(129 days)
The Flyte System is intended for strengthening of the pelvic floor muscles to treat women with mild, moderate, and severe stress urinary incontinence
The Flyte System is a repeat use, non-sterile, vaginal device intended to condition and strengthen the pelvic floor muscle (PFM) system to treat women with urinary incontinence. The Flyte System is designed for in-home use to deliver treatment to the pelvic floor muscles during normal Kegel exercises. The product consists of an intravaginal wand and a hand-held controller. The Flyte wand is placed in the vagina and, under the direction of the controller, delivers a series of mechanical vibrations while the pelvic floor muscles are contracting. This treatment is called mechanotherapy.
The Flyte controller controls the wand, guides the user through the treatment session and provides visual information to inform the user when the correct muscles are being contracted during a Kegel exercise. The wand is designed to make optimal contact within the vaginal canal and to deliver vibrations via an eccentric weight driven by an electric motor which causes the wand to oscillate at a specific frequency as directed by the controller. The wand additionally provides a resistive surface against which the user can contract the PFM. A cable connects the wand and the controller.
Controller: The controller consists of a 3.7V Lithium-ion Polymer rechargeable battery with a capacity of 700-750 mAh and built-in safety protection. The controller also contains a PCB assembly used to control the motor speed and frequency and to provide the user with visual information. The controller housing is made of ABS plastic (Acrylonitrile-butadiene-styrene copolymer).
Wand: The wand contains an accelerometer and gyroscope which enable the Controller to generate visual information. It also houses the motor and weight used to generate mechanical vibrations. The wand is available in large and small sizes. The wand housing is cylindrical and is made of ABS plastic. The wand is the only part of the device that directly contacts the user's vaginal cavity (mucosal membrane contact,
The provided text describes a 510(k) premarket notification for the "Flyte Mechanotherapy System, MTI-1.5". This document focuses on the substantial equivalence of the new device (MTI-1.5) to a predicate device (MTI-1.0) and presents non-clinical and clinical data to support this claim.
However, the document is a regulatory submission for a physical medical device (perineometer) that uses mechanical vibrations and a mobile app. It is not for an AI/ML-driven diagnostic or prognostic device that relies on complex algorithms to interpret data or images. Therefore, the acceptance criteria and study design elements typically associated with AI/ML device evaluations (e.g., specific acceptance metrics like AUC, sensitivity, specificity, expert ground truth adjudication for image interpretation, MRMC studies) are not applicable in this context.
The study described is a clinical trial to demonstrate the effectiveness of the physical device in treating stress urinary incontinence based on a specific clinical outcome (24-hour pad weight).
Here's an attempt to answer the questions based only on the provided text, while acknowledging the inherent mismatch in the questions asked and the nature of the device:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the format of a table with specific thresholds for performance metrics. Instead, it reports on the clinical benefits observed in a clinical trial.
| Performance Metric (Clinical Endpoint) | Reported Device Performance (MTI-1.5) | Note on "Acceptance Criteria" |
|---|---|---|
| Primary Efficacy Endpoint: Change in 24-Hour Pad Weight (24-HR PW) from Baseline to Week 6 | A reduction in 24-hour pad weight occurred among all participants from baseline to 6-weeks (P50% reduction in 24-hour pad weight in the first 6 weeks. | The text indicates statistical significance (P50% reduction is stated as a clinically meaningful outcome. |
| Secondary Efficacy Endpoint: 24-HR PW at 12 Weeks | A reduction in 24-hour pad weight occurred among all participants from baseline to 12-weeks (P50%) in pad weight by 12 weeks of therapy. | |
| Median reduction in 24-HR PW was 68% by 12 weeks. | ||
| Overall, 61% of participants achieved continence with |
§ 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).