(75 days)
The MEMOMETAL MEMORY STAPLES (MEMOCLIP, EASYCLIP and FOR FUSION) are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
MEMOMETAL MEMORY STAPLES are single-use bone fixation appliances intended to be permanently implanted. Memory staples are bipodal or quadripodal compression staples made of shape memory nickel titanium alloy.
The provided text describes the regulatory clearance of a medical device (MEMOMETAL MEMORY STAPLES) and includes performance data based on adherence to industry standards, rather than a study against a specific set of acceptance criteria with reported device performance metrics in the format requested.
Here's an attempt to structure the information based on the request, extracting what is available and noting what is not:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance and Compliance |
|---|---|---|
| Material Properties | Conformance to ASTM F2063-05 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants. | The MEMOMETAL STAPLES (MEMOCLIP, EASYCLIP and FOR FUSION) "conform to ASTM F2063-05". |
| Mechanical/Functional | Conformance to ASTM F564-02 (2006) Standard Specification and Test Methods for Metallic Bone Staples. This standard outlines requirements and test methods for metallic bone staples, likely covering aspects like mechanical strength, corrosion resistance, and other relevant performance characteristics for surgical staples. | The MEMOMETAL STAPLES (MEMOCLIP, EASYCLIP and FOR FUSION) "conform to ASTM F564-02 (2006)". |
| Substantial Equivalence | Demonstrated substantial equivalence to legally marketed predicate devices (K964226 MEMORY STAPLE (LANDOS - DEPUY Inc) and K993714 MEMOGRAPH STAPLE (BIOMEDICAL ENT. INC)) in terms of intended use, indications for use, material, design, and function, with no new questions of safety and effectiveness raised by minor differences. | The MEMOMETAL STAPLES are "substantially equivalent to their predicate devices... in terms of intended use and indications for use, material, design and function. Any minor differences between these two devices do not raise new questions of safety and effectiveness." |
No information is available for the following points as the document pertains to a 510(k) submission for a physical medical device, not an AI/software device requiring a clinical study with image data and expert review.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for this type of device and submission. Performance is based on compliance with material and mechanical standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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 device is a physical bone staple, not an AI/software for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" here is compliance with established engineering and material standards.
8. The sample size for the training set
- Not applicable.
9. How the ground truth for the 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.