The Biomet JuggerLoc™ Bone system is intended for repair in the foot and ankle including indications for: Midfoot repair including but not limited to Lisfranc repair, ankle syndesmosis fixation (syndesmosis disruptions), and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures.

Device Description

The new JuggerLoc Bone to Bone system is a suture based construct intended to stabilize fractures. The construct consists of a JuggerKnot Soft Anchor with ZipLoop Technology, featuring combinations of suture and metal button fixation.

AI/ML Overview

The provided text describes a medical device called the "JuggerLoc Bone to Bone System," a suture-based construct intended to stabilize fractures. The submission is a 510(k) for a new device construct, claiming substantial equivalence to predicate devices (K130033 - Biomet ToggleLoc System, K110145 - Biomet JuggerKnot Soft Anchors, K133275 - Arthrex Mini-Tightrope).

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly state acceptance criteria in a quantitative or numerical format (e.g., a specific tensile strength in Newtons, or a particular displacement under load). Instead, it refers to "Preclinical performance tests are provided to address the subject construct's strength." The general acceptance is that "Results indicate that the subject construct is substantially equivalent to legally marketed devices."

Therefore, a table cannot be fully constructed with explicit numerical criteria. However, based on the text, the performance goal is implicitly to meet or exceed the performance of the predicate device(s) in terms of strength.

Acceptance Criteria (Implicit)	Reported Device Performance
Demonstrated strength and performance similar to legally marketed predicate devices.	Preclinical performance tests were conducted to address the subject construct's strength. Results indicate that the subject construct is substantially equivalent to legally marketed devices. The technological characteristics (design, dimensions, function, materials) are similar.
Biocompatibility	A biocompatibility rationale was provided.
No new concerns of safety or efficacy compared to predicate devices.	"No new concerns of safety or efficacy have been raised."

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 mentions "Preclinical performance tests" but does not specify the sample size used for these tests. It also does not specify the data provenance beyond stating they are "Preclinical performance tests," implying laboratory testing rather than human subject data. There is no information on country of origin or whether it was retrospective or prospective.

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 section is not applicable as the study described is a preclinical performance test (likely mechanical and material testing), not a study requiring human expert assessment of a test set, like in imaging or diagnostic device evaluations. There is no "ground truth" to be established by experts in the context of this submission.

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

This is not applicable for the same reasons as point 3. No human expert adjudication was involved in these preclinical performance tests.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation, not for mechanical fixation systems like the JuggerLoc Bone to Bone System. There is no mention of AI assistance.

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

This is not applicable. The device is a physical medical implant, not an algorithm or software. Therefore, an algorithm-only standalone performance evaluation is not relevant.

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

For the preclinical performance tests, the "ground truth" would be objective physical measurements of the device's mechanical properties (e.g., tensile strength, displacement, fatigue resistance), compared against established industry standards or the performance of predicate devices. The document does not specify the exact parameters measured, but implies mechanical strength testing as the basis for evaluation.

8. The sample size for the training set

This is not applicable. There is no mention of a "training set" as this device is a physical construct, not a learning algorithm or AI.

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

This is not applicable for the same reason as point 8.

Summary

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JUL 1 8 2014

Section 5 - 510(k) Summary

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92

Submitter Information
Name	Biomet Manufacturing Corp.
Address	56 East Bell DriveP.O. Box 587Warsaw, IN 46581
Phone number	(574) 372-1941
Fax number	(574) 371-1027
Establishment	1825034
Registration Number
Name of contact person	Jared CooperRegulatory Affairs Specialist
Date prepared	29 April 2014
Name of device
Trade or proprietary name	JuggerLoc Bone to Bone System
Common or usual name	Bone Fixation Anchor
Classification Name	Single/multiple component metallic bone fixation appliances and accessories.
Classification panel	Orthopedics
Regulation	21 CFR § 888.3030
Product Code(s)	HTN - washer, bolt nut

Legally marketed device(s) to which equivalence is claimed	K130033 - Biomet ToggleLoc SystemK110145 - Biomet JuggerKnot Soft AnchorsK133275 - Arthrex Mini-Tightrope
Reason for 510(k) submission	New Device Construct
Device description	The new JuggerLoc Bone to Bone system is a suture based construct intended to stabilize fractures. The construct consists of a JuggerKnot Soft Anchor with ZipLoop Technology, featuring combinations of suture and metal button fixation.
Indications for use	The JuggerLoc Bone to Bone System is intended for repair in the foot and ankle including indications for:Midfoot repair including but not limited to Lisfranc repair, ankle syndesmosis fixation (syndesmosis disruptions), and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures.
Summary of the Technologies

The technological characteristics of the JuggerLoc Bone to Bone System are similar to the predicate devices including design, dimensions, function, and materials. The JuggerLoc design differs from the predicate devices by having one soft anchor and one metal button to achieve fixation rather than two metal buttons.

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PERFORMANCE DATA

SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION

Performance Test Summary - New Device

The JuggerLoc Bone to Bone System components have the same basic technological and material characteristics as the predicate devices except for slight modifications to the general design as described in this 510(k) notification. Preclinical performance tests are provided to address the subject construct's strength. A biocompatibility rationale was also provided. Results indicate that the subject construct is substantially equivalent to legally marketed devices.

SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION

Clinical Performance Data/Information: None provided as a basis for substantial equivalence.

CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The results of preclinical tests and the similarities with legally marketed devices indicate the JuggerLoc Bone to Bone System is substantially equivalent to currently marketed devices. No new concerns of safety or efficacy have been raised.

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Public Health Service

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

July 18, 2014

Biomet Manufacturing Corp. Dr. Jared Cooper Regulatory Affairs Specialist 56 East Bell Drive. PO Box 587 Warsaw, Indiana 46581

Re: K141219

Trade/Device Name: JuggerLoc TM Bone to Bone System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN Dated: May 23, 2014 Received: May 27, 2014

Dear Dr. 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 docs 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 cither 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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Page 2 - Dr. Jared Cooper

(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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" (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/ReportalProblem/default.hun 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Lori A. Wiaqins

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

Enclosure

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Section 4 - Indications for Use Statement

K141219 510(k) Number:

JuggerLoc™ Bone to Bone System Device Name:

Indications For Use:

The Biomet JuggerLoc™ Bone system is intended for repair in the foot and ankle including indications for:

Midfoot repair including but not limited to Lisfranc repair, ankle syndesmosis fixation (syndesmosis disruptions), and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures.

× Prescription Use_ (Per 21 CFR 801 Subpart D) AND/OR Over-the-Counter_ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth 臨歐ank -S

Division of Orthopedic 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.