(266 days)
The Perifit is a perineometer designed to treat stress, mild-moderate urge and mixed urinary incontinence in women, by strengthening of the pelvic floor muscles through exercise. This device provides biofeedback via smart phone technology.
Perifit is indicated for an adult female.
The Perifit device consists of a rigid probe covered in a silicone sheath that is temporarily inserted into the vagina. Sensors located under the sheath measure the strength of the user's pelvic floor muscles. This information is then transmitted wirelessly to a smartphone application in order to provide real-time feedback to the user. It is a single patient, reusable device to be supplied over-the-counter.
The Perifit is a perineometer designed to treat stress, mild-moderate urge, and mixed urinary incontinence in women by strengthening pelvic floor muscles through exercise. It provides biofeedback via smartphone technology. The Perifit is indicated for adult females and is available over-the-counter.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance and Compliance |
|---|---|---|
| Intended Use | Treat stress, mild-moderate urge, and mixed urinary incontinence in women, by strengthening of the pelvic floor muscles through exercise. Provides biofeedback via smartphone technology. | The Perifit has the identical intended use as the predicate device (Analytica Ltd.'s PeriCoach® OTC, K160758). No specific quantitative performance metrics are provided for "treatment" effectiveness within this documentation, but the device's ability to provide biofeedback for muscle strengthening is implied as the mechanism of action. |
| User Population | Adult females with urinary incontinence; available over-the-counter. | Identical to the predicate device. |
| Technological Equivalence | Similar technological characteristics to the predicate device, not raising new questions of safety or effectiveness. | Principle of Operation: Identical (probe inserted into the vagina to determine muscle strength, sends signals to external device to indicate contraction strength). |
| Sensing Method: Identical (Output from force sensing resistors, wireless). | ||
| Parameter Monitored: Identical (Analogue to digital output of uncalibrated force). | ||
| User Interface: Identical (Smartphone GUI). | ||
| Anatomical Sites: Identical (Female Pubococcygeus muscle area). The minor differences (sensor placement, external shape (two egg-shaped sensing areas vs. one), shaft length, weight, power source) were deemed not to raise new questions of safety or effectiveness. | ||
| Biocompatibility | Patient contacting materials must be safe for intended purpose, tested in accordance with ISO 10993 standards. | Tested in accordance with ISO 10993 standards for Cytotoxicity (ISO 10993-5, 2009), Sensitization (ISO 10993-10, 2010), Vaginal Irritation (ISO 10993-10, 2010), and Systemic Toxicity (ISO 10993-11, 2006). Found to be safe. |
| Electrical Safety & EMC | Tested in accordance with relevant IEC 60601 standards. | Tested in accordance with IEC 60601-1-2 and IEC 60601-1-11. |
| Software V&V | Verification and validation in accordance with FDA guidance and IEC 62304:2006. | Software verification and validation conducted in accordance with FDA guidance (Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices) and IEC 62304:2006. |
| Mechanical Durability | Demonstrated durability and appropriate mechanical behavior. | Mechanical drop testing and durability testing conducted. |
| Usability/Labeling Comprehension | Users understand key labeling provisions and how to operate the device. | Sensor behavior testing through a questionnaire supports that users understand the key labeling provisions and how to operate the device. |
| Sterilization | Non-sterile device. | Confirmed as a non-sterile device, identical to the predicate. |
2. Sample size used for the test set and the data provenance:
The provided document does not specify a separate "test set" in the context of clinical performance data in the typical sense of evaluating diagnostic accuracy or treatment efficacy with patient outcomes. The performance data focuses on device safety, electrical safety, biocompatibility, software validation, and mechanical durability, which are typically evaluated through engineering tests and specific standards.
- Biocompatibility: The ISO 10993 tests would involve specific biological samples or animal models depending on the sub-part (e.g., cell cultures for cytotoxicity, animal models for sensitization/irritation/toxicity). The sample sizes for these specific tests are not detailed.
- Mechanical Tests: The number of devices subjected to mechanical drop and durability testing is not specified.
- Sensor Behavior/User Comprehension: A "questionnaire" was used, but the sample size of users and data provenance (e.g., country of origin, retrospective/prospective) for this survey are not stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable or provided in the document. The document describes a 510(k) submission for a perineometer, which is a biofeedback device, not an AI/ML diagnostic or prognostic tool that would typically involve expert-established ground truth for a test set. The "ground truth" for this device relates to its adherence to safety and performance standards (e.g., biocompatibility standards, electrical safety standards, mechanical performance).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. The document does not describe a clinical study requiring adjudication of expert interpretations or diagnoses.
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:
Not applicable. The Perifit is a perineometer for pelvic floor muscle exercise and biofeedback, not an AI-assisted diagnostic or interpretation system that would involve human "readers" or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The Perifit is a physical device that works with a smartphone app for biofeedback. Its performance is intrinsically linked to user interaction and physical measurements. It is not an algorithm that operates "standalone" in a diagnostic or interpretive capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the Perifit's performance is its compliance with established engineering and safety standards and its ability to provide biofeedback, rather than a clinical ground truth like pathology or expert consensus on a diagnosis.
- Biocompatibility: ISO 10993 standards define the "ground truth" for material biological safety.
- Electrical Safety: IEC 60601 standards define the "ground truth" for electrical safety.
- Software Validation: FDA guidance and IEC 62304 define the "ground truth" for software quality and safety.
- Mechanical Performance: Internal specifications and durability testing protocols define the "ground truth" for mechanical integrity.
- Functionality (Biofeedback): The device's ability to accurately sense pelvic floor muscle contractions and transmit them to the app for user feedback is the functional ground truth, demonstrated through sensor behavior testing.
8. The sample size for the training set:
Not applicable. The device is not an AI/ML model that undergoes "training" in the traditional sense. The development and verification process involves engineering design, testing against standards, and software validation.
9. How the ground truth for the training set was established:
Not applicable. As there is no "training set" for an AI/ML model, there is no ground truth established for such a set.
§ 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).