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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:

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.

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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

Study Information

1. 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.
2. 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.
3. 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.
4. 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.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical implant.
6. 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).
7. The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/machine learning device.
8. How the ground truth for the training set was established: Not applicable.

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