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510(k) Data Aggregation
(146 days)
The MEMOMETAL INTRA MEDULLARY BONE FASTENER (SMART TOE / X-FUSE) are indicated for small bone reconstruction limited to inter-digital fusion of fingers and toes and small bones fusion
MEMOMETAL INTRAMEDULARY MEMORY BONE FASTENER are single-use bone fixation appliances intended to be permanently implanted. Intramedulary memory bone fastener are a "double X-shape K-Wire" made of shape memory nickel titanium alloy.
The provided text describes a 510(k) premarket notification for a medical device, not a study evaluating software or AI performance. Therefore, many of the requested categories (such as sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable to this document.
The document indicates that the device's performance was assessed against established industry standards.
Here's a summary based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Conformance: Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants (ASTM F2063-05) | The MEMOMETAL INTRAMEDULARY MEMORY BONE FASTENER (SMART TOE & X-FUSE) conform to ASTM F2063-05. |
| Performance Conformance: Standard Specification and Test Methods for Metallic Bone Staples (ASTM F564-02 (2006)) | The MEMOMETAL INTRAMEDULARY MEMORY BONE FASTENER (SMART TOE & X-FUSE) conform to ASTM F564-02 (2006). |
| Substantial Equivalence: Equivalent to predicate devices in terms of intended use, indications for use, design, function, and material, without raising new questions of safety and effectiveness. | The MEMOMETAL INTRAMEDULARY MEMORY BONE FASTENER (SMART TOE & X-FUSE) are substantially equivalent to their predicate device K-WIRE (K022599) in terms of intended use, indications for use, design and function, and their predicate device MEMORY STAPLE (K964226) in terms of material. Minor differences do not raise new questions of safety and effectiveness. |
Study Information
- Sample size used for the test set and the data provenance: Not applicable. This is a premarket notification for a physical device, and the "test set" in this context refers to the device itself undergoing standard material and performance tests, not a dataset for software evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/software evaluation is not relevant here. The "ground truth" for this device's performance is compliance with ASTM standards.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are for conflicting expert opinions in data labeling, not for material and performance testing of a physical implant.
- 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 an intramedullary bone fastener, not an AI or software product.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical implant.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the device's performance is adherence to established industry-wide ASTM standards for metallic bone staples and nickel-titanium shape memory alloys (ASTM F564-02 (2006) and ASTM F2063-05).
- The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
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