FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Ulnar or lateral collateral ligament reconstruction, Repair/reconstruction of collateral ligaments, flexor and extensor tendon at the PIP (proximal interphalangeal, DIP (distal interphalangeal), and MCP (metacarpal interphalangeal) joints for all digits, Scapholunate ligament reconstruction.

Device Description

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the JuggerKnot™ Mini Soft Anchors, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance
Mechanical Fixation	Equivalent fixation strength to predicate devices	"The test results indicate that the Biomet Sports Medicine JuggerKnot™ Mini Soft Anchors provide equivalent fixation strength to the predicate devices and would be functional within their intended use."

Note: The document explicitly states "None provided as a basis for substantial equivalence" under "Clinical Testing." This indicates that biological safety and efficacy were demonstrated through non-clinical testing and comparison to predicate devices, rather than human trials.

Study Details

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated. The summary mentions "mechanical pullout testing" where the JuggerKnot™ Mini Soft Anchors were compared to two predicate devices. This implies a sample size of anchors for each device type subjected to the pullout test, but the exact number isn't quantified.
Data Provenance: The testing was "Non-clinical laboratory testing," indicating it was conducted in a controlled lab environment. The country of origin is not specified, but the applicant "Biomet Sports Medicine" is located in Warsaw, Indiana, USA, suggesting the testing likely occurred in the US or under US guidance. The testing is retrospective in the sense that it's performed on manufactured devices, not on living subjects over time.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This question is not applicable in the context of this device and study. The "ground truth" for non-clinical mechanical testing is typically established by engineering standards and validated testing protocols, not by expert consensus in the way clinical diagnostic image interpretation would be. The outcome (fixation strength) is objectively measured by testing equipment.

4. Adjudication Method for the Test Set

This question is not applicable. As the testing is mechanical and quantitative (fixation strength), there is no "adjudication" of expert opinions. The measurements from the mechanical tests are the primary data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical cases. This submission focuses on the mechanical performance of a soft tissue fixation device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable. This is not an AI/algorithm-based diagnostic device. The "device" itself is a physical implant. The "standalone" performance here refers to the mechanical performance of the anchor itself when tested in a controlled laboratory setting. The non-clinical testing described is essentially demonstrating the "standalone" mechanical performance of the anchors.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical testing was objective mechanical measurements of fixation strength, as determined by standardized laboratory pullout tests.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of this 510(k) submission for a mechanical device. The device's design is based on engineering principles and similarity to predicate devices, not on machine learning from a dataset.

9. How the Ground Truth for the Training Set was Established

This question is not applicable for the reasons stated in point 8.

Summary

Regulation Number and Section

§ 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.