(226 days)
Biofeedback/monitoring vaginal probe intended for:
- Treatment of stress, urge, and mixed incontinence.
- Facilitation in identification of the pubococcygeus muscles.
- Strengthening of the pelvic floor muscles through biofeedback-assisted pelvic floor exercises.
The Periform® is a vaginal perineometric probe designed specifically for the acquisition of the naturally present superficial EMG signals of the human vaginal wall. Surface electromyography (sEMG) is the technique of measuring and filtering the electrical impulse (action potential) signals generated by muscle fibers during contraction. The probe conducts these signals to a biofeedback device for further processing. The anatomy of the pelvic floor presents a difficulty in obtaining these signals. The use of a perineometric probe overcomes this difficulty. The purpose of the Periform® is to improve the voluntary control and strength of the pelvic floor muscles with the aid of biofeedback equipment.
The provided text describes the Periform® Perineometric Probe and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the way typically expected for a detailed performance study with statistical endpoints.
Instead, the submission focuses on:
- Substantial Equivalence: Demonstrating that the Periform® is as safe and effective as previously approved devices (Verimed Electromyographic Perineometer™ and PerryVaginal™ Sensor) through a detailed feature comparison.
- Non-Clinical Performance Data: Providing basic engineering and material testing rather than clinical effectiveness.
- Biocompatibility Testing: Ensuring the materials are safe for human contact.
Here's an breakdown of the information that is available related to your request categories, and where the information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance |
|---|---|
| Material Biocompatibility: | |
| USP Class VI Plastics (for Polystyrene type 564) | Meets the requirements |
| Nontoxic (for Medical Grade Stainless Steel 316S31) | Nontoxic |
| Electrical Signal Transport: | |
| Low impedance values (below 200 Hz) | Around 10 ohms at all tested frequencies |
| Premarket Approval: | |
| Substantially equivalent to predicate devices | Determined substantially equivalent by FDA |
Missing: The document does not define specific clinical acceptance criteria for effectiveness (e.g., a target percentage reduction in incontinence episodes, or a threshold improvement in pelvic floor muscle strength). The "performance" described is primarily about safety and technical specifications that demonstrate it functions as a perineometric probe.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document describes non-clinical performance and biocompatibility testing, not a clinical trial with a test set of human subjects for effectiveness.
- Impedance Test: "Various frequencies were used" (no sample size provided beyond this qualitative statement).
- Biocompatibility Tests: Performed on the materials themselves, not human subjects.
- Data Provenance: Not applicable for these types of tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. No clinical test set with human subjects requiring expert ground truth establishment is described.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set with human subject data requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. A MRMC comparative effectiveness study was not conducted or reported. The device's approval is based on substantial equivalence to existing devices and non-clinical testing, not a study comparing performance with and without AI assistance or human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a sensor (perineometric probe) and does not involve an "algorithm" in the sense of AI or image analysis. Its function is to acquire biological signals for a biofeedback device or for a Pelvic Floor Contraction Indicator. The "standalone" performance here refers to its ability to acquire signals, which is addressed by the impedance test.
7. The Type of Ground Truth Used
For the non-clinical tests:
- Biocompatibility: Established by compliance with recognized standards (e.g., USP Class VI Plastics, confirmation of medical grade material toxicity).
- Electrical Signal Transport (Impedance): Established by demonstrating low impedance values across relevant frequencies, indicating effective signal transmission.
Missing: No clinical ground truth (e.g., pathology, clinical outcomes, expert consensus on patient improvement) is mentioned because no clinical effectiveness study was reported.
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning or AI that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, no training set is relevant for this device.
§ 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).