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The JAWS® Nitinol Staple System implants are indicated for use in osteotomy, arthrodesis, and fragment fixation of the bones and joints of the foot including fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement) located in the long bones of the lower extremities such as the fibula and tibia.

The JAWS® Nitinol Staple System are bone staples of various sizes to accommodate a variety of small bone applications. The implants and instruments are sold sterile.

Please note that the provided document is a 510(k) summary for a medical device (JAWS® Nitinol Staple System) seeking substantial equivalence to a predicate device, not an AI/ML-enabled imaging device. Therefore, the information requested in your prompt regarding acceptance criteria and studies for an AI device (e.g., sample size for test set, data provenance, ground truth establishment, MRMC studies, standalone performance) is not directly applicable or available in this document.

The document discusses performance testing in the context of demonstrating substantial equivalence for a physical medical implant, not an AI algorithm. The performance testing referred to here would typically involve mechanical, material, and functional tests of the staple itself, rather than diagnostic accuracy or effectiveness studies in the way you're asking for AI.

However, I can extract the information relevant to their definition of "acceptance criteria" and "study" as presented for this specific medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The specific numerical acceptance criteria for mechanical properties, MR compatibility, or corrosion are not detailed in this summary document. The "results...demonstrated the modified designs are substantially equivalent to the predicate devices" implies that the device met internal and regulatory standards for these tests. "All performance testing conducted...met the predetermined acceptance criteria or were otherwise considered acceptable."

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 applicable and thus not provided in the document as it pertains to a physical medical device (staple) and not a software/AI device. The "test set" here refers to physical samples of the staple and its components.

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 as this is not an AI/diagnostic device. Ground truth, in the context of a physical device, would relate to manufacturing specifications, material properties, and mechanical performance standards, which are evaluated by engineers and technical experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable as this is not an AI/diagnostic device. Adjudication methods are relevant for subjective interpretations, typically in diagnostic imaging or clinical trials.

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 fixation staple, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. This document is for a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For this physical device, the "ground truth" would be objective engineering specifications, material standards (e.g., ASTM, ISO), and performance benchmarks for mechanical strength, fatigue, corrosion resistance, and MR compatibility. These are established through scientific principles and standardized testing methodologies rather than expert consensus on medical images or pathology.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established:

• Not applicable. This is not an AI/ML device.

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The JAWS Nitinol Staple System implants are indicated for use in osteotomy, arthrodesis and fragment fixation of the bones and joints of the foot including fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement) located in the long bones of the lower extremities such as the fibula and tibia.

The JAWS Nitinol Staple System includes three styles of bone staples having various sizes to accommodate a variety of small bone applications. The implants and instruments are sold sterile.

The provided text describes a 510(k) premarket notification for the JAWS Nitinol Staple System, focusing on substantial equivalence to a predicate device and MRI safety and compatibility testing. It does not describe an AI/ML powered device, and therefore does not contain information on acceptance criteria for an AI model, a study proving an AI model meets acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

The "Performance Testing" section states that "MR Safety and Compatibility Testing has been completed and presented in the submission as recommended in the FDA Guidance 'Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment' issued May 20, 2021, including FDA-recognized standards tests for the following potential hazards."

Therefore, I cannot fulfill your request for an AI/ML-specific acceptance criteria and study description based on the provided document. The document describes a physical medical device (bone staples) and its testing for safety and compatibility in an MRI environment.

Ask a specific question about this device