(164 days)
The JuggerKnot Soft Anchors are intended for soft tissue to bone fixation for the following indications:
Shoulder: Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction. Deltoid repair, Rotator cuff tear repair, Biceps tenodesis, Pectoralis major repair
Foot and Ankle: Medial/lateral repair and reconstruction, mid- and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair
Elbow: Ulnar or radial collateral ligament reconstruction. Lateral epicondylitis repair. Biceps tendon reattachment
Knee: Extra-capsular repair: MCL, LCL, and posterior oblique ligament, Iliotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure, Medial Patellofemoral Ligament (MPFL) repair or reconstruction, Quadriceps tendon repair
Hand and Wrist: Collateral ligament repair, Scapholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction
Hip: Acetabular labral repair, Proximal hamstring repair
The JuggerKnot Self-Punching Soft Anchors are intended for soft tissue to bone fixation for the following indications:
Shoulder: Rotator cuff tear repair
Foot and Ankle: Achilles tendon repair
The JuggerKnot Soft Anchors consists of a coreless sleeve structure and suture. The anchors are intended for use in soft tissue fixation by bunching against bone when deployed.
The provided text is a 510(k) premarket notification for the "JuggerKnot Soft Anchors" and "JuggerKnot Self-Punching Soft Anchor" for soft tissue to bone fixation. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a study with defined performance metrics.
Therefore, much of the requested information (like a table of acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC study results, and detailed ground truth methodology) is not available in the provided document. The document describes a comparison to a predicate device, not a standalone performance study against pre-defined acceptance criteria.
Here's an attempt to answer the questions based only on the provided text, highlighting what is not available due to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly stated in the provided document. The document describes a comparison to a predicate device, not performance against pre-defined acceptance criteria. The performance data is stated as:
"The test results indicate that the JuggerKnot Soft Anchors achieved statistically equivalent or greater pullout strength to the predicate device and would be functional within their intended use."
The acceptance criterion, by inference, was demonstrating "statistically equivalent or greater pullout strength" compared to the predicate.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Statistically equivalent or greater pullout strength compared to predicate device | Achieved statistically equivalent or greater pullout strength to the predicate device |
2. Sample size used for the test set and the data provenance
The document mentions "non-clinical laboratory testing was performed to verify the fixation strength... as compared to the predicate JuggerKnot Soft Anchors (K110145)". However, the sample size for this test set is not specified. The data provenance is also not specified, though it is a non-clinical laboratory test, implying it was conducted as part of the device development and testing process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable/not provided as the "test set" described is a mechanical pullout strength test, not an evaluation by human experts requiring ground truth establishment in the traditional sense of clinical or image-based studies.
4. Adjudication method for the test set
This information is not applicable/not provided for the same reasons as #3.
5. 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
No, a multi-reader multi-case comparative effectiveness study was not conducted or reported. This document pertains to a medical device for soft tissue fixation, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This refers to an "algorithm-only" performance, which is a concept for AI/software devices. The JuggerKnot Soft Anchors are physical medical devices. The performance testing was a standalone mechanical test of the physical device's pullout strength, compared to a predicate device.
7. The type of ground truth used
The "ground truth" for the mechanical pullout strength test was the measured pullout strength values obtained during the laboratory testing. This is a direct measurement of a physical property, not based on expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This information is not applicable/not provided. The device is a physical medical device, not an AI algorithm that requires a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reasons as #8.
§ 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.