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510(k) Data Aggregation
(66 days)
US SPINE FACET FIXATION SYSTEM
The Facet Fixation System is indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.
When properly used, facet screws will provide temporary stabilization as an adjunct to spinal bone grafting processes.
The US Spine Facet Fixation System consists of two implantable components, the screw in various lengths and an optional washer. Both components are made from implant grade wrought Titanium 6-Aluminum 4-Vanadium (Ti6Al4V) alloy.
The provided text describes a medical device, the "US Spine Facet Fixation System," and its 510(k) submission. However, it does not include information about a study based on AI/ML.
Here's a breakdown of the requested information based on the provided text, with "N/A" indicating information not present:
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What the device needed to achieve) | Reported Device Performance (What the device actually achieved) |
|---|---|
| Provide temporary stabilization as an adjunct to spinal bone grafting processes when properly used. | Biomechanical testing (static and fatigue 3-Point Bend Testing and Cantilever Testing) performed. The specific results of these tests showing that it meets the criteria are not detailed in the provided text. The text only states that testing was performed. This performance data was deemed sufficient for substantial equivalence to predicates. |
Missing Information: The specific quantitative acceptance criteria (e.g., "withstanding X N of force for Y cycles") and the actual quantitative results achieved by the device are not provided in this summary. It only states that testing was performed.
Study Details (Focusing on AI/ML, which is not present)
2. Sample size used for the test set and the data provenance
N/A - The document describes biomechanical testing, not a study involving a test set of data for an AI/ML device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A - This is not an AI/ML study.
4. Adjudication method for the test set
N/A - This is not an AI/ML study.
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
N/A - This is not an AI/ML study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A - This is not an AI/ML study.
7. The type of ground truth used
N/A - The performance data is based on biomechanical testing of the physical device. For a physical device, the "ground truth" would be objective measurements from these tests and observation of the device's physical integrity and stability under load.
8. The sample size for the training set
N/A - This is not an AI/ML study.
9. How the ground truth for the training set was established
N/A - This is not an AI/ML study.
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