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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.

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The Flyte System is intended for strengthening of the pelvic floor muscles to treat women with 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. 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 a wand and a hand-held controller. The Flyte wand is placed in the vagina and delivers a series of mechanical vibrations while the pelvic floor muscles are contracting. The hand-held controller controls the wand, guides the user through the treatment session and provides a visual feedback function to inform the user when the correct muscles are being contracted during a Kegel exercise. The wand provides a resistive surface against which the user can contract the PFM, and houses an electric motor containing an eccentric weight that generates mechanical oscillations when the motor is running. A cable connects the wand and the controller.

The provided document [K233362] is a special 510(k) submission for a labeling modification to the Pelvital USA, Inc. Flyte System (aka Flyte System) (MTI-1.0). This means the device itself, its technological characteristics, and its principles of operation have not changed from its already cleared predicate device (K212655 Flyte System).

Therefore, this specific submission does not contain new acceptance criteria or a new study to demonstrate device performance. The document explicitly states: "Given the changes proposed in this submission were limited to minor labeling changes, no clinical and non-clinical performance data was submitted in this submission to support the changes."

To answer your questions, we would need the documentation associated with the original K212655 Flyte System clearance, which established the acceptance criteria and presented the performance study data that supported the substantial equivalence of the original device.

Without that original document, I can only provide general information based on the typical requirements for predicate devices.

Based on the information provided in K233362, the following answers apply:

1. A table of acceptance criteria and the reported device performance:

• No new acceptance criteria or reported device performance are presented in this submission. The submission is for a labeling modification only, indicating no changes to the device itself.

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

• Not applicable to this submission. No new performance studies were conducted or presented. The original premarket notification (K212655) would contain this information.

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

• Not applicable to this submission. No new performance studies were conducted or presented.

4. Adjudication method for the test set:

• Not applicable to this submission. No new performance studies were conducted or presented.

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 to this device. The Flyte System is a perineometer for strengthening pelvic floor muscles and does not involve AI or human readers evaluating medical images, which is typically where MRMC studies are performed.

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

• Not applicable to this device. The Flyte System is a physical medical device, not an algorithm, and is intended for user-operated rehabilitative exercise, not an automated diagnostic or treatment system in the context of standalone algorithm performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable to this submission. No new performance studies were conducted or presented. For the original device, performance would likely have been evaluated based on outcomes data related to pelvic floor muscle strengthening and reduction in stress urinary incontinence symptoms.

8. The sample size for the training set:

• Not applicable to this submission. No new performance studies were conducted or presented. This device does not have a "training set" in the context of machine learning.

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

• Not applicable to this submission. As above, this device does not have a "training set" in the machine learning sense.

In summary, this document K233362 explicitly states that no new performance data was submitted because the submission is solely for a minor labeling modification, and the device itself is identical to its predicate (K212655). To obtain the requested information, you would need to review the original 510(k) submission for the K212655 Flyte System.

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The Pelvital System is intended for the strengthening of the pelvic floor muscles, which has been found to help women with stress urinary incontinence.

Not Found

This is an FDA premarket notification (510(k)) letter for the Pelvital USA, Inc. Flyte™ System. The letter itself does not contain detailed information about acceptance criteria or the study that proves the device meets those criteria. It primarily states that the device is substantially equivalent to legally marketed predicate devices, meaning it has similar intended use and technological characteristics as a device already on the market.

To answer your request, I would need access to the actual 510(k) submission (K212655) or accompanying clinical study documentation, which is not provided in these FDA letters. The provided text only confirms the clearance of the device and its intended use: "The Pelvital System is intended for the strengthening of the pelvic floor muscles, which has been found to help women with stress urinary incontinence."

Without the actual study data, I cannot provide the requested information regarding:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method
5. Multi-reader multi-case (MRMC) comparative effectiveness study results
6. Standalone performance
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

For this specific FDA letter, the requested details are not present.

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The Pelvital Flyte™ System is intended for the strengthening of the pelvic floor muscles, which has been found to help women with stress urinary incontinence.

Not Found

The provided text is an FDA 510(k) clearance letter for the Pelvital Flyte™ System, a device intended for strengthening pelvic floor muscles to help women with stress urinary incontinence.

Unfortunately, the document does not contain any information regarding the following:

• Acceptance criteria for device performance.
• The study that proves the device meets acceptance criteria.
• Reported device performance metrics.
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of AI assistance on human readers.
• Whether standalone (algorithm only) performance was done.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

This document is primarily a regulatory clearance letter, confirming that the device is substantially equivalent to legally marketed predicate devices and outlining the regulatory requirements for the manufacturer. It does not delve into the specific details of performance studies or acceptance criteria.

To obtain the information requested, one would typically need to refer to the 510(k) summary or other supporting documentation submitted by the manufacturer to the FDA, which would detail the performance data and testing conducted for the device. This information is not present in the provided FDA clearance letter.

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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.

• 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.

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