(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.
§ 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.