(98 days)
The Arthrex iBalance® TKA System is indicated for use in individuals undergoing surgery for:
· Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis:
· Post-traumatic loss of knee joint configuration and function;
· Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability:
· Revisions of previous unsuccessful knee replacement or other procedure.
Additional indications for posteriorly stabilization components:
· Ligamentous instability requiring implant bearing surfaces with increased constraint;
· Absent or non-functioning posterior cruciate ligament.
These devices are single use only and are intended for implantation with the exception of porous coated femoral components which can be used cemented (biological fixation).
The Arthrex iBalance® TKA System consists of femoral components, tibial tray, tibial bearing components and patellar components. All components are available in a range of sizes to fit varying anatomical requirements. Femoral components and tibial bearing components are available in both posteriorly stabilized (PS) and cruciate retaining (CR) configurations. Femoral components are available in left and right versions, as well as cemented and uncemented (biological fixation) versions and are designed to work with the Arthrex dome patella components. Femoral and tibial tray components are manufactured from either cobalt-chromium alloy conforming to ASTM F75 or titanium alloy conforming to ASTM F136. Tibial bearing and patellar components are manufactured from UHMWPE conforming to ASTM F648.
The Arthrex iBalance® Modular Tibial Tray line extension offers the option of using stem extensions and/or tibial augments in a tray manufactured from titanium alloy. The Arthrex iBalance® Modular Tibial Tray would have two additional larger sizes—coming in sizes 1-10 rather than the size 1-8 range of the predicate. Two additional larger sized tibial bearing components and femoral components, size 9 & size 10, are also being offered.
This document is a 510(k) premarket notification for the Arthrex iBalance® TKA System, specifically a line extension to its Modular Tibial Tray. This is a medical device, and the information provided is not about a software-based AI device, thus it does not contain the detailed performance metrics, ground truth establishment, or study designs typically associated with AI/ML medical devices.
Therefore, many of the requested items (e.g., acceptance criteria for AI performance, sample sizes for AI test/training sets, expert qualifications for AI ground truth, MRMC studies, standalone AI performance) are not applicable to this document.
However, based on the provided text, I can extract information relevant to the device's equivalence and testing.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria and reported device performance in the way one would for an AI/ML device (e.g., sensitivity, specificity thresholds). Instead, for this orthopedic implant, "acceptance criteria" are tied to demonstrating substantial equivalence to predicate devices and compliance with FDA Guidance and industry standards through various mechanical tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device in basic design features and intended uses. | The Arthrex iBalance® TKA System is substantially equivalent to the predicate devices (K081127: AccinTM Total Knee System and K122765: Zimmer® PersonaTM Knee System) in which the basic design features and intended uses are the same. Differences are considered minor and do not raise questions concerning safety and effectiveness. |
| Compliance with FDA Guidance and industry standards for mechanical properties. | Fatigue, wear, interlock, and assembly/disassembly testing demonstrates Arthrex iBalance® Modular Tibial Tray compliance with FDA Guidance and industry standards. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of an "AI test set." For a physical device, testing typically involves a number of units or simulated conditions to meet mechanical testing standards. The document doesn't specify the "sample size" of devices tested for fatigue, wear, etc.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for mechanical device testing. The testing would be conducted in a laboratory environment, not on patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This is not applicable as this is a physical medical device (knee prosthesis), not an AI/ML device relying on an "expert ground truth" from human interpretation of data. Compliance is based on engineering standards and mechanical test results.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
- Not applicable for mechanical device testing. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical evaluations or image interpretation for AI/ML devices.
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
- Not applicable. MRMC studies are specific to evaluating the impact of AI on human interpretation performance, which is not relevant for a knee prosthesis.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm. The "standalone performance" of the device is essentially its mechanical performance as tested in a lab.
7. The Type of Ground Truth Used
- Ground Truth: For this device, the "ground truth" or standard of comparison is based on established engineering standards, FDA guidance for orthopedic implants, and the performance characteristics of predicate devices. This includes validated measurement techniques for fatigue, wear, interlock, and assembly/disassembly.
8. The Sample Size for the Training Set
- Not applicable as this is not an AI/ML device with a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable as this is not an AI/ML device with a "training set."
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 16, 2015
Arthrex, Incorporated Leon Brown II, Ph.D. Regulatory Project Manager 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K152252
Trade/Device Name: Arthrex iBalance® TKA System Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: September 22, 2015 Received: September 23, 2015
Dear Dr. Brown:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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" (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 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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Expiration Date: January 31, 2017
See PRA Statement below
Indications for Use
510(k) Number (if known)
Device Name
Arthrex iBalance® TKA System
Indications for Use (Describe)
- The Arthrex iBalance® TKA System is indicated for use in individuals undergoing surgery for:
- · Painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis:
- · Post-traumatic loss of knee joint configuration and function;
- · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability:
- · Revisions of previous unsuccessful knee replacement or other procedure.
Additional indications for posteriorly stabilization components:
- · Ligamentous instability requiring implant bearing surfaces with increased constraint;
- · Absent or non-functioning posterior cruciate ligament.
These devices are single use only and are intended for implantation with the exception of porous coated femoral components which can be used cemented (biological fixation).
| 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) |
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2.6 510(K) SUMMARY
| Date Summary Prepared | November 10, 2015 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA |
| 510(k) Contact | Leon Brown II, Ph.D.Regulatory Project ManagerArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 72028Fax: 239/598.5508Email: Leon.Brown@Arthrex.com |
| Trade Name | Arthrex iBalance® TKA System |
| Common Name | Knee Prosthesis |
| Primary Product Code -Classification NameCFR | MBH888.3565: Knee joint patellofemorotibial metal/polymerporous-coated uncemented prosthesis. |
| Secondary Product Code -Classification NameCFR | JWH888.3560: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Predicate Device | K081127: AccinTM Total Knee SystemK122765: Zimmer® PersonaTM Knee System |
| Purpose of Submission | This traditional 510(k) premarket notification issubmitted to obtain clearance for the Arthrex iBalance®Modular Tibial Tray line extension to the current ArthrexiBalance® TKA System. |
| Device Description | The Arthrex iBalance® TKA System consists of femoralcomponents, tibial tray, tibial bearing components andpatellar components. All components are available in arange of sizes to fit varying anatomical requirements.Femoral components and tibial bearing components areavailable in both posteriorly stabilized (PS) and cruciateretaining (CR) configurations. Femoral components areavailable in left and right versions, as well as cementedand uncemented (biological fixation) versions and aredesigned to work with the Arthrex dome patellacomponents. Femoral and tibial tray components aremanufactured from either cobalt-chromium alloyconforming to ASTM F75 or titanium alloy conforming toASTM F136. Tibial bearing and patellar components aremanufactured from UHMWPE conforming to ASTM |
| F648. | |
| The Arthrex iBalance® Modular Tibial Tray lineextension offers the option of using stem extensionsand/or tibial augments in a tray manufactured fromtitanium alloy. The Arthrex iBalance® Modular TibialTray would have two additional larger sizes—coming insizes 1-10 rather than the size 1-8 range of the predicate.Two additional larger sized tibial bearing components andfemoral components, size 9 & size 10, are also beingoffered. | |
| Intended Use | The Arthrex iBalance® TKA System is indicated for usein individuals undergoing surgery for:Painful, disabling joint disease of the knee resultingfrom degenerative arthritis, rheumatoid arthritis orpost-traumatic arthritis; Post-traumatic loss of knee joint configuration andfunction Moderate varus, valgus, or flexion deformity in whichthe ligamentous structures can be returned to adequatefunction and stability; Revisions of previous unsuccessful knee replacementor other procedure. Additional indications for posteriorly stabilizedcomponents: Ligamentous instability requiring implant bearingsurfaces with increased constraint; Absent or non-functioning posterior cruciate ligament. These devices are single use only and are intended forimplantation with bone cement, with the exception ofporous coated femoral components which can be usedcemented or uncemented (biological fixation). |
| Substantial EquivalenceSummary | The Arthrex iBalance® TKA System is substantiallyequivalent to the predicate device in which the basicdesign features and intended uses are the same. Anydifferences between the Arthrex iBalance® TKA Systemand the predicate are considered minor and do not raisequestions concerning safety and effectiveness.The predicate Arthrex iBalance® TKA System is a totalknee arthroplasty system consisting of femoral |
| components, tibial tray, tibial bearing components and | |
| patellar components. The proposed Arthrex iBalance® | |
| TKA System consists of the same four components plus a | |
| line extension to the currently available tibial trays. This | |
| Arthrex iBalance® Modular Tibial Tray line extension is | |
| equivalent to the currently available Arthrex predicate | |
| tibial trays in size range, use and performance, with the | |
| exception that the Arthrex iBalance® Modular Tibial Tray | |
| line extension offers the option of using stem extensions | |
| and/or tibial augments in a tray manufactured from | |
| titanium alloy. | |
| Fatigue, wear, interlock and assembly/disassembly testing | |
| demonstrates Arthrex iBalance® Modular Tibial Tray | |
| compliance with FDA Guidance and industry standards. | |
| on the indication for use, technologicalBased | |
| characteristics, and testing data submitted, Arthrex, Inc. | |
| has determined that the Arthrex iBalance® TKA System | |
| is substantially equivalent to currently marketed predicate | |
| devices. | |
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§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.