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The device is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female urinary incontinence.

The BTL-398 is a non-invasive therapeutic device that delivers magnetic pulses to stimulate the pelvic floor muscles for the treatment of urinary incontinence in adult population. The BTL-398 device is intended for professional use in healthcare facilities as a prescription use only. The BTL-398 consists of a main unit and a Chair Applicator. The main unit consists of the electromagnetic field generators, the microprocessor-driven control unit, and the touch-screen control panel. The Chair Applicator is designed for non-invasive treatment of urinary incontinence. The magnetic coil is in the center of the seat, and its position is user-adjustable during therapy. Ongoing therapy is indicated by illuminated segments. The Chair Applicator is designed for precise patient positioning, ensuring the most appropriate posture before and during therapy. Prior to High-Intensity Focused Electromagnetic (HIFEM) therapy, the seat height and coil position can be adjusted using an attached remote controller. The Dynamic HFEM Technology (DHT) feature ensures the coil is optimally positioned at the right location beneath the patient before starting therapy. At the start of therapy, air is circulated through the seat cushion with the Pressure Wave Technology (PWT) feature (intensity of the PWT function is set based on patient feedback). The PWT feature helps patients maintain the correct therapeutic position during therapy. Both the PWT and DHT features can be readjusted, and the PWT feature can be turned off, at any time during the session. The touch screen display guides the user step-by-step through the entire therapy procedure. During therapy, the screen displays information about the applied therapy, remaining therapy time, and main therapy parameters. Therapy is administered through clothing.

The provided text is a 510(k) Premarket Notification from the FDA for a device called "BTL-398". This document primarily focuses on demonstrating substantial equivalence to a predicate device (HPM-6000UF) for regulatory clearance. It does not include information about clinical studies with human participants, AI components, or detailed performance data against acceptance criteria for such clinical or AI-specific assessments.

Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes, expert involvement, and ground truth establishment, particularly concerning AI or human-in-the-loop performance, cannot be extracted from this document. The document explicitly mentions "non-clinical testing" and "performance bench data," suggesting that equivalence was primarily established through engineering and electromagnetic performance tests, not clinical efficacy trials for the UI treatment itself.

However, I can extract information related to what was used for acceptance and testing:

Acceptance Criteria and Device Performance (Based on "Non-clinical Testing")

Study Details (as per available information):

1. A table of acceptance criteria and the reported device performance:
   (See table above) The document states, "All pre-determined acceptance criteria were met." However, it does not provide specific numerical targets or results for the bench performance tests (e.g., exact magnetic field strength measured vs. target range). It only confirms compliance with standards and successful completion of tests.

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

   • Test Set Sample Size: Not applicable in the context of human subjects or AI test sets. The testing described is non-clinical bench testing of the device's electrical, mechanical, thermal, electromagnetic, and software functions.
   • Data Provenance: N/A for clinical data. The data is from internal bench testing (performance bench data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable. Ground truth for clinical outcomes or diagnoses is not mentioned as this was primarily non-clinical testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable. No human reader or expert adjudication process for clinical data or AI output is described.

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 study was mentioned. The device is a non-invasive electromagnetic stimulator, not an imaging or diagnostic AI device that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable for an AI algorithm. The device, the BTL-398, is a physical medical device. Its software functions were verified and validated, but this does not imply an AI component in the typical sense of diagnostic or image analysis AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the non-clinical tests, the "ground truth" was established based on engineering specifications and compliance with recognized standards (IEC 60601-1, IEC 60601-1-2) and FDA guidance for software verification and validation. For magnetic field strength, coil surface temperature, and PWT features, the ground truth would be the expected performance range derived from design specifications.

8. The sample size for the training set:
   Not applicable. No machine learning training set is mentioned.

9. How the ground truth for the training set was established:
   Not applicable. No machine learning training set is mentioned.

Summary of what the document focuses on:

The entire document pertains to establishing substantial equivalence of the BTL-398 to a predicate device (HPM-6000UF) through non-clinical testing. The key differences noted between the subject device (BTL-398) and the predicate are the inclusion of a "PWT feature" (Pressure Wave Technology for patient positioning) and a "DHT Feature" (Dynamic HFEM Technology for coil adjustment). The non-clinical tests were conducted to ensure these new features and the overall device design do not raise new questions of safety or effectiveness.

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