(108 days)
The MEMOMETAL INTRAMEDULLARY 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 INTRAMEDULLARY MEMORY BONE FASTENER new device designs are single-use bone fixation appliances intended to be permanently implanted. Intramedullary memory bone fastener are a "double X-shape K-Wire" made of shape memory nickel titanium alloy.
The provided text refers to a 510(k) summary for a medical device called the "MEMOMETAL INTRAMEDULLARY BONE FASTENER (SMART TOE / X-FUSE)". This document is a premarket notification to the FDA, not a study report. It states that the device is substantially equivalent to a previously cleared predicate device based on performance data and a comparison to established standards. Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, a specific study proving it, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or detailed ground truth establishment for a study set.
However, based on the information available in the 510(k) summary, here's an attempt to structure an answer, highlighting what is and is not present:
The provided document is a 510(k) summary for a medical device and thus does not describe a clinical study in the typical sense with discrete acceptance criteria and a detailed study report. Instead, it demonstrates substantial equivalence to a predicate device based on compliance with recognized standards.
1. A table of acceptance criteria and the reported device performance
The document does not present a table of specific acceptance criteria from a clinical study for device performance. Instead, it states that the device conforms to established industry standards:
| Acceptance Criteria (Standards Conformed To) | Reported Device Performance |
|---|---|
| ASTM F564-02 (2006) Standard Specification and Test Methods for Metallic Bone Staples | Device conforms to this standard. |
| ASTM F2063-05 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants | Device conforms to this standard. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The document focuses on material and design conformance to standards, not a specific clinical testing sample.
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)
This information is not provided in the 510(k) summary, as it describes a regulatory submission based on engineering and material standards, not a clinical study involving expert ground truth assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the 510(k) summary.
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
An MRMC study is not mentioned and is not relevant to this type of device (a bone fastener) or the context of a 510(k) submission based on substantial equivalence through material and design standards. This device is not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to the described medical device, which is a physical implant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" here is the conformance to established engineering and material standards. This is verified through laboratory testing against the specifications outlined in ASTM F564-02 and ASTM F2063-05. The document does not refer to clinical outcomes or expert consensus for "ground truth" in the context of diagnostic accuracy.
8. The sample size for the training set
This information is not provided and is not applicable to the type of device or the regulatory submission. There is no machine learning model involved that would require a training set.
9. How the ground truth for the training set was established
This information is not provided and is not applicable, as there is no training set mentioned or implied.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.