(142 days)
The Pelvital System is intended for the strengthening of the pelvic floor muscles, which has been found to help women with stress urinary incontinence.
The Pelvital System is a repeat use, a non-sterile vaginal device intended to condition and strengthen the pelvic floor muscle (PFM) system. The model MTI-1 is designed for in-home use to enhance PFM training during normal Kegel exercises. The product consists of a probe that is inserted into the vagina and a handheld control unit that provides a biofeedback function to inform the correct muscles are being contracted during a Kegel exercise. The probe is designed to provide a resistive surface against which the user can contract the PFM, and an electric motor containing an eccentric weight that causes the probe to oscillate . The probe and the control unit are connected by a cable.
Control Unit: The control unit consists of a 3.7V Lithium-ion Polymer rechargeable battery with a capacity of 680-710 mAh and built-in safety protection. The unit also contains a PCB assembly used to control the motor speed and frequency and to provide the user with the biofeedback information. The control unit housing is made of ABS plastic (Acrylonitrile-butadiene-styrene copolymer).
Probe Unit: The probe unit contains an accelerometer and gyroscope which generate the biofeedback information. It also houses the motor and weight used to generate oscillations. The maximum diameter is 36 mm, and the maximum length is 100 mm. The design includes a winged flange that limits the maximum insertion length to 88 mm. The probe housing is cylindrical and is made of ABS plastic. The probe is the only part of the device that directly contacts the user's vaginal cavity (mucosal membrane contact, ≤24hr) and is covered entirely with a biocompatible medical-grade silicone sheath.
The Pelvital System is intended for strengthening pelvic floor muscles to help women with stress urinary incontinence.
Here is a summary of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state formal acceptance criteria in a quantitative table for the clinical effectiveness outcome. Instead, it reports the clinical trial's results and concludes that these results support the device's safety and effectiveness.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Effectiveness: Significant improvement in involuntary urine loss (24-hour pad weight test) from baseline. | - Treatment Arm (with oscillations): Significant improvement in 24-hour pad weight from baseline (p=0.0007). Mean change in pad weight: $17.0 \pm 40.6$ gm, representing a 33% reduction. |
- Control Arm (without oscillations): Significant improvement in 24-hour pad weight from baseline (p=0.009). Mean change in pad weight: $20.2 \pm 64.0$ gm, representing a 33% reduction.
- Note: There was no statistically significant difference in improvement between the treatment and control arms at 6 weeks (p=0.96). |
| Safety: No unacceptable adverse events. | - A total of 55 patients (44%) had 89 adverse events. - There was one serious adverse event (Grade 3) deemed unrelated to the study device.
- All other adverse events were graded severity levels 1 or 2.
- Conclusion: "Results of the clinical investigation support the safety, effectiveness, and indications for the use of the Pelvital System..." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 144 subjects were randomized into the study, with 72 in the control arm and 72 in the treatment arm. All 144 subjects were evaluated for the 6-week primary endpoint based on the intent-to-treat (ITT) population.
- Data Provenance: The clinical study was conducted across four clinical sites in the United States. It was a prospective, randomized, double-blind, crossover trial. The document also references a prior study by Nilsen et al. (2017) conducted at the University Hospital of Northern Norway,
which was a prospective cohort study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications for establishing a "ground truth" for the test set. The primary endpoint for effectiveness was quantified objectively via a 24-hour pad weight test, while secondary outcomes included patient-reported questionnaires (PGI-I, I-QOL, ICIQ-UI-SF).
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. Clinical outcomes were measured using objective tests (pad weight) and standardized questionnaires, which typically do not require adjudication in the same way imaging studies might.
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
This is not applicable as the Pelvital System is a medical device for direct patient use (pelvic floor muscle strengthening) and not an AI-assisted diagnostic or imaging device that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable since the Pelvital System is a physical medical device used by patients, not an algorithm. The biofeedback function is integrated into the device, providing real-time information to the user during Kegel exercises.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The primary "ground truth" for the effectiveness of the device was outcomes data, specifically the 24-hour pad weight test, which objectively measures involuntary urine loss. Patient-reported outcomes from questionnaires also contributed to assessing effectiveness. For safety, recorded adverse events served as the ground truth.
8. The Sample Size for the Training Set
The document describes a clinical study as a test set for evaluating the device's safety and effectiveness. It does not mention a separate "training set" in the context of machine learning or AI algorithm development. The device's design and functionality were developed based on engineering principles and preclinical testing, rather than an AI training set.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" in the context of AI or machine learning for this device,
this question is not applicable. The device's efficacy is demonstrated through its clinical performance on the study subjects.
§ 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).