(57 days)
JuggerKnot Soft Anchor OC 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 OC is identical to the previously cleared JuggerKnot Soft Anchor OC except for the presence of a bioceramics embedded in the anchor portion of the device. The JuggerKnot Soft Anchor OC is comprised of a suture sleeve structure and working suture. Nonabsorbable braided ultra-high molecular weight polyethylene (UHMWPE) sutures are spliced through a suture anchor sleeve comprised of non-absorbable braided polyester. Up to two nonabsorbable round or flat braided UHMWPE working sutures can be added inside the suture anchor sleeve. The UHMWPE sutures are available undyed (white) and black. The hydroxyapatite and bioceramic particles are embedded in the surface of the suture anchor material. Sutures 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 over molded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use. The JuggerKnot Soft Anchor OC are available in common sizes and lengths and will be sold sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.
The provided text describes a medical device, the JuggerKnot Soft Anchor OC, and its clearance under a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a full clinical trial to prove efficacy and safety from scratch.
Therefore, the specific information requested about acceptance criteria and a study proving the device meets those criteria (especially in terms of diagnostic performance, human reader improvement with AI assistance, standalone algorithm performance, and ground truth establishment for training and test sets) is not applicable in the context of this 510(k) submission.
The document focuses on non-clinical performance testing and substantial equivalence to a predicate device, as opposed to a diagnostic device for which such performance metrics would be relevant.
Here's a breakdown based on the information provided and what is implied by a 510(k) submission for this type of device:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: For this device (a bone fixation fastener), acceptance criteria are primarily related to mechanical performance, biocompatibility, sterilization, and material properties, demonstrating it is as safe and effective as the predicate.
- Reported Device Performance:
- Mechanical Testing: "performed comparably to the predicate device in insertion, cyclic and pullout testing."
- Sterilization: "sterilization adoption validation"
- Biocompatibility: "biocompatibility testing per ISO10993- 1:2018"
- Stability: "stability testing on the product packaging per ISO 11607-1:2006"
- Usability Engineering: "usability engineering validation with simulated use in a cadaveric models performed per EN62366: 2015"
- Endotoxin/Pyrogenicity: "Endotoxin/pyrogenicity testing was performed per ANSI/AAMI ST72:2019, USP , USP and USP ."
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set (for mechanical and other non-clinical tests): Not explicitly stated numbers for each test, but standard engineering and biological testing samples would have been used.
- Data Provenance: The tests were likely conducted in laboratories or facilities chosen by the manufacturer, Riverpoint Medical, LLC, which is based in Portland, Oregon, USA. The studies are prospective in the sense that they were conducted for the purpose of this submission.
- Animal Study: "An animal study was performed to evaluate the biological safety and in vivo performance associated with the JuggerKnot Soft Anchor OC." No specific animal numbers are provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This is not applicable as the device is a medical implant (bone fixation fastener), not a diagnostic device requiring expert interpretation of images or other medical data for ground truth. Ground truth for this device relates to physical and biological properties.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable for the reasons stated above. Adjudication methods are typically for diagnostic interpretations.
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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:
- This is not applicable. The device is an implantable fastener, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The device is a physical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" is based on established engineering standards, material science properties, and biological safety parameters. For the animal study, the "ground truth" would be the observed biological response to the implant in vivo.
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The sample size for the training set:
- This is not applicable. This is a physical device submission; there is no "training set" in the context of machine learning or AI.
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How the ground truth for the training set was established:
- This is not applicable for the reason stated above.
§ 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.