(76 days)
The Cayenne Medical, Inc. CuffLink Knotless Anchors are intended for use for the reattachment of soft tissue to bone for shoulder procedures such as Rotator Cuff Repairs.
The CuffLink™ Knotless 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. The anchor is mounted on an inserter. The CuffLink Knotless 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 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 anchor is offered in two different sizes. 4.5mm and 5.5mm. The PEEK and titanium alloy anchor is offered in one size, 4.5mm.
The provided text is a 510(k) summary for the Cayenne Medical, Inc. CuffLink™ Knotless Anchor. This document describes a medical device, its intended use, and its substantial equivalence to previously marketed products. However, it does not include information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically discussed for AI/ML device evaluations.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance. This means showing that the new device is as safe and effective as a legally marketed device, not necessarily that it meets specific performance thresholds against a predefined acceptance criterion in a clinical study setting.
Here's a breakdown based on the provided text, addressing your questions where possible and noting where information is absent:
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Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic or AI device. The "acceptance criteria" here is implicitly "demonstrate substantial equivalence to predicate devices."
- Device Performance: The document states, "Mechanical testing was performed on the CuffLink Knotless Anchor and Inserter. It was shown that ultimate pull-out strength is significantly higher than that of a predicate device." This is a mechanical performance claim, not an AI/ML performance claim.
Since this is a physical medical device (suture anchor) and not an AI/ML diagnostic tool, the typical "acceptance criteria" for AI/ML are not relevant here. The "performance" described is related to mechanical strength, not diagnostic accuracy.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
Not applicable (N/A). The document refers to "mechanical testing," not a clinical "test set" for diagnostic performance. No details on the sample size for this mechanical testing or data provenance are provided beyond the general statement. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
N/A. This concept of expert-established ground truth for a test set is not relevant for the mechanical testing of a suture anchor. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
N/A. This is relevant for AI/ML diagnostic studies, not for the mechanical testing of a physical device. -
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:
N/A. This is a physical device, not an AI system. No human readers or AI assistance are involved in its primary function. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
N/A. This is a physical device, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
N/A. For the described mechanical testing, the "ground truth" would be the direct measurement of physical properties like pull-out strength, as determined by engineering standards and validated testing methods. It's not a diagnostic "ground truth." -
The sample size for the training set:
N/A. This device is not an AI/ML model that requires a training set. -
How the ground truth for the training set was established:
N/A. This device is not an AI/ML model.
In summary:
The provided 510(k) summary focuses on demonstrating "substantial equivalence" of a physical medical device (a suture anchor) to existing predicate devices based on its intended use, design principles, and mechanical properties. It explicitly states that "Mechanical testing was performed... [and] ultimate pull-out strength is significantly higher than that of a predicate device."
The questions posed are primarily relevant for the evaluation of Artificial Intelligence (AI) or Machine Learning (ML) medical devices, which involve diagnostic performance, ground truth establishment, expert reviews, and reader studies. The CuffLink™ Knotless Anchor is not an AI/ML device, and thus, most of the requested information (related to AI acceptance criteria, test sets, ground truth for AI, MRMC studies, etc.) is not present in this document.
§ 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.