(315 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like algorithms that learn or adapt. The device description focuses on hardware components and data transfer for monitoring and programming.
Yes
The device is indicated for the treatment of patients with symptoms of urgency incontinence, which directly implies a therapeutic function.
No
The device is indicated for the "treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency," which is a therapeutic rather than diagnostic function. While it gathers data for "status evaluation" and "data acquisition," this is primarily for monitoring treatment efficacy and device function, and not for diagnosing a medical condition.
No
The device description clearly outlines multiple hardware components including an implantable neurostimulation component, a rechargeable wearable unit with a battery and antenna, and a Hub device. While there are software components (Clinician Programmer), the system is not solely software.
Based on the provided information, the Revi System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Revi System Function: The Revi System is a neuromodulation system that directly treats symptoms of urgency incontinence and urinary urgency by stimulating the tibial nerve. It does not analyze biological specimens.
- Device Components: The components described (implant, wearable unit, programmer, hub) are all involved in delivering electrical stimulation to the nerve, not in analyzing samples.
- Intended Use: The intended use is for the treatment of symptoms, not for diagnosis or monitoring through the analysis of biological samples.
Therefore, the Revi System falls under the category of a therapeutic device, specifically a neuromodulation device, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency.
Product codes
QXM
Device Description
The Revi System is a tibial neuromodulation system that consists of the following four different components:
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- Implant: An implantable wireless neurostimulation component that is implanted in the vicinity of the tibial neurovascular bundle. The implant is battery-less and does not have an internal power source.
-
- Rechargeable Wearable Unit: This unit is comprised of a wearable device and leg band. The wearable device contains an electrical circuit board, flexible antenna, and rechargeable battery with dedicated charger. The Rechargeable Wearable Unit, when used by the patient, is designed to be paired to a specific implant. Once paired, the Rechargeable Wearable Device transmits power and can only communicate (through magnetic coupling) with the specific implant to which it is paired.
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- Clinician Programmer (CP): This application is the system's interface used by the healthcare providers for treatment control, status evaluation, parameter programming and data acquisition. Access to the CP is password protected to allow access only to authorized users. The CP transfers data to and from the Rechargeable Wearable Unit via a wireless Bluetooth connection.
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- HealthGo Micro (Hub): The Hub communicates with the Rechargeable Wearable Unit using a Bluetooth connection and acquires and transmits data to the Cloud only during the charging sessions of the Rechargeable Unit. The Hub allows health care providers access to device data logs between visits without the need for in-person visits. The Hub is a Class I 510(k) exempt device (Product code OUG, 21 CFR 880.6310).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
tibial nerve (in proximity to the ankle)
Implant is surgically placed subfascially (underneath the fascia) in the right or left leg.
Indicated Patient Age Range
Female aged 18 or greater (21 or greater in the US)
Intended User / Care Setting
Healthcare providers (Clinician Programmer), Patients (Rechargeable Wearable Unit)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
USABILITY STUDY
Study type: Usability validation study
Sample size: 21 participants
Key results: Sixteen critical tasks and 28 user errors were observed. The sponsor revised the post operative instructions and other instructions relevant to the use errors in the patient manual. Overall, the study demonstrated that the users were able to complete most critical tasks successfully, and the sponsor appropriately updated the labeling to mitigate the use errors identified.
PIVOTAL CLINICAL STUDY (OverActive Bladder Stimulation System Study (OASIS))
Study type: Interventional, prospective, multi-center, single arm open label pivotal study.
Sample size: 151 implanted subjects (ITT analysis set). 144 completed 6-month visit, 140 completed 12-month follow-up.
Key results:
- Primary Safety Endpoint: Among 151 implanted subjects, 117 (77.5%) had at least 1 AE, for a total of 286 AEs. No procedure/device related SAEs or unanticipated device/procedure related AEs. 6 subjects (4%) experienced 6 device related AEs and 16 subjects (10.6%) experienced 16 procedure related AEs. All device and procedure related AEs were considered mild/moderate.
- Primary Effectiveness Endpoint: The Revi System demonstrated a 76.4% (CI: 68.7%-82.6%) responder rate at 6 months, where a responder was defined as a subject improving at least 50% in their UUI episodes compared to baseline. P-Value
N/A
0
DE NOVO CLASSIFICATION REQUEST FOR REVI SYSTEM
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Implanted tibial electrical urinary continence device. An implanted tibial electrical urinary continence device is an implanted prescription device that receives power from a non-implanted external power source to provide electrical stimulation of the tibial nerve in proximity to the ankle. The device is intended for the treatment of overactive bladder related symptoms of urge urinary incontinence, urinary urgency, urinary frequency and nocturia.
NEW REGULATION NUMBER: 21 CFR 876.5305
CLASSIFICATION: Class II
PRODUCT CODE: QXM
BACKGROUND
DEVICE NAME: Revi System
SUBMISSION NUMBER: DEN220073
DATE DE NOVO RECEIVED: October 5, 2022
SPONSOR INFORMATION:
BlueWind Medical Ltd. 6 Maskit Street Herzliya, Israel 4614002
INDICATIONS FOR USE
The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency.
LIMITATIONS
The sale, distribution, and use of the Revi System are restricted to prescription use in accordance with 21 CFR 801.109.
Contraindications:
Patients contraindicated for the Revi therapy are those who:
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- Are men who have Benign Prostatic Hyperplasia (BPH) or other lower urinary tract obstructions.
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- Are pregnant.
Precaution:
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- Physicians should follow current clinical guidelines as applicable and should use their discretion to determine whether the patient should fail or not tolerate more conservative treatments before using the Revi System.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
- Physicians should follow current clinical guidelines as applicable and should use their discretion to determine whether the patient should fail or not tolerate more conservative treatments before using the Revi System.
DEVICE DESCRIPTION
The Revi System is a tibial neuromodulation system that consists of the following four different components:
-
- Implant: An implantable wireless neurostimulation component that is implanted in the vicinity of the tibial neurovascular bundle. The implant is battery-less and does not have an internal power source.
-
- Rechargeable Wearable Unit: This unit is comprised of a wearable device and leg band. The wearable device contains an electrical circuit board, flexible antenna, and rechargeable battery with dedicated charger. The Rechargeable Wearable Unit, when used by the patient, is designed to be paired to a specific implant. Once paired, the Rechargeable Wearable Device transmits power and can only communicate (through magnetic coupling) with the specific implant to which it is paired.
-
- Clinician Programmer (CP): This application is the system's interface used by the healthcare providers for treatment control, status evaluation, parameter programming and data acquisition. Access to the CP is password protected to allow access only to authorized users. The CP transfers data to and from the Rechargeable Wearable Unit via a wireless Bluetooth connection.
-
- HealthGo Micro (Hub): The Hub communicates with the Rechargeable Wearable Unit using a Bluetooth connection and acquires and transmits data to the Cloud only during the charging sessions of the Rechargeable Unit. The Hub allows health care providers access to device data logs between visits without the need for in-person visits. The Hub is a Class I 510(k) exempt device (Product code OUG, 21 CFR 880.6310).
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Image /page/2/Picture/0 description: The image shows a diagram of a medical device system. The system includes an implant with an electrode, a wearable unit, a hub, and a clinician programmer. The wearable unit is connected to the implant via a wireless signal, and it is connected to the hub and clinician programmer via Bluetooth.
Figure 1: Revi System Components
| Table 1: Revi System Technological Specifications | |||
|---|---|---|---|
| -- | -- | --------------------------------------------------- | -- |
| Device Technology
| Description: | Revi System |
|---|---|
| Stimulation Parameters | |
| Stimulation Waveform | Biphasic charge - neutral |
| Stimulation Polarity | Configurable |
| Pulse Repetition | |
| Frequency | Up to 30Hz |
| Pulse Amplitude | Up to 14mA |
| Pulse Width | Up to 790µsec |
| Typical Stimulation Session Duration | |
| Duration | 30 - 60 minutes for 1-2 times per day, as instructed by the |
| physician | |
| Stimulation Parameter Increments | |
| Amplitude | 0.1mA increments |
| Frequency | 1Hz increments |
| Pulse Width | 20µsec increments |
| Treatment Duration | 5 minute increments |
| Battery | |
| Battery | Li-ion Rechargeable, 1400mAh |
| Battery Operation | Battery operational voltage: 3.1 - 4.2V |
| Charging: Up to 1 week of therapy on a single charge. The | |
| patient should charge the Wearable Unit after each therapy | |
| session. | |
| Battery Life | 1 year (365 therapy days) |
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| Battery charger | Manufacturer: FRIWO Gerätebau GmbH (Ostbevern,
Germany)
Model number: FW8002.1MUSB/05 Power rating:
6W |
| ----------------- | ----------------------------------------------------------------------------------------------------------------- |
|---|
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
The Revi System has two patient contacting components, the Implant and the Leg Band of the Rechargeable Wearable Unit. The sponsor conducted biocompatibility testing of these components per the FDA guidance document, 'Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process' published in 2020. The neurostimulator component (made of silicone, titanium and zirconia) is categorized as an implant device contacting tissue/bone for a permanent duration of exposure (> 30 days). Therefore, per ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, the following biocompatibility endpoints were assessed for the Implant:
| Endpoint | Test Method |
|---|---|
| Cytotoxicity | ISO 10993-5: 2009 |
| ISO Elution Method | |
| Sensitization | ISO 10993- 10:2009/2010 |
| ISO Maximization Sensitization (Guinea Pig) | |
| Irritation/ Intracutaneous | |
| Reactivity | ISO 10993-10:2010 |
| ISO Intracutaneous Reactivity (Rabbit) | |
| Acute Systemic Toxicity | ISO 10993-11:2017 |
| ISO Acute Systemic Toxicity (Mouse) | |
| Material-Mediated | |
| Pyrogenicity | USP 34 |
| Rabbit Pyrogen Test | |
| Subchronic and Chronic | |
| Systemic Toxicity | ISO 10993-18:2020 |
| Chemical Characterization | |
| ISO 10993-17:2002 | |
| Toxicological Risk Assessment | |
| Genotoxicity | ISO 10993-3:2014 |
| Bacterial Reverse Mutation | |
| ISO 10993-3:2014 | |
| In Vitro Mammalian Cell Chromosomal | |
| Aberration | |
| Implantation | ISO 10993-6:2007 |
| Implantation Study (Rat) | |
| Carcinogenicity | ISO 10993-18:2020 |
| Chemical Characterization | |
| ISO 10993-17:2002 |
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| Toxicological Risk Assessment | |
|---|---|
| Reproductive and | |
| Developmental Toxicity | ISO 10993-18:2020 |
| Chemical Characterization | |
| ISO 10993-17:2002 | |
| Toxicological Risk Assessment |
The Leg Band, which is made of (6)(4) | is categorized as a surface device contacting intact skin for a permanent duration of exposure (based on cumulative exposure - 8 hours of use per day). The sponsor conducted biocompatibility testing of this component per the FDA guidance document. 'Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process' published in 2020. Per ISO 10993-1:2018, the following biocompatibility endpoints were assessed for the leg band:
| Endpoint | Test Method |
|---|---|
| Cytotoxicity | ISO 10993-5: 2009 |
| ISO Elution Method | |
| Sensitization | ISO 10993-10:2009/2010 |
| ISO Guinea Pig Maximization Sensitization | |
| Irritation/Intracutaneous | |
| Reactivity | ISO 10993-10:2010 |
| ISO Skin Irritation Study in Rabbits |
The results demonstrate that the Revi System is biocompatible.
STERILITY/ SHELF LIFE/REPROCESSING
The Implant is the only component of Revi System which is provided sterile. The Implant is sterilized by ethylene oxide (EO) gas to an assurance level (SAL) of 106 per ISO 11135:2014. Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices. The sponsor tested the implant for EO residuals in conformance with ISO 10993-7 to ensure that the maximum residual levels of EO and ethylene chlorohydrin (ECH) remaining on the Implant after sterilization do not exceed the recommended limits for medical devices with permanent patient contact.
The sponsor also conducted simulated shipping distribution in conformance with ASTM D4169-22, Standard Practice for Performance Testing of Shipping Containers and Systems. Following simulated shipping distribution, the sponsor conducted packaging integrity testing as described below.
The shelf-life for the implant component of the Revi System is established at one year based on an accelerated aging study per ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. To support the oneyear shelf life, package integrity testing and functional testing were conducted. Package integrity testing consisted of the following:
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- Visual inspection (per ASTM F1886/F1886M-16, Standard Test Method for . Determining Integrity of Seals for Flexible Packaging by Visual Inspection)
- Seal strength (ASTM F88/F88M-21, Standard Test Method for Seal Strength . of Flexible Barrier Materials)
- Dye penetration (per ASTM F1929-15, Standard Test Method for Detecting . Seal Leaks in Porous Medical Packaging by Dye Penetration)
The functional testing conducted after accelerated aging is described in Table 2 below.
The results demonstrated that Revi System has acceptable package integrity and functional performance over the duration of its one-year shelf life and after simulated shipping distribution
The Leg Band needs reprocessing (cleaning) during its use life. The reprocessing validation testing provided for the Leg Band demonstrated that the reprocessing instructions are adequate.
ELECTROMAGNETIC COMPATIBILITY & ELECTRICAL SAFETY
The sponsor conducted electromagnetic compatibility and electrical safety testing on the Revi System in accordance with the following standards:
- . ISO 14708-1:2014: Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
- ISO 14708-3:2017 Implants for surgery Active implantable medical devices . - Part 3: Implantable neurostimulators.
- IEC 60601-1-2: 2020, General requirements for basic safety and essential . performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + . A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-11:2015 (Second Edition), Medical electrical equipment Part . 1-11: General requirements for basic safety and essential performance -Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 62133-2:2017, Safety Test Standard of Li-Ion Cell and Battery and UN . 38.2 Rev.6: UN manual of tests and criteria Part III - Test Requirements for lithium cells/batteries.
The Revi System passed electrical safety and electromagnetic compatibility testing consistent with the acceptance criteria outlined in these standards. The sponsor provided adequate labeling instructions related to electrical safety and electromagnetic compatibility of the Revi System.
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The Revi System uses wireless technology. The sponsor conducted testing on the wireless technology per the FDA guidance document, Radio Frequency Wireless Technology in Medical Devices published in 2013. The sponsor also conducted wireless coexistence testing per AAMI TIR69:2017:2020, Risk management of radio-frequency wireless coexistence for medical devices and systems. The Revi System passed all the wireless technology testing, i.e., wireless coexistence, quality of service and wireless security testing. The sponsor provided adequate labeling instructions related to the wireless technology of the Revi System.
MAGNETIC RESONANCE (MR) COMPATIBILITY
The sponsor conducted MRI compatibility testing on the Implant to verify that it can be used in MRI environments (of 1.5Tesla and 3Tesla) per ISO/TS 10974:2018, Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device. The results demonstrated that the Implant is MR compatible under the conditions specified on the labeling.
SOFTWARE
The Revi System's software documentation and verification testing is based on a Moderate Level of Concern per the FDA guidance document. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices published in 2023. Prior to mitigation of hazards, failure of the Revi System software could result in minor injury to the patient.
The sponsor submitted all the necessary documentation describing the software development program. In addition, the sponsor submitted documentation that they performed a hazard analysis to characterize software risks, including device malfunction. The sponsor provided adequate verification and validation (V&V) testing to address the potential hazards. The sponsor also provided adequate documentation describing the software, firmware, software specifications, architecture design, software development environment, traceability, revision level history, and unresolved anomalies to support that the software will operate in a manner as described in the specifications.
The sponsor also conducted cybersecurity testing on the Revi System as the Rechargeable Wearable Unit is intended to be connected to the Hub which transfers data to the Cloud. The cybersecurity test results for the Revi System were satisfactory and demonstrated that all the cybersecurity threats were adequately mitigated.
PERFORMANCE TESTING - BENCH
The sponsor evaluated the performance of the Revi System using the non-clinical bench testing summarized in Table 2. The sponsor accelerated aged all samples used in the performance testing to simulate three years of aging (i.e., 73ºC for 35 days). The accelerated aged samples represent a worse-case aging for performance testing compared to baseline as the device has a shelf-life of 1-year.
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| Test | Purpose | Method | Acceptance Criteria | Result |
|---|---|---|---|---|
| Implant | ||||
| Overheating | To evaluate thermal | |||
| safety of the implant | (b)(4) | The temperature elevation | ||
| (above baseline | ||||
| temperature) relative to | ||||
| the ambient temperature | ||||
| changes should not | ||||
| exceed (b)(4) throughout | ||||
| the entire test. | Pass | |||
| Implant | ||||
| Functional | ||||
| Testing | To verify stimulation | |||
| output parameters | The measured values of | |||
| the stimulation | ||||
| parameters should be | ||||
| within the specified range | ||||
| per the device | ||||
| specifications in Table 1. | Pass | |||
| Implant | ||||
| Direct | ||||
| Current | ||||
| Density | To verify that the | |||
| Implant's leakage | ||||
| current density is | ||||
| within the range | ||||
| specified in ISO | ||||
| 14708-1:2014. | The direct current density | |||
| at the surface of any | ||||
| conductive surface or | ||||
| electrode should be | ||||
| (b)(4) | Pass | |||
| Implant | ||||
| Operation | ||||
| Under | ||||
| Extreme | ||||
| Body | ||||
| Temperatures | To demonstrate that the | |||
| Implant can function | ||||
| properly over a wide | ||||
| temperature range. | ||||
| Low temperature | ||||
| range: 11°C - 18°C High temperature | ||||
| range: 42°C - 43°C | The pulse amplitude error | |||
| should be 50 BMI). |
- . Any psychiatric or personality disorder at the discretion of the study physician.
- . PHO-15 Patient Somatization Score > 20.
- . Any metal or other implant in the area of BlueWind RENOVA iStim™ implantation site (20cm distance).
- . Variation in diuretics consumption within the last 6 months.
- . Subjects who have received botulinum toxin injections within the past 12 months.
- . Failure to respond to previous neuromodulation therapy for overactive bladder.
- . Subjects who have received neurostimulation in the last 3 months.
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- . Previous urinary incontinence surgery or prolapse surgery using graft material within the last 12 months.
- . Any spinal or genitourinary surgery within the last 6 months.
- . Previous abdominoperineal resection of the rectum or previous radical hysterectomy.
- . Skin, peripheral edema, orthopedic or neurologic anatomical limitations that preclude implantation or/and use of the device.
- . Diagnosis of interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines.
- . . More than minimal level of suspected stress incontinence or mixed incontinence with stress component likely to confound study outcome, based on a 7-day voiding diary or medical history, or when stress incontinence score in the Medical, Epidemiologic, and social aspects of Aging (MESA) incontinence questionnaire is higher than the urgency incontinence score.
- . Subjects with suspected urinary retention and/or PVR>150ml.
- . Any neurological disease or disorder including Alzheimer's, Parkinson, Multiple Sclerosis (MS), Cortical Visual Impairment (CVI) caused by stroke, neuropathy or injury resulting in neuropathy and/or suspected neurogenic bladder.
- . Current or recurrent urinary tract infection (3 or more infections in the last 6 months). or presence of urinary fistula, or urinary tract obstruction such as cancer, urethral stricture or presence of urinary stone.
- . History of chemotherapy or pelvic radiotherapy that might have affected bladder control or caused neuropathies (i.e., peripheral neuropathy).
- . Diabetes with peripheral nerve neuropathy or severe uncontrolled diabetes (with HbA1C > 7%). Note: patients with HbA1C in the range of 7.1-7.5% may be considered eligible based on their complete medical record.
- . Uterine prolapse, cystocele, enterocele or rectocele with pelvic prolapse to or beyond the hymen.
- . Subjects with a documented history of allergic response to Platinum iridium, Titanium, Zirconia, Gold, Silicone or Parylene.
- . Other active implantable electronic device/s regardless of whether stimulation is ON or OFF.
- . Have a life expectancy of less than 1 year.
- . Subjects who are breastfeeding.
- . History of drug or alcohol abuse.
Subject Disposition
Overall, 282 patients consented and were screened for the study, with 151 patients implanted (Intent to Treat (ITT) analysis set). Nine subjects prematurely terminated from the study prior to implantation. Seven participants were terminated from trial participation prior to the 6-month visit, and 4 subjects terminated from the study before the 12-month visit. Each of the remaining 144 participants completed the 6-month visit, and 140 patients completed the 12-month follow-up. Figure 2 provides a flow chart of the follow-up schedule and complete subject accounting.
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Image /page/15/Figure/0 description: This image shows a flowchart of a study. The study starts with 282 participants screened for eligibility, and then 151 participants received an implantation. Next, 151 participants went through activation, and then 149 participants had a 1-month post-activation follow-up. The study ends with 140 participants having a 12-month follow-up.
Figure 2: Flow Chart of Follow-Up Schedule and Subject Accounting
Study Endpoints
Primary Safety Endpoint
The primary safety endpoint is the incidence of adverse events from implantation to 12months post-activation.
The safety analyses are presented as descriptive and narrative in nature, with AEs, including serious adverse events (SAEs), coded and tabulated by body system, preferred term, group, severity and relation to device or procedure.
Primary Effectiveness Endpoint
The primary effectiveness endpoint is the proportion of responders at 6 months post system activation as demonstrated by ≥50% improvement in the average number of UUI episodes as compared to baseline, measured by a 7-day patient voiding diary. The statistical hypothesis for the primary effectiveness endpoint was defined as follows:
H0: TRenova ≤ nPG H1: nRenova > TPG,
where nRenova is the proportion of subjects who are responders (≥ 50% improvement in average number of UUI episodes) and nPG is the pre-specified performance goal (PG) of 50%.
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The hypothesis testing was conducted by constructing a two-sided, 95% Clopper-Pearson confidence interval. The trial was considered successful if the lower bound of this confidence interval was above 50%.
Secondary Effectiveness Endpoint
The secondary effectiveness endpoints and their associated performance goals were as follows:
- . Proportion of subjects with ≥10 points (minimally important difference (MID)) improvement in Health Related Quality of Life (HROL) (based on Overactive Bladder Questionnaire (OAB- q)) at 6 months post system activation, with a performance goal of 50%.
- . Proportion of responders at 12 months post system activation as demonstrated by ≥50% improvement in either average number of urgency related incontinence episodes or average number of severe/large urgency related incontinence episodes, as measured by the 7-day patient voiding diary, with a performance goal of 50%.
- li Proportion of responders at 6 months post system activation as demonstrated by ≥50% improvement in the average number of moderate-severe urgency episodes Patient Perception of Intensity of Urgency Scale (PPIUS) degree 3, 4 or