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.

AI/ML Overview

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.

Performance Metric	Acceptance Criteria (Predicate: Bionx Arrow)	Arthrex Meniscal Dart Performance
Pull-Out (Overall)	33.3 lbs. (Average)	24.9 lbs. (Average)
Pull-Out (Medial Posterior)	30.9 lbs. (Average)	29.9 lbs. (Average)

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.

Summary

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K983577

510(k) Summary

10/5/98

Company:	Arthrex, Inc.
Address:	2885 S. Horseshoe Drive, Naples, FL 34104
Phone:	(941) 643-5553
Fax:	(941) 643-6218
Contact:	Scott M. DurlacherDirector of Regulatory Affairs and Quality Assurance (ext. 117)
Trade Name:	Arthrex Meniscal Dart System
Trade Name:	Arthrex Meniscal Dart System
Common Name:	NA
Classification:	Fastener, Fixation, Biodegradable, Soft Tissue

Description:

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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.

Intended Use:

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

Substantial Equivalence:

By definition, substantial equivalence means that a device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the device is as safe and effective as the predicate device and does not raise different questions regarding safety and effectiveness from the predicate device.

The material for the Meniscal Dart, Poly (L,DL-Lactide), has undergone extensive in-vitro and in-vivo testing. Further evaluation of the material was conducted by Claes et. al. ("New bioresorbable pin for the reduction of small bony fragments: design, mechanical properties and in vitro degradation" - Biomaterials, 1996, Vol. 17 No. 16).

A substantial equivalence comparison is given in Table A. The Arthrex Meniscal Dart System is as safe and effective as the predicate device. Furthermore, it does not raise any different questions regarding safety and effectiveness from the predicate device.

162

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Company	Device	Material	Size(s)	Insertion	Pull-Out(overall)	Pull-Out(medial posterior)
Arthrex	Meniscal Dart	Poly (L, DL-lactide)	Diameter: 1.3 mmLength: 10, 12, 14 mm	Impact	24.9 lbs.	29.9 lbs.
Bionx	Arrow	Poly-L-lactide(SR-PLLA)	Diameter: 1.1 mmLength: 10, 13, 16 mm	Impact	33.3 lbs.	30.9 lbs.
InnovasiveDevices	Clearfix	Poly-L-lactide	Diameter: unknownLength: 10, 11, 13 mm	Screw	unkown	unkown

(9))

Table A: Substantial Equivalence Comparison

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 13 1999

Mr. Vernon Brown Manager of Regulatory Affairs Arthrex, Incorporated 2885 South Horseshoe Drive Naples, Florida 34104

Re: K983577

Trade Name: Arthrex Meniscal Dart System Regulatory Class: II Product Code: MAI Dated: August 4, 1999 Received: August 5, 1999

Dear Mr. Brown:

We have reviewed your Section 510(k) notification of intent to market the device referenced above, and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may. therefore, market the device, subject to the general control provisions of the Act. The general control provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820), and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Vernon Brown

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows the logo for Arthrex. The logo consists of the word "Arthrex" in a bold, sans-serif font. To the right of the word is an image of a surgical tool, possibly scissors. The logo is simple and professional, and it is likely used to represent the company's brand.

Indications for Use

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

Prescription Use
(Per 21 CFR 801.109)

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Islon Sign-Off) on of General Restorative Devices 48 35 510(k) Number

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.