(25 days)
The threaded Anchor holds sutures in bone for the period of time required to allow for patient rehabilitation and tissue healing. Rotator cuff repair
The Mitek FASTIN® RC threaded titanium alloy suture anchor is preloaded on a disposable inserter assembly intended for fixation of two strands of #2 suture to bone. The Mitek FASTIN® RC Anchor is designed to be used in the surgical repair of the rotator cuff.
The Mitek FASTIN® RC Anchor is substantially equivalent to the Mitek FASTIN® anchor, which was cleared in March 1995.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Holding power equal to or greater than Mitek FASTIN® | Mechanical tests indicated holding power is equal to or greater than Mitek FASTIN®. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the mechanical tests, nor does it specify the country of origin or whether the data was retrospective or prospective. It only mentions "mechanical tests done and contained in the literature."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document. The performance assessment relies on mechanical testing against a predicate device, not on expert ground truth in a clinical or diagnostic context.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. The study is based on mechanical testing, not on human case adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes mechanical testing for device performance.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) Study
This concept is not applicable here as the device is a physical medical device (suture anchor), not an algorithm or AI system. The performance evaluated is the mechanical holding power of the anchor.
7. Type of Ground Truth Used
The "ground truth" for acceptance in this context is the mechanical holding power of the predicate device (Mitek FASTIN®) established through mechanical tests. The Mitek FASTIN® RC Anchor was then compared against this established performance.
8. Sample Size for the Training Set
This information is not applicable as this is a physical medical device and not an AI/algorithm-based product that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above.
§ 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.