(197 days)
The Fastin RC Anchor is intended for: Shoulder: Rotator cuff repair.
The Mitek FASTIN RC Anchor is a threaded titanium alloy implantable suture anchor preloaded on a disposable inserter assembly intended for fixation of two strands of suture. The anchors are designed to be used in the surgical repair of the rotator cuff, and are made from Titanium 6Al-4V ELI per ASTM F-136. The attached suture is then used to reattach soft tissue back to bone where it reconnects through the healing process. Once the tissue has healed (about six weeks) the anchor function is complete and the implant becomes dormant in the bone. The proposed Fastin RC Anchor is available in 5.0mm and 6.5mm sizes and is offered with three suture options, non-absorbable Ethibond, absorbable Panacryl, and composite Orthocord.
I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) summary for a medical device (Fastin RC Anchor) and it primarily focuses on establishing substantial equivalence to a predicate device.
Here's what the document does state regarding testing:
- "Non-clinical laboratory testing was performed demonstrating that the device is safe and performs as intended." (Page 1, under "Safety and Performance")
However, it does not provide any details about:
- Specific acceptance criteria.
- The methodology, results, or outcome of these non-clinical laboratory tests.
- Any of the specific study parameters you requested such as sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set information.
The document indicates that the determination of substantial equivalence was based on a detailed device description and "changes that intend to be made to currently marketed devices," and that the changes were "either dimensional or a material change." The core argument for substantial equivalence is that these changes are minor and do not affect the safety or effectiveness of the device compared to the predicate device (K983818), and that an existing material (Orthocord suture, K040004) was added as an option.
Therefore, the requested information about acceptance criteria and detailed study results is not present in the provided text.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.