(64 days)
The Feminine Personal Trainer (FPT) is indicated for the strengthening of the perineal pelvic floor muscles by providing resistance to an individual's voluntary contractions of these muscles. It seeks to correct, through exercise, urinary incontinence in women.
The FPT is designed specifically for women for their use in strengthening the pelvic floor musculature. It is a single, reusable, home-use device that comes into contact with the vaginal mucosal membrane for a limited (
The provided text describes a 510(k) premarket notification for a medical device called the "Feminine Personal Trainer (FPT)." This document is a regulatory submission for premarket clearance and does not contain the level of detail typically found in reports of clinical studies, especially those involving AI/ML components or human reader performance.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be found in this document.
Here's an analysis based on the information available in the text:
The FPT is a physical device (hourglass-shaped surgical stainless steel) used for strengthening pelvic floor muscles, similar to a perineometer. It does not appear to involve any AI/ML components, image analysis, or complex algorithms that would require the types of studies outlined in your request (e.g., MRMC studies, standalone algorithm performance).
The "study" referenced in the document is "Non-clinical Performance Testing," which focuses on biocompatibility and material safety rather than clinical efficacy through comparative trials or complex performance metrics.
Information that CANNOT be extracted from the document:
- A table of acceptance criteria and the reported device performance: The document states the device is "as safe and effective as the predicate" based on "performance testing" and "same intended use." Specific performance metrics with acceptance criteria are not provided. The non-clinical tests were for biocompatibility (cytotoxicity, irritation, sensitization), not efficacy metrics.
- Sample sizes used for the test set and the data provenance: Not applicable. The "testing" was biocompatibility testing, not a clinical trial with a test set of patient data.
- 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 endpoints or image interpretation is not relevant for this device's testing.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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. The device is a physical, non-AI product.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as there's no diagnostic or interpretative function. The ground truth for biocompatibility is whether the materials exhibit toxic, irritating, or sensitizing effects as per ISO standards.
- The sample size for the training set: Not applicable, as there is no AI/ML model for training.
- How the ground truth for the training set was established: Not applicable, as there is no AI/ML model for training.
Information that can be extracted or inferred from the document:
- Device Type: Feminine Personal Trainer (FPT), a physical device (perineometer) for strengthening pelvic floor muscles. It is not an AI/ML device.
- Purpose of "Study": Non-clinical performance testing focused on biocompatibility of the device materials.
- Acceptance Criteria (Implied for Biocompatibility): The materials must not be cytotoxic, irritating, or sensitizing.
- Reported Device Performance (for Biocompatibility): "Test results from the tests listed above supported that the device is not cytotoxic, not irritating, and not sensitizing. The FPT device has been demonstrated to be biocompatible."
- Testing Standards: ISO 10993-5:2009 (Tests for In Vitro Cytotoxicity) and ISO 10993-10:2010 (Tests for Irritation and Skin Sensitization, Vaginal Irritation and Guinea Pig Maximization Sensitization).
Conclusion:
This document is a 510(k) summary for a physical medical device. The "study" mentioned is non-clinical biocompatibility testing to demonstrate material safety, not a clinical efficacy trial or a study assessing the performance of an AI/ML system. Therefore, the vast majority of your detailed questions regarding acceptance criteria, sample sizes, expert involvement, and ground truth for AI/ML or clinical performance studies are not relevant to this specific device or the information provided in this regulatory submission.
§ 884.1425 Perineometer.
(a)
Identification. A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.(b)
Classification. Class II (performance standards).