Search Results

The Innova® ComfortPulse® Vaginal Electrodes are a component of the Innova Pelvic Floor Stimulation (PFS) System which is indicated for use in the treatment of urinary incontinence. These electrodes are also a component of the Innova® Clinical EMG System which is indicated for monitoring and evaluating EMG activity of the pelvic floor muscles.

The Innova® ComfortPulse® Vaginal Electrodes, small and standard sizes, have three conductive elements separated by non-conductive elements of thermoplastic material. The small size electrode has a flared cylindrical shape and the standard size electrode has an hourglass shape. The electrodes are designed for repeated intermittent use in the home or clinic for up to one year by a single user. Because it is designed for use by a single user, it does not require sterilization. It does, however, require washing with soap and water and drying between uses. Both small and standard size electrodes have a permanently attached, insulated 40 inch leadwire cable that connects directly to the Stimulation System, but requires an adapter to connect to the EMG System.
The small size electrode is approximately 2.3 inches in length from tip to end, with a maximum diameter of 0.8 inches. The standard size electrode is approximately 2.8 inches in length from tip to end, with a maximum diameter of 1.025 inches.

This information is not provided in a structured format in the document, but can be extracted from the text.

Acceptance Criteria and Device Performance:

The document doesn't explicitly lay out quantitative acceptance criteria in a table format with corresponding performance metrics. However, it states that the device was evaluated against its ability to:

• Produce a pelvic floor muscle contraction equivalent to the current Innova® Vaginal Electrode as demonstrated by the generation of increased urethral pressure.
• Sense voluntary pelvic muscle contraction by an EMG System.

The reported performance states:

• "The electrically stimulated pelvic muscle contractions induced by both new Innova® ComfortPulse® Vaginal Electrodes and the currently marketed Innova® Vaginal Electrodes were clinically observable, palpable and measurable."
• "When stimulation induced pelvic muscle contractions were compared, the new Innova® ComfortPulse® Vaginal Electrodes, both small and standard sizes, produced contractions substantially equivalent to those of the currently marketed Innova® Vaginal Electrodes."
• "All of the electrodes discriminated between volitional contraction and rest, demonstrating that the Innova® ComfortPulse® Vaginal Electrodes, both small and standard sizes, are substantially equivalent to the currently marketed Innova® Vaginal Electrodes in sensing volitional contraction and rest."

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated. The document refers to "an acute clinical test" but does not specify the number of participants.
• Data Provenance: Not explicitly stated. It is referred to as "an acute clinical test," implying prospective data collection, likely within a clinical setting. The country of origin is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not specified. The observation that contractions were "clinically observable, palpable and measurable" suggests medical professionals were involved in the assessment, but their number and specific qualifications are not detailed.

4. Adjudication method for the test set:

• Not specified.

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 document describes a medical device (electrode) and its function, not an AI or imaging diagnostic tool that would typically involve human readers or MRMC studies.

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

• Not applicable. This device is a physical electrode and does not involve an algorithm for standalone performance evaluation in the context of AI. The performance discussed is the physical function of the electrode.

7. The type of ground truth used:

• Clinical Observation/Measurement: For muscle contractions, the ground truth was based on "clinically observable, palpable and measurable" muscle contractions and the generation of "increased urethral pressure."
• Volitional Contraction/Rest: For sensing performance, the ground truth was based on the ability to discriminate between "volitional contraction and rest."

8. The sample size for the training set:

• Not applicable. This product is a physical medical device (electrode), not a machine learning model that would typically have a "training set." The development of the device would involve engineering and material testing, not data training.

9. How the ground truth for the training set was established:

• Not applicable, as there is no "training set" in the context of a machine learning algorithm. The "ground truth" for the device's design and manufacturing would be based on engineering specifications, material science, and established physiological principles.

Ask a specific question about this device