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The Pin Care Kit is intended for cleaning and protection of pin site wounds for patients with external fixation devices (halos, Ilizarov®, etc.). The Pin Care Kit is intended to enable patients to manage their own pin site wounds at home.

The Pin Care Kit is a comprehensive system designed to allow patients with external orthopedic fixation devices to manage their own pin site wounds at home.

The provided documents (K973299) do not contain information related to specific acceptance criteria, device performance studies, or clinical trial data. This submission is for a Pin Care Kit, which is an unclassified device. The FDA's letter (K973299) confirms substantial equivalence to legally marketed predicate devices based on design, materials, function, and intended use, but it does not detail specific performance metrics or studies.

Therefore, I cannot provide the requested table or answer the questions regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth.

The documents indicate:

• Device Name: Pin Care Kit
• Intended Use: For cleaning and protection of pin site wounds for patients with external fixation devices (halos, Ilizarov®, etc.). The Pin Care Kit is intended to enable patients to manage their own pin site wounds at home.
• Predicate Devices: Smith + Nephew Richards Ilizarov System, AME PinCare Management System.
• Substantial Equivalence: Claimed based on "same design, materials, function and intended use as the aforementioned devices."

Without a detailed study report, it's impossible to describe the acceptance criteria and the study that proves the device meets those criteria. The FDA approval in this case appears to be based on substantial equivalence to existing devices rather than a de novo clinical performance study against pre-defined quantitative acceptance criteria.

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