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The Innovo is a transcutaneous electrical stimulator indicated for the treatment of stress urinary incontinence in adult females.

The Innovo is indicated for prescription use only.

The Innovo is a single channel, rechargeable, non-implanted electrical stimulator that is intended for the treatment of stress urinary incontinence.

The Innovo is comprised of the following main components, along with accessories:

• Controller
• Body Garments (right and left)
• Gel Pads (8 surface electrodes)
• Battery Charger
• Lead Wire
• Neck Strap

The Controller generates the electrical stimulation patterns for coupling the stimulation signals to the body when sued with the Gel Pad electrodes and lead wire. The Body Garments, equipped with 8 surface electrodes, are worn by the patient and cover the buttocks, lateral pelvis, and upper thighs. The electrodes have a skin conductive adhesive hydrogel laver, a current dispersing layer, and a garment conductive adhesive hydrogel layer.

The four electrodes on the right side are combined into a single equivalent electrode (and similarly as are the electrodes on the left side). The electrical stimulation current is passed across the pelvic area (from the right side to the left site), thereby stimulating the pelvic floor muscles.

Innovo Device Acceptance Criteria and Study Analysis

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Innovo device are primarily derived from the "Summary of Clinical Information" and "Benefit-Risk Determination" sections, particularly an observed meaningful clinical improvement for the target condition.

2. Sample Sizes and Data Provenance

The primary clinical evidence supporting the Innovo device comes from two studies:

• Study 1 (Germany - Sham Controlled Trial):
  • Sample Size: N=50 women (N=24 in treatment arm, N=26 in control/sham arm completed 12 weeks of treatment). This study was "prematurely stopped."
  • Data Provenance: Germany, prospective, randomized, double-blinded, sham-controlled.
• Study 2 (USA - Randomized Non-Inferiority Study):
  • Sample Size: N=180 subjects (N=89 in Innovo group, N=91 in iTouch Sure group).
  • Data Provenance: USA (12 US sites), prospective, multicenter, randomized, non-inferiority clinical study.

3. Number of Experts and their Qualifications for Ground Truth

The document does not explicitly state the number or specific qualifications of experts used to establish ground truth for the clinical studies. However, the patient population for both studies consists of "women clinically diagnosed with stress urinary incontinence." This implies that the diagnoses were made by qualified medical professionals (e.g., urologists, gynecologists, or primary care physicians with relevant expertise), who would have established the initial inclusion criteria and therefore the "ground truth" of the SUI diagnosis for enrollment.

For objective measures like the 1-hour and 24-hour pad weight tests, the "ground truth" is established by the quantifiable weight of leaked urine, measured according to standardized protocols rather than a subjective expert assessment of individual cases. Similarly, questionnaires like iQoL and MESA rely on patient self-assessment.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for determining the "ground truth" of the test set beyond the initial clinical diagnosis for enrollment and the objective measurements of the primary and secondary endpoints. For quantitative outcomes like pad weight tests, the measurement itself serves as the ground truth. For patient-reported outcomes (QOL questionnaires), the patient's response is the ground truth.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The studies described are clinical trials evaluating the device's effectiveness and safety directly on patients, not AI-assisted reader performance. Therefore, there is no mention of the effect size of how much human readers improve with AI vs. without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The Innovo device is a physical transcutaneous electrical stimulator, not an AI algorithm. Its "performance" refers to its efficacy in treating SUI in patients, not a standalone algorithm's diagnostic or predictive accuracy. Therefore, a standalone (algorithm only) performance study was not conducted or applicable to this device. The software in the controller manages stimulation patterns but is not described as an AI algorithm.

7. Type of Ground Truth Used

The ground truth used in the clinical studies was based on a combination of:

• Clinical Diagnosis: Women "clinically diagnosed with stress urinary incontinence" (for patient enrollment).
• Objective Outcome Measures:
  • Pad Weight Tests: 1-hour and 24-hour pad weight tests (quantifiable leakage in grams). This could be considered a form of "objective measurement" or "outcomes data" rather than expert consensus on retrospective images.
• Patient-Reported Outcome (PRO) Measures:
  • Incontinence Quality of Life Questionnaire (iQoL)
  • Medical Epidemiologic and Social Aspects of Aging Urinary Incontinence (MESA) Questionnaire
  • Global Impression of Improvement (PGI-I)

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of an AI algorithm or machine learning. The clinical studies (Study 1 and Study 2) served as the primary data for evaluating the device's performance, but these are "test sets" in the clinical trial sense, not an AI training set. Therefore, a sample size for a training set is not applicable here.

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

As noted above, there is no mention of a "training set" for an AI algorithm. If "training set" is instead interpreted as data used to inform the device's design or initial performance parameters, these would likely come from pre-clinical research, feasibility studies, and possibly literature reviews, but the specific methods for establishing ground truth for such development phases are not detailed in this regulatory summary. The "series of smaller feasibility studies conducted during the development of the device" hint at such activities, but specific ground truth establishment for these is not provided.

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HIVOX self-adhesive electrode gel pads are intended for use as disposable, conductive adhesive interface between the patient's skin and the electrical stimulator. The device is a gel pad for use with an electrode itself.

HIVOX self-adhesive electrode gel pads are series of cutaneous electrodes with various shapes and sizes, which use the same materials from the predicate suppliers, i.e. K070612 (Top-Rank Health Care Equipment Co., Ltd. ) and K000947 (Axelgaard Mfg. Co., Ltd.). HIVOX self-adhesive electrode gel pads are non-sterile, self-adhesive, for single patient use only, and to be disposable.

The provided text describes HIVOX self-adhesive electrode gel pads and their substantial equivalence to predicate devices, rather than an AI/algorithm-based device. Therefore, many of the requested categories (e.g., test set sample size, number of experts, adjudication method, MRMC study, standalone performance, training set) are not applicable or cannot be extracted from this document, as they pertain to algorithm performance evaluation.

However, I can extract information related to the device's technical specifications and the non-clinical tests performed to demonstrate its safety and effectiveness.

Here's the available information presented in the requested format, with "N/A" for criteria not applicable to this type of device or not found in the documentation:

Acceptance Criteria and Device Performance

Study Details:

• Sample size used for the test set and the data provenance: N/A (This is a medical device, not an algorithm, and its performance is established through non-clinical testing and comparison to predicates, not a clinical "test set" in the AI sense).
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No external "ground truth" or expert consensus dataset for evaluating an algorithm; safety and performance are evaluated against established medical device standards and predicate devices).
• Adjudication method for the test set: N/A
• 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: N/A (Not an AI device).
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (Not an AI device).
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A. The "ground truth" for this device's safety and effectiveness is established by compliance with ISO 10993 standards for biocompatibility and comparison to the established performance and materials of legally marketed predicate devices.
• The sample size for the training set: N/A (Not an AI device).
• How the ground truth for the training set was established: N/A (Not an AI device).

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The RS Medical Conductive Garments and associated accessories are indicated for use with RS Medical Stimulators to facilitate electrode placement and maintenance of electrode positioning for stimulation treatments of the lower, middle and upper back.

The RS Medical Conductive Garments consist of the RS-LB™ Low Back Conductive Garment and RS-FBG" Full Back Conductive Garment. The RS-LB" Low Back Conductive Garment is a wrap designed for the low back that uses Velcro® closures to affix the garment around the waist and lower back. The garment contains eight conductive metal snaps onto which a snap cable can be connected to the outside of the garment. These snaps extend through the garment and an adhesive backed electrode pad is affixed to the snap surface on the inner surface of the garment. The garment allows for easy electrode placement and stabilization of electrode locations on the back for repeated electrostimulation treatments to facilitate treatment compliance. The RS-FBG" Full Back Conductive Garment is a similar vest type compliance accessory that has sixteen metal snaps spaced from the lower back on either side of the spinal column to the middle and upper back. The RS Medical Conductive Garments utilize the identical UltraStim® Electrode pads used with the predicate device.

The provided document describes a 510(k) submission for RS Medical Conductive Garments (RS-LB™ Low Back Conductive Garment, RS-FBG™ Full Back Conductive Garment). This is a premarket notification for a Class II medical device, indicating that its review focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than on extensive clinical trials for effectiveness.

Therefore, the study did not involve human subjects, and many of the requested fields related to clinical study design and human reader performance are not applicable. The assessment primarily relied on non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size: Not specified for the non-clinical tests. Typically, for such tests, a small number of representative units would be tested (e.g., 3-5 units).
• Data Provenance: Not applicable. The tests were non-clinical, likely conducted in a lab setting by the manufacturer, RS Medical, or a contracted testing facility (e.g., Underwriters Laboratories, Inc. is mentioned in the FDA letter).

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

N/A - This was a non-clinical performance study; therefore, no human experts were involved in establishing ground truth for clinical outcomes. The "ground truth" here would be the physical and electrical properties of the materials and design, evaluated against engineering specifications.

4. Adjudication Method for the Test Set

N/A - No human adjudication was involved. The tests were objective measurements against predefined engineering specifications.

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

N/A - No MRMC study was conducted. The device is a conductive garment, not an imaging or diagnostic device requiring human interpretation of results. The study was focused on the device's physical and electrical performance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

N/A - This device is a conductive garment, not an algorithm or AI system. Its performance is assessed based on its physical and electrical properties.

7. Type of Ground Truth Used

For the non-clinical performance tests, the ground truth was established by engineering specifications for electrical continuity and mechanical forces (attachment/removal). These are objective, measurable parameters relevant to the device's function as a conductive garment.

8. Sample Size for the Training Set

N/A - This refers to a manufactured product; there is no "training set" in the context of machine learning or algorithms.

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

N/A - Not applicable as there is no training set. The design and manufacturing processes for the garments would be guided by industry standards, material specifications, and internal engineering design documents.

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The Well Life Self Adhesive Electrode / CM, FA, PU and SP series are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Well Life Self Adhesive Electrode / AP, CM, FA, PU and SP series are designed and intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), MENS (Microcurrent Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) and PGS (Pulsed Galvanic Stimulation).

Well Life Self Adhesive Electrode / CM, FA, PU, and SP series are non-sterile, disposable laminated, flexible structures composed of the following three main construction layers: First Layer – the exterior layer which may be made of the following different type of material coated with adhesive : white fabric(CM), white foam(FA), printed plastic film(PU) or silicon pad(SP). Second Layer - Conductive plastic film. Third Layer – Biocompatible conductive hydrogel coupling media. The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible hydrogel, no securing materials are required to secure the device the patient's skin. The electrode has one type of connection point that can be used to connect the stimulation device to the electrodes. This connection point is compatible with all standard, marketed Neurostimulation and muscle-stimulation devices. For the electrical connection, Well Life provides two different types: 1 > Snap Series Snap connection 1.65" standard size of mail. Snap is provided to connect to the wire female snap. 2> Wire Series Lead wire assembly 4.5" ~ 6" wire with .080 in. diameter female socket connected to one side of the wire.

The provided text describes the submission for a 510(k) premarket notification for the "Well Life Self Adhesive Electrode / CM, FA, PU, and SP series." This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a novel device that requires extensive clinical studies with new acceptance criteria.

Therefore, many of the requested points regarding acceptance criteria, specific study designs, sample sizes for test and training sets, expert qualifications, and ground truth establishment are not explicitly present in this type of submission. This is typical for a 510(k) for a Class II medical device where substantial equivalence is demonstrated primarily through technological characteristics and adherence to recognized performance standards and biocompatibility tests.

Here's an analysis of what information is available from the provided text, structured as per your request, explaining why certain points are not found:

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

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

• Not explicitly stated for the device itself. The submission relies on the pre-existing qualification of the Axelgaard gel and the adherence to an electrical performance standard (ANSI/AAMI EC12). The sample size, provenance, and study design for proving the biocompatibility of the gel or for the electrical standard's development are not detailed in this submission. This is because the component (Axelgaard gel) itself was already cleared in other 510(k)s (K983741 and K000947).

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

• Not applicable in this context. For a 510(k) submission based on substantial equivalence to a predicate device and adherence to industry standards, "ground truth" as established by medical experts for a diagnostic or AI device is not typically required or presented. The "ground truth" here would be the validated performance of the materials used and the adherence to technical standards.

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

• Not applicable in this context. Adjudication methods are relevant for studies involving subjective interpretation of data (e.g., medical images) by multiple human readers, often used to establish a robust ground truth for AI model development or evaluation. This is not the type of study presented here.

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 MRMC study was done or is relevant. This type of study assesses the impact of AI assistance on human reader performance, which is not applicable to a self-adhesive electrode.

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

• Not applicable. This device is an electrode, not an algorithm. Therefore, "standalone algorithm performance" is not a concept that applies.

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

• The "ground truth" in this submission is indirectly established by:
  • Prior regulatory clearance: The use of Axelgaard gel, which has already been proven suitable through previous 510(k) clearances (K983741 and K000947).
  • Standardized testing: Compliance with the requirements of the Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993-1 for skin contact and ANSI/AAMI EC12 for electrical performance. The ground truth essentially relies on the validity and acceptance of these established standards and guidelines.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of this device and submission. This device is not an AI algorithm.

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

• Not applicable. As there is no training set for an AI algorithm, this question is not relevant.

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System-Arms, Type 390, Model E60 is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation ("EMS") through skin contact electrodes for the purpose of exercising the muscles of the upper arms.

Indications for use: Toning of the triceps muscles of the upper arms.

System-Arms, Type 390, Model E60 is intended for over-the-counter use.

System-Arms, Type 390, Model E60 is a two-channel, battery powered muscle stimulation system. The System-Arms accessory pack consists of two arms garments (left and right arm), four straps, a pack of 4 adhesive backed gel based electrodes, instructions for use (manual and separate quick start guide) and a carry pouch. The hand-held control unit, which may be purchased separately, is interchangeable between all the System models from Slendertone® range of garments (i.e. System-Abs Type 390, Model E10/X10, System-Shorts Type 390, Model E20, System-Mini, Type 390, Model E30 and System Arms Type 390, Model E60).

The four equal sized electrodes (approx. size 50 x 50 mm) are attached to the inner surface of the garments to cover stainless steel studs by using the electrode outlines to ensure correct placement. The garments are connected to the control unit by leads and an over-molded SATA 7-pin connector, which also incorporates the EEPROM (ID chip) device.

As with the predicate System-Abs, the ID chip contains the data that identifies the garment type and the stimulation parameters intended for that garment. The model number of the garment itself is displayed on the LCD at power-on and on a label on the garment. When the control unit is connected to the garment combination, the data is read, identifying the specific garment type and also the stimulation parameters. The appropriate signals are then delivered to the garment electrodes. Three programs in total (beginner, intermediate and advanced) are available to the System-Arms user. All internal connections are over-molded to prevent moisture ingress and the user has no access to the wiring or connectors within the garments and is unable to alter the current path.

Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit. As with the predicate System-Abs, System-Arms cannot be used when charging.

For purposes of hygiene, the garment may be cleaned and instructions for device care are included in the user manual

Acceptance Criteria and Study Details for System-Arms, Type 390, Model E60

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria for the device beyond the successful completion of a clinical trial demonstrating efficacy and compliance with referenced safety standards. However, the overall acceptance criterion for this 510(k) submission is "Substantial Equivalence" to the predicate device, System-Abs, Type 390, Model E10/X10.

• EN 60601-1-2:2001 (Electromagnetic compatibility)
• CISPR 22:2003 & CFR 47 Part 15:2005 (Radio disturbance)
• DIN EN 60601-1:1996; EN 60601-1:1990+A1:1993+A2:1995; IEC 60601-1:1988, IEC 60601-1/A1:1991, IEC 60601-1/A2:1995 (General requirements for safety)
• DIN EN 60601-2-10; IEC 60601-2-10 (Safety of nerve and muscle stimulators)
• Battery Charger complies to safety standards IEC 60950 and UL 1950.
  The manufacturer is registered to IS EN ISO 13485:2003. |
  | Effectiveness: Demonstration of "toning of the triceps muscles of the upper arms." | A single-blind, prospective, randomized, controlled trial titled "The effect of triceps brachii electrical muscle stimulation training on muscle strength, arm anthropometrics, triceps brachii skinfold and psychometric measures" was conducted. The study concluded that the proposed device, System-Arms, "delivers effective toning component of the therapy." (Specific quantitative results, such as percentage improvement in muscle strength, firmness, or tone, are not detailed in this summary.) |
  | Substantial Equivalence: Similar technological characteristics and intended use to a legally marketed predicate device. | The device is deemed substantially equivalent to System-Abs, Type 390, Model E10/X10. Both devices use identical electronic hardware. The principal physical differences are the garment type, and the number, size, and positioning of the electrodes, which are adapted to target different muscle groups (upper arms vs. abdomen). The predicate device was shown to be effective for the improvement of strength, firmness, and tone of the abdominal muscles. The System-Arms device demonstrated effective toning for the triceps. |

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not specify the exact number of participants in the clinical trial. It only states that a "single-blind, prospective, randomized, controlled trial" was conducted.
• Data Provenance: The trial was prospective. The country of origin of the data is not explicitly stated, but given the manufacturer's location in Ireland and the European Union's CE mark mentioned, it's plausible the study was conducted in Europe.

3. Number of Experts and Qualifications for Ground Truth

• The document does not provide information on the number or qualifications of experts used to establish ground truth for the test set.

4. Adjudication Method

• The document does not specify an adjudication method for the clinical trial results.

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

• No MRMC comparative effectiveness study was done as this device is a muscle stimulator and not typically evaluated using MRMC studies. The study described is a clinical trial assessing the device's direct effect on muscle toning/strength.

6. Standalone (Algorithm Only) Performance

• Not applicable. This device is a muscle stimulator used directly by the human, so there isn't a "standalone algorithm" performance that would be evaluated outside of human interaction. The clinical trial assesses the device's performance when applied to human users.

7. Type of Ground Truth Used

• The ground truth in the clinical trial appears to be established through objective measures such as "muscle strength, arm anthropometrics, triceps brachii skinfold" and "psychometric measures." These are direct measurements of physiological and perceived effects, rather than expert consensus on an image or pathology.

8. Sample Size for the Training Set

• Not applicable. This is a hardware device (muscle stimulator) that does not involve a "training set" in the context of machine learning algorithms. The device's programs (beginner, intermediate, advanced) are pre-programmed and are not "trained" on data supplied by the user during operation.

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

• Not applicable. As stated above, there is no "training set" in the context of machine learning for this device. The device's parameters are likely based on established physiological principles of electrical muscle stimulation and potentially prior research or development from the manufacturer.

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System-Mini, Type 390, Model E30 is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation ("EMS") through skin contact electrodes for the purpose of exercising the gluteal muscles. Proposed indications for use are: Strengthening, toning and firming of the bottom. System-Mini, Type 390, Model E30 is intended for over-the-counter use.

System-Mini, Type 390, Model E30 is a two-channel, battery powered muscle stimulation system. It consists of a skirt-shaped garment which is available in small (24-38"), medium (36-45") and large (40-48") sizes for best fit, a pack of 4 electrodes and instructions for use and is used with the Slendertone® System rechargeable handheld control unit which may be purchased separately or used from an existing Slendertone® System device i.e. System-Abs, Type 390, E10/X10 or the predicate System-Shorts, Type 390, Model E20. The four equal sized electrodes (6 cm x 15 cm) are attached to the inner surface of the garment to cover stainless steel studs by using the electrode outlines to ensure correct placement. The garment is connected to the control unit by a lead and an over-molded SATA 7-pin connector, which incorporates an EEPROM (ID chip) device. As with the predicate System-Shorts, the ID chip contains the data that identifies the garment type and the stimulation parameters intended for that garment. The model number of the garment itself is displayed on the LCD at power-on and on a label on the garment. When the control unit is connected to the garment, the data is read, identifying the specific garment type and also the stimulation parameters. The appropriate signals are then delivered to the garment electrodes. There are four programs in total available to the System-Mini user and these are designated as "beginner", "intermediate", "advanced" and "expert". All internal connections are over-molded to prevent moisture ingress. The user has no access to the wiring or connectors within the garment and is unable to alter the current path. Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit. As with the predicate System-Shorts, System-Mini cannot be used when in charge mode. For purposes of hygiene, the garment may be cleaned and instructions for belt care are included in the user manual.

The provided document details a 510(k) submission for the System-Mini, a muscle stimulator, and does not contain information about acceptance criteria or a study proving the device meets said criteria. The document focuses on demonstrating substantial equivalence to a predicate device (System-Shorts) rather than presenting performance metrics against predefined acceptance criteria.

The submission states: "No new clinical studies have been submitted as part of this Premarket Notification." Instead, the manufacturer relies on the equivalence to the predicate device, which was previously shown to be effective.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study, or effect size.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily addresses the technological characteristics, intended use, and a comparison to the predicate device to justify substantial equivalence for regulatory approval.

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