The Offset Junction Box is part of the Balanced Knee® Revision System and is a single use modular device used in revision knee surgery to provide an attachment point between a modular femoral component and a stem extension.
The Offset Junction Box is available in four size options: 0mm and 5mm offset configurations with either a 5° or 7° valgus angle.

AI/ML Overview

This document describes a medical device, the "Balanced Knee Revision System - Offset Junction Box," and its FDA 510(k) clearance. This is a traditional medical device approval, not related to AI/ML software. Therefore, the questions regarding acceptance criteria and studies that prove the device meets these criteria in the context of an AI/ML device cannot be fully answered from the provided text.

The provided text details the device's indications for use, its classification, and the basis for its substantial equivalence to a predicate device (K060569). It mentions mechanical tests conducted but does not provide specific acceptance criteria or detailed results in a comparative table format as requested for AI/ML devices.

However, I can extract the information provided about the non-clinical mechanical tests and state that, based on the document, these tests were used to demonstrate the device's safety and effectiveness in line with established standards for knee joint prostheses.

Here's an attempt to structure the available information, noting the absence of AI/ML-specific details:

Acceptance Criteria (Not Explicitly Stated for AI/ML, but inferred from device type)	Reported Device Performance (Summary from text)
Device functions as intended for total knee arthroplasty procedures.	"The Offset Junction Box has the same technological characteristics as the predicate device."
Mechanical integrity under various loads (static torsion, static axial and shear, cyclic fatigue).	"The mechanical test results demonstrate that the Offset Junction Box is safe and effective."
Biological safety (e.g., absence of bacterial endotoxins).	"Bacterial endotoxin testing was also performed using LAL pyrogen testing methodology and met the predetermined acceptance criteria."

Regarding the specific questions for AI/ML devices:

A table of acceptance criteria and the reported device performance: As seen above, specific quantitative acceptance criteria or performance metrics (like sensitivity, specificity, AUC) for an AI/ML algorithm are not provided because this is a physical medical device. The "performance" is described in terms of meeting mechanical and biological safety standards.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this physical device. The testing involved mechanical tests of the device itself, not analysis of a data set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model is not relevant here. The ground truth for device performance would be established by physical testing standards and expert engineering evaluation, but the specifics are not detailed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a physical device.
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: Not applicable. This is not an AI/ML device involving human readers or interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the mechanical tests, the ground truth would be defined by the ASTM standards (ASTM F-1814 for static torsion, static axial and shear, cyclic fatigue) and regulatory requirements for bacterial endotoxin testing. These standards define acceptable performance limits.
The sample size for the training set: Not applicable. There is no training set for a physical device.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) clearance letter for a physical knee implant component. It addresses the device's substantial equivalence through mechanical testing against established standards, not through AI/ML model performance evaluation. Therefore, most of the questions tailored for AI/ML devices cannot be answered from this specific text.

Summary

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Ortho Development Corporation Dan Petersen Regulatory Affairs Specialist 12187 So. Business Park Drive Draper, Utah 84020

June 20, 2018

Re: K180743

Trade/Device Name: Balanced Knee Revision System - Offset Junction Box Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: March 20, 2018 Received: March 22, 2018

Dear Dan Petersen:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K180743

Device Name

Balanced Knee® Revision System - Offset Junction Box

Indications for Use (Describe)

This device is intended for use in total knee arthroplasty procedures for the following conditions:

1. Loss of joint configuration and joint function.
1. Osteoarthritis of the knee joint.
1. Rheumatoid arthritis of the knee joint.
1. Post-traumatic arthritis of the knee joint.
1. Valgus, varus, or flexion deformities of the knee joint.
1. Revision procedures where other treatments or devices have failed.

Type of Use (Select one or both, as applicable)
☑ Residential Use (Part 1 of SEC 201 Subject Site)☐ On-Site Construction (21-277 SEC Subject Site)	☑ Residential Use (Part 1 of SEC 201 Subject Site)	☐ On-Site Construction (21-277 SEC Subject Site)
☑ Residential Use (Part 1 of SEC 201 Subject Site)	☐ On-Site Construction (21-277 SEC Subject Site)

X 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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12187 So. Business Park Drive Draper, Utah 84020 801-553-9991/ fax 553-9993 Orthodevelopment.com

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510(k) Summary

Name of Sponsor:	Ortho Development Corporation12187 South Business Park DriveDraper, Utah 84020
510(k) Contact:	Dan PetersenRegulatory Affairs SpecialistTelephone: (801) 619-3416Facsimile: (801) 619-8916Email: RA@OrthoDevelopment.com
Date Prepared:	March 20, 2018
Submission Type:	Traditional 510(k)
Proprietary Name:	Balanced Knee® Revision System - Offset Junction Box
Common Name:	Offset Junction Box
Classification:	21 CFR 888.3560: Knee joint patellofemorotibialpolymer/metal/polymer semi-constrained cemented prosthesis.
Device Class:	Class II device
Device Product Code:	JWH
Predicate Devices:	K060569 – Balanced Knee Revision System, Stem Junction Box;Ortho Development Corporation

5.1 Device Description

The Offset Junction Box is available in four size options: 0mm and 5mm offset configurations with either a 5° or 7° valgus angle.

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5.2 Indications for Use

This device is intended for use in total knee arthroplasty procedures for the following conditions:

1. Loss of joint configuration and joint function.
1. Osteoarthritis of the knee joint.
Rheumatoid arthritis of the knee joint. 3.
1. Post-traumatic arthritis of the knee joint.
1. Valgus, varus, or flexion deformities of the knee joint.
1. Revision procedures where other treatments or devices have failed.

5.3 Basis for Substantial Equivalence:

The Offset Junction Box has the same technological characteristics as the predicate device. These include:

1. Indications for use
1. Intended use
1. Basic design
1. Function
1. Manufacturer
1. Manufacturing Process
1. Sterilization
1. Packaging

The following non-clinical mechanical tests were conducted on the worst-case configurations of the Offset Junction Box:

1. Static torsion per ASTM F-1814
1. Static axial and shear per ASTM F-1814
1. Cyclic fatigue per ASTM F-1814

Bacterial endotoxin testing was also performed using LAL pyrogen testing methodology and met the predetermined acceptance criteria.

The fundamental scientific technology of the Offset Junction Box is the same as the previously cleared device. The mechanical test results demonstrate that the Offset Junction Box is safe and effective.

Based on similarities in intended use, design, manufacturing methods, sterilization, packaging, and the mechanical test results, the Offset Junction Box is substantially equivalent to the predicate device that was cleared under K060569.

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.