(70 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 stabilized 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 bone cement.
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 and are designed to work with the Arthrex dome patella components. Femoral and tibial tray components are manufactured from Cobalt-Chromium Alloy conforming to ASTM F-75. Tibial bearing and patellar components are manufactured from UHMWPE conforming to ASTM F-648.
The CR Plus line of tibial bearing components are comparable to the system's current tibial bearing components with the exception of having dimensional specifications modification in order to offer a taller anterior lip for each size of the tibial bearing component.
The provided text describes the Arthrex iBalance® TKA System, specifically a line extension (CR Plus tibial bearing components), and its clearance via a 510(k) premarket notification. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance data in the format of AI/ML device studies.
Therefore, many of the requested elements for an AI device study (such as sample sizes for test/training sets, ground truth establishment methods, number of experts, adjudication, MRMC studies, or standalone performance) are not applicable or cannot be extracted from this document, as it pertains to a mechanical medical device (knee prosthesis).
However, I can extract the information related to the demonstration of substantial equivalence, which serves a similar purpose to meeting acceptance criteria in the context of a 510(k) submission.
Acceptance Criteria and Device Performance (Demonstration of Substantial Equivalence)
In the context of the 510(k) submission, the "acceptance criteria" are implicitly understood as demonstrating substantial equivalence to a predicate device. This involves showing that the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness. For mechanical devices, this is often achieved through comparative mechanical testing.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Arthrex iBalance® TKA System CR Plus) |
|---|---|
| No significant difference in performance between the proposed and predicate devices regarding contact stress. | "The contact stress... information submitted demonstrates that there is no significant difference in performance between the proposed and predicate devices." |
| No significant difference in performance between the proposed and predicate devices regarding constraint. | "The... constraint... information submitted demonstrates that there is no significant difference in performance between the proposed and predicate devices." |
| No significant difference in performance between the proposed and predicate devices regarding interlock. | "The... interlock... information submitted demonstrates that there is no significant difference in performance between the proposed and predicate devices." |
| No significant difference in performance between the proposed and predicate devices regarding range of motion. | "The... range of motion testing information submitted demonstrates that there is no significant difference in performance between the proposed and predicate devices." |
| Technological characteristics (e.g., material, use, size range, thickness at sulci for CR Plus tibial bearing components) are equivalent to the predicate tibial bearing components. | The CR Plus tibial bearing components are "equivalent to the currently available predicate tibial bearing components in size range, thickness at the sulci, material, use and performance with the exception that the CR Plus tibial bearing components have a dimensional specifications modification to provide a taller anterior lip." The modifications are considered minor and do not raise questions concerning safety and effectiveness. The predicate device is the Arthrex iBalance® TKA System (K081127: Accin™ Total Knee System is the further predicate for the entire system). |
| Indications for Use for the new device align with the predicate device. | The Arthrex iBalance® TKA System, including the CR Plus line extension, has the same stated indications for use as the predicate Arthrex iBalance® TKA System (which is the predicate for this specific line extension, though K081127 is listed as the overall predicate). These indications include painful, disabling joint disease of the knee from various arthritides, post-traumatic loss of configuration/function, moderate deformities where ligaments can be restored, revisions, and for PS components, ligamentous instability and absent/non-functioning PCL. |
Since this is a submission for a mechanical device and not an AI/ML device, the following points are not applicable or cannot be answered from the provided text.
- 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 mechanical device testing where physical samples are used for mechanical tests, not a "test set" of patient data. The document does not specify the number of physical samples tested.
- 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. Ground truth as typically understood in AI/ML is not established for mechanical device testing.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is not an AI-assisted diagnostic or therapeutic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. "Ground truth" for a mechanical device is based on established engineering principles, material science, and mechanical testing standards (e.g., ASTM F-75 for Cobalt-Chromium Alloy, ASTM F-648 for UHMWPE), demonstrating properties like strength, wear, and biomechanical compatibility.
- The sample size for the training set: Not applicable. There is no concept of a "training set" for a mechanical device in this context.
- How the ground truth for the training set was established: Not applicable.
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| Date Summary Prepared | January 19, 2013 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples. FL 34108-1945 USA |
| 510(k) Contact | Leon Brown II, Ph.D.Regulatory Affairs SpecialistArthrex, 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 |
| Product Code -Classification | JWH |
| Name | 888.3560: Prosthesis, Knee, Patellofemorotibial, Semi- |
| CFR | Constrained. Cemented, Polymer/Metal/Polymer |
| Predicate Device | K081127: Accin™ Total Knee System |
| Purpose of Submission | This special 510(k) premarket notification is submitted toobtain clearance for the CR Plus line extension to thecurrent tibial bearing components of the 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 and are designed towork with the Arthrex dome patella components. Femoraland tibial tray components are manufactured from Cobalt-Chromium Alloy conforming to ASTM F-75. Tibialbearing and patellar components are manufactured fromUHMWPE conforming to ASTM F-648.The CR Plus line of tibial bearing components arecomparable to the system's current tibial bearingcomponents with the exception of having dimensionalspecifications modification in order to offer a taller |
| anterior lip for each size of the tibial bearing component. | |
| 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. |
| 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 femoralcomponents, tibial tray, tibial bearing components andpatellar components. The proposed Arthrex iBalance®TKA System consists of the same four components plus aline extension to the currently available tibial bearingcomponents. This line extension is referred to as the CRPlus tibial bearing components. The CR Plus tibialbearing components are equivalent to the currentlyavailable predicate tibial bearing components in sizerange. thickness at the sulci, material, use andperformance with the exception that the CR Plus tibialbearing components have a dimensional specificationsmodification to provide a taller anterior lip to the |
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| component. |
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| The contact stress, constraint, interlock and range of motion testing information submitted demonstrates that there is no significant difference in performance between the proposed and predicate devices. |
| Based on the indication for use, technological characteristics, and the summary of mechanical 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is a symbol of medicine, with three lines forming the wings. The caduceus is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
10903 New Hampshire A Document Control Center - WO Silver Spring, MD 20993-0007
February 27, 2014
Arthrex, Incorporated Leon Brown II. PhD Regulatory Affairs Specialist 1370 Creekside Boulevard Naples. Florida 34108-1945
Re: K133854
Trade/Device Name: Arthrex iBalance"TKA System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patcllofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: January 20. 2014 Received: January 23, 2014
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 is 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
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Page 2 - Leon Brown II, PhD
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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); 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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/Reportal?roblem/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 Small Manufacturers. International and Consumer Assistance 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,
Vincent J. Devlin -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2.5 INDICATIONS FOR USE
Indications for Use
K133854 510(k) Number (if known):
Device Name: Arthrex iBalance® TKA System
Indications For Use:
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; .
- o 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. 0
These devices are single use only and are intended for implantation with bone cement.
Prescription Use _ V_ AND/OR Over-The-Counter Use __ (Per 21 CFR 801 Subpart D) (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)
PAGE I of 1
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§ 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.