(27 days)
OC JuggerKnot® Soft Anchor 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 |
| 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 OC 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 non- absorbable 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). The hydroxyapatite and bioceramic particles are embedded in the surface of the suture anchor material.
Suture supplied meet United States Pharmacopeia (USP) requirements for nonabsorbable 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. OC JuqgerKnot® 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 describes a medical device, the "OC JuggerKnot® Soft Anchor," and its FDA 510(k) submission for substantial equivalence. However, the document does not contain the specific acceptance criteria, reported device performance metrics in a table, or details of a study that proves the device meets specific performance criteria in the format the user requested.
Instead, the document primarily focuses on establishing substantial equivalence to a predicate device (K232411 – Riverpoint Medical JuggerKnot® Soft Anchor with OC Coating) and a reference device (K231128 – Riverpoint Medical JuggerKnot® Soft Anchor).
Based on the information provided, here's what can be extracted and what is missing:
Missing Information:
- A table of specific numerical acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for establishing ground truth.
- Adjudication method for the test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Detailed results of a standalone (algorithm only) performance study.
- Specific ground truth type (e.g., pathology, outcomes data) for non-mechanical tests.
- Sample size for the training set.
- How the ground truth for the training set was established.
Information that can be inferred or directly stated from the document regarding the study and performance:
The document mentions non-clinical mechanical testing and usability engineering validation.
Study Description (Inferred and direct quotes):
The device underwent non-clinical mechanical testing and usability engineering validation.
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Non-clinical Mechanical Testing:
- Purpose: To verify the fixation strength of the OC JuggerKnot® Soft Anchor with self-punching inserter.
- Types of tests: Insertion, cyclic, and pullout testing.
- Comparison: Compared to the predicate device and other currently marketed soft anchor devices with self-punching inserters.
- Conclusion: "Results of performance testing for the OC JuggerKnot® Soft Anchor device with self-punching inserter concluded that the device performed comparably to the predicate device and to other currently marketed soft anchor devices with self-punching inserters in insertion, cyclic and pullout testing and the validations performed demonstrated that the OC JuggerKnot® Soft Anchor with selfpunching inserter met all requirements for its intended use."
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Usability Engineering Validation:
- Purpose: Performed per EN62366: 2015- Medical devices - Application of usability engineering to medical devices.
- Methodology: Involved "simulated use in a cadaveric models."
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Other Testing Mentioned:
- Endotoxin/pyrogenicity testing per ANSI/AAMI ST72:2019, USP , USP and USP .
- Suture testing per USP performance requirements for needle attachment and tensile strength.
Regarding your specific questions:
-
A table of acceptance criteria and the reported device performance:
Not explicitly provided in the document. The document states that "the device performed comparably to the predicate device and to other currently marketed soft anchor devices with self-punching inserters in insertion, cyclic and pullout testing" and "met all requirements for its intended use," but specific numerical criteria and corresponding performance values are absent. -
Sample size used for the test set and the data provenance:
Not explicitly stated for the mechanical testing or usability studies. For the usability study, it mentions "cadaveric models" but not the number. Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable or not stated as this is a physical medical device, not an AI/software system requiring expert consensus for ground truth on disease detection. The "ground truth" for mechanical testing would be the physical outcome measurements. -
Adjudication method for the test set:
Not applicable or not stated. -
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:
Not applicable. This device is a physical surgical anchor, not an AI diagnostic tool. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical device. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For mechanical testing, the ground truth would be physical measurements of fixation strength (e.g., load at failure, displacement) under controlled conditions. For usability, it would involve evaluation of user interaction and safety in a simulated environment. -
The sample size for the training set:
Not applicable as this is a physical device. -
How the ground truth for the training set was established:
Not applicable.
§ 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.