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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, <24hr) and is covered entirely with a biocompatible medical-grade silicone sheath.

Additional Components:
Charging Cable: Connects the Controller to the Charging Block
Charging Block: AC adapter that allows you to plug the Controller into a wall outlet for charging.

Optional Flyte App and Provider Portal:
The Flyte App is a mobile application that provides an optional additional interface for the user. The Flyte App enables the user to create an account, pair the App with the Controller, and view general Flyte information and instructions. The Controller provides information to the App, unidirectionally. During a treatment session, the Flyte App provides an optional additional interface guiding the user through the treatment session and providing information to inform the user when correct muscles are being contracted and relaxed during the session. The Flyte App also collects two patient reported outcomes surveys at regular intervals over the treatment period. The Flyte App enables the user to view treatment history, including dates a treatment session was completed, contraction and relaxation data from those sessions, and the patient reported outcomes data. The Flyte App stores data in an encrypted database on the device, and securely uploads data to a secure, HIPAA-compliant cloud database. The Flyte App is not required for use of the Flyte System.

The Flyte Provider Portal is a HIPAA-compliant web portal that enables providers to send invitations to users/patients for Flyte App registration. If a user accepts the provider's invitation and provides consent during registration, the Flyte Provider Portal enables the provider to view historical treatment and patient reported outcomes data for that user. The Flyte Provider Portal is not required for use of the Flyte System.

AI/ML Overview

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 (P<0.001). 57% (68/119) had a >50% reduction in 24-hour pad weight in the first 6 weeks.	The text indicates statistical significance (P<0.001) for reduction, suggesting this was a key measure of efficacy. A >50% 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 (P<0.001). 71% (81/114) achieved a clinically meaningful reduction (>50%) 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 <10g. Median pad weight at 12 weeks for the 71% was 5.3g.	These metrics demonstrate sustained and significant improvement.
Secondary Efficacy Endpoint: Changes in Quality of Life (QoL) from Baseline to 6 and 12 weeks (using ICIQ-UI-SF and I-QOL)	Two-part mechanotherapy significantly improved QoL across all severities of SUI.	QoL improvement was significant.
Safety Outcomes	The incidence of Adverse Events (AEs) did not differ greatly between arms. Safety outcomes did not differ by SUI severity group.	Indicating that the device is safe and comparable to control/predicate in terms of adverse events.
Non-Clinical Performance (Examples from list provided in text: Dimensional, Wand Compression, Accelerometer functionality, Therapy Timing, Motor Rotation Speed, Post-Treatment Temperature, Electrical Safety, Software and cybersecurity)	All testing confirmed the safety and efficacy of the MTI-1.5.	The text generally states that these tests were conducted to "confirm the safety and efficacy," implying successful meeting of internal design and regulatory standards, but specific numerical acceptance criteria are not provided in this summary.

2. Sample size used for the test set and the data provenance

Sample Size: The clinical trial included 119 subjects (n=119).
Data Provenance: The document states this was a "multi-center, prospective, double-blinded, randomized clinical trial." The country of origin of the data is not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. The "ground truth" for this device is the objective clinical outcome of urinary incontinence as measured by 24-hour pad weight and patient-reported quality of life, not an expert interpretation of an image or signal.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable as the "ground truth" is a direct clinical measurement, not a subjective interpretation requiring adjudication.

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 question is not applicable. This is not an AI-assisted diagnostic device, and no human "readers" are involved in interpreting outputs. The study compared a device treatment with mechanical pulses to one without mechanical pulses, and both against baseline.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is a physical product for treatment, not an algorithm. While it has a software component (mobile app), its performance is tied to the physical device's function and clinical outcomes, not algorithmic standalone diagnostic performance.

7. The type of ground truth used

The primary ground truth used was objective clinical outcomes data, specifically:

24-hour Urine Pad Weight (24-HR PW): This is a direct, quantifiable measure of urine leakage.
Patient-Reported Outcomes (PROs): Using validated disease-specific instruments (International Consultation on Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-UI-SF) and Urinary Incontinence Quality of Life (I-QOL)). This is a subjective outcome but derived from standardized questionnaires.

8. The sample size for the training set

This is not an AI/ML device that requires a distinct "training set" for model development. The described study (n=119) is a clinical trial for device efficacy and safety, not a dataset for training a machine learning model.

9. How the ground truth for the training set was established

Not applicable, as there is no training set in the context of AI/ML. The "ground truth" for the clinical trial was established through direct measurement of 24-hour pad weight and administration of validated PRO questionnaires.

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