(45 days)
The JuggerKnot™ Soft Anchor is intended to be used for soft tissue to bone fixation with indications for use in: Shoulder, Foot and Ankle, Elbow, Knee, Hand and Wrist, Hip.
The JuggerKnot™ 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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the JuggerKnot™ Soft Anchors:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Equivalent fixation strength to predicate devices | "The test results indicate that the Biomet Sports Medicine JuggerKnot™ Soft Anchors provide equivalent fixation strength to the predicate devices and would be functional within their intended use." |
Explanation of "Acceptance Criteria (Implicit)": The document doesn't explicitly state quantitative acceptance criteria (e.g., "must meet 90% of predicate device strength"). Instead, the acceptance criterion for the non-clinical testing is implied to be "equivalent fixation strength" when compared to the specified predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "mechanical pullout testing" and "test results" but does not provide details on the number of samples tested.
- Data Provenance: The testing was "Non-clinical laboratory testing" performed by Biomet Sports Medicine. The country of origin is not specified, but the company's address is in Warsaw, Indiana, USA, suggesting the testing likely occurred in the US or under US guidance. The data is entirely retrospective as it was conducted before the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The ground truth for this device's performance was established via "mechanical pullout testing," not expert opinion on diagnostic images or clinical outcomes.
- Qualifications of Experts: Not applicable for mechanical testing. The expertise would lie with engineers or technicians performing and analyzing the mechanical tests.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As the testing was mechanical pullout testing, the "ground truth" was derived directly from the physical measurements and not through an adjudication process involving human reviewers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." The evaluation was based solely on non-clinical mechanical testing comparisons to predicate devices.
- Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study Done: Yes, in a sense. The non-clinical mechanical testing represents a "standalone" evaluation of the device's physical performance without human intervention in its efficacy measurement. The device itself is a physical implant, not an algorithm. The "performance" being evaluated is its structural integrity and fixation strength.
7. Type of Ground Truth Used
- Ground Truth Type: Objective physical measurements from "mechanical pullout testing." The "truth" in this context is the quantitative force required to pull out the anchors, measured under controlled laboratory conditions, which formed the basis for comparison to predicate devices.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" in the context of its development and validation for regulatory submission.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: 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.