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510(k) Data Aggregation
(59 days)
ELITONE Urge is a non-implanted muscle stimulator designed to treat urge urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding tissues.
The ELITONE Urge Urinary Incontinence Device (hereafter ELITONE URGE or ELITONE UUI) provides electrical muscle stimulation (commonly called EMS or E-stim) to treat urge urinary incontinence. Stimulation is delivered to the pelvic floor muscles and surrounding structures through a disposable cutaneous electrode applied to the perineal region. One end of the thin, flexible electrode is positioned proximate the pubis and the other end is positioned proximate the ischial tuberosity. Mildly adhesive and electrically conductive hydrogel portions of each electrode to the perineal tissues and allow comfortable transfer of electrical stimulation through the pelvic floor. The stimulation is controlled by a battery powered, wearable control unit. The housing of the control unit is approximately 55mm x 45mm x 10mm. It includes two pushbuttons that allow the user to increment the voltage (i.e., intensity), and to start, pause and stop device operation. The stimulation utilizes a symmetric, amplitude-modulated, sinusoidal waveform. The output intensity operates over a range of levels (0-35) that approximately correspond to a 0-15mA RMS current. The stimulation frequency is 10 Hz, a frequency typically used to calm detrusor muscle activity, decreasing symptoms of urgency type incontinence. Each treatment session lasts 20 minutes, after which the device turns off automatically. Women are recommended to use the device 4-5 times per week.
The Elidah ELITONE Urge Urinary Incontinence Device (ELITONE UUI) is a non-implanted muscle stimulator designed to treat urge urinary incontinence in women. The device applies stimulation to the pelvic floor muscles and surrounding tissues.
Here's an analysis of its acceptance criteria and the study that proves it meets them:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ELITONE UUI device are primarily based on achieving significant reductions in key symptoms of urge urinary incontinence and maintaining a good safety profile. These criteria and the reported performance are summarized below:
| Acceptance Criteria (Primary Efficacy Endpoint) | ELITONE UUI Reported Performance |
|---|---|
| ≥50% reduction in urge leaks per day | 76% of participants responded |
| Acceptance Criteria (Secondary Efficacy Endpoints) | ELITONE UUI Reported Performance |
|---|---|
| ≥50% reduction in urgency episodes | 76% of participants responded |
| ≥50% reduction in pad use | 32% of participants responded |
| ≥2.5 points change in I-QoL score | 91% of participants responded |
| Acceptance Criteria (Safety Endpoint) | ELITONE UUI Reported Performance |
|---|---|
| Proportion of adverse events that result in an injury or require medical treatment | None reported |
2. Sample Size and Data Provenance for the Test Set
- Sample Size for Test Set: 34 subjects
- Data Provenance: The clinical testing was conducted on women with urge urinary incontinence in the U.S. The study was prospective in nature, with subjects self-administering treatment for 6-weeks.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number of experts used to establish the ground truth or their qualifications. The study design was a single-arm study where the patient served as their own control (comparison to baseline). This suggests that the ground truth for individual symptom reduction was self-reported by the participants based on their baseline data and data collected during treatment.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method involving multiple experts for the test set. Given the self-reported nature of the primary and secondary endpoints (urge leaks per day, urgency episodes, pad use, and I-QoL score), it appears that participant self-reporting against a pre-treatment baseline served as the primary measure.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The study focused on the effectiveness of the device itself rather than comparing human reader performance with and without AI assistance.
6. Standalone Performance Study
Yes, a standalone clinical performance study was conducted. The study evaluated the ELITONE UUI device by itself without a human-in-the-loop component. The device is intended for self-administration.
7. Type of Ground Truth Used
The primary ground truth used for efficacy was patient self-reported data against a baseline.
- Primary Efficacy Endpoint: Percent change in urge leaks per day was determined by comparing 7-day baseline data with data from the 6th week of treatment.
- Secondary Efficacy Endpoints: Changes in urgency episodes, pad use, and I-QoL score were similarly assessed by comparing pre-treatment baseline data to and data from the 6th week of treatment.
- Safety Endpoint: Self-reported adverse events that resulted in an injury or required medical treatment.
8. Sample Size for the Training Set
The document does not mention a separate "training set" in the context of an algorithm or AI model development. The clinical study described served as the primary evidence for the device's efficacy and safety for regulatory submission.
9. How the Ground Truth for the Training Set was Established
Since no separate training set for an AI algorithm is explicitly mentioned, this question is not directly applicable in the context of the provided information. The "training" of the device's effectiveness was evaluated through the described clinical study.
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(140 days)
The INNOVO® is a transcutaneous electrical stimulator indicated for the treatment of stress urinary incontinence in adult females.
The INNOVO® is a powered transcutaneous electrical continence device intended for the treatment of stress urinary incontinence. The device is provided with an internally wired garment which locates eight conductive electrodes around the pelvic area. An electronic controller, which is attached to the garment using a leadwire, delivers an amplitude modulated symmetric biphasic stimulation current to the electrode array to evoke timed muscle contractions in the pelvic floor muscles. A neck strap clips to the unit to allow it to be worn around the neck. The neck strap contains a safety clip which pops open if there is a forceful pull on the neck strap The current amplitude is adjusted by the patient using a push-button intensity control. A treatment lasts for 30 minutes and is self-administered by the patient at home. The electronic controller operates from rechargeable batteries and a mechanical interlock is provided to prevent simultaneous connection to the patient and the charger. The INNOVO® is supplied with a non-sterile, electrically conductive, electrolyte spray.
The provided text describes a 510(k) summary for the INNOVO® device intended for treating urinary incontinence. While it details non-clinical performance testing and general acceptance criteria like compliance with electrical safety and EMC standards, it does not contain information about a study proving the device meets specific performance acceptance criteria for its effectiveness in treating urinary incontinence.
The document primarily focuses on demonstrating substantial equivalence to a predicate device, adherence to safety standards (e.g., IEC 60601 series, ISO 14971, ISO 10993), and usability testing for over-the-counter use.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and the reported device performance: This document does not present quantitative performance metrics for treating urinary incontinence for the INNOVO® device.
- Sample size used for the test set and the data provenance: No clinical test set data for performance is presented. The usability study involved 15 subjects.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no performance study (e.g., diagnostic accuracy for an AI/CAD system) is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 a medical device for treatment, not an AI/CAD diagnostic system.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not described for device efficacy. Usability testing ground truth was expert observation.
- The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set in the conventional sense.
- How the ground truth for the training set was established: Not applicable.
The "Summary of Non-Clinical Performance Testing" in section VII details testing against various electrical safety, usability, and biological compatibility standards. For example, usability testing involved 15 subjects to assess suitability for safe over-the-counter use, and its findings relate to users understanding instructions and applying treatment safely. However, this is not a clinical study proving the treatment efficacy of the device for urinary incontinence.
The document states: "Performance testing has demonstrated that the INNOVO® is substantially equivalent to the predicate INNOVO®." This implies that the effectiveness is established by comparison to a previously cleared device, not necessarily by new clinical efficacy data for this specific submission, especially when the changes are primarily related to making it available as an Over-The-Counter device (which required Human Factors testing).
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(52 days)
ELITONE is a non-implanted muscle stimulator designed to treat stress urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding tissues.
The Elitone Device provides electrical muscle stimulation (commonly called EMS or E-stim) to treat stress urinary incontinence. Stimulation is delivered to the pelvic floor muscles and surrounding structures through a disposable cutaneous electrode applied to the perineal region. One end of the thin, flexible electrode is positioned proximate the pubis and the other end is positioned proximate the ischial tuberosity. Mildly adhesive and electrically conductive hydrogel portions of each electrode attach the electrode to the perineal tissues and allow comfortable transfer of electrical stimulation through the pelvic floor. The stimulation is controlled by a battery powered, wearable control unit. The housing of the control unit is approximately 55mm x 45mm x 10mm and made of ABS plastic. It includes two pushbuttons that allow the user to increment the voltage (i.e. intensity), and to start, pause and stop device operation. The stimulation utilizes a symmetric, amplitude modulated (2000Hz), sinusoidal waveform. The output intensity operates over a range of levels (0-35) that approximately correspond to a 0-30mA RMS current. The stimulation frequency alternates between a higher frequency portion (50Hz) and a lower frequency portion (10Hz). Higher frequency stimulation is typically used to encourage muscle contraction and strengthening of the pelvic floor muscles. Lower frequency stimulation is typically used to calm detrusor muscle activity, decreasing symptoms of urgency type incontinence. Each treatment session lasts 20 minutes, after which the device turns off automatically. Women are recommended to use the device 3-5 times per week.
The Elitone Device is a non-implanted muscle stimulator designed to treat stress urinary incontinence in women by applying stimulation to the pelvic floor muscles and surrounding tissues. The following information details its acceptance criteria and the studies conducted to demonstrate its performance.
1. Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria for the clinical performance of the Elitone device. However, based on the Clinical Testing section, "Key findings includes clinically significant improvements in incontinence episodes, pad usage and quality of life measures." This implies that improvement in these areas was considered the acceptance criteria for efficacy. For safety, the acceptance criterion was "no adverse events that resulted in injury or required medical treatment."
| Aspect | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Clinical Efficacy | Clinically significant improvements in incontinence episodes, pad usage, and quality of life measures. | Clinically significant improvements in incontinence episodes, pad usage and quality of life measures. |
| Safety | No adverse events resulting in injury or requiring medical treatment. | There were no adverse events that resulted in injury or required medical treatment. |
| Usability | Participants could self-select, understand instructions, and apply treatment safely and correctly for OTC use. | Participants with diversity in age, education and familiarity with incontinence were able to self-select as appropriate users... understand the instructions... and able to apply treatment safely and correctly. |
| Software | Software verification and validation completed as recommended by FDA guidance. | Verification and validation testing was completed as recommended by FDA guidance pertaining to medical device software. |
| Electrical Safety & EMC | Compliance with IEC 60601-1, IEC 60601-2-10, and IEC 60601-1-2 standards. | Testing was completed by external labs per IEC 60601-1 and IEC 60601-2-10 standards for safety and IEC 60601-1-2 standard for EMC. |
| Other Performance (Electrode) | Impedance, adhesiveness, and current dispersion comparable to legally marketed EMS electrodes. | Comparisons were made to legally marketed EMS electrodes. (Passed) |
| Biocompatibility | Compliance with ISO 10993-1 and comparable to legally marketed electrodes. | Biocompatibility evaluation completed... materials, manufacturing processes and use application are the same as those of legally marketed electrodes. (No new testing needed) |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set:
- Clinical Testing: 20 subjects
- Usability Testing: 15 subjects
- Data Provenance: The document does not explicitly state the country of origin. The studies appear to be prospective, as they involve subjects self-administering treatment and participating in usability assessments.
3. Number of Experts and Qualifications for Ground Truth
- Clinical Testing: The document does not specify the number of experts used to establish ground truth or their qualifications. The study focused on subject-reported outcomes (incontinence episodes, pad usage, quality of life) and adverse events, which do not typically require external expert adjudication for ground truth beyond standard clinical trial oversight.
- Usability Testing: One "qualified healthcare professional (observer)" was used to verify that participants correctly self-identified as candidates for the device based on indications for use and contraindications. Specific qualifications beyond "qualified healthcare professional" are not provided.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method for the clinical or usability test sets in the typical sense (e.g., 2+1 or 3+1 expert consensus for image interpretation).
- For the clinical study, ground truth appears to be based on self-reported outcomes and adverse event monitoring.
- For usability testing, verification was done by a single "qualified healthcare professional (observer)."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. The study evaluates the device's effectiveness directly, not its impact on human readers' performance with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was done in the form of the "Clinical Testing" where 20 subjects self-administered treatment with Elitone for 6 weeks. This study assessed the algorithm (device) performance directly without human-in-the-loop assistance for interpretation or decision-making.
7. Type of Ground Truth Used
- Clinical Testing: The ground truth was based on patient-reported outcomes (incontinence episodes, pad usage, quality of life measures) and observed adverse events.
- Usability Testing: The ground truth was based on the direct observation and verification by a qualified healthcare professional of participants' ability to self-select, understand instructions, and safely and correctly apply treatment.
8. Sample Size for the Training Set
The document does not mention any "training set" in the context of an algorithm or AI model development. The Elitone Device is an electrical muscle stimulator, and its functionality is based on predefined electrical stimulation parameters, not on machine learning that would require a separate training set.
9. How Ground Truth for Training Set Was Established
Since there is no mention of a training set for an algorithm or AI model, this question is not applicable. The device's operation is based on established principles of electrical muscle stimulation rather than data-driven machine learning.
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(414 days)
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.
| Acceptance Criteria | Reported Device Performance (Innovo) |
|---|---|
| Primary Effectiveness Endpoint: Clinically meaningful improvement in provocative pad weight test | 56.3% of patients showed at least a 50% reduction in the provocative pad weight test at Week 12 (Study 2, ITT Population/Multiple Imputation). This was deemed "clinically meaningful" by the review. |
| Improvement in Incontinence Quality of Life (iQOL) | Study 1: Treatment group had at least a 10-point improvement in iQOL score at 12 weeks from baseline. |
| Study 2: Mean change from baseline in iQOL was 13.41 (compared to 15.42 for the comparator device, both showing improvement). | |
| Global Impression of Improvement (PGI-I) | 70.7% of patients in the Innovo group reported improvement at 12 weeks (Study 2). |
| Safety: Low adverse event profile, with most events mild/moderate and reversible. | Overall: Innovo had a low adverse event profile. Most device-related adverse events (19.1% of subjects) were mild or moderate and resolved by stopping treatment or reducing intensity. |
| Biocompatibility | Components found to be biocompatible for its use (based on ISO 10993-1 and prior clearances for components). |
| Electromagnetic Compatibility & Electrical/Mechanical/Thermal Safety | Conformed to IEC 60601-1, IEC 62133, IEC 60601-1-2, IEC 60601-2-10, and IEC 60601-1-11 standards. |
| Software Verification and Validation | Software for the Controller has a "moderate" level of concern and was addressed by supporting documentation. Output specifications verified by bench testing. |
| Labeling | Provided with instructions for use, prescription statement, and proper placement/care instructions. |
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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