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The KMI Wrist Fusion System is comprised of the total wrist fusion plate which is intended for wrist arthrodesis, providing fixation of small bones such as the radius and carpal bones and indicated for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed wrist fusions, segmental bone loss, or rheumatoid arthritis, and the KMI limited wrist fusion plate is intended for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis.

The KMI Wrist Fusion System consists of metal plates with holes to accommodate specific screws and the screws, all manufactured of 316L stainless steel.

The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. It is a 510(k) summary for a medical device (KMI Wrist Fusion System) seeking clearance based on substantial equivalence to predicate devices, not on performance against specific acceptance criteria.

Therefore, I cannot populate the requested table or answer the questions related to studies, sample sizes, experts, adjudication, or ground truth.

The document explicitly states:

• "Summary of Performance Date: Not applicable." (Page 2)
• "Conclusions Drawn from Nonclinical and Clinical Tests: Not applicable." (Page 2)

This indicates that a performance study as typically understood for new device claims was not conducted or required for this 510(k) submission, which relies on predicates.

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The KMI Wrist Fusion System is intended for wrist arthrodesis, providing fixation of small bones such as the radius and carpal bones and indicated for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed wrist fusions, segmental bone loss, or rheumatoid arthritis

The KMI Wrist Fusion System consists of a rigid bar measuring 77.47 mm in length with holes to accommodate specific screws and the screws, both manufactured of 316L stainless steel.

The provided text does not contain information related to acceptance criteria, device performance, clinical studies, or an AI/ML powered device.

The document is a 510(k) submission for the KMI Wrist Fusion System, a medical device for wrist arthrodesis. It primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or AI-related metrics.

Ask a specific question about this device