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510(k) Data Aggregation
(366 days)
The Genesys Spine Apache® Anchored Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation (i.e. cleared cervical plating system) and with autograft to facilitate fusion. These patients should have had six weeks of non-operative treatment.
The Genesys Spine Apache® Anchored Cervical Interbody Fusion System includes a PEEK interbody that is implanted with two (2) titanium bone nails. The Apache® Anchored Cervical Interbody Fusion System was designed to provide additional biomechanical strength to traditional ACDF procedures through integrated fixation combined with supplemental fixation.
The Genesys Spine Apache® Anchored Cervical Interbody Fusion System implants are comprised of two components; 1) PEEK interbodies with tantalum markers and 2) titanium alloy cervical bone nails. Both the interbodies and the cervical bone nails are offered in various sizes. The bone nails are inserted through the channels in the PEEK interbody and into the adjacent cervical vertebrae. The device is inserted after a discectomy and the integrated fixation provides additional stabilization to the spine during fusion.
The interbody devices are made of polyether-ether-ketone (Invibio's PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the PEEK implants contain tantalum markers per ASTM F560 to assist the surgeon with proper placement of the device in the disc space. The bone nail components are manufactured from medical grade Ti-6A1-4V ELI titanium alloy per ASTM F-136.
The provided document describes a medical device, the Genesys Spine Apache® Anchored Cervical Interbody Fusion System, and its substantial equivalence to predicate devices, rather than a study proving an AI device meets acceptance criteria. Therefore, most of the requested information regarding AI device performance, sample sizes for test/training sets, expert involvement, and ground truth establishment is not applicable to this document.
However, I can extract information related to the non-clinical performance data and the conclusion of the tests which serves as the "acceptance criteria" for this specific medical device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test | Predetermined Pass-Fail Criterion | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Static Axial Compression | Equivalent to (or greater than) previously cleared interbody fusion systems | Met, as concluded to be substantially equivalent to predicate devices. |
| Dynamic Axial Compression | Equivalent to (or greater than) previously cleared interbody fusion systems | Met, as concluded to be substantially equivalent to predicate devices. | |
| Static Torsion | Equivalent to (or greater than) previously cleared interbody fusion systems | Met, as concluded to be substantially equivalent to predicate devices. | |
| Dynamic Torsion | Equivalent to (or greater than) previously cleared interbody fusion systems | Met, as concluded to be substantially equivalent to predicate devices. | |
| Static Subsidence | Equivalent to (or greater than) previously cleared interbody fusion systems | Met, as concluded to be substantially equivalent to predicate devices. | |
| Expulsion Testing | Equivalent to (or greater than) previously cleared interbody fusion systems | Met, as concluded to be substantially equivalent to predicate devices. | |
| Bone Nail Back-Out Force | Determined to meet acceptable force for bone nail back-out under worst-case conditions | Met, as concluded to be substantially equivalent to predicate devices. | |
| Material Conformance | PEEK Interbodies | Conformance to ASTM F2026 | Conforms to ASTM F2026. |
| Tantalum Markers | Conformance to ASTM F560 | Conforms to ASTM F560. | |
| Titanium Alloy | Conformance to ASTM F-136 | Conforms to ASTM F-136. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "a cadaveric validation study" but does not specify the sample size for this study or its provenance. It is a non-clinical, pre-market submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a physical implant, not an AI or diagnostic device that requires expert ground truth establishment for its performance metrics in the context of this submission. The "ground truth" here is the performance of predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not a diagnostic or AI device study involving human interpretation.
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 document is for a physical medical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for proving substantial equivalence was the mechanical performance and material characteristics of legally marketed predicate devices. The mechanical tests were performed against established standards (ASTM F2077-11, ASTM F2267-04, and an ASTM draft standard for expulsion testing, plus a test for bone nail back-out force).
8. The sample size for the training set
Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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