(75 days)
The MEMOMETAL varisation staple is intended to be implanted for fixation of small bone fractures or for small bone reconstruction. The MEMOMETAL varisation staple is indicated for Akin type osteotomy.
MEMOMETAL varisation staple is a staple with two self drilling tips. The treatment with a varisation staple allows, after possible treatment of the second ray, to correct the valgus deformation of the first ray and to recreate a square or Greek foot. Two types of staples are available depending on the bone surface
This submission is for a medical device (MEMOMETAL varisation staples), not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable. The documentation focuses on demonstrating substantial equivalence to a predicate device, as required for traditional 510(k) submissions for non-AI medical devices.
However, I can extract the relevant performance data and the study type conducted for this medical device:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Conformance | Conforms to ISO 5832-1 Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-1:1997). |
| Functional & Mechanical Performance | Conforms to ASTM F564-02 Standard Specification and Test Methods for Metallic Bone staples. |
2. Sample Size and Data Provenance
Not applicable. The submission is for a non-AI medical device and relies on material and mechanical standard conformance rather than clinical or algorithmic data.
3. Number and Qualifications of Experts for Ground Truth
Not applicable for a non-AI device.
4. Adjudication Method
Not applicable for a non-AI device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This type of study is relevant to AI-assisted diagnostic devices to assess the impact of AI on human reader performance, which is not the subject of this 510(k) submission.
6. Standalone Algorithm Performance
Not applicable as this is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
For this physical device, the "ground truth" is defined by established engineering standards for metallic implants and bone staples. This includes:
- Material composition and properties: Defined by ISO 5832-1.
- Mechanical performance (e.g., strength, fatigue): Defined by ASTM F564-02.
8. Sample Size for Training Set
Not applicable as there is no algorithm or training set for a physical medical device.
9. How Ground Truth for Training Set Was Established
Not applicable.
§ 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.