(125 days)
The JuqqerKnotless™ Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, elbow, knee, hand/wrist, and hip. Specific indications are as follows:
Shoulder
Acromio-clavicular Separation, Anterior Shoulder Instability Repair, Bankart lesion repair, Biceps tenodesis, Capsule Repair or Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuff Repair, S.L.A.P Lesion Repairs
Foot and Ankle
Achilles Tendon Repair/Reconstruction, Hallux Valgus Reconstruction, Lateral/Medial Stabilization Repairs/Reconstruction, Midfoot/Forefoot Reconstruction/Repairs
Elbow
Biceps Tendon Reattachment, Biceps Tendon Reconstruction, Lateral/Medial Repairs, Lateral Epicondy/itis Repair (Tennis Elbow Repair), Ulnar & Radial Collateral Ligament Reconstruction
Knee
Iliotibial Band Tenodesis, Joint Capsule Closure, Lateral/Medial Collateral Liqament Repair, Patellar Ligament Repair, Patellar Tendon Repair, Patellar Realignment/Repair, Posterior Oblique Ligament Repair, VMO Advancement
Hand and Wrist
Collateral Ligament Repair (Gamekeeper's Thumb), Scapholunate Ligament Reconstruction, Tendon Transfers in Phalanx, Volar Plate Reconstruction
Hip
Labral
The JuggerKnotless™ Soft Anchors consist of a coreless sleeve structure and a knotless construct incorporating ZipLoop™ Technology. The anchors are intended for use in soft tissue fixation by bunching against bone when deployed.
Here's an analysis of the provided text regarding the acceptance criteria and study for the JuggerKnotless™ Soft Anchors:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated as such, but inferred from testing) | Reported Device Performance |
|---|---|
| Equivalent fixation strength to predicate devices | "The test results indicate that the Biomet Sports Medicine JuggerKnotless™ Soft Anchors provide equivalent fixation strength to the predicate devices and would be functional within their intended use." |
Explanation of "Acceptance Criteria" for this device:
The document does not explicitly list numerical "acceptance criteria" in the way one might see for diagnostic software (e.g., target specificity/sensitivity). Instead, for this type of medical implant, the primary "acceptance criterion" for non-clinical testing is typically demonstrated equivalence in performance (specifically, mechanical fixation strength) to an already legally marketed and accepted predicate device. This is a common approach for 510(k) submissions where substantial equivalence is claimed.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "mechanical pullout testing," but the number of anchors or tests performed is not specified.
- Data Provenance: The testing was "non-clinical laboratory testing," implying it was conducted in a controlled lab setting, likely in the USA where Biomet Sports Medicine is located. It is by definition retrospective in the context of device development, as it assesses the device's properties before market release.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not applicable to the provided document. The "ground truth" for this type of device (medical implant fixation) is established through objective mechanical testing (fixation strength measurements) against a control, not through expert consensus or interpretation of images.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in studies involving human interpretation (e.g., radiologists reviewing images), not for objective mechanical testing of device performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
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Was it done? No. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." MRMC studies typically involve human readers interpreting cases, often to compare AI-assisted performance with unassisted performance. This was a non-clinical, mechanical performance study.
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Effect size of human readers improving with AI vs without AI assistance: Not applicable, as no MRMC study or clinical study involving human-AI interaction was performed or reported.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Was it done? Yes, in a sense. The mechanical testing performed on the JuggerKnotless™ Soft Anchors is a form of "standalone" evaluation of the device's physical performance, independent of human interaction during its assessment. The device itself is an implant, not an algorithm. The testing evaluated the device's intrinsic mechanical property (fixation strength) without human-in-the-loop performance assessment of that specific property.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth used was objective mechanical measurements of "fixation strength." This is determined through physical testing protocols that measure parameters like pullout force, displacement, or ultimate load to failure, compared against a predicate device.
8. The Sample Size for the Training Set
This question is not applicable. This device is a physical medical implant, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device's design and manufacturing are based on engineering principles and material science, not data training.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for this device.
§ 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.