(59 days)
The Michelangelo Bunion System is intended for the following surgical indication: To assist in the correction of hallux valgus deformities by providing reduction of the 1st intermetatarsal angle.
The Instratek Michelangelo Bunion System is intended to assist in the correction of Hallux Valgus deformities by providing reduction of the 1st. intermetatarsal angle. Like the predicate device, the Michelangelo Bunion System is intended to assist in the correction of hallux valgus deformities by providing reduction of 1st intermetatarsal angles up to and including 16 degrees. The Michelangelo Bunion System may eliminate the necessity of a traditional osteotomy in the correction of Hallux Valgus deformities within the indicated criteria. The implanted device consists of three components: Medial Plate, Lateral Plate, Suture. There are 6 accessories required to implant the device: suture lasso, kwire, cannulated drill bit, kwire guide, plate bender, suture scissor.
The provided document is a 510(k) summary for the Michelangelo Bunion System and does not contain detailed information about acceptance criteria or a comprehensive study demonstrating direct device performance against such criteria. The document states that performance tests included "knot pull testing," but no specific acceptance criteria or results from this testing are provided.
Instead of a study proving the device meets acceptance criteria, the submission concludes that the device is "substantially equivalent" to predicate devices (HAV-Lok Bunion Correction System, K082384, and Arthrex Mini-Tightrope, K061925) based on similar technological characteristics and intended use. The core of the submission relies on this substantial equivalence argument rather than presenting a standalone study with defined acceptance metrics.
Therefore, most of the requested information cannot be extracted from this specific document.
However, based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Knot pull strength (specific threshold not provided) | Knot pull testing was performed (results not provided). The technological characteristics and intended use are the same as predicate devices. The device is considered "as safe and effective as the predicate devices." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document only mentions "knot pull testing" was performed, but no number of samples or tested units is provided.
- Data Provenance: Not specified. The document does not indicate the country of origin of any test data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not provided. The study mentioned (knot pull testing) is a mechanical performance test, not one requiring expert human interpretation or ground truth establishment in a clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. Adjudication methods are typically associated with clinical studies involving human readers or expert consensus, which is not the nature of the "knot pull testing" mentioned.
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
- This is not applicable as the Michelangelo Bunion System is a surgical device, not an AI-based diagnostic or assistive technology for human readers. No MRMC study was done, and therefore, no effect size related to AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable for this device. The device is a surgical implant and associated accessories, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the "knot pull testing," the ground truth would be the objectively measured force at which the knot failed. This is a physical measurement, not a clinical ground truth like pathology or expert consensus. No specific measurement data is provided.
8. The sample size for the training set
- Not applicable/Not provided. As this is a 510(k) submission for a physical device relying on substantial equivalence, there is no mention of a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable/Not provided for the same reasons as above.
§ 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.