The JuggerStitch Meniscal Repair Device is indicated for repair of vertical longitudinal full thickness tears (i.e. buckethandle) in the red-red and red-white zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.

Device Description

The JuggerStitch Meniscal Repair Device is a permanent fixation anchor system comprised of UHMWPE suture, with two non-resorbable polyester sleeves. The device comes as a unit, preassembled on either a straight or curved inserter.

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to complete the table and answer all the questions regarding the acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary for a medical device, the JuggerStitch Meniscal Repair Device, and primarily focuses on establishing substantial equivalence to a predicate device.

Here's what I can extract and what's missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions "non-clinical laboratory testing was performed to verify the fixation strength of the JuggerStitch Meniscal Repair Device in mechanical testing as compared to the MaxFire MarXmen Meniscal Repair Device." It then states, "The test results indicate that the JuggerStitch Meniscal Repair Device provides equivalent fixation strength to the predicate device and would be functional within their intended use."

However, specific numerical acceptance criteria (e.g., minimum fixation strength in Newtons) and the exact reported performance values for both the JuggerStitch and the predicate device are not provided. Therefore, a table with specific acceptance criteria and reported performance cannot be generated from this text.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in the document.
Data Provenance: The document states "non-clinical laboratory testing was performed." It does not mention country of origin or whether it was retrospective or prospective, though "non-clinical laboratory testing" typically implies a controlled, prospective lab setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as this was non-clinical mechanical testing, not a study requiring expert clinical ground truth assessment.

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

Not applicable as this was non-clinical mechanical testing.

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:

No MRMC or human-in-the-loop study was mentioned. The device is a physical medical device, not an AI or imaging diagnostic tool.

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

Not applicable as this is a physical medical device.

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

For the non-clinical mechanical testing, the "ground truth" or reference was the fixation strength of the predicate device. The goal was to show equivalence.

8. The sample size for the training set:

Not applicable. This document describes a non-clinical performance test for a physical device, not a machine learning model that would have training data.

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

Not applicable.

In summary, the provided document is a 510(k) summary that focuses on demonstrating substantial equivalence through comparison to a predicate device, primarily via non-clinical mechanical testing. It does not provide the detailed quantitative data, sample sizes for mechanical testing beyond a general statement, or information on clinical studies, expert reviews, or AI performance metrics.

Summary

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May 15, 2015

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Biomet Manufacturing Corporation Ms. Patricia S. Beres Senior Regulatory Affairs Specialist P.O. Box 57 56 East Bell Drive Warsaw, Indiana 46581

Re: K150424

Trade/Device Name: JuggerStitch Meniscal Repair Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: February 17, 2015 Received: February 19, 2015

Dear Ms. Beres:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K150424

Device Name JuggerStitch Meniscal Repair Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the JuggerStitch Meniscal Repair Device 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.

Sponsor:	Biomet Inc.56 East Bell DrivePO Box 587Warsaw, IN 46581Establishment Registration Number: 1825034
Contact:	Patricia S. BeresSenior Regulatory Affairs Specialist
Date:	February 17, 2015
Subject Device:	Trade Name: JuggerStitch Meniscal Repair Device
	Common Name: Soft Tissue Fixation Device
	Classification Name:

MBI– Fastener, Fixation, Nondegradable, Soft Tissue (Smooth or threaded metallic bone fixation fastener 21 CFR 888.3040)

Legally marketed devices to which substantial equivalence is claimed:

0 MaxFire MarXmen Meniscal Repair Device (K111564)

Device Description

Intended Use and Indications for Use

The JuggerStitch Meniscal Repair device is indicated for repair of vertical longitudinal full thickness tears (i.e. bucket-handle) in the red-red and red-white zones. These devices are not to be used for meniscal tears in the avascular zone of the meniscus.

Summary of Technological Characteristics

The technological characteristics (materials, design, sizing, and indications) of the JuggerStitch Meniscal Repair Device are similar or identical to the predicate devices or other previously cleared devices.

The rationale for substantial equivalence is based on consideration of the following characteristics:

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Intended Use: The proposed JuggerStitch Meniscal Repair Device is intended for the repair of the vertical longitudinal full thickness tears (i.e. bucket-handle) in the red-red and red-white zones, which is identical to the intended use of the predicate device.
Materials: The proposed JuggerStitch Meniscal Repair Device uses the same implant material as the predicate device.
. Design Features: The proposed JuggerStitch Meniscal Repair Device incorporates similar design features as the predicate device.
Sterilization: The proposed JuggerStitch Meniscal Repair device is provided sterile via Ethylene Oxide (EtO), the same sterilization method utilized for the predicate device.

Summary of Performance Data (Nonclinical and/or Clinical)

Non-Clinical Tests
- o Non-clinical laboratory testing was performed to verify the fixation strength of the JuggerStitch Meniscal Repair Device in mechanical testing as compared to the MaxFire MarXmen Meniscal Repair Device. The test results indicate that the JuggerStitch Meniscal Repair Device provides equivalent fixation strength to the predicate device and would be functional within their intended use.
Clinical Tests
- None provided as a basis for substantial equivalence. O

Substantial Equivalence Conclusion

The proposed JuggerStitch Meniscal Repair Device has similar intended use, technology characteristics, and mechanical performance as the predicate devices. The performance testing data identified no new risks and substantial equivalence to the legally marketed predicate devices.

Regulation Number and Section

N/A