(222 days)
The MIS Bunion Plating System is intended for fixation of osteotomies and corrective procedures of the hallux and associated disorders such as hallux valgus.
The CrossRoads MIS Bunion System contains a buttressing implant which can be surgically implanted using a minimally invasive surgical technique to correct hallux valgus. The MIS Bunion implant is to be made of implant grade titanium (Ti-6A1-4V ELI) per ASTM F136 with features allowing it to accept a CrossRoads MotoBAND CP screw (previously cleared in K 152306 ) in the distal end of the implant. Instrumentation required for performing this surgery include a k-wire, for use with an osteotomy guide, and osteotome. Additional general surgical instrumentation utilized include reamers, drill guide, and depth guage. The MIS Bunion implant is tapered on the proximal end so that it can be easily inserted into the intramedullary canal of the metatarsal and the distal head of the implant will seat directly against the osteotomy surface. The effect of the MIS Bunion implant being wedged firmly within the intramedullary canal is that it acts as a buttress to hold the metatarsal head in place. To accommodate a range of anatomical sizes and severities of corrections. the implant will be offered in an array of configurations; wherein each incremental size will increase in thickness on the distal end, resulting in different buttressing offsets. The tapered proximal end of the implant will also have interrupted surfaces to gain traction within the cancellous bone, thus resisting pullout. Finally, the MIS bunion implant will accept Ø3.0mm or Ø3.5mm CrossRoads MotoBAND CP screws (K152306) to secure the metatarsal head firmly in place, allowing fusion to occur.
The provided text does not describe an AI/ML device or a study involving such a device. Instead, it describes a medical device called the "MIS Bunion System" which is a metallic bone fixation appliance. The document is an FDA 510(k) premarket notification, which focuses on device design, materials, and substantial equivalence to predicate devices, rather than algorithmic performance.
Therefore, many of the requested categories related to AI/ML device acceptance criteria and study design (like ground truth, expert adjudication, MRMC studies, training set, effect size of AI assistance) are not applicable to this document.
However, I can extract the relevant "acceptance criteria" (performance testing) and the study that proves the device meets them, based on the information provided for this specific type of medical device:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Performance Testing) | Reported Device Performance |
|---|---|
| Mechanical Performance: | |
| Worst-case cross-sectional strength | Theoretical analysis showed the subject device to be substantially equivalent in terms of performance to the predicate device (CrossTIE Intraosseous Fixation System, K151270). |
| Pull-out strength | Pull-out testing showed the subject device to be substantially equivalent to the predicate device (CrossTIE Intraosseous Fixation System, K151270). |
| Biocompatibility (Pyrogenicity) | Pyrogen testing confirmed that the MIS Bunion System meets the endotoxin limit of 20 Endotoxin Units (EU)/Device. |
| Substantial Equivalence (Overall Conclusion) | No substantial differences between the MIS Bunion System and the predicate devices (CrossTIE Intraosseous Fixation System, K151270, and In2Bones Kirschner Wires, K153204) with respect to intended use and technological characteristics (basic design, materials, mechanical properties, intended effect). |
2. Sample size used for the test set and the data provenance:
- Mechanical Testing: The document does not specify a numerical "sample size" for the theoretical analysis or pull-out testing beyond implying that worst-case cross-sections were analyzed and pull-out tests were conducted. It doesn't mention data provenance in terms of country of origin or retrospective/prospective; these tests are typically internal laboratory tests.
- Pyrogen Testing: The document does not specify the number of samples or batches tested for pyrogenicity. Data provenance is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the studies are mechanical and biocompatibility tests, not studies requiring expert interpretation or ground truth establishment in the clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for mechanical and biocompatibility testing. The "adjudication" is based on meeting defined engineering and safety limits.
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 as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For mechanical testing, the "ground truth" is defined by established engineering principles, material properties (e.g., ASTM F136 for Ti-6A1-4V ELI), and performance metrics (e.g., pull-out force), often in comparison to a predicate device.
- For pyrogen testing, the "ground truth" is the established endotoxin limit (20 Endotoxin Units (EU)/Device).
8. The sample size for the training set:
- Not applicable as this is not an AI/ML device. There is no concept of a "training set" for this type of mechanical device.
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI/ML device.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.