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The Anspach Arthroscopic Knotless Anchor is indicated for use in reattachment (fixation) of soft tissues to bone in applications including the pubis, ischium, ileum, humerus, scapula, radius, ulna, femur, tibia, fibula, patella and bones of the hand and foot. The Anspach Arthroscopic Knotless Anchor is specifically not intended for use in the spine or for repair of the anterior or posterior cruciate ligaments.

The Anspach Arthroscopic Knotless Anchor is used with specific brands and types of suture materials including: Arthrotek "MaxBraid"; Smith & Nephew "UltraBraid"; Opus Medical "Magnum Wire"; and Linvatec "Herculine". Suture materials identified as "Braided # 2 polyester" and Arthrex # 2 "Fiberwire" are not recommended for use with The Anspach Arthroscopic Knotless Anchor.

A suture Anchor per CFR 21, Part 888.3040, is a smooth or threaded metallic bone fixation fastener and is a Class II device.

The Anspach anchor is a design modification of the existing Anspach Suture Anchor that permits soft tissue attachment to bone but does so in a manner that eliminates the need for the surgeon to have to tie sutures to the anchor.

This device can reduce surgical procedure time, surgeon frustration and fatigue associated with arthroscopic knot tying.

The Anspach Knotless Anchor is constructed of the same materials under the same manufacturing process controls as existing devices. It introduces no new or modified indications for use, risks, hazards, safety or effectiveness issues, and may help reduce surgical time which for abo, halto, fiazar as, our entient. Testing has confirmed the Knotless Anchor to be as effective (or more so) in placement and performance as other marketed devices, including the predicate Anspach device(s).

Packaging, labeling, handling and storage conditions are consistent with current designs and accessory tools used in placement of the anchor are essentially the same as existing devices. There are no changes to cleaning, storage processes from existing accessory devices.

The Anspach Knotless Anchor is distributed pre-sterilized to an SAL of 10°. Accessory surgical tools are packaged clean, non-sterile and distributed separate from the anchor device.

This document describes a medical device called the Anspach Knotless Suture Anchor, a Class II device (CFR 21, Part 888.3040) used for reattachment of soft tissues to bone. The information provided is a 510(k) summary for the device seeking substantial equivalence to existing predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a tabular format. Instead, it makes a general statement: "Testing has confirmed the Knotless Anchor to be as effective (or more so) in placement and performance as other marketed devices, including the predicate Anspach device(s)."

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the study).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not specify the number of experts used or their qualifications to establish ground truth.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

The document does not mention or describe an MRMC comparative effectiveness study. This type of study is more common for diagnostic imaging devices where human reader performance is a direct measure. For a physical device like a suture anchor, the effectiveness is typically measured through biomechanical testing and clinical outcomes, rather than cognitive human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This question is not applicable to a physical medical device like a suture anchor. "Standalone performance" typically refers to the performance of an AI algorithm without human intervention, which is not relevant for this product.

7. The Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used. However, given the nature of the device (suture anchor), it is highly probable that the "ground truth" for performance evaluations would be established through:

• Biomechanical testing: Measuring pull-out strength, cyclic loading, and other mechanical properties in a lab setting (e.g., using cadaveric bone or synthetic bone models).
• Clinical outcomes data: While not explicitly mentioned as a "ground truth" method for this 510(k) submission, long-term clinical studies would provide the ultimate ground truth for effectiveness. This 510(k) is based on demonstrating substantial equivalence, which often relies on bench testing and comparison to predicate devices.

8. The Sample Size for the Training Set:

The concept of a "training set" is primarily relevant for machine learning algorithms. Since this is a physical medical device, there is no training set in the AI sense. The development of such a device involves engineering design, material selection, and iterative physical testing rather than algorithmic training.

9. How the Ground Truth for the Training Set Was Established:

As explained in point 8, there is no training set in the context of this device.

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