(249 days)
The MIS Precision Chevron Bunion System is indicated for fixing and stabilizing the elective osteotomies of the mid-foot bones and the metatarsal and phalanges of the foot only.
The MIS Precision Chevron Bunion System™ is a kit designed to allow surgeons to perform a chevron bunion osteotomy, and subsequent fixation of the osteotomy, with a minimally invasive surgical technique. The MIS Precision Chevron Bunion System™ consists of a single, sterile-packaged SKU that contains both implants and instruments needed for the procedure. The implants in the kit are cannulated headless compression screws, made from titanium (Ti-6AL-4V ELI). There are two implants in the kit, however only one is used in a surgical procedure. Two implants are provided to allow the physician to select the proper size for the patient at the time of surgery. The implants are 3.5 mm diameter, with lengths of 24 mm and 27 mm. There are also single-use instruments, made of injection molded polycarbonate, PEEK, and stainless steel included in the MIS Precision Chevron Bunion System™. Instruments include an osteotomy guide (one each for left and right feet), a targeting guide, a screw guide, screwdriver, drill bit, and several K-wires and a guidewire. Additional general surgical instrumentation is utilized, but not part of the RELJA system, such as sagittal saw, drivers, and scalpel.
Based on the provided text, the device is the "MIS Precision Chevron Bunion System," which is a metallic bone fixation fastener (specifically, cannulated headless compression screws) used for foot osteotomies. The text does NOT describe an AI/ML-based device.
Therefore, many of the requested criteria such as acceptance criteria for AI performance (e.g., sensitivity, specificity), sample size for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable. The provided document is a 510(k) summary for a medical device (surgical system), not for an AI/ML algorithm.
I can, however, extract the relevant performance evaluation information for this non-AI medical device.
Acceptance Criteria and Reported Device Performance (Non-AI Device)
For this type of medical device (bone fixation fastener and surgical system), acceptance criteria are typically related to mechanical performance, biocompatibility, sterility, and usability, rather than diagnostic accuracy metrics.
| Acceptance Criteria (Type of Test) | Reported Device Performance (RELJA System) | Predicate Comparison (if applicable) |
|---|---|---|
| Biocompatibility | Complies with ISO 10993-1, ISO 10993-5 (in vitro cytotoxicity), and ISO 10993-10 (irritation and skin sensitization). | Not directly compared, but compliance indicates meeting safety standards. |
| Sterility | Complies with ISO 11137-1 and ISO 11137-2 (radiation sterilization). Bacterial endotoxin testing in accordance with FDA guidance. | Not directly compared, but compliance indicates meeting accepted standards. |
| Shelf Life | Confirmed five-year shelf-life with accelerated aging per ASTM F1980. Packaging integrity verified per ASTM F1886, ASTM F2096, and ASTM F88. | Not directly compared, but compliance indicates meeting accepted standards. |
| Static Torsion | Stronger than the predicate in torsion, per ASTM F543. | RELJA screw is stronger than the predicate (Stryker Fixos Screw System). |
| Driving Torque | Meets FDA requirements for non-spinal metallic screws, per ASTM F543. | Meets FDA requirements. Predicate comparison not explicitly stated for this metric, but implying comparable or better. |
| Axial Pullout Strength | Meets FDA requirements for non-spinal metallic screws, in accordance with FDA Guidance Document. | Meets FDA requirements. Predicate comparison not explicitly stated for this metric, but implying comparable or better. |
| Performance/Usability (Simulated Surgical Procedures) | Procedure successfully completed on male (14 total) and female (11 total) feet ranging in size from small to large. Precision osteotomy guide was properly positioned on any size foot. Fixation and fluoroscopy images showed proper location of osteotomy and implant placement. | Compared favorably in usability; the RELJA system uses single-use sterile instrumentation, while the predicate uses metal and/or reusable instruments, suggesting a potential improvement in handling or sterility control. |
As this is not an AI/ML device, the following points are not directly applicable. However, I will state what could be inferred if one were to try to map the request to the provided information, noting the disclaimers.
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2. Sample size used for the test set and the data provenance:
- Test Set (Performance/Usability Evaluation): 25 cadaveric surgical procedures (14 male, 11 female feet).
- Data Provenance: Cadaveric tissue, implying a laboratory/simulated setting, no country of origin specified. Retrospective/Prospective is not applicable in this context; it's a prospective in vitro (cadaveric) study.
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3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The "experts" were "trained foot and ankle physicians" who conducted the performance and usability testing. The number is not specified, but it was stated as "physicians" (plural). Their qualifications are "trained foot and ankle physicians." Ground truth in this context is successful completion of the procedure and proper placement as verified by fixation and fluoroscopy images, and the ability to position the guide on various foot sizes.
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4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable in the context of device performance testing. The "adjudication" was the successful completion and observation of proper placement during the simulated surgeries by the performing physicians.
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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 physical medical device, not an AI system.
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6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device, not an AI system. The mechanical testing (Static Torsion, Driving Torque, Axial Pullout Strength) could be considered "standalone" in mechanical terms, but not in the context of an AI algorithm.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For mechanical tests: Engineering standards (ASTM F543) and FDA guidance for screws.
- For usability/performance: Successful completion of surgical steps, proper guide positioning, and visual confirmation of osteotomy and implant placement via fluoroscopy images during simulated procedures. This is a form of "expert judgment/observation" within a cadaveric model.
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8. The sample size for the training set:
- Not applicable. There is no AI model to train.
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9. How the ground truth for the training set was established:
- Not applicable. There is no AI model to train.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.