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ApexMV is a non-implantable muscle stimulator intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of stress, urge, or mixed urinary incontinence in adult women.

ApexMV is a non-implantable muscle stimulator intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of stress, urge, or mixed urinary incontinence and/or fecal incontinence in adult women.

The ApexMV device is a non-implantable muscle stimulator intended to provide electrical stimulation and/or visual biofeedback (via manometry) for the treatment of stress, urge, or mixed urinary incontinence and/or fecal incontinence in adult women for Over-the-Counter use. The ApexMV device is to be distributed as a kit that contains the following items:

• · 1 ApexMV device
• 1 4 pack of AA batteries
• · 1 2 oz. tube of InControl Medical Electrode Gel**
• 1 ApexMV IFU/ User Manual
• · 1 ApexMV Quick Reference Card
• 1 Screw driver
• 1 Travel Bag
• 1 Animation Video

The ApexMV device consists of a hand held control unit with bio-feedback and inflation pump attached to a customizable inflatable probe via flexible tubing. The customizable inflatable probe is inserted vaginally or rectally and manually inflated by the end user to ensure a customized fit. Electrical stimulation is delivered via stainless steel electrodes on the inflatable probe to induce a contraction of the pelvic floor muscles. Muscle stimulation is used to train and strengthen the pelvic floor muscles in a controlled manner. Muscle stimulation is also used to improve the ability of the muscles to hold a contraction for an extended period of time for the treatment of stress, urge, or mixed urinary and/or fecal incontinence in adult women. During a session, high and low frequency stimulation is delivered by the device. The higher frequency stimulation is delivered to specific muscles to encourage their contraction, strengthening the muscles and helping the end user recognize which muscles to activate during self-directed contractions. Lower frequency stimulation calms the detrusor muscle, decreasing symptoms of urgency. The level of electrical stimulation is easily controlled by the end user using manual, push-button controls.

This document describes the regulatory submission for the ApexMV device, which is a non-implantable muscle stimulator for treating urinary and/or fecal incontinence in adult women.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" in the format of specific thresholds for performance metrics. Instead, the "acceptance criteria" are implied by the successful completion of various tests and the determination of substantial equivalence to previously cleared predicate devices. The reported "device performance" is primarily qualitative, stating that the device "successfully passed all of this testing" and is "safe and effective."

Below is a table summarizing the tests performed and the reported outcomes, which implicitly serve as the device meeting the acceptance criteria for regulatory clearance:

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

• Test Set Sample Size:
  • For the Human Factors Usability Study, the document states "the subject/end users were able to properly self-identify...". However, it does not specify the exact number of participants (sample size) in this study.
  • For other tests (Software, Electrical Safety, EMC), sample sizes are not applicable in the same way as clinical studies. These typically involve testing the device itself or its components against a set of standards.
  • For clinical literature evaluation, no specific sample size from a new study is mentioned; instead, it's a review of existing literature on predicate devices.
• Data Provenance:
  • Human Factors Usability Study: Prospective study, conducted specifically for the ApexMV device. The country of origin for the study is not explicitly stated, but the submitter is InControl Medical, LLC, located in Brookfield, WI, USA, suggesting the study was likely conducted in the US.
  • Clinical Literature Evaluation: Retrospective (review of existing literature). The origin of this data would be diverse, based on the studies reviewed.
  • Software, Electrical Safety, EMC, Biocompatibility: These are engineering and bench tests, not directly involving patient data. For biocompatibility, the data used was retrospective from previous predicate device submissions.

3. 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)

• Human Factors Usability Study: The document states that the study was "conducted with collaboration with a supervising physician." This indicates at least one physician was involved in supervising and possibly establishing the ground truth regarding patient self-identification and safe device use based on labeling. Specific qualifications (e.g., years of experience, specialty beyond "physician") are not detailed.
• Clinical Literature Evaluation: An "appraisal of each article was completed." This implies experts reviewed the literature, but the number or specific qualifications of these experts are not provided.
• Other tests: Ground truth establishment by experts as described for medical image analysis is not directly applicable to these engineering and bench tests. Compliance with standards is the "ground truth."

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

The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for the Human Factors Usability Study. The assessment seems to be based on whether participants "were able to properly self-identify" and "complete critical tasks successfully" with the guidance of the supervising physician. For the clinical literature review, an "appraisal" was done but no specific adjudication process is mentioned.

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

No MRMC comparative effectiveness study was done. The ApexMV device is a muscle stimulator, not an AI software intended to assist human readers in interpreting medical images. The primary evaluation method was substantial equivalence to existing predicate devices and direct testing of the device's adherence to safety and performance standards, and user interaction.

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

The ApexMV is a direct-to-consumer medical device used by the patient. Its "standalone performance" refers to its electrical stimulation characteristics and biofeedback capabilities operating as designed, independent of a clinician's direct real-time intervention for each session. The software and electrical safety tests can be considered evaluations of its standalone functional performance against specifications.

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

• For Human Factors Usability Study: The ground truth was established by the performance of the test subjects in self-identifying and successfully using the device, as assessed by a supervising physician and the study protocol. The "ground truth" for self-identification was based on the subjects' actual condition and their ability to determine it based on the provided labeling.
• For Electrical Safety, EMC, Software, Biocompatibility: The "ground truth" is adherence to established international and FDA-recognized standards and internal specifications. For biocompatibility, the ground truth was established from previous testing on identical materials in predicate devices.
• Clinical Literature Review: The ground truth here is the evidence for safety and efficacy of similar electrical stimulation technologies as established and published in existing clinical literature.

8. The sample size for the training set

The document does not mention a "training set" in the context of machine learning or AI models. This device is an electrical stimulator, not an AI/ML diagnostic or assistive tool, so a training set in that sense is not applicable. The device's design and features are based on the established technology of predicate devices and general engineering principles.

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

As there is no mention of a "training set" in the context of an AI/ML model, this question is not applicable. The "ground truth" for the device's design and performance claims is established through compliance with regulatory standards, engineering principles, and demonstration of substantial equivalence to already-cleared devices.

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