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JuggerKnot® Soft Anchors are intended for use in soft tissue to bone fixation for the following indications:
Knee MPFL
Knee Patellar tendon repair
Knee MCL
Knee Quadriceps tendon repair
Hip Acetabular labral repair
Hip Proximal hamstring repair
Hip Hip Labral reconstruction
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 metallic shaft with 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 document describes the JuggerKnot® Soft Anchor device and its substantial equivalence to a predicate device (K150768 – Zimmer Biomet JuggerKnot® Soft Anchor). This document is a 510(k) summary, which focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. It addresses performance testing but not in the format of a clinical study with detailed acceptance criteria, sample sizes, expert involvement, or comparative effectiveness studies of human readers with and without AI.

Therefore, much of the requested information regarding detailed acceptance criteria, a specific study proving device meets criteria, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, and standalone performance for an AI/algorithm-based device is not applicable to this submission, as the JuggerKnot® Soft Anchor is a physical medical device (a soft anchor for tissue fixation), not an AI/software device.

However, I can extract information related to the performance data provided for the physical device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of specific quantitative acceptance criteria or detailed reported performance values for mechanical testing. Instead, it states that the device "performed comparably to the predicate device and to other currently marketed soft anchor devices."

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

• Sample Size: Not explicitly stated for mechanical or bench testing. Performance testing normally involves a defined number of units, but "sample size" in the context of an AI device's test set (e.g., number of images or cases) is not relevant here.
• Data Provenance: The usability engineering validation involved "simulated use in a cadaveric models." This implies the data originates from cadaveric human tissue. It is not specified if these cadavers are from a particular country or origin.
• Retrospective or Prospective: Not applicable in the context of this type of device testing.

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

• Experts: Not applicable for mechanical bench testing or biocompatibility where ground truth is established by objective measurements against established standards.
• Qualifications: For usability testing ("simulated use in a cadaveric models"), it is implied that qualified surgeons or medical professionals would perform the simulated use, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

• Not applicable as this is not an AI/algorithm-based diagnostic device requiring expert adjudication of results. Ground truth for most tests (e.g., tensile strength, sterilization) is determined by quantitative measurements against standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This is a physical medical device, not an AI/diagnostic software. MRMC studies are not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• No. This is a physical medical device. "Standalone performance" in the context of an algorithm is not relevant.

7. The Type of Ground Truth Used

• For Mechanical Properties (Insertion, Cyclic, Pullout): Comparative performance against a legally marketed predicate device (K150768 JuggerKnot® Soft Anchor) and "other currently marketed soft anchor devices." The criteria for comparability would be defined by the mechanical testing protocols.
• For Material and Biological Properties: Conformance to established international standards (e.g., USP, ISO 10993-1, ISO 11607-1, EN62366, ANSI/AAMI ST72).

8. The Sample Size for the Training Set

• Not applicable. This device does not use a "training set" in the context of machine learning or AI.

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

• Not applicable. This device does not use a "training set" in the context of machine learning or AI.

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