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1. Hand and foot bone fragment and osteotomy fixation and joint arthrodesis of the hand and foot bones.

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I am sorry, but the provided text does not contain information regarding acceptance criteria, device performance, or any studies related to the Biopro Memory Staple. The document is a 510(k) premarket notification letter from the FDA, confirming the device's substantial equivalence to legally marketed predicate devices and outlining regulatory requirements. It does not include details on testing, clinical trials, or performance metrics.

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1. Hand and foot bone fragment and osteotomy fixation and joint arthrodesis of the hand and foot bones.
2. Fixation of soft tissue to bone such as anterior cruciate reconstruction

Not Found

I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for a device called "Biopro Memory Staple," indicating that the device has been found substantially equivalent to a predicate device.

The letter discusses:

• The trade/device name and regulation information.
• The substantial equivalence determination by the FDA.
• General controls and potential additional controls applicable to the device.
• Requirements for marketing the device.
• Contact information for further inquiries.
• Indications for Use for the Biopro Memory Staple.

There is no mention of:

• Specific acceptance criteria (e.g., performance metrics, thresholds).
• A study design, methodology, or results demonstrating performance against any criteria.
• Details regarding sample sizes, data provenance, expert qualifications, ground truth establishment, or comparative effectiveness studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the text provided.

Ask a specific question about this device