(176 days)
The JuggerKnot™ Mini Soft Anchors are intended to be used for soft tissue to bone fixation with indications for use in:
Maxillofacial
For the repair, repositioning or reattachment of soft tissues, ligament and tendons to the mandible for surgical stabilization of the TMJ articular disc.
The JuggerKnot™ Mini Soft Anchors consist of a coreless sleeve structure and suture. The anchors are intended for use in soft tissue fixation by bunching against bone when deployed.
The JuggerKnot™ Mini Soft Anchors device underwent non-clinical testing to demonstrate substantial equivalence to its predicate devices.
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| The average pullout strength of the JuggerKnot™ Mini Soft Anchors would be statistically equal to or greater than that of the Mitek Mini QUICKANCHOR® Plus. | "The test results indicate that the Biomet Sports Medicine JuggerKnot™ Mini Soft Anchors provide at least equivalent fixation strength to the predicate devices. The acceptance criteria were met, demonstrating that the JuggerKnot™ Mini Soft Anchors are substantially equivalent in pullout strength to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the exact sample size used for the mechanical pullout testing. It mentions "comparison testing" was conducted, implying multiple samples of both the JuggerKnot™ Mini Soft Anchors and the Mitek Mini QUICKANCHOR® Plus were tested. The data provenance is not specified, but it's likely from a prospective laboratory setting given it's non-clinical testing. No country of origin for the data is provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This was non-clinical mechanical testing, not a study requiring expert clinical assessment for ground truth.
4. Adjudication Method for the Test Set:
Not applicable. This was non-clinical mechanical testing, not a study involving human interpretation. The "ground truth" was established by objective mechanical measurement of pullout strength.
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. This document describes a K140908 510(k) submission for a medical device (soft tissue anchors), not an AI/CAD device. Therefore, no MRMC comparative effectiveness study involving human readers or AI assistance was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth used was objective mechanical measurement of pullout strength. This is determined by a testing machine that measures the force required to pull the anchor out of the bone material, rather than expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device and not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there was no training set.
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.