM F1717-96 for static and fatigue compression testing of spinal implant constructs).
8. The sample size for the training set
- Not applicable/Not provided. There is no "training set" as this is not an AI/machine learning product.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.