The J-Fx Cerclage System is indicated for use in general orthopaedic repairs. This includes such procedures as reinforcement of bone, reattachment of the greater trochanter, fixation of long bone fracture with grafting, fixation of patellar fractures, and closure of sternum following open heart surgery.

Device Description

The J-Fx Cerclage System consists of implants and instruments. The implants are cables and sleeves in both stainless steel and cobalt chromium alloy. The cables are available in two diameters, 1.6 mm and 2.0 mm. Instrumentation is also part of the system to assist in the placement of the implants.

AI/ML Overview

This document is a 510(k) summary for the J-Fx Cerclage System, a medical device. It does not include information about performance evaluations based on AI, image analysis, or expert-based ground truth. Therefore, many of the requested sections about AI-specific criteria cannot be fulfilled from this document.

The document describes the device, its intended use, and compares its technological characteristics to predicate devices for substantial equivalence. It does not provide details of a study that establishes acceptance criteria in the way one would for a diagnostic or AI-driven device (e.g., sensitivity, specificity, accuracy). Instead, substantial equivalence is claimed based on similarities in design, materials, and intended use with previously approved devices.

Here's an attempt to answer the questions based only on the provided text, noting where the information is not applicable or unavailable:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify quantitative acceptance criteria in terms of performance metrics (like sensitivity, specificity, or accuracy) for the J-Fx Cerclage System, nor does it report device performance against such criteria. The "performance standards" section explicitly states, "No performance standards have been developed for this device."

The approval is based on "substantial equivalence" to predicate devices, meaning its technological characteristics are deemed sufficiently similar so that it can be marketed without new, extensive clinical trials to prove efficacy and safety from scratch.

Acceptance Criteria (Implied from Substantial Equivalence to Predicate Devices)	Reported Device Performance (Specific metrics not provided in document)
Flexible Cable Fixation Method: Yes	Yes (Matches predicate devices)
Crimped Sleeve: Yes	Yes (Matches predicate devices)
Chamfered Sleeve Hole Edges: Yes	Yes (Matches predicate devices for available information, "?" for some predicates)
Cable Thickness (2mm or 1.6mm): Yes	Yes (Matches predicate devices)
Uses Cable Passer: Yes	Yes (Matches predicate devices)
Uses Cable Tensioner: Yes	Yes (Matches predicate devices)
Uses Sleeve Crimper: Yes	Yes (Matches predicate devices)
Uses Cable Cutter: Yes	Yes (Matches predicate devices)
Cable Material (Co-Cr or SS): Yes	Yes (Matches predicate devices in general type, Vitallium® for DALL-MILES, Co-Cr for FX-CABLELOK)
Sleeve Material (Co-Cr or SS): Yes	Yes (Matches predicate devices in general type, Vitallium® for DALL-MILES, Co-Cr for FX-CABLELOK)
Intended Use: General orthopaedic repairs, reinforcement of bone, reattachment of the greater trochanter, fixation of long bone fracture with grafting, fixation of patellar fractures, and closure of sternum following open heart surgery.	Same as Intended Use claimed for predicate devices (implied by substantial equivalence).

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This device is a physical medical implant system, not a diagnostic or AI-powered device that would typically use a "test set" of data for performance evaluation in the context of sensitivity/specificity. The evaluation for substantial equivalence is based on a comparison of device characteristics and intended use. There is no mention of a "test set" of patient data in this document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth, in the context of expert consensus, is not established for this type of device in this document. The assessment for substantial equivalence is performed by the FDA based on the provided technical characteristics and comparison to predicate devices, not on human expert reads of data.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" or human reader adjudication process described in this document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a surgical implant system, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This device is a surgical implant system, not an algorithm.

7. The Type of Ground Truth Used

Not applicable in the typical sense of a diagnostic or AI device. The "ground truth" for this submission is essentially the established safety and efficacy of the predicate devices based on their prior marketing approval and clinical experience. The J-Fx Cerclage System is deemed substantially equivalent because its design, materials, and intended uses are so similar to these already approved devices.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or data analysis.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no "training set" for this device.

Summary

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JUN 2
K971682
Johnson-Johnson
PROFESSIONAL, INC.

510(k) Summary

Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, MA 02767-0350

Contact Person: John D. Ferros Phone:(508) 880-8287 Fax: (508) 828-3212

Name of Device

Classification Name: Bone Fixation Cerclage has been placed in Class II by the FDA under 21 CFR 888.3010. This falls under the Orthopaedics panel/87. Common Name: Cerclage Fixation Device.

Trade Name/Proprietary Name: J-Fx Cerclage System Performance Standards: No performance standards have been developed for this device.

Predicate Device

OSTEO-CLAGE™ Cable system by Acumed, Inc. (K921480) ●
DALL-MILES Trochanter Cable Grip System by Howmedica. (K934058)
FX-CABLELOK" System by Biodynamic Technologies, Inc. (K935646) .

Description of Device

Intended Use

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Technological Characteristics Compared to Predicate Device

	J-Fx	OSTEO-CLAGE	DALL-MILES	FX-CABLELOK
Design
Flexible CableFixation Method	Yes	Yes	Yes	Yes
	CrimpedSleeve	CrimpedSleeve	CrimpedSleeve	CrimpedSleeve
ChamferedSleeve HoleEdges	Yes	Yes	?	?
Cable Thickness	2mm or1.6mm	2mm or1.6mm	2mm or1.6mm	2mm
Uses:
Cable Passer	Yes	Yes	Yes	Yes
CableTensioner	Yes	Yes	Yes	Yes
SleeveCrimper	Yes	Yes	Yes	Yes
Cable Cutter	Yes	Yes	Yes	Yes
Materials
Cable	Co-Cr or SS	Co-Cr or SS	Vitallium®	Co-Cr
Sleeve	Co-Cr or SS	Co-Cr or SS	Vitallium®	Co-Cr

Similarities and Differences Matrix

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 27 1997

Mr. John D. Ferros ·Senior Regulatory Affairs Specialist Johnson & Johnson Professional, Inc. 325 Paramount Drive Raynham, Massachusetts 02767

Re : K971682 J-Fx Cerclage System Requlatory Class: II Product Code: LRN Dated: May 5, 1997 Received: May 6, 1997

Dear Mr. Ferros:

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 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.

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. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Fractice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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. John D. Ferros

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 requlation (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,

Marin Schroeder, MS, PT
Celia M. Witten, Ph.D., M.D.

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

Enclosure

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K971682 510(k) Number (if known):

Device Name: J-Fx Cerclage System . . . . . . . .

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Maie H. Schroeder msPTfa cmu

(Division Sign-Off) Division of General Restorative Devices 510(k) Number Y

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use OR

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(Optional Format 1-2-96)

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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.