(88 days)
The CuffLink Implant System is intended to reattach soft tissue to bone in orthopedic surgical procedures.
The Implant System may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriative immobilization, throughout the healing period.
The CuffLink™ Implant System consists of six kits that will be provided sterile, for singleuse only. Each kit will contain four suture anchors, one disposable broaching punch, and one suture passing loop assembled in a single PETG tray, and sealed in a Tyvek pouch. The tray is subsequently placed in a folding carton.
The provided document is a 510(k) premarket notification from the FDA to CONMED Corporation regarding their CuffLink Implant System. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study data with acceptance criteria for device performance.
Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth establishment cannot be found in this document. The document focuses on showing the new device is as safe and effective as a previously approved one, often through non-clinical testing.
Here's what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific quantitative acceptance criteria or detailed reported performance data for the CuffLink Implant System in the way one would expect for a clinical study evaluating diagnostic accuracy or a specific functional outcome. It states that "Testing has been completed to demonstrate that the Cufflink Implant System performs as intended and is substantially equivalent to the predicate device."
It lists categories of completed test data:
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Met requirements (in accordance with ISO 10993-1 and FDA# G95-1) |
| Packaging | Testing completed (details not provided) |
| User Validation | Testing completed (details not provided) |
| Shelf-life | 18 months shelf-life established through testing (details not provided) |
| Sterilization | Testing completed (details not provided) |
| Transportation | Testing completed (details not provided) |
| Pyrogenicity (Bacterial Endotoxin) | Conducted and met the limits |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for any of the performance testing categories. It also does not mention clinical test sets or data provenance (e.g., country of origin, retrospective/prospective) because the submission focuses on non-clinical performance and a comparison to a predicate device for substantial equivalence, not a clinical outcomes study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This type of submission relies on engineering and laboratory testing for device performance characteristics, not expert consensus on clinical data.
4. Adjudication method for the test set
Not applicable. There is no mention of a test set requiring adjudication in the context of this submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device for reattaching soft tissue to bone (suture anchors), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests mentioned (biocompatibility, pyrogenicity, shelf-life, etc.), the "ground truth" would be established by validated test methods and industry standards (e.g., ISO standards for biocompatibility, specific microbial limits for pyrogenicity). No clinical or expert consensus ground truth is described in this document.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.