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The RONAVIS-FX is intended to be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system and for temporary bone stabilization (<24 hours) of bone fragments in extremity and orthopedic procedures.

The RONAVIS-FX is an external fixation device configured as a pin, which is inserted into the bone unicortically during orthopedic procedures. It consists of three components: a sleeve, an inner pin, and an anchor head. It is made of SUS316L and is provided non-sterilized. It should be sterilized by the user before use and is prohibited from being reused.

The provided document is an FDA 510(k) clearance letter for a medical device called RONAVIS-FX. This letter does not contain any information regarding clinical studies, acceptance criteria for an AI/algorithm, or the performance of such an AI/algorithm. It pertains to a physical medical device (an anchor pin) for bone fixation, not a digital health product or an AI-based diagnostic tool.

Therefore, I cannot fulfill the request for information regarding a study that proves the device meets acceptance criteria for an AI/algorithm, as the provided input does not describe such a device or study.

The document discusses:

• Device Type: Smooth or Threaded Metallic Bone Fixation Fastener (an anchor pin).
• Indications for Use: Applied to the skeletal system for pulling force (traction) and temporary bone stabilization (<24 hours).
• Components: Sleeve, inner pin, and anchor head made of SUS316L.
• Performance Testing: Mechanical testing (torsional strength, axial pull-out, bending strength) and biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity). These tests are standard for physical medical devices and do not involve AI or algorithmic performance evaluation against clinical ground truth.

To answer your request, I would need a different input document that describes an AI/algorithm-based medical device and its validation study.

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