Shoulder Bankart lesion repair SLAP lesion repairs Acromio-clavicular repair Capsular shift/capsulolabral reconstruction Deltoid repair Rotator cuff tear repair Biceps Tenodesis
Foot and Ankle Medial/lateral repair and reconstruction Mid- and forefoot repair Hallux valgus reconstruction Metatarsal ligament/tendon repair or reconstruction Achilles tendon repair
Elbow Ulnar or radial collateral ligament reconstruction Lateral epicondylitis repair Biceps tendon reattachment
Knee Extracapsular repair: MCL, LCL, and posterior oblique ligament Illiotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure

Device Description

The JuggerLoc and 2.9 ToggleLoc Soft Tissue System is a non-resorbable system intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue to bone fixation. The system construct includes various components including; Juggerknot Soft Anchors or ToggleLoc Button with ZipLoop Technology with or without needles. These implants are single use devices and are provided sterile by exposure to Ethylene Oxide.

AI/ML Overview

This document is a 510(k) premarket notification for the ToggleLoc 2.9 and JuggerLoc Soft Tissue System, seeking to demonstrate substantial equivalence to previously cleared predicate devices. The document explicitly states that no animal or clinical testing was required or performed to support substantial equivalence. Therefore, it does not contain information about acceptance criteria for device performance based on human or animal studies, nor does it describe a study showing the device meets such criteria.

The information provided only discusses non-clinical mechanical tests.

Here's a breakdown of the requested information based only on the provided text, primarily outlining what is NOT present in this type of submission:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified in the document. Specific quantitative acceptance criteria for mechanical testing (e.g., minimum tensile strength, maximum displacement under cyclic loading) are not provided. The document generally states that the device is "substantially equivalent to the predicate devices" based on mechanical testing.	Device Insertion Testing: Results demonstrate substantial equivalence to predicate devices. (No quantitative data provided.)
	Cyclic and Static Tensile Testing: Results demonstrate substantial equivalence to predicate devices. (No quantitative data provided.)

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

Test Set Sample Size: Not specified for any of the non-clinical mechanical tests.
Data Provenance: Not specified. This is non-clinical mechanical test data, likely performed in-house or by a contract lab; country of origin and retrospective/prospective don't apply in the same way they would for clinical data.

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)

Not applicable. This document describes non-clinical mechanical testing, not a study involving expert assessment or ground truth establishment in a clinical context.

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

Not applicable. This document describes non-clinical mechanical testing, not a study involving adjudication of clinical findings.

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. The document explicitly states, "No animal or clinical testing was required to support substantial equivalence." This is not a study assessing AI or human reader performance.

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

No. This is not a study of an algorithm; it is a submission for a medical device (surgical implants).

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

Not applicable. This document describes non-clinical mechanical testing. Ground truth in this context would refer to the actual physical properties of the materials and device constructs, measured by validated test methods, rather than clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

Not applicable. There is no training set mentioned as this is not an AI/machine learning device or a clinical study that would involve such a set.

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

Not applicable. There is no training set mentioned.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of three abstract human profiles facing right, stacked on top of each other, with flowing lines connecting them. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

Biomet Manufacturing Corp. Mr. Jared Cooper Regulatory Affairs Specialist 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587 November 19, 2014

Re: K141263

Trade/Device Name: ToggleLoc 2.9 and JuggerLoc Soft Tissue System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR, MBI Dated: October 16, 2014 Received: October 17, 2014

Dear Mr. Cooper:

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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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" (21 CFR 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 yours,

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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t Notification [510(k)] Submission Under 21 CFR § 807.87 for ToggleLoc 2.9 and JuggerLoc Soft Tissue Devices

Indications for Use

510(k) Number (if known): K141263

Device Name: ToggleLoc 2.9 and JuggerLoc Soft Tissue System

Indications for Use:

The 2.9 ToggleLoc and JuggerLoc Soft Tissue devices are intended for soft tissue to bone fixation for the following indications:

Shoulder
Bankart lesion repair SLAP lesion repairs Acromio-clavicular repair Capsular shift/capsulolabral reconstruction Deltoid repair Rotator cuff tear repair Biceps Tenodesis

Foot and Ankle Medial/lateral repair and reconstruction Mid- and forefoot repair Hallux valgus reconstruction Metatarsal ligament/tendon repair or reconstruction Achilles tendon repair

Elbow Ulnar or radial collateral ligament reconstruction Lateral epicondylitis repair Biceps tendon reattachment

Knee
Extracapsular repair: MCL, LCL, and posterior oblique ligament Illiotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR (21 CFR 801 Subpart C)

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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K141263 - Page 1 of 3 fication [510(k)] Submission Under 21 CFR § 807.87 for ToggleLoc 2.9 and JuggerLoc Soft Tissue Devices

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the ToggleLoc 2.9 and JuggerLoc Soft Tissue System 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.

Date: November 13, 2014

Submitter:

Biomet Manufacturing Corp. 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587 Establishment registration number: 1825034

Official Correspondence/Contact Person:

Jared Cooper, PhD Regulatory Affairs Specialist, SET jared.cooper@biomet.com (574) 372-1941

510(k) Preparer:

Jared Cooper

Product Name:

ToggleLoc 2.9 and JuggerLoc Soft Tissue Devices

Device Classification:

JDR - Staple, Fixation, Bone (21 CFR 888.3030)

MBI - Fastener, Fixation, nondegradable, soft tissue (21 CFR 888.3040)

Legally Marketed Predicates:

Biomet ToggleLoc System (K130033) Biomet JuggerKnot Soft Anchor (K110145) Conmed-Linvatec Y-Knot Anchor (K131035)

Device Description:

The JuggerLoc and 2.9 ToggleLoc Soft Tissue System is a non-resorbable system intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue to bone

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fixation. The system construct includes various components including; Juggerknot Soft Anchors or ToggleLoc Button with ZipLoop Technology with or without needles. These implants are single use devices and are provided sterile by exposure to Ethylene Oxide.

Intended Use and Indications for Use:

The 2.9 ToggleLoc and JuggerLoc Soft Tissue devices are intended for soft tissue to bone fixation for the following indications:

Shoulder Bankart lesion repair SLAP lesion repairs Acromio-clavicular repair Capsular shift/capsulolabral reconstruction Deltoid repair Rotator cuff tear repair Biceps Tenodesis
Foot and Ankle Medial/lateral repair and reconstruction Mid- and forefoot repair Hallux valgus reconstruction Metatarsal ligament/tendon repair or reconstruction Achilles tendon repair

Elbow

Ulnar or radial collateral ligament reconstruction Lateral epicondylitis repair Biceps tendon reattachment

Knee

Extracapsular repair: MCL, LCL, and posterior oblique ligament Illiotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure

Technological Characteristics:

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

. Intended Use: The proposed ToggleLoc 2.9 and JuggerLoc Soft Tissue System have the same intended use as the predicate devices for soft tissue to bone fixation.
Materials: The ToggleLoc 2.9 and JuggerLoc Soft Tissue System Implants are manufactured from UHMWPE and Polyester suture and metal button materials as the predicate JuggerKnot and ToggleLoc devices, which include the same manufacturing processess.

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Notification [510(k)] Submission Under 21 CFR § 807.87 for ToggleLoc 2.9 and JuggerLoc Soft Tissue Devices

Design Features: The ToggleLoc 2.9 and JuggerLoc Soft Tissue System incorporate the same design features as the predicate devices.
. Sterilization: The proposed ToggleLoc 2.9 and JuggerLoc Soft Tissue System are provided sterile via the same sterilization methods for single-use as the predicates.

Performance Data (Nonclinical and/or Clinical):

Non clinical Tests
Results from mechanical testing demonstrate the proposed ToggleLoc 2.9 and JuggerLoc Soft Tissue System are substantially equivalent to the predicate devices. No animal or clinical testing was required to support substantial equivalence. A description of the tests and analyses is listed below.
Device Insertion testing
Cyclic and Static Tensile testing
Clinical Tests ●

Not required for this device.

Conclusions:

The proposed ToggleLoc 2.9 and JuggerLoc Soft Tissue System have similar intended use, technological characteristics, and mechanical performance as the predicate devices. The performance testing data identified no new risks and is substantially equivalent to the legally marketed predicate devices.

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.