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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. Tibial bearing components are offered in PS, CR and CR Plus configurations.

The proposed Arthrex iBalance® TKA System line extension of this submission adds Vitamin E blended tibial bearing components and Vitamin E blended patella components to the product offering.

This is a 510(k) premarket notification for a medical device (Arthrex iBalance® TKA System - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis), not an AI/ML device. Therefore, the requested information about acceptance criteria, study data, sample sizes, ground truth, expert adjudication, MRMC studies, and training/test sets is not applicable in the context of an AI/ML device.

Here's why:

• Device Type: The document describes a traditional medical device (a knee replacement system), not a software or AI/ML-driven diagnostic or therapeutic tool.
• Regulatory Pathway: A 510(k) submission demonstrates substantial equivalence to a legally marketed predicate device, primarily through performance testing (e.g., mechanical tests) and material characterization, rather than clinical efficacy studies often found in AI/ML device submissions.
• Content of the Document: The summary focuses on material properties, design changes (addition of Vitamin E blended components), and mechanical testing to demonstrate that the new components perform similarly to the predicate devices and meet industry standards. There is no mention of algorithms, data sets for training or testing, or human reader performance.

However, I can extract the general acceptance criteria and the study type conducted from the document, tailored to the context of this traditional medical device:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated in the provided text. The testing would involve a certain number of physical device components for mechanical testing.
• Data Provenance: Not applicable in the context of patient data. The provenance relates to laboratory testing of manufactured components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. "Ground truth" in the AI/ML sense (e.g., expert consensus on clinical findings) is not relevant for the mechanical testing of a knee implant. The "ground truth" here would be the physical properties and performance characteristics determined by validated testing methods.

4. Adjudication method for the test set:

• Not applicable. Adjudication is typically associated with human interpretation of data. For mechanical testing, the results are quantitative and compared against established engineering standards.

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:

• No. This is not an AI-assisted device, so MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No. This is not an AI algorithm.

7. The type of ground truth used:

• Material and mechanical performance standards. The "ground truth" for this device's performance would be established engineering specifications, material properties, and outputs from standardized mechanical tests (wear, fatigue, shear).

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the AI/ML sense.

9. How the ground truth for the training set was established:

• Not applicable. No training set for an AI/ML algorithm is involved.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The study referenced is a series of mechanical performance tests. The document states:

• "The wear, fatigue and shear testing demonstrates the Arthrex iBalance® TKA System remains in compliance with FDA Guidance and industry standards."
• "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."

This indicates that specific laboratory tests for wear, fatigue, and shear properties were conducted on the device components (including the new Vitamin E blended components). The results of these tests were then compared against predetermined acceptance criteria derived from FDA guidance and established industry standards for knee prostheses. The successful outcome of these tests led to the conclusion that the device performs equivalently to previously cleared predicate devices and is suitable for its intended use.

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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.

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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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, with the exception of porous coated femoral components which can be used cemented or uncemented (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. Tibial bearing components are offered in PS, CR and CR Plus configurations.
The proposed Arthrex iBalance® TKA System line extension of this submission adds an additional smaller tibial bearing component size (i.e. Size 1) to the product offering.

This document is a 510(k) premarket notification for a medical device called the "Arthrex iBalance® TKA System", a knee prosthesis. It details a submission to obtain clearance for a line extension that adds a new smaller-sized component to the existing system.

Based on the provided text, there is no information present regarding acceptance criteria, reported device performance in those terms, or a specific study designed to "prove" the device meets acceptance criteria in the format of a clinical or comparative effectiveness study.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through various means, primarily through the assertion that the new component size does not alter the fundamental safety and effectiveness of the system.

Here's a breakdown of the specific points requested, based on the available information:

1. Table of acceptance criteria and the reported device performance:

This information is not explicitly provided in the document as a formal table with acceptance criteria linked to specific performance metrics. The document broadly states: "The fatigue, wear and interlock testing demonstrates the Arthrex iBalance® TKA System remains in compliance with FDA Guidance and industry standards." This implies that the device did meet compliance standards, but the specific, quantified criteria and results are not detailed.

2. Sample size used for the test set and the data provenance:

• Sample Size: This information is not provided. The text mentions "fatigue, wear and interlock testing" but does not specify the number of components or iterations tested.
• Data Provenance: This information is not provided. It's implied the testing was conducted by Arthrex, Inc., but details like country of origin, retrospective or prospective nature are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable and not provided. The testing mentioned (fatigue, wear, interlock) are mechanical engineering tests, not clinical studies requiring expert ground truth establishment in the traditional sense of diagnostic accuracy or clinical outcomes.

4. Adjudication method for the test set:

This information is not applicable and not provided for the same reasons as point 3. Mechanical tests typically rely on predefined engineering specifications for pass/fail, not expert adjudication.

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:

This information is not applicable and not provided. The device is an orthopedic implant (knee prosthesis), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to "human readers improving with AI" would not be relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This information is not applicable and not provided. As mentioned, this is a physical medical device (a knee prosthesis), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the mechanical testing would be the established engineering specifications and industry standards for fatigue, wear, and interlock performance of knee prostheses. The document states compliance with "FDA Guidance and industry standards." There's no mention of expert consensus, pathology, or outcomes data being used as ground truth for this specific submission for a line extension.

8. The sample size for the training set:

This information is not applicable and not provided. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

This information is not applicable and not provided for the same reasons as point 8.

Ask a specific question about this device

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, with the exception of porous coated femoral components which can be used cemented or uncemented (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 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 Arthrex iBalance® BioSync™ Femoral Components line offers the option of affixing the system's femoral components without cement through the use of a titanium scaffold porous coating (biological fixation).

The provided document is a 510(k) premarket notification for a medical device, the Arthrex iBalance® TKA System. It does not describe an AI/ML powered device, therefore, the requested information about acceptance criteria and the study proving the device meets those criteria, particularly as it relates to AI/ML performance metrics, is not present.

The document discusses the substantial equivalence of the Arthrex iBalance® TKA System to legally marketed predicate devices, focusing on design features, intended uses, materials, and mechanical testing.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study proving performance for an AI-powered device, as this document pertains to a traditional orthopedic implant.

The document details the following for the Arthrex iBalance® TKA System:

• Device Description: A total knee arthroplasty system consisting of femoral components, tibial tray, tibial bearing components, and patellar components. The BioSync™ Femoral Components line extension offers the option of uncemented fixation through a titanium scaffold porous coating.
• Intended Use/Indications for Use: For individuals undergoing surgery for painful, disabling joint disease of the knee (degenerative, rheumatoid, or post-traumatic arthritis), post-traumatic loss of knee joint configuration and function, moderate varus, valgus, or flexion deformity, and revisions of previous unsuccessful knee replacement. Additional indications for posteriorly stabilized components include ligamentous instability and absent or non-functioning posterior cruciate ligament.
• Substantial Equivalence Summary: The device is considered substantially equivalent to the predicate device (K081127: Accin™ Total Knee System and K121771: Zimmer® Persona™ Personalized Knee System). Differences are considered minor and don't raise questions concerning safety and effectiveness.
• Testing Information: Fatigue, biocompatibility, metallurgical, corrosion, microstructure, strength, bonding, abrasion, and ingrowth testing information was submitted to demonstrate consistency with FDA Guidance for porous-coated orthopedic implants.

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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.

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.

1. 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.
2. 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.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. 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.
7. The sample size for the training set: Not applicable. There is no concept of a "training set" for a mechanical device in this context.
8. How the ground truth for the training set was established: Not applicable.

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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 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 (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 provided text describes a 510(k) premarket notification for the Arthrex iBalance® TKA System, specifically addressing a change in the sterilization method for the UHMWPE tibial bearing components from EtO to Gamma Irradiation. The submission focuses on demonstrating substantial equivalence to a predicate device (K081127: Accin™ Total Knee System) despite this change.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample size used for the mechanical testing of the UHMWPE components. It generally refers to "mechanical testing data submitted."

The data provenance is not explicitly stated. However, given that it's a 510(k) submission to the FDA, the testing would typically be conducted according to recognized ASTM standards, implying a controlled laboratory setting. It is a retrospective analysis comparing the properties of gamma-sterilized and EtO-sterilized UHMWPE.

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

This information is not provided in the document. The study described is a laboratory-based mechanical testing study, not one requiring expert human interpretation of medical images or clinical outcomes for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable to the type of study described (mechanical testing). Adjudication methods are typically used in studies involving human interpretation or clinical outcomes.

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?

No, an MRMC comparative effectiveness study was not done. This submission is for a knee prosthesis and focuses on material properties after a sterilization change, not on AI assistance for human readers or interpretation of data.

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

No, a standalone algorithm performance study was not done. This submission is about the physical properties of a medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for this study is based on established material science standards and physical measurements. Specifically, the "ground truth" for the material properties of UHMWPE is defined by ASTM standard F648 for Type 2 PE, and the characterization of material properties after gamma sterilization was conducted per ASTM F2565. The comparison of mechanical strength between EtO and Gamma specimens relies on direct physical measurement of these properties.

8. The Sample Size for the Training Set

This information is not applicable as there is no "training set" in the context of this mechanical testing study. The device is a physical implant, not an AI system that requires training data.

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

This information is not applicable as there is no "training set."

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