(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.
§ 876.5330 Transcutaneous electrical continence device.
(a)
Identification. A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must characterize the electrical stimulation, including the following: Waveforms, output modes, maximum output voltage, maximum output current, pulse duration, frequency, net charge per pulse, maximum phase charge at 500 ohms, maximum current density, maximum average current, and maximum average power density.
(2) The patient-contacting materials must be demonstrated to be biocompatible.
(3) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, thermal safety, and mechanical safety of the device.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Labeling must include the following:
(i) Instructions for use, including specific instructions regarding the proper placement of electrodes;
(ii) A summary of electrical stimulation parameters; and
(iii) Cleaning instructions and reuse information.