(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."
§ 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.