(27 days)
JuggerKnot® Soft Anchors are intended for soft tissue to bone fixation for the following indications: Knee MPFL Knee Patellar tendon repair Knee MCL Knee Quadriceps tendon repair Foot and Ankle Achilles tendon repair Foot and Ankle Medial/lateral repair and reconstruction Foot and Ankle Plantar plate repair Foot and Ankle Mid- and forefoot repair Foot and Ankle Metatarsal ligament/tendon repair or reconstruction Shoulder Rotator Cuff Shoulder Shoulder Instability Shoulder Biceps Tenodesis Elbow Lateral epicondylitis repair Elbow Biceps tendon reattachment
The JuggerKnot® Soft Anchor is comprised of a suture sleeve structure and working suture. Non-absorbable braided ultra-high molecular weight polyethylene (UHMWPE) sutures are spliced through a non-absorbable braided polyester suture anchor sleeve. Up to three nonabsorbable round and flat braided UHMWPE working sutures can be added inside the suture anchor sleeve. The UHMWPE sutures are available undyed (white), blue, black or with or without a stainless steel needle attached. Available Suture sizes are standard according to USP requirements (dependent on suture type). Suture supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The inserter is comprised of a metallic shaft with a self-punching tip and an overmolded handle. The device is sterilized by ethylene oxide gas, and is provided sterile for single use. JuggerKnot® Soft Anchors are available in common sizes and lengths with or without pre-attached 302 stainless steel needles and will be sold sterile for single use with no components or accessories. The device is intended for use in a hospital/clinic/surgical setting.
The provided text is a 510(k) summary for a medical device (JuggerKnot® Soft Anchor) that has received FDA clearance. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of an AI/ML algorithm or diagnostic test.
Therefore, the information required to populate the fields related to AI/ML device performance (like "acceptance criteria table," "sample size for the test set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "training set sample size," and "ground truth for training set") is not present in the provided document.
The document describes non-clinical mechanical testing and usability engineering validation, but these are not the types of studies that would generate the performance metrics typically requested for an AI/ML or diagnostic device's acceptance criteria table.
Here's a breakdown of what is available and what is not:
Information Present in the Document (relevant to general device clearance, but not AI/ML specific):
- Device Name: JuggerKnot® Soft Anchor
- Intended Use/Indications for Use: Detailed list of soft tissue to bone fixation indications (e.g., Knee MPFL, Shoulder Rotator Cuff).
- Predicate Device: K203740 – Riverpoint JuggerKnot® Soft Anchor.
- Performance Data (General):
- Sutures meet USP requirements (except diameter).
- UMHWPE sutures tested for needle attachment and tensile strength per USP.
- Followed FDA Guidance documents for "Bone Anchors" and "Surgical Sutures."
- Biocompatibility, sterilization method, packaging, material stability are the same as the predicate.
- Non-clinical performance testing:
- Usability engineering validation with simulated use in cadaveric models per EN62366:2015.
- Endotoxin/pyrogenicity testing per ANSI/AAMI ST72:2019, USP , USP , USP .
- Mechanical testing (insertion, cyclic, and pullout testing) comparing to predicate and other marketed soft anchor devices.
- Conclusion: Device performed comparably to the predicate and met all requirements for its intended use, demonstrating substantial equivalence.
Information NOT Present in the Document (required for the requested AI/ML acceptance criteria study description):
- A table of acceptance criteria and the reported device performance: This document does not present performance in terms of sensitivity, specificity, accuracy, or similar metrics typically seen for AI/ML or diagnostic devices. Instead, it discusses mechanical performance relative to a predicate.
- Sample sized used for the test set and the data provenance: No "test set" in the context of an AI/ML algorithm is mentioned. The mechanical testing implicitly used a "test set" of anchors, but the size and provenance are not detailed, nor is it the type of test set requested (e.g., patient data).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no diagnostic ground truth being established.
- Adjudication method: Not applicable.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This is not an AI-assisted diagnostic device.
- Standalone performance: While the device has "standalone performance" as a mechanical anchor, this isn't relevant to "algorithm only without human-in-the-loop performance."
- The type of ground truth used: Not applicable in the AI/ML context. Ground truth for a mechanical device is its physical performance characteristics.
- The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document describes the clearance of a mechanical medical device (a surgical anchor) based on its substantial equivalence to an existing predicate. It does not pertain to an AI/ML algorithm or a diagnostic device, and therefore, the requested information regarding AI/ML acceptance criteria and study details cannot be extracted from this text.
§ 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.