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Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA) include Vaginal Probe SA-2876, SA-25145, SA-20100, SA-3478, SA-2687 & Rectal Probe SA-1483, SA-19108, SA-1563, SA-2486 are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of week pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

Well-Life Probe Electrodes for Stimulation/EMG Probes (Model: SA) contains two types of products, Vaginal Probe and Rectal Probe. The Well-Life Probe Electrode for Stimulation/EMG Probe are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of week pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.

Well-Life Probe Electrode for Stimulation/EMG (Vaginal Probe) SA-2876, SA-25145, SA-20100, SA-3478, SA-2687 are lightweight cylinders consisting of two or three independent conductive rings or plates that are paired and isolated, physically, and electrically. The cylinder is shaped with a waist and handle for positioning in the vaginal canal for incontinence treatment and easy removal after treatment. It is watertight to allow for washing with soap and water between uses. The electrode is designed for repeated intermittent use by a single user in home or clinic up to 300 times, 15 minutes per session equal to 10 months of daily operation. It does not require sterilization, but does require washing before and after reuse according to the cleaning method as recommended in the user manual.

Well-Life Probe Electrode for Stimulation/EMG (Rectal Probe) SA-1483, SA-19108, SA-1563, SA-2486 are lightweight cylinders consisting of two or three independent conductive rings that are paired and isolated, physically, and electrically. The cylinder is shaped with a waist and handle for positioning in the rectal canal for incontinence treatment and easy removal after treatment. It is watertight to allow for washing with soap and water before and after uses. The electrode is designed for repeated intermittent use by a single user in home or clinic up to 300 times, 15 minutes per session equal to 10 months of daily operation. It does not require sterilization, but does require washing before and after reuse according to the cleaning method in user manual. The probe is constructed of stainless steel, acrylonitrile butadiene styrene (ABS), and polyvinyl chloride (PVC).

Here's a breakdown of the acceptance criteria and study information for the Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), based on the provided FDA 510(k) summary:

This device is an electrode probe and does not generate energy itself, but rather interfaces with an external electrical stimulator device. Therefore, the acceptance criteria and testing focus on the safety, material compatibility, and physical performance of the probe itself, and its equivalence to predicate devices that have established a safe and effective profile. The "device performance" in this context refers to its ability to meet these safety and functional specifications, rather than a diagnostic or therapeutic accuracy metric typical of AI-powered devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes non-clinical bench testing rather than human clinical studies with a "test set" in the traditional sense of AI data.

• Test Set Sample Size: Not applicable in the context of clinical data for algorithmic performance. The "samples" refer to units of the manufactured device used for physical and material testing. The exact number of units tested for each benchmark is not specified but is implicitly sufficient to meet the requirements of the cited standards.
• Data Provenance: Not applicable as this is bench testing of physical device components, not retrospective or prospective clinical data from human subjects. The testing was conducted by or on behalf of the manufacturer, Well-Life Healthcare Ltd., based in Taiwan.

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

Not applicable. The ground truth for this type of device (a probe electrode) is established by adherence to recognized national and international standards (e.g., ISO, ASTM, AAMI, IEC) for material safety, electrical performance, and mechanical integrity. There are no "experts" establishing a "ground truth" for diagnostic or clinical accuracy as this is a passive medical device component. The "experts" involved would be the engineers and technicians performing the tests and comparing the results to the predetermined pass/fail criteria of the standards.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation or clinical outcomes that would require an adjudication method like 2+1 or 3+1. Testing involves objective measurements against predefined engineering and biocompatibility standards.

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

Not applicable. This device is a passive probe electrode for stimulation and EMG, not an AI-powered diagnostic or therapeutic tool that would involve "human readers" or AI assistance.

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

Not applicable. There is no algorithm or AI component in this device. It is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for this device's safety and performance is based on:

• Established engineering standards: e.g., electrical safety parameters, mechanical strength thresholds.
• Biocompatibility standards: ensuring materials are non-toxic, non-irritating, and non-sensitizing.
• Predicate device characteristics: demonstrated safe and effective use of similar devices already on the market.

8. The Sample Size for the Training Set

Not applicable. There is no AI or machine learning component, therefore no training set.

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

Not applicable. As there is no training set.

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