(22 days)
The CUFFLOK Anchor is indicated for shoulder rotator cuff repair.
The CUFFLOK Anchor is a partially bioabsorbable three-part polymer implant designed for use in shoulder rotator cuff repair and is used to secure soft tissue to bone. The three components of the implant are a tapered tip (PLA with blue dye #6), a sleeve (polypropylene blue) and an inner suture pin (PLA with blue dye #6). The anchor is also provided with ETHIBOND non-absorbable sutures and a stainless steel needle. Similar to the currently marketed CUFFTACK Anchor, the implant is mounted on a stainless steel trocar and placement of the implant is facilitated via use of a Delivery Gun.
Here's an analysis of the provided text regarding the CUFFLOK Anchor's acceptance criteria and studies:
Summary of Device and Approval:
The CUFFLOK Anchor is a partially bioabsorbable three-part polymer implant designed for use in shoulder rotator cuff repair. It is intended to secure soft tissue to bone. The FDA granted substantial equivalence (K031519) to the CUFFTACK Anchor (K003076) based on the information provided.
Acceptance Criteria and Study Details for CUFFLOK Anchor:
The provided document does not contain information about specific acceptance criteria related to a performance study with defined metrics (e.g., accuracy, sensitivity, specificity, or specific mechanical strength values) and subsequent reporting of device performance against these criteria.
Instead, the approval for the CUFFLOK Anchor appears to be based on demonstrating substantial equivalence to a predicate device (CUTTACK Anchor) and confirming biological compatibility.
Below, I've structured the answer based on the questions, indicating where information is present or absent in the provided text.
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Reported Device Performance Biocompatibility: Non-toxic Demonstrated to be non-toxic (as stated in the "Safety" section). Biocompatibility: Non-irritating Demonstrated to be non-irritating (as stated in the "Safety" section). Biocompatibility: Non-sensitizing Demonstrated to be non-sensitizing (as stated in the "Safety" section). Biocompatibility: Non-cytotoxic Demonstrated to be non-cytotoxic (as stated in the "Safety" section). Substantial Equivalence: Similar indications for use (shoulder rotator cuff repair) Met: Indicated for shoulder rotator cuff repair, same as predicate (implied by FDA's substantial equivalence determination). Substantial Equivalence: Similar technology/design (three-part polymer implant, delivery method via trocar/Delivery Gun) Met: "Similar to the currently marketed CUFFTACK Anchor, the implant is mounted on a stainless steel trocar and placement of the implant is facilitated via use of a Delivery Gun." Performance (e.g., mechanical strength, pull-out force, tissue integration, etc.) Not specified/Explicitly reported in the provided text. The document relies on substantial equivalence to the predicate for assumed performance. -
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document refers to "biocompatibility studies" but does not detail the sample size or design of these studies. No performance "test set" in the context of an AI/software device is mentioned.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. The document does not describe a process involving human experts to establish ground truth for a test set, as this is a physical medical device, not an AI/software product requiring image interpretation or similar.
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Adjudication Method for the Test Set:
- Not applicable. No test set requiring expert adjudication is described.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document makes no mention of an MRMC study. This type of study is typically relevant for interpretative AI devices where human performance with and without AI assistance is evaluated.
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Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No. This is a physical medical device, not an algorithm.
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Type of Ground Truth Used:
- The "ground truth" for the CUFFLOK Anchor in the context of this submission appears to be:
- Biocompatibility test results: Demonstrating non-toxicity, non-irritation, non-sensitization, and non-cytotoxicity.
- Design and Material Equivalence: Comparison to the predicate device (CUTTACK Anchor) for design, materials (PLA, polypropylene), and intended use. The FDA's substantial equivalence finding validates this comparison.
- No pathology, imaging, or outcomes data used as "ground truth" for performance comparison is described in this document.
- The "ground truth" for the CUFFLOK Anchor in the context of this submission appears to be:
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Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device that requires a training set.
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How the Ground Truth for the Training Set Was Established:
- Not applicable. No training set is involved.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.