(77 days)
The ALLY™ Facet Screws are indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels:
- Trauma, including spinal fractures and/or dislocations;
- Spondylolisthesis;
- Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity: and
- 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 radios and/ or (b) degenerative disease of the facets with instability.
The ALLY™ Facet Screws provide temporary stabilization as an adjunct to spinal fusion.
The ALLY™ Facet Screws are permanent implant devices manufactured from Titanium-6AL-4V ELI. The device is available in a variety of diameters and lengths to accommodate patient anatomy. The device is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved. The device is supplied sterile and single-use only.
The provided text describes a 510(k) premarket notification for the ALLY™ Facet Screws. This document focuses on demonstrating substantial equivalence to a predicate device through technological characteristics and performance testing. It does not contain information typically found in a study proving a device meets acceptance criteria related to AI/ML performance.
Instead, the document details bench testing for a medical implant (facet screws) to demonstrate its mechanical properties and safety.
Here's an analysis based on the provided text, while noting the absence of AI/ML-specific study details:
1. A table of acceptance criteria and the reported device performance
The document states: "In all instances, the ALLY™ Facet Screws functioned as intended and met all pre-determined acceptance criteria. Bench testing results of the ALLY™ Facet Screws exceeded those of the predicate Spartan S Facet System."
While the specific numerical acceptance criteria values for each test are not explicitly provided, the document implies that such criteria exist and were met or exceeded. The tests performed are listed as:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Met pre-determined criteria for Static and Dynamic Cantilever Bending per ASTM F2193-14 | ALLY™ Facet Screws functioned as intended and met all pre-determined acceptance criteria. Bench testing results exceeded those of the predicate Spartan S Facet System. |
| Met pre-determined criteria for Static Torsion Testing per ASTM F543-13 | ALLY™ Facet Screws functioned as intended and met all pre-determined acceptance criteria. Bench testing results exceeded those of the predicate Spartan S Facet System. |
| Met pre-determined criteria for Static Pull-Out Testing per ASTM F543-13 | ALLY™ Facet Screws functioned as intended and met all pre-determined acceptance criteria. Bench testing results exceeded those of the predicate Spartan S Facet System. |
| Met pre-determined criteria for Drive Torque per ASTM F543-13 | ALLY™ Facet Screws functioned as intended and met all pre-determined acceptance criteria. Bench testing results exceeded those of the predicate Spartan S Facet System. |
| *Met pyrogenicity criteria (e.g., Endotoxin limit of * | Pyrogenicity Testing was conducted in compliance, and Bacterial Endotoxin Testing (BET) was used to achieve the Endotoxin limit of . |
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Mechanical and biological testing results are typically objective measurements with pass/fail criteria based on standards, not subjective assessments requiring adjudication by multiple experts.
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 (facet screws), not an AI/ML diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant to this submission.
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 (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance evaluation is based on:
- Established ASTM (American Society for Testing and Materials) standards for mechanical properties (e.g., F2193-14 for spinal fixation components, F543-13 for metallic bone screws).
- FDA guidance documents and pharmacopeial standards (USP ) for biological safety (pyrogenicity/endotoxin testing).
These standards define the expected performance benchmarks.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable for the same reason as above.
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