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The Innova Rectal Stimulation Electrode is designed for use with the Innova PFS System which has market clearance for the treatment of unnary incominence.

The Innova Rectal Stimmlation Electrode assembly is a light-weight cylinder consisting of two conductive rings that are paired and isolated, physically. The cylinder is shaped with a waist and a handle for confort, positioning and ease in removing, It is watertight to allow for washing with socop and water between uses. The electrode is designed for repeated intermittent use in the home or clinic for up to one year by a single user. It does not require sterilization, but does require washing with soap and water and drying between uses.

The provided text describes the "Innova Rectal Stimulation Electrode" and its performance in comparison to a predicate device, the "InCare Rectal Electrode."

Here's an analysis of the acceptance criteria and study data based on the provided input:

Acceptance Criteria and Reported Device Performance

Study Details

This submission focuses on establishing substantial equivalence to the predicate device, the Innova Vaginal Stimulation Electrode and the InCare Rectal Electrode.

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • The document states "All subjects had pelvic muscle contractions using both electrodes," but does not explicitly state the number of subjects in the clinical test.
   • The study is described as an "acute clinical test," suggesting a prospective design.
   • Data provenance (country of origin) is not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Ground truth for the clinical test was based on "observable and measurable response" of pelvic muscle contractions. It was assessed by an "investigator." The number and qualifications of this investigator(s) are not specified.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • The document implies a single "investigator" observing and measuring responses. No adjudication method is mentioned, suggesting "none" explicitly.

4. 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:

   • No MRMC comparative effectiveness study was done. This is a medical device, not an AI or imaging diagnostic tool. The comparison is between two physical electrodes.

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

   • Not applicable as this is a physical medical device (electrode), not an algorithm or AI.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the clinical testing, the ground truth was based on physiological measurements and observations of "pelvic muscle contractions" and "contraction induced pressures." This is a form of physiological measurement/observable response.

7. The sample size for the training set:

   • Not applicable. This is a medical device, not an algorithm requiring a training set. The "product verification and validation" (functional testing) refers to engineering tests against specifications, not a machine learning training set.

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

   • Not applicable, as there is no training set for an algorithm. The "product specifications" served as the benchmark for the functional tests.

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