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510(k) Data Aggregation
(374 days)
The MYKRES Spinal System is 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 imparment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudathrosis).
The MYKRES Spinal System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients undergoing fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion.
The MYKRES Spinal System is an internal fixation device for spinal surgery consisting of rods, screws, hooks and connectors available in various lengths, diameters, and configurations to enable close conformance to patient anatomy. A series of manual instruments (not a subject of this submission) intended to assist in the insertion and placement of the implants is provided in separate trays.
The rods, screws, hooks and connectors of the MYKRES Spinal System are made of Ti-6Al-4V titanium alloy conforming to ASTM F 136.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench Testing per ASTM F 1717) | Reported Device Performance |
|---|---|
| Static compression performance | Substantially equivalent to legally marketed spinal fixation systems |
| Static torsion performance | Substantially equivalent to legally marketed spinal fixation systems |
| Dynamic axial compression bending performance | Substantially equivalent to legally marketed spinal fixation systems |
2. Sample Size and Data Provenance for Test Set
- Sample Size: Six (6) samples for each of the worst-case MYKRES construct for the bench testing.
- Data Provenance: The data is from laboratory bench testing performed by Showa Ika Kohgyo Co., LTD. It is not patient data with country of origin.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
Not applicable. The ground truth for this device is based on objective mechanical bench testing standards (ASTM F 1717), not expert consensus on medical images or clinical outcomes.
4. Adjudication Method (Test Set)
Not applicable. This was a mechanical engineering test against established ASTM standards, not a clinical trial requiring adjudication of observations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The device is a spinal fixation system, and its evaluation focuses on mechanical performance and substantial equivalence to existing devices, not on human reader interpretation of images.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical medical device (spinal implant), not a software algorithm orAI.
7. Type of Ground Truth Used
The ground truth used was the established performance metrics and requirements outlined in the ASTM F 1717 standard for static compression, static torsion, and dynamic axial compression bending tests of spinal implants.
8. Sample Size for Training Set
Not applicable. This submission describes the evaluation of a physical medical device (spinal implant), not an AI/ML algorithm that requires a training set.
9. How Ground Truth for Training Set Was Established
Not applicable, as there is no training set for this type of device evaluation.
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