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The FemiScan™ devices are intended as an aid for exercising and training pelvic floor muscle activation, control and optionally coordination with the abdominal muscle group. It is indicated in the treatment of stress and mixed female urinary incontinence under the supervision of a physician. The FemiScan™ Clinic System is used in the physician office, clinic, or hospital environment. The FemiScan™ Personal System is used to supplement these exercises in the home environment.

The FemiScan™ Clinic and Personal Systems consist of a palmsized measuring unit with a computer-based user interface and data acquisition system for data collection and data transfer. The devices feature a 2 channel EMG vaginal probe.

Here's an analysis of the provided text regarding the FemiScan™ Clinic System and FemiScan™ Personal System, focusing on acceptance criteria and supporting studies:

Based on the provided K993411 document, the information regarding study details for establishing performance criteria is limited. The document focuses more on substantial equivalence to predicate devices and general safety/performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed reported device performance in a numerical format. It broadly states that the device was subjected to safety and performance tests to ensure compliance with applicable recognized standards and to establish performance and reliability characteristics.

Therefore, a table of specific acceptance criteria and reported device performance cannot be created from the given text.

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

• Test Set Sample Size: The document mentions a "user study conducted under the direction of Kuopio University Hospital" for evaluating the FemiScan™ Personal System for suitability as a prescription home use device. However, the specific sample size for this user study is not provided.
• Data Provenance:
  • Country of Origin: Kuopio University Hospital is located in Finland.
  • Retrospective or Prospective: The description "user study conducted" suggests a prospective study design.

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

The document does not specify the number of experts used to establish ground truth for the user study or their qualifications. The study was conducted under the "direction of Kuopio University Hospital," implying medical oversight, but details about individual expert contributions are absent.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the user study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study to evaluate how human readers improve with AI vs. without AI assistance. The FemiScan™ is a biofeedback monitoring device, not an imaging interpretation or diagnostic AI device in the typical sense that would necessitate such a study design.

6. Standalone (Algorithm Only) Performance Study

The document does not explicitly describe a standalone (algorithm only without human-in-the-loop) performance study in terms of diagnostic accuracy or similar metrics. While "system level tests, integration tests, data calculations, display results" were conducted, these describe internal validation steps rather than an independent performance study of the FemiScan™'s biofeedback algorithm against predetermined clinical outcomes or a gold standard without human interaction. The description of the user study implies human interaction for home use.

7. Type of Ground Truth Used

For the "user study conducted under the direction of Kuopio University Hospital," the ground truth implicitly relates to the suitability and safety for home use, and potentially the effectiveness of the device in aiding "exercising and training pelvic floor muscle activation and control" and "treatment of stress and mixed female urinary incontinence." The document notes "No adverse events occurred during the study," which is a safety outcome. Specific objective clinical outcomes or a "gold standard" for the effectiveness of training are not detailed as ground truth.

8. Sample Size for the Training Set

The document makes no mention of a training set or any machine learning/AI development process that would typically involve a separate training set. The FemiScan™ operates on electromyography (EMG) monitoring technology and biofeedback principles, which are well-established, rather than relying on a complex AI model trained on large datasets.

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

Since there is no mention of a training set, there is no information on how its ground truth would have been established.

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