(112 days)
The Cayenne Medical, Inc. CuffLink™ Suture Anchors are intended for use for the reattachment of soft tissue to bone for Rotator Cuff Repairs.
The CuffLink™ Suture Anchor is a sterile, manually operated, single procedure suture anchor device for reattachment of soft tissue to bone in procedures such as shoulder rotator cuff repair. There are two sutures loaded through the center of the anchor around, an eyelet at the distal tip of the anchor and back through the center. The suture anchor is mounted on a driver. The CuffLink Suture Anchor incorporates design features that facilitate suture anchor placement under arthroscopic or open, limited access conditions in soft tissue to bone reattachment procedures such as shoulder rotator cuff repair.
The CuffLink Suture Anchor is offered in two different sizes with four suture color options. The anchor sizes are 5.5 x 16 mm and 6.5 x 16 mm. Sutures used in the anchor are size # 2 nonabsorbable surgical sutures. The CuffLink driver has a working length of 14 cm with an outer shaft diameter of 3 mm.
This document is a 510(k) Summary for the Cayenne Medical, Inc. CuffLink™ Suture Anchor. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with acceptance criteria for device performance.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not explicitly provided in this type of submission document.
However, based on the provided text, here's what can be inferred or directly stated:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a formal table of acceptance criteria with specific numerical targets. Instead, it states that "Mechanical testing was performed on the CuffLink Suture Anchor and a predicate device. Testing showed ultimate pull-out strength was equivalent to the predicate device."
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Ultimate Pull-Out Strength | Equivalent to the predicate device (exact value not specified) | Ultimate pull-out strength was equivalent to the predicate device. |
2. Sample Size and Data Provenance for Test Set
- Sample Size: Not specified for the mechanical testing. The document only mentions "mechanical testing was performed."
- Data Provenance: Not specified. It's likely that the testing was conducted in a laboratory setting by the manufacturer, but the location or whether it involved patient data (retrospective or prospective) is not applicable for this type of mechanical comparison testing.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. Mechanical testing for pull-out strength does not involve human experts establishing ground truth in the same way clinical or diagnostic studies do. The "ground truth" would be the objective measurement of pull-out strength.
4. Adjudication Method for Test Set
Not applicable. No expert adjudication method (like 2+1 or 3+1) is mentioned or relevant for mechanical pull-out strength testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a mechanical suture anchor, not a diagnostic or imaging device that would typically involve human readers interpreting results with or without AI assistance. The submission focuses on the mechanical properties of the anchor.
6. Standalone Performance Study
Yes, in a sense. The mentioned "Mechanical testing" on the CuffLink Suture Anchor, comparing its ultimate pull-out strength to a predicate device, is a form of standalone performance evaluation for the device's physical properties. It's algorithm-only performance is not applicable since there is no algorithm involved.
7. Type of Ground Truth Used
The ground truth used for the mechanical testing was objective mechanical test measurements of ultimate pull-out strength. This is not expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set
Not applicable. This is a medical device (suture anchor), not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
§ 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.