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The C.T.M. Mobility Scooter HS-118 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

The C.T.M. Mobility Scooter HS-118 is an indoor/outdoor Mobility Scooter that is battery operated. It has a base with four wheels and a lightweight adjustable seat. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an off board battery charger.

The provided text is a 510(k) summary for the C.T.M. Mobility Scooter HS-118. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and proving performance through a study in the way a medical diagnostic AI device might.

Therefore, many of the requested categories (e.g., sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance, specific types of ground truth) are not applicable to this type of submission.

Here's a breakdown of the information that can be extracted or deduced from the provided text, tailored to the context of this device:

Acceptance Criteria and Study for C.T.M. Mobility Scooter HS-118

The C.T.M. Mobility Scooter HS-118 sought 510(k) clearance by demonstrating "substantial equivalence" to predicate devices, namely the Go-Go Ultra X (K063389) and VCS S3T (K051131). The primary "acceptance criteria" were met by showing that its technological characteristics, intended use, and performance data were comparable to these predicates, and that any differences did not raise new questions of safety or effectiveness.

1. Table of "Acceptance Criteria" and Reported Device Performance

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

• Test Set Sample Size: Not applicable. This was a submission for a physical device, not an AI/diagnostic algorithm tested on a dataset of patient samples. The "test set" in this context refers to bench testing of the scooter itself.
• Data Provenance: Not applicable in the traditional sense of clinical data. The "data" comes from bench testing of the physical scooter and comparison of its specifications to predicate devices. The country of origin for the data generation would be where C.T.M. Homecare Product, Inc. conducted its testing, likely in China or the US given the company's address and contact. The testing was prospective in the sense that it was performed on the device being submitted for clearance.

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

• Number of Experts: Not applicable. The "ground truth" for a mechanical device like a scooter is its physical performance against established engineering and safety standards. There isn't a concept of expert consensus for labeling a case as positive or negative.
• Qualifications of Experts: Not applicable. Testing would have been conducted by engineers or technicians familiar with relevant standards (e.g., ISO, ANSI, FDA guidance).

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There's no "test set" of cases requiring adjudication by multiple readers or experts.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." MRMC studies are typically used for diagnostic devices to assess human reader performance with and without AI assistance.

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

• Standalone Performance: Not applicable. This is a physical mobility device, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the "bench testing," the ground truth corresponds to accepted engineering specifications and safety standards outlined in the "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Scooters, and Motorized Three Wheeled Vehicles, July 1995." Compliance with these predetermined thresholds and successful completion of the specified tests served as the "ground truth" for the device's functional and safety performance.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. There is no AI algorithm being "trained" in this context.

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

• Ground Truth for Training Set: Not applicable.

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The C.T.M. Mobility Scooter HS-628 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

The C.T.M. Mobility Scooter HS-628 is an indoor/outdoor scooter that is battery operated, has three wheels, a padded seat with adjustable armrests, and hand controls at the top of the steering column allowing the rider to control the scooter. It is provided with an off-board battery charger.

This document is a 510(k) premarket notification for a C.T.M. Mobility Scooter HS-628. It does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI-driven medical device.

The document states:

• "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."
• The device is a "C.T.M. Mobility Scooter HS-628 or Orion Electric scooter Motorized three-wheeled vehicle."
• Its intended use is to "provide transportation for a disabled or elderly person."
• The 510(k) notification focuses on demonstrating "substantial equivalence" to a predicate device (C.T.M. Mobility Scooter HS-890) based on similar technological characteristics (e.g., both are battery operated, have two wheels, one motor, automatic braking systems).
• It mentions "Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Powered Wheelchairs and Scooters, and Motorized Three Wheeled Vehicles" were conducted, but the specific results or acceptance criteria are not detailed, nor are they framed as performance metrics for an AI system.

Therefore, I cannot provide the requested information for an AI-driven medical device, as this document pertains to a mobility scooter and explicitly states that comparative performance testing and clinical evaluations were not submitted. The questions you've asked are relevant for AI/ML-based medical devices or diagnostics, which this product is not.

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The C.T.M. Mobility Scooter HS-310 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

The C.T.M. Mobility Scooter HS-310 is an indoor/outdoor scooter that is battery operated. It has a base with three wheels, a padded seat with adjustable armrests, and hand controls at the top of the steering column which allow the rider to control the movement of the scooter. It can be disassembled for transport and has an on-board battery charger.

I am sorry, but based on the provided text, there is no information available regarding acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) summary for the C.T.M. Mobility Scooter HS-310 explicitly states:

"Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."

This indicates that the submission did not include a study designed to evaluate the device's performance against specific acceptance criteria. The clearance was based on substantial equivalence to a predicate device (C.T.M. Mobility Scooter HS-320) due to similar technological characteristics and intended use, rather than a direct performance study of the HS-310 itself.

Therefore, I cannot provide the requested information in the table or answer the specific questions about sample size, ground truth, experts, adjudication, MRMC studies, or standalone performance.

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The C.T.M. Mobility Scooter HS-250 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

The C.T.M. Mobility Scooter HS-250 is an indoor/outdoor electric scooter that is battery operated. It has a base with four wheels with a lightweight seat, armrests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.

The provided 510(k) summary for the C.T.M. Mobility Scooter HS-250 does not include a table of acceptance criteria, detailed device performance, or a study proving that the device meets specific acceptance criteria in the way described for typical AI/ML medical devices.

Instead, this submission is for a physical medical device (a mobility scooter) and relies on a demonstration of substantial equivalence to a predicate device (C.T.M. Mobility Scooter HS-360) rather than a performance study against predefined acceptance criteria.

Here's an analysis based on the information provided, highlighting why a direct answer to your request is not possible with this type of document:

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

• Acceptance Criteria: Not explicitly stated as pass/fail metrics in the context of an AI/ML device. For this physical device, the "acceptance criteria" are implied by showing the device's technological characteristics are "very similar" to the predicate device and that it meets the "Intended Use" (providing transportation for disabled/elderly persons). The testing conducted refers generally to "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995," but specific performance targets or thresholds from that document are not detailed in this summary.
• Reported Device Performance:
  • Braking distance at maximum speed: 4.67 feet
  • Minimum turning radius: approximately 35.4 inches
  • Forward speed range: 0-4.1 mph
  • Reverse speed range: 0-1.5 mph
  • Heaviest single component: 27.7 pounds
  • Total weight with batteries: approximately 107 pounds
  • Motor: 250 watt, 3800 rpm
  • Batteries: two 12-volt 12Ah batteries
  • Battery Charger: 24-volt constant current charger, plugs into 110V or 220V socket.
  • Self-diagnostic signals: 9 distinct codes for problems like battery, motor, or brake malfunctions.
    The document does not state how these performance metrics were tested or what thresholds they had to meet. They are presented as characteristics of the device.

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

• Sample Size: Not applicable. This is a physical device, and the "testing" involved verifying its mechanical and electrical characteristics, likely in a laboratory or engineering testing environment, rather than a clinical study with a "test set" of patient data.
• Data Provenance: Not applicable for a typical AI/ML "test set." The testing was likely internal by the manufacturer following industry guidance for mobility devices.

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 context of AI/ML, refers to validated data labels. For this physical device, "ground truth" would relate to engineering specifications and safety standards, which are typically established by engineers and regulatory bodies, not clinical experts for "ground truth labeling."

4. Adjudication method for the test set

• Not applicable. There is no mention of "adjudication" as would be performed in a clinical study for an AI/ML device.

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 background document in the input indicates a MRMC study. This is a physical mobility device and does not involve "human readers" or "AI assistance" in the sense of an AI/ML diagnostic or predictive tool.

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

• No background document in the input indicates standalone performance. This is not an AI/ML algorithm.

7. The type of ground truth used

• Not applicable in the AI/ML sense. For this device, "ground truth" implicitly relates to engineering specifications, safety standards, and functional requirements for mobility scooters. For example, the braking distance being 4.67 feet is a measured characteristic against an engineering design, not a clinical pathology or outcome.

8. The sample size for the training set

• Not applicable. There is no AI/ML model for which to describe a "training set."

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

• Not applicable. There is no AI/ML model for which to describe a "training set" or its ground truth establishment.

In summary: The provided 510(k) pertains to a physical medical device (mobility scooter) and therefore does not contain the information requested for an AI/ML device's acceptance criteria and study data. The regulatory pathway for this device is based on demonstrating substantial equivalence to a predicate device, supported by engineering tests rather than clinical performance studies with "test sets" or "training sets" in the context of AI/ML. The document explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."

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The C.T.M. Mobility Scooter HS-235 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

The C.T.M. Mobility Scooter HS-235 is an indoor/outdoor electric scooter that is battery operated. It has a base with three wheels with a lightweight seat, armrests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.

The submitted text describes a 510(k) premarket notification for a medical device, the C.T.M. Mobility Scooter HS-235. However, it explicitly states that "Clinical performance evaluations are not necessary to demonstrate substantial equivalence to the predicate device" and "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)."

Therefore, based on the provided text, there is no study that proves the device meets specific acceptance criteria in the way a clinical performance study would for an AI/ML medical device. This 510(k) relies on demonstrating substantial equivalence to a predicate device (C.T.M. Mobility Scooter HS-120), rather than proving independent performance against acceptance criteria through specific studies.

For the purpose of your request, which implies a study proving performance against acceptance criteria, the provided document does not contain the information requested in points 1-9 because such a study was not conducted or submitted for this 510(k) clearance.

To directly address your points:

1. A table of acceptance criteria and the reported device performance: Not applicable. No specific acceptance criteria for performance metrics are defined in the document, nor are performance results reported beyond the general statement of "Tests listed in the Guidance Document... were conducted."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No clinical test set described.
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. No ground truth establishment for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set adjudication detailed.
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/ML device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No clinical ground truth established or used for performance evaluation.
8. The sample size for the training set: Not applicable. This is not an AI/ML device, so no training set is described.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device, so no training set or ground truth for it.

Summary based on the provided document:

The C.T.M. Mobility Scooter HS-235 gained 510(k) clearance by demonstrating substantial equivalence to a predicate device (C.T.M. Mobility Scooter HS-120). This process primarily involved comparing technological characteristics and intended use, and confirming that non-clinical tests specified in relevant guidance documents were conducted. There was no clinical study or performance evaluation against specific acceptance criteria submitted or required for this clearance.

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The C.T.M. Mobility Scooter HS-120 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

The C.T.M. Mobility Scooter HS-120 is an indoor/outdoor electric scooter that is battery operated. It has a base with three wheels with a lightweight seat, armrests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.

The provided text describes a 510(k) submission for a mobility scooter and does not contain information about acceptance criteria or a study proving its performance in the context of medical device AI or diagnostic tools. The document is for a physical device (a mobility scooter) and explicitly states that "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." Therefore, I cannot generate the requested table and study details.

The document focuses on:

• Device Identification: C.T.M. Mobility Scooter HS-120.
• Substantial Equivalence: Comparison to a legally marketed predicate device (C.T.M. Mobility Scooter HS-320).
• Device Description and Intended Use: An indoor/outdoor electric scooter for disabled or elderly persons.
• Testing Conducted: Mention of tests listed in a "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995." However, specific results or acceptance criteria for these tests are not detailed in the provided text.
• Lack of Performance/Clinical Data: Crucially, it states that comparative performance testing and clinical evaluations were not submitted.

To answer your request, I would need a document that describes the acceptance criteria for a specific performance metric (e.g., sensitivity, specificity, accuracy for a diagnostic device) and details a study designed to demonstrate that the device meets those criteria.

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The C.T.M. Mobility Scooter HS-890 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person.

The C.T.M. Mobility Scooter HS-890 is an indoor/outdoor electric scooter that is battery operated. It has a base with four wheels with adjustable padded seat, armrests, and headrests. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with a battery charger.

The provided text describes a 510(k) submission for a mobility scooter, the C.T.M. Mobility Scooter HS-890. While it details the device and its intended use, it explicitly states that "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." This means that the document does not contain information about specific acceptance criteria or a study proving the device meets those criteria through performance testing.

The submission focuses instead on demonstrating substantial equivalence to a legally marketed predicate device (Laser 4, K003059) based on similar technological characteristics. It mentions that "Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995, were conducted." However, the results of these tests and how they relate to specific acceptance criteria are not provided.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document.
2. Sample size used for the test set and the data provenance: Not provided, as comparative performance testing was not submitted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as detailed performance testing for ground truth establishment was not submitted.
4. Adjudication method for the test set: Not applicable.
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, as this is not an AI device and no clinical effectiveness study was submitted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable, as detailed performance testing for ground truth establishment was not submitted.
8. The sample size for the training set: Not applicable, as this is not an AI device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI device.

In summary, the provided document focuses on regulatory compliance through substantial equivalence, not on detailed performance study results against specific acceptance criteria.

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The C.T.M. Mobility Scooter HS-320 is an indoor/outdoor scooter that provides transportation for disabled or elderly persons.

The C.T.M. Mobility Scooter HS-320 is an indoor/outdoor electric scooter that is battery operated. It has a base with three wheels with adjustable padded seats, armrests and headrests. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. This modes can be disassembled for transport and is provided with a battery charger.

The provided 510(k) summary for the C.T.M. Mobility Scooter HS-320 does not contain acceptance criteria or a detailed study proving the device meets such criteria in the way typically expected for medical devices involving diagnostic performance or clinical outcomes. Instead, it focuses on substantial equivalence to a predicate device based on technological characteristics and general safety testing.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

As stated, no explicit acceptance criteria with quantitative thresholds are provided in the document. The submission relies on demonstrating similarity to a legally marketed predicate device (Sunrunner TE-777-3). The "performance" mentioned refers to general device features and safety tests rather than diagnostic accuracy or clinical effectiveness.

Therefore, a table cannot be constructed as requested.

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

• Sample size: Not applicable. The submission states, "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." This indicates that no specific test set of users or data for comparative performance was used.
• Data Provenance: Not applicable for comparative performance testing. The "Testing conducted" refers to general safety and design verification tests listed in a guidance document, but details on sample size or provenance for these tests are not provided and are not related to clinical or diagnostic performance.

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

Not applicable. No clinical or comparative performance test set was used, and thus no ground truth establishment by experts for such a set was performed or reported.

4. Adjudication Method for the Test Set

Not applicable. No clinical or comparative performance test set was used, and thus no adjudication method was employed.

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 mobility scooter, not a diagnostic imaging or AI-assisted device. Therefore, an MRMC study or assessment of AI assistance is irrelevant.

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

Not applicable. This device is a physical mobility scooter, not an algorithm or software-based device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of diagnostic or clinical performance. The "ground truth" for this device's safety and functionality would implicitly be established by engineering standards and internal testing to ensure the scooter operates as intended and meets safety specifications (e.g., braking performance, stability, battery life). The document mentions "Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995," which implies that the ground truth for these tests is defined by the standards and methodologies within that guidance document.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML or a diagnostic device that requires a "training set" in the conventional sense.

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

Not applicable. As above, no training set was used.

Summary of the Device's "Acceptance" Basis from the Provided Text:

The C.T.M. Mobility Scooter HS-320 received 510(k) clearance based on substantial equivalence to a previously marketed predicate device (Sunrunner TE-777-3). The primary arguments for substantial equivalence are:

• Similar Intended Use: Both are indoor/outdoor scooters for disabled or elderly persons.
• Similar Technological Characteristics: Both are battery-operated electric scooters with three wheels, adjustable seating, hand controls, and automatic braking systems.
• Performance Differences: The document acknowledges "varying only slightly with selected parameters, such as with the maximum distance that each scooter can be driven," implying these slight variations were not deemed significant enough to warrant a finding of non-equivalence.
• Conformance to Guidance Document: Tests outlined in the "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995" were conducted. While the specific results or acceptance criteria for these tests are not detailed in the summary, their completion contributes to the overall demonstration of safety and effectiveness consistent with the predicate.

Crucially, the submission explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." This reinforces that the clearance was not based on demonstrating superior or even equivalent performance in a clinical study sense, but rather on the similarity of design, function, and intended use as well as compliance with recognized safety standards for this class of device.

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The C.T.M. Mobility Scooter HS-686 is an indoor/outdoor scooter which provides transportation for a disabled or elderly person.

The C.T.M. Mobility Scooter HS-686 is an indoor/outdoor four-wheeled scooter which is battery operated. It consists of a platform which connects the four wheels, an adjustable steering column, and a seat for the rider. The rider drives the scooter using hand controls located at the top of the steering column. It can be disassembled into five parts for transport in a car trunk. It comes with a battery charger.

The provided 510(k) summary for the C.T.M. Mobility Scooter HS-686 does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document states: "Performance testing: Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." This explicitly indicates that the type of study you're asking for was not conducted or submitted for this specific device clearance.

Therefore, I cannot fulfill your request for the specific details outlined (table of acceptance criteria, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information).

The 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device (Shoprider The TE889) based on intended use, technological characteristics, and conformance to general guidance documents rather than specific performance metrics and extensive clinical or performance studies. The "Testing conducted" section vaguely refers to "Tests listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995," but does not provide the results or specific acceptance criteria for these tests within the provided text.

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