(56 days)
The Arthrex Spine Compression FT Screws are intended to stabilize the spine as an aid to fusion through immobilization of the facet joints, either through bilateral transfacet fixation, or unilateral transfacet fixation when used contralateral to pedicle screw fixation. The Arthrex Spine Compression FT Screws are intended to be used with or without bone graft, at a single or multiple levels, from C2 to S1, for treatment of any or all of the following: pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity; spondylolisthesis; spondylolysis; degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies; degeneration of the facets with instability and trauma including spinal fractures and/or dislocations. The Arthrex Spine Compression FT Screw is also indicated for fracture fixation of small bones and bone fragments including pars interarticularis and odontoid. The fracture fixation of pars interarticularis is indicated for the adult and adolescent population (12 to 21 years of age).
The Arthrex Spine Compression FT Screws are headless, threaded, cannulated titanium implants that are available in a variety of sizes. The screws have a fully threaded screw shaft with a tapering head and a variable-stepped thread pitch that allows the screw the ability to provide compression and stability between bony fragments or joints.
The provided FDA approval letter heavily focuses on the regulatory and administrative aspects of the device, primarily confirming its substantial equivalence to predicate devices based on non-clinical performance data. It does not contain information about a study proving specific acceptance criteria related to AI/algorithm performance, human reader improvement with AI assistance (MRMC), or detailed clinical trial information.
The document discusses the mechanical performance of the Arthrex Spine Compression FT Screw, which is a physical medical device (a screw for spinal fixation), not a software or AI-driven diagnostic tool. Therefore, many of the requested points (e.g., sample size for test set, ground truth for test set, number of experts, MRMC study, standalone algorithm performance, training set details) are not applicable to the type of device described in this FDA letter.
However, based on the information provided, I can infer and state what is available regarding the device's performance demonstration:
Device: Arthrex Spine Compression FT Screw
Purpose of Submission: To obtain clearance for the Arthrex Spine Compression FT Screws for spine indications, demonstrating substantial equivalence to predicate devices.
Type of Device: A physical, implantable medical device (a screw for spinal fixation), not an AI/software diagnostic tool.
Acceptance Criteria and Device Performance (Non-Clinical)
Since this is a physical device, the "acceptance criteria" discussed are related to its mechanical performance and safety for implantation and MR compatibility, not diagnostic accuracy or AI performance.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Axial Push-out (per ASTM F2193 Annex 4) | Demonstrated performance substantially equivalent to predicate devices. |
| Static Cantilever Bending (per ASTM F2193 Annex 4) | Demonstrated performance substantially equivalent to predicate devices. | |
| MR Compatibility | Magnetically Induced Displacement Force | Maximum mass of subject device is less than worst-case predicate, thus not representing a new worst-case. |
| Magnetically Induced Torque | Maximum mass of subject device is less than worst-case predicate, thus not representing a new worst-case. | |
| Radiofrequency (RF) Induced Heating (per ASTM F2182-19) | Evaluated, specific results not detailed but implied acceptable for clearance. | |
| Image Artifact (per ASTM F2119-13) | Evaluated, specific results not detailed but implied acceptable for clearance. |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated for mechanical or MR compatibility testing. These are typically bench tests following established standards, not patient-based test sets.
- Data Provenance: The studies are described as "non-clinical testing" conducted by Arthrex. This implies in-house laboratory testing. Not applicable to country of origin, retrospective/prospective data as these are not clinical trials.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. The "ground truth" for mechanical and MR compatibility tests is defined by the test standards (e.g., ASTM F2193, F2182-19, F2119-13) and physical measurements, not by expert interpretation.
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical image interpretation, not for bench testing of mechanical properties.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is designed to assess human reader performance, typically with and without AI assistance, for diagnostic tasks. This device is a surgical implant, not a diagnostic AI tool.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used:
- For mechanical testing: Engineering specifications and direct physical measurements according to validated test methods (ASTM standards).
- For MR compatibility: Measurements against established safety limits and comparisons to predicate devices, verified through standardized test methods (ASTM standards) and in-vivo electromagnetic simulation.
8. The Sample Size for the Training Set:
- Not applicable. This device does not use a training set as it is not an AI/machine learning product.
9. How the Ground Truth for the Training Set was Established:
- Not applicable.
Important Note:
The letter does mention, "A clinical literature summary was provided to support the expansion of indications." This indicates that existing clinical data from published literature was used to support the broadened indications for use of the device, rather than a new, dedicated clinical trial being conducted for this 510(k) submission. However, details of this literature review are not provided in the letter.
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