(91 days)
The Cayenne Medical, Inc. Quattro™ Link Knotless Anchors are intended for use for the reattachment of soft tissue to bone for the following indications:
Shoulder
- Capsular stabilization
- o Bankart repair
- o Anterior shoulder instability
- o SLAP lesion repairs
- o Capsular shift or capsulolabral reconstructions
- Acromioclavicular separation repairs t
- Deltoid repairs
- -Rotator cuff repairs
- Bicep tenodesis |
Elbow, Wrist, and Hand
- ו Biceps tendon reattachment
- Ulnar or radial collateral ligament reconstruction |
- -Lateral epicondylitis repair
Knee
- Extra-capsular repairs ।
- o Medial collateral ligament
- o Lateral collateral ligament
- o Posterior oblique ligament
- । Patellar realignment and tendon repairs
- o Vastus medials obliquous advancement
- Illiotibial band tenodesis ।
Foot and Ankle
- Hallux valgus repairs ।
- -Medial or Lateral instability repairs/reconstructions
- Achilles tendon repairs/reconstructions -।
- Midfoot reconstructions l
- Metatarsal ligament/tendon repairs/reconstructions 1
- l Bunionectomy
The Quattro™ Link Knotless Anchor is a sterile, manually operated, single procedure suture anchor device for reattachment of soft tissue to bone in shoulder, elbow, wrist, hand, knee, foot, and ankle procedures. The anchor is mounted on an inserter. The Quattro Link Knotless Anchor incorporates design features that facilitate suture anchor placement under arthroscopic or open, limited access conditions in soft tissue to bone reattachment procedures. The anchor is offered in two different configurations, with or without a self-punching (SP) metal tip (PEEK anchor body and titanium alloy tip and PEEK only). The all PEEK anchor is offered in three different sizes, 2.9mm, 4.5mm. The PEEK and titanium alloy tip anchor is offered in one size, 4.5mm.
Here's a breakdown of the acceptance criteria and study information for the Quattro™ Link Knotless Anchor, based on the provided document:
The document states that a non-clinical study for the device was performed but does not explicitly provide information such as acceptance criteria beyond establishing that the "maximum suture slip force (ultimate pull-out strength) is significantly higher than that of the predicate devices." It also states that "product dimensional analysis met the components and product specifications."
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Ultimate Pull-Out Strength (Suture Slip Force): Must be significantly higher than predicate devices. | "maximum suture slip force (ultimate pull-out strength) is significantly higher than that of the predicate devices." |
| Dimensional Analysis | Product Dimensions: Must meet specified components and overall product specifications. | "Product dimensional analysis met the components and product specifications." |
| Substantial Equivalence | Indications and Design Principles: Must be substantially equivalent to predicate devices. | "demonstrated that...the Quattro Link Knotless Anchor is substantially equivalent in indications and design principles to predicate devices." |
| Safety and Efficacy | Technological Characteristics: Any differences from predicate devices must not raise new issues of safety or efficacy. | "Any differences in the technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for the mechanical testing or dimensional analysis test sets. It only mentions that "Mechanical testing was performed" and "Dimensional analysis was performed."
The data provenance is not explicitly stated in terms of country of origin. The study is a non-clinical study, specifically mechanical testing, and therefore doesn't involve human subject data (retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable as the study described is a non-clinical, mechanical testing study. "Ground truth" in the context of expert consensus is typically relevant for studies involving image interpretation, diagnosis, or clinical outcomes, not for the physical properties of a medical device.
4. Adjudication Method for the Test Set
This question is not applicable as the study described is a non-clinical, mechanical testing study. Adjudication methods (like 2+1 or 3+1) are used for resolving disagreements among human experts, which is not relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The described study is a non-clinical mechanical performance test, not a clinical study involving human readers or cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone study (in the context of an algorithm or AI) was not done. This device is a physical surgical anchor, not a software algorithm.
7. The Type of Ground Truth Used
For the mechanical testing, the "ground truth" would be the measured physical properties of the device (ultimate pull-out strength, dimensions) obtained through standardized engineering tests, not a clinical "ground truth" like pathology or expert consensus.
8. The Sample Size for the Training Set
This question is not applicable as the described study is a non-clinical, mechanical testing study of a physical device. There is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons as #8.
§ 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.