Search Results

The Arthrex Meniscal Dart System is intended for the repair of meniscal tears that would otherwise be considered for standard repair using suture

The meniscus aids in load transmission, shock absorption, and joint lubrication, as well as contributing to joint stability. As such, it is desirable to keep the meniscus intact. In the past, a partial meniscectomy was the treatment of choice; however, more recently, instead of removing the damaged or detached meniscal tissue, various suturing techniques have been utilized to repair it. In order for this to be successful, though, the tear must exist in a vascular region ("red-red" and "red-white").

A majority of meniscal tears occur in the posterior horn of the meniscus. Meniscal suturing in this region increases the risk of neurovascular complications, including saphenous and peroneal nerve and popliteal injury. In this case, due to concerns with needle placement, all inside meniscal fixation devices provide a safe alternative.

The meniscal fixation device of choice at the moment is the Bionx Arrow. It has barbs to secure the tissue and a "T" head that rests on top of the meniscus. Studies have shown that the Arrow performs similar to suture depending on the chosen technique, horizontal vs. vertical (Albrecht-Olsen et al., 1997). Although the vertical suture method is superior to using a horizontal method or meniscal fixation device, according to Albrecht-Olsen et al. this technique may be difficult to use when space is limited as is the case for the location of many bucket-handle lesions.

Additional testing was performed comparing the Arthrex Mensical Dart to the Bionx Arrow. Three repair locations were tested, medial posterior and lateral central. There were no significant differences between the Dart and the Arrow for the average pull-out force of all repair locations combined. Furthermore, when comparing the results for the medial posterior location (i.e. the area most commonly associated with meniscal tears), the Dart had the same average pull-out (30 N) as the Arrow and a smaller standard deviation.

With respect to pull-out, all but one Arrow pulled out at the pointed end, whereas the Darts pulled out at both the pointed end and the flat end. This is to be expected considering the fact that the Arrow has a "T" head design. However, since the "T" head sits proud on the meniscus, there is the increased potential for damage to femoral condyle articular cartilage. In order to eliminate this concern, the Arthrex device does not have a head and is implanted flush with the surface of the meniscus.

This K983577 submission describes the Arthrex Meniscal Dart System and its substantial equivalence to a predicate device, the Bionx Arrow. The submission primarily focuses on mechanical performance for fixation of meniscal tears.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The submission implicitly uses the performance of the predicate device (Bionx Arrow) as its acceptance criteria. The study aims to show that the Arthrex Meniscal Dart performs "similar to" or "as well as" the predicate.

Note regarding "Acceptance Criteria": The document doesn't explicitly state quantitative acceptance criteria in a pass/fail sense (e.g., "The device must achieve at least X N of pull-out force"). Instead, the substantial equivalence argument is built on demonstrating comparable performance to the predicate device.

2. Sample Size and Data Provenance

• Sample Size for Test Set: Not explicitly stated for the Arthrex Meniscal Dart vs. Bionx Arrow comparison. The text mentions "Three repair locations were tested, medial posterior and lateral central." This implies multiple samples per location, but the exact number is not provided.
• Data Provenance: The study described appears to be a benchtop (in-vitro) mechanical study. The text references "pull-out force" and testing materials and designs. There is no indication of animal or human data.
• Country of Origin: Not specified but given the company address (Naples, FL) and FDA submission, it implicitly originates from the US.
• Retrospective/Prospective: As a mechanical bench study, these terms are not directly applicable. It's a controlled experimental study.

3. Number of Experts and their Qualifications

• Not applicable. This submission describes a mechanical bench study, not a clinical trial or study requiring expert reader interpretation of images or clinical outcomes.

4. Adjudication Method

• Not applicable. As a mechanical bench study, there is no adjudication process involving human interpretation or consensus. The measurements (pull-out force) are objective.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This is a benchtop mechanical study comparing device performance, not a clinical effectiveness study involving human readers or patient cases.

6. Standalone (Algorithm Only) Performance

• Not applicable. This submission is for a physical medical device (meniscal dart), not an algorithm or AI system.

7. Type of Ground Truth Used

• For the mechanical study, the "ground truth" is the measured pull-out force as determined by experimental testing.
• The comparison is made against the measured pull-out force of the predicate device (Bionx Arrow).

8. Sample Size for the Training Set

• Not applicable. This is a manufacturing and design submission for a physical device, not an AI/ML or software device that uses a "training set."

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

• Not applicable. As there is no training set for an AI/ML algorithm, this question is irrelevant to this submission.

Summary of the Study:

The core study presented for the Arthrex Meniscal Dart System is an in-vitro (benchtop) mechanical comparison study against the Bionx Arrow predicate device. The study measured "pull-out force" at various repair locations (medial posterior and lateral central). The key findings were:

• No significant differences between the Dart and the Arrow for the average pull-out force across all repair locations combined (details of this specific comparison are given as "24.9 lbs." for Dart and "33.3 lbs." for Arrow, suggesting that overall the Dart was lower, but the text claims "no significant differences" in the combined average, which could mean specific statistical tests were used. The provided table seems to contradict this "no significant difference" claim for the overall average, as 24.9 lbs is considerably less than 33.3 lbs. However, for the medial posterior location, which is highlighted as most common, the performance was very similar).
• For the medial posterior location (most common for tears), the Dart had the same average pull-out force (30 N / 29.9 lbs.) as the Arrow (30.9 lbs.) and a smaller standard deviation. This indicates comparable, and potentially more consistent, performance in the most critical area.
• The design of the Dart (flush implantation without a "T" head) was presented as an advantage to prevent potential damage to articular cartilage, addressing a concern with the predicate.

The material for the Dart, Poly (L,DL-Lactide), was also supported by references to existing in-vitro/in-vivo testing and a publication by Claes et al. to establish its biocompatibility and degradation characteristics.

Ask a specific question about this device