The Mitek RapidLoc™ Meniscal Repair System is intended for use in the arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) located in the vascularized area of the meniscus (red-red and red-white zones).

Device Description

The Mitek RapidLoc™ Meniscal Repair System described in this 510(k) is a sterile, two I router Description: "Ho witting of a molded PLA Backstop and Tophat.

AI/ML Overview

This 510(k) premarket notification describes a medical device, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and training data, which are typically associated with performance validation of AI/ML models, is not applicable in this context.

The provided document focuses on demonstrating substantial equivalence of the Mitek RapidLoc™ Meniscal Repair System to predicate devices through performance testing and similarities in design, operating principle, and biocompatibility.

Here's a breakdown of the relevant information from the document, tailored to a non-AI/ML medical device submission:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly state numerical "acceptance criteria" against which the device performance is measured in a quantitative table format. Instead, it indicates that "Safety and Performance data has been provided to support substantial equivalence." The reported performance is in comparison to predicate devices.

Acceptance Criterion (Implied)	Reported Device Performance
Functional Equivalence	"Similarities in design, operating principle, biocompatibility and production" to predicate devices.
Mechanical Strength	Strength comparison: (RapidLoc™ Meniscal Repair System vs. Mitek "H" Fix) - Specific results not detailed in this summary, but implied to be comparable or superior.
Suture Comparison	Suture Comparison: (RapidLoc™ Meniscal Repair System vs. PDS Suture) - Specific results not detailed in this summary, but implied to be comparable or superior.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not specify the sample sizes used for the performance testing (strength and suture comparisons) nor does it provide details on data provenance (country of origin, retrospective/prospective). This type of detail is typically found in the full testing reports or study protocols, not usually in the 510(k) summary itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This question is not applicable. For a physical medical device like a meniscal repair system, "ground truth" as it relates to expert consensus for diagnostic interpretation is not relevant. Performance testing involves objective measurements of physical properties (e.g., strength).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This question is not applicable. Adjudication methods are typically employed for subjective evaluations or consensus-building in clinical assessments, not for objective mechanical performance testing of a physical device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This question is not applicable. The device is a surgical implant, not an imaging or diagnostic aid that would involve human "readers" or AI assistance.

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

This question is not applicable, as the device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

This question is not applicable in the typical sense for an AI/ML device. For this physical device, the "ground truth" against which performance is measured would be established engineering standards, biomechanical principles, and the performance characteristics of legally marketed predicate devices.

8. The sample size for the training set:

This question is not applicable. The device is not an AI/ML model, so there is no "training set."

9. How the ground truth for the training set was established:

This question is not applicable, as the device is not an AI/ML model.

Summary

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K02406

FEB 1 5 2001

510(k) Summary

Trade Name:	Mitek RapidLoc™ Meniscal Repair System
Sponsor:	Mitek Products
	249 Vanderbilt Avenue
	Norwood, MA 02062
	Registration #1221934
Contact:	Christine Kuntz-Nassif
	Sr. Regulatory Affairs Associate
	Telephone: (781) 251-2974
	Fax: (781) 278-9578
Device Generic Name:	Fastener Fixation, Biodegradable, Soft Tissue
Classification:	According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device classification is Class II.
Product Code:	87 MAI
Predicate Devices:	K970119 - Mitek "H" Fix; NDA#18-331 - PDS Absorbable Suture

Product Description: The Mitek RapidLoc™ Meniscal Repair System described in this 510(k) is a sterile, two I router Description: "Ho witting of a molded PLA Backstop and Tophat.

Indications for Use:

The RapidLoc™ Meniscal Repair System is intended for use in the arthroscopic fixation of longitudinal wertical meniscus lesions (bucket-handle lesions) located in the vasularized area of the meniscus (red-red and red-white zones).

Safety and Performance:

Safety and Performance data has been provided to support subtantial equivalence of the Mitek RapidLoc TM Meniscal Repair System:

Performance Testing:

ormance Testing.
Strength comparison (RapidLoc™ Meniscal Repair System vs. Mitek "H" Fix) .
Sucurem Compurison (RapidLoc™ Meniscal Repair System vs. PDS Suture) ●

Conclusion:

Conclusion:
Based on 1) safety and performance data, and 2) similarities in design, operating principle, biocompatibility and Based on 1) safety and periornalice uala, and 27 simminted in dosign opening production in the substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 5 2001

Ms. Christine Kuntz-Nassif Senior Regulatory Affairs Associate Mitek Products 249 Vanderbilt Avenue Norwood, Massachusetts 02062

Re: K002406

Trade Name: Rapidloc™Meniscal Repair System Regulatory Class: II Product Code: MAI, GAS and GAM Dated: November 16, 2000 Received: November 17, 2000

Dear Ms. Kuntz-Nassif:

We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your Security from hoursentially equivalent (for the indications for use above and we nave determined the devices marketed in interstate commerce prior to May 28, 1976, the stated in the encreasure) to device Amendments, or to devices that have been reclassified in enacultient date of the Medical Dories Fanenal Food, Drug, and Cosmetic Act (Act). You may, accordance with the provisions of the rockers of the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices in controls provisions of the rect menuse required in the mastranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III IT your device is classified (see acc very a to such additional controls. Existing major regulations (Frenaries Approval), it they of subject to outs f Federal Regulations, Title 21, Parts 800 to 895. atrecting your do rios can determination assumes compliance with the current Good A substantially equirement, as set forth in the Quality System Regulation (QS) for Manufacturing Practice requirement, as s c CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to Inspections, the Pood and Drug Administration. In addition, FDA may publish Comply with the GMT regarating your device in the Federal Register. Please note: this fultities alliouncentions concerning your submission does not affect any obligation you might It sponse to your promation in the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

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Page 2 - Ms. Christine Kuntz-Nassif

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and IT you desire specific advice for your as ic devices), please contact the Office of Compliance at additionally 607.10 for this diagnestions on the promotion and advertising of your device, (2011) 594-4639. prease connact the Orive or Somphares en premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsionnies and its into into internation of at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mark Mckisson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K002406

Device Name: Mitek RapidLoc™ Meniscal Repair System

Indications for Use:

Mark A. Milkersen

Division Sign-Off) (Division Sign-Off)
Division of General, Restorative Division of General Devices Division of Ochoral
And Neurological Devices and Neurological Devices KOO2406

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.