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PharmGuard™ Toolbox is intended to provide a vehicle to create and securely upload user-defined configuration parameters, a library of drug names and associated user-defined infusion parameters to Medex Infusion Pumps. The PharmGuard Toolbox collects and downloads operational, infusion, and alarm history events, library usage counts, and PharmGuard™ safety events from motory overner lardly assomment it is intended to provide a rich dataset users can collect and analyze to improve overall processes and lessen the likelihood of operator error when entering infusion parameters into the Medex Infusion Pumps.

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This document is a 510(k) clearance letter from the FDA for a device called "PharmGuard™ Toolbox." It primarily addresses regulatory aspects and does not contain detailed information about the device's technical acceptance criteria or the specific study details you've requested.

Therefore, I cannot provide the information you've asked for based on the provided text. The document confirms market clearance but does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Information on experts, adjudication methods, or ground truth for a test set.
4. Details of a multi-reader multi-case (MRMC) comparative effectiveness study or human-in-the-loop performance.
5. Results of a standalone algorithm performance study.
6. The type of ground truth used for a study.
7. Sample size or ground truth establishment for a training set.

The document describes the device's intended use: "PharmGuard™ Toolbox is intended to provide a vehicle to create and securely upload user-defined configuration parameters, a library of drug names and associated user-defined infusion parameters to Medex Infusion Pumps. The PharmGuard Toolbox collects and downloads operational, infusion, and alarm history events, library usage counts, and PharmGuard™ safety events from motory overner lardly assomment it is intended to provide a rich dataset users can collect and analyze to improve overall processes and lessen the likelihood of operator error when entering infusion parameters into the Medex Infusion Pumps."

This indicates it's a software tool for managing and configuring infusion pumps and collecting data, rather than a diagnostic device that would typically have the performance metrics you've inquired about.

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The Medex 3000 Series MRI Syringe Infusion Pump indications for use are as follows:

• in the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
• in the following delivery routes: arterial, epidural, intravenous, spinal, subcutaneous, and enteral.
• in the following delivery modes: continuous, volume/time, mass, body weight, custom dilution, intermittent and bolus.
• in critical care, anesthesia, neonatal and pediatric applications or other healthcare settings where the use of the syringe infusion pump can be monitored or supervised by a clinician.
• inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla or less.

The syringe infusion pump is contraindicated for use on the inlet side of Extracorporeal Membrane Oxygenation (ECMO) systems where the negative pressure is greater than -100mm Hg as the high negative pressures can result in uncontrolled fluid flow.

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The provided text is a 510(k) premarket notification letter from the FDA to Medex, Incorporated regarding their Medex 3000 Series MRI Syringe Infusion Pump. This document does not include information about acceptance criteria or a study that proves the device meets those criteria.

The letter confirms that the FDA has reviewed the notification and determined the device is substantially equivalent to legally marketed predicate devices. It lists the indications for use of the device.

Therefore, I cannot provide the requested information based on the input text. The document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test set.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study, effect sizes, or human reader improvement with/without AI assistance.
6. Information about a standalone (algorithm only) performance study.
7. The type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

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The TranStar Intracranial Pressure Transducer is intended for external monitoring of Intracranial pressures (ICP). Intracranial pressure waveforms are conducted from the patient to the transducer through a column of fluid. The fluid pressure waveforms are converted into electrical signals that can then be displayed using separate monitoring equipment.

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I am sorry, but the provided text does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for the TranStar Intracranial Pressure Transducer, which states that the device is substantially equivalent to legally marketed predicate devices.

The letter mentions the indications for use but does not detail any performance metrics, study results, sample sizes, ground truth establishment, or expert qualifications that would be required to fulfill your request. It's a regulatory approval document, not a scientific study report.

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The Medex 3000 Series Syringe Infusion Pump indications for use are as follows; - in the administration of fluids requiring precisely controlled infusion rates including . blood or blood products, lipids, drugs, antibiotics and other therapeutic fluids. - in the following delivery routes: arterial, epidural, intravenous, spinal, and . subcutaneous. - . in the following delivery modes: continuous, volume/time, mass, body weight, custom dilution, intermittent and bolus. - in critical care, anesthesia, neonatal and pediatric applications or other healthcare . settings where the use of the Syringe Infusion Pump can be monitored or supervised by a clinician. - . the Syringe Infusion Pump is contraindicated for use on the inlet side of extracorporeal membrane oxygenation (ECMO) systems where high negative pressures may occur.

The Syringe Infusion Pump is a software driven, microprocessor controlled, electromechanical system that contains within its case: user interface, power supply, motor, pumping mechanism, and electronic circuits required to effect the controlled infusion of fluids through a syringe and a sterile administration set. The pump operates by controlled displacement of the syringe plunger.

Acceptance Criteria and Study for Medex 3000 Series Syringe Infusion Pump

This document outlines the acceptance criteria for the Medex 3000 Series Syringe Infusion Pump and the study conducted to demonstrate that the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided 510(k) summary does not explicitly state the numerical acceptance criteria for a "reduction in post-occlusion bolus volume." It only states that testing was conducted to confirm a reduction compared to the predicate device.

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

The 510(k) summary does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It simply states that "Medex conducted flow rate testing" and "Medex conducted testing to confirm that the 3000 Series Syringe Infusion Pump delivered a reduction in post-occlusion bolus volume."

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the device is a syringe infusion pump, and the performance criteria are objective measurements of mechanical and fluid delivery accuracy, rather than clinical assessments requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not performed as the device is a syringe infusion pump and not an AI or imaging-based diagnostic or assistive technology. The study focused on objective device performance metrics.

6. Standalone Performance Study

A standalone performance study was performed. The testing described for flow rate accuracy and post-occlusion bolus reduction was conducted on the Medex 3000 Series Syringe Infusion Pump as a standalone device, without human-in-the-loop assistance.

7. Type of Ground Truth Used

The ground truth used for these tests would be based on objective measurements from calibrated instruments that measure flow rate and volume, consistent with engineering and metrology standards for medical devices. This is not "expert consensus, pathology, or outcomes data."

8. Sample Size for the Training Set

This information is not applicable as the Medex 3000 Series Syringe Infusion Pump is a hardware device with software controls, and the testing described does not involve machine learning algorithms that require a specific "training set" in the conventional sense. The "training" for such a device would be part of its design validation and verification processes, not a distinct dataset for a learning algorithm.

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

As per point 8, this question is not applicable. The "ground truth" for the device's design and verification would be its engineering specifications and the validated performance of its components and overall system against established industry standards and regulatory requirements.

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The Control Device (CCD) is intended for use in the IV delivery of contrast media during imaging procedures with a secondary intended use of conservation of contrast media.

The CCD is made up of two parts: Part A, which is the reusable spike assembly (intended for use on only one container of contrast media/dye and considered an extension of the contrast container) and; Part B, which is the disposable valve and tubing set (intended for use on only one patient). The two in-line backcheck valves in Part B prevent inadvertent retrograde flow thereby protecting Part A from contamination.

The provided text describes a 510(k) premarket notification for a medical device called the "Contrast Control Device" (CCD). However, it does not contain information about acceptance criteria, actual device performance (beyond intended use), specific studies conducted, sample sizes, ground truth establishment, or expert involvement.

The document primarily focuses on:

• Administrative details: Submitter information, device names, predicate devices, and the date of submission.
• Device description: How the two parts of the CCD work (reusable spike assembly and disposable valve/tubing set) and its multi-patient use protocol within a 6-hour timeframe.
• Intended use: IV delivery of contrast media during imaging procedures and conservation of contrast media.
• FDA's response: A letter confirming substantial equivalence to predicate devices and allowing marketing.
• Indications for Use statement.

Therefore, I cannot provide the requested information in the format specified because the input text does not contain the necessary data regarding performance studies or acceptance criteria.

To answer your request, I would need a section of the 510(k) or accompanying documentation that details the verification and validation (V&V) activities performed for the device. This would typically include:

• Test methods: Descriptions of how the device was tested.
• Test results: Specific quantitative or qualitative outcomes of the tests.
• Acceptance criteria: Predefined limits or conditions for the test results to demonstrate safety and effectiveness.
• Study design details: Information on sample sizes, data collection, and ground truth.

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The intended medical application of Medex Medfusion 2000 Series syringe pumps is to produce controlled movement of the plunger of a syringe to inject a set amount of therapeutic fluid into a patient within a hospital setting at a set rate and at set times.

The new model Medex Medfusion Series 2000 pumps are identical to their predicate models with the exception that the microprocessor/memory chip is replaced by a drop-in replacement microprocessor-EPROM daughter board and that associated memory addresses in the software are modified to accommodate the hardware change.

The exterior surfaces are made of plastics. There are no fluid or drug contacting surfaces.

This document is a 510(k) summary for the Medex Medfusion 2001, 2010, & 2010i syringe pumps with a new microprocessor/memory system. It is a submission to the FDA (Food and Drug Administration) for regulatory clearance for a medical device. This type of document does not typically contain the kinds of detailed performance study data you're asking for (e.g., acceptance criteria, test set sample sizes, ground truth establishment, expert qualifications, MRMC studies, or standalone performance).

The purpose of a 510(k) submission, especially for a device modification like this where only the microprocessor/memory system is changed, is to demonstrate substantial equivalence to a predicate device that is already legally marketed. This usually involves showing that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate device.

Based on the provided text, here's what can be inferred or stated about your questions:

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

   • Not provided in the document. The document states, "The new model Medex Medfusion Series 2000 pumps are identical to their predicate models with the exception that the microprocessor/memory chip is replaced... They are identical in operation, function, features, and form as their predicate devices and represent no technological differences." This implies that the acceptance criteria and performance expected for this modified device would be the same as the predicate devices, but these specific criteria or performance metrics are not detailed here.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not provided in the document. Since the change is internal (microprocessor/memory), any testing would likely focus on verifying the functionality of the new chip and its integration, rather than extensive clinical efficacy studies typically associated with new device types.

3. 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/Not provided. For a syringe pump, 'ground truth' in the context of expert diagnosis or interpretation isn't relevant. Verification would be against engineering specifications and functional testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable/Not provided. This method is used for resolving discrepancies in expert interpretations, which is not relevant for this device type or the nature of the change.

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. This device is a syringe pump, not an AI-assisted diagnostic tool. Therefore, MRMC studies are not relevant.

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

   • Not applicable. This device is a physical medical device (syringe pump) not an algorithm. Performance validation would involve engineering tests, not standalone algorithm performance.

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

   • Likely engineering specifications and functional performance metrics. For a syringe pump, 'ground truth' would refer to whether the pump accurately delivers fluids at the programmed rates and volumes, within specified tolerances, and whether the new microprocessor/memory system performs as intended without errors. This would be verified through calibration and performance testing against established engineering benchmarks.

8. The sample size for the training set:

   • Not applicable/Not provided. As this is a hardware modification to an existing device, and not an AI/machine learning product, there is no "training set" in the sense of data used to train an algorithm.

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

   • Not applicable. See point 8.

In summary: The provided 510(k) summary is for a minor technical modification to an existing device (changing a microprocessor/memory chip). It focuses on demonstrating equivalence to predicate devices rather than detailing extensive clinical study results or AI performance metrics. Therefore, most of the specific questions about acceptance criteria, detailed study design, and ground truth establishment (as typically applied to diagnostic algorithms) are not addressed in this type of document.

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The MX960 reusable pressure transducer is used to convert hemodynamic pressure waveforms via a piezoresistive bridge circuit into electrical signals which can then be displayed using separate monitoring equipment.

The MX960 reusable pressure transducer is a non-fluid pathway device. A pressure waveform is conveyed through a disposable dome which is coupled to the reusable pressure transducer during pressure monitoring. Both the transducer and dome have mutually exclusive diaphragms. Accordingly, fluid contact is limited to the dome portion of the system. The materials which comprise the MX960 have been aggressively tested per the ANSVAAMI/ISO 10993 "Biological Evaluation of Medical Devices" and the "Tripartite Biocompatibility Guidance for Medical Devices". All materials have successfully met these standards.

The Medex, Inc. MX960 Reusable Pressure Transducer underwent performance testing against the ANSI/AAMI BP22-1994 standard for blood pressure transducers.

Here's a breakdown of the acceptance criteria and the study details:

1. Acceptance Criteria and Reported Device Performance

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

• The document does not explicitly state the sample size used for the test set in terms of the number of individual devices or the duration/number of tests performed for each parameter. It indicates that the MX960 was "aggressively tested."
• The data provenance is not specified (e.g., country of origin, retrospective or prospective). It is an in-house performance test against a recognized standard.

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

• This device is a physical transducer, not an AI or diagnostic imaging device that requires expert interpretation for ground truth. The "ground truth" for its performance is established by standardized measurements against the ANSI/AAMI BP22-1994 specifications using calibrated testing equipment. Therefore, no human experts are directly involved in establishing "ground truth" in the way they would be for image analysis or disease diagnosis.

4. Adjudication method for the test set:

• Not applicable, as this is a performance test against objective engineering specifications, not a diagnostic task requiring 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:

• Not applicable. This is a performance test for a reusable pressure transducer, not a device involving AI or human interpretation in a diagnostic context.

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

• Not applicable. This is a standalone performance test of a physical medical device. The "algorithm" here is the transducer's internal mechanism, and its performance is measured directly.

7. The type of ground truth used:

• The ground truth is based on the ANSI/AAMI BP22-1994 standard specifications for blood pressure transducers. This standard defines the acceptable ranges and limits for various operational and performance parameters.

8. The sample size for the training set:

• Not applicable. This is a physical device performance test, not a machine learning model that requires a training set.

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

• Not applicable for the reasons mentioned above.

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The MX703/MX730 is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, backleakage, and waveform damping

The MX703 and the MX730 are 3cc/hr and 30cc/hr metering flushes, respectively. The MX703 3cc/hr flush has two (2) primary functions. First, it acts as a flow restrictor, allowing only a certain volume of flush solution to infuse per hour. This small hourly infused volume is necessary to maintain patency of a pressure line. The amount of volume infused per hour through the flush is maintained by pressure exerted on the flush solution by a pressure infusor. With the pressure gradient differences between the flush solution and the patient's physiological pressures, the volume of solution is infused through the flush and patency of the cannulated vasculature is maintained. The second function of the 3cc/hr flush is to give the clinician the ability to "fast flushes are necessary to clear the line following certain line manipulations (i.e. blood draws or medication administration). The MX730 30cc/hr flush has two (2) primary functions. First, it is used in pressure measurements which require continuous flow and the use of an infusion pump. The flush permits the fluid flow to be controlled by the infusion pump while it functions to isolate the pressure transducer from the pressure waveform noise generated by the pump. The 30cc/hr flow is great enough to allow the infusion pump complete control over the fluid flow while still restrictive enough to isolate the transducer from the noise generated by the pump during normal opperation. Secondly, the MX730 is used to perform "fast flushes" under the same conditions and requirements as the MX703 above.

The provided 510(k) summary describes the MX703/MX730 continuous flush devices and presents performance testing data to demonstrate their substantial equivalence to two predicate devices: Medex, Inc.'s MicroflushTM and Sorenson Research Company, Inc. C.F.S. INTRAFLO®.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are presented as "SPECIFICATION" in the table, and the reported device performance is shown for the "Button Flush" (MX703/MX730), "MICROFLUSH", and "INTRAFLO" devices.

*Note: For metering rates, while the mean values do not precisely match the "Approximate" specification, the device meets the critical Minimum (99% Lower Tail) and Maximum (99% Upper Tail) specifications, which define the acceptable range for the metering rate with high confidence. The "Approximate" specification might be a target mean, whereas the min/max define the regulatory acceptable range. The submission states "In all cases, the MX703/MX730 met or exceeded the performance of the predicates." indicating that the critical ranges were met.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size:
  • MX703/MX730 ("Button Flush"): N=40
  • MICROFLUSH: N=10 (except for metering rates, where N=8 or N=7 in some cases)
  • INTRAFLO: N=10 (except for metering rates, where N=9)
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Given the nature of performance testing for medical devices, it is highly likely to be prospective laboratory testing of manufactured units rather than patient data.

3. 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)

This study involves laboratory performance testing of mechanical/fluidic properties of a device. It does not involve human expert interpretation of data (e.g., medical images). Therefore, there were no experts used to establish "ground truth" in the traditional sense of clinical decision-making. The ground truth is objective measurements derived from calibrated instruments and established engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study involving human interpretation or clinical adjudication. The results are quantitative measurements against predefined specifications.

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. This is not a study evaluating a diagnostic or interpretive AI device with human readers. It is a performance test of a continuous flush device.

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

Not applicable. This device is not an algorithm or AI. It is a mechanical medical device with fluidic properties. The tests performed are standalone tests of the device's physical performance, not algorithm performance.

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

The ground truth used here is objective, quantitative laboratory measurements against predefined engineering specifications for device performance (e.g., flow rates, pressure withstand, leak tests).

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI-based device.

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

Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for it.

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A stopcock is a typical element of fluid or drug administration. It is used to control/direct fluid flow and permit fluid access to the patient. A Luer lock plug is used to terminate any open Luer port. The silver antimicrobial additive will enhance performance by minimizing the possibility the devices will be microbially compromised.

The Medex, Inc. antimicrobial stopcock and Luer lock plug are functionally conventional devices, which incorporate antimicrobial properties through the addition of a elemental, metallic silver additive.

This document describes performance testing for Medex, Inc.'s MX531-1LT Antimicrobial IV Set Stopcock and MX491T Antimicrobial Luer Lock Plug.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the study design: to demonstrate a statistically significant reduction in microbial contamination compared to non-antimicrobial counterparts. The specific performance metrics are the percentage reduction in microbial contamination.

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

• Sample Size: 200 units were divided into four groups for the in vitro study. This means 50 units per group. The document doesn't specify if this refers to 200 antimicrobial devices and 200 non-antimicrobial devices, or 200 total devices (100 of each type). Given the comparative nature, it's highly probable it refers to 200 of each type (antimicrobial and non-antimicrobial) or 100 of each type to make up the 200 units. Assuming the "200 units" refers to the entire study, it would be 100 antimicrobial and 100 non-antimicrobial devices for comparison.
• Data Provenance: The study was an in vitro study. No country of origin is specified for the data, but it's likely connected to Medex, Inc. in Dublin, Ohio, USA. Since it's an in vitro study, the concept of "retrospective or prospective" doesn't directly apply in the same way it would to human clinical trials; it's a controlled laboratory experiment.

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

Not applicable. This was an in vitro microbiological study, not a study requiring expert interpretation of medical images or patient data. The "ground truth" was the measured microbial contamination (CFU count).

4. Adjudication Method for the Test Set

Not applicable. As an in vitro study measuring quantifiable microbial counts, there was no need for 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

Not applicable. This is not an AI/imaging device, but an antimicrobial medical device designed for fluid administration.

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

Not applicable. This is not an algorithm, but a physical medical device. The "standalone" performance here refers to the device's ability to reduce microbial contamination on its own in a controlled environment.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth was direct measurement of microbial contamination in Colony Forming Units (CFUs).

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is a physical medical device undergoing performance testing, not a machine learning model.

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

Not applicable. There is no "training set" or corresponding ground truth establishment in the context of this device's performance testing. The "ground truth" related to its antimicrobial efficacy was established through direct empirical measurement of bacterial and fungal growth in a controlled laboratory setting.

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