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510(k) Data Aggregation
(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, <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.
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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(88 days)
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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(29 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.
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:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study results
- Standalone performance
- Type of ground truth used
- Sample size for the training set
- 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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(29 days)
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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(111 days)
The Stryker Flyte Hybrid Hoods are components of a personal protection system and are intended to protect the patient, healthcare personnel, and operating room personel against contamination, exposure of infectious bodily fluids, the transfer of microorganisms and particulate material.
The devices are provided sterile and for single use only.
The Stryker Flyte Hybrid Hoods are intended to be worn over a Flyte Helmet to provide protection to the user's face and head region during surgery. Hoods are worn in conjunction with surgical gowns where the hood material extends beyond the user's upper back and shoulders, while the surgical gown covers the lower portion of the hood up to the user's neck.
The Stryker Flyte Hybrid Hood is comprised of 3 main parts: Hood, Filter and Lens. Stryker Flyte Hybrid Hoods are available with either a standard or peel away lens.
The devices are prescription devices, provided sterile and single use only.
This document describes the acceptance criteria and performance data for the Stryker Flyte Hybrid Hoods.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Performed | Acceptance Criteria | Reported Device Performance (Conclusion) |
|---|---|---|
| CO₂ Level Inside the Hood (Internal test) | CO₂ Level < 5000 ppm | Pass |
| Flammability (16 CFR Part 1610) | No burn time or burn time ≥ 3.5 s | Pass |
| Linting (ISO 9073-10) | ≤ 4.0 CL | Pass |
| Tensile Strength (BS EN 29073-3:1992) | ≥ 20 N | Pass |
| Water Spray Impact Penetration (AATCC Test Method 42-2007) | ≤ 4.5 g | Pass |
| Tear Resistance (ASTM D5587-08) | Hood ≥ 2.50 lbfFilter ≥ 2.00 lbf | Pass |
| Evaporative Resistance (ASTM F1868-12 Part B) | Hood ≤ 25.22 Pa·m²/W | Pass |
| Seam Strength Testing (ASTM D1683/D1683M – 11a) | Lens to Hood peel ≥ 2.00 lbfLens to Hood shear ≥ 6.00 lbfAll other seams ≥ 4.00 lbf | Pass |
| Biocompatibility (in vitro cytotoxicity) | Non-cytotoxic | Non-cytotoxic |
| Biocompatibility (primary skin irritation) | Not an irritant | Not an irritant |
| Biocompatibility (skin sensitization) | Not a sensitizer | Not a sensitizer |
| Bacterial Filtration Efficiency (per ASTM F2101-07) | Compliant - Pass | Compliant - Pass |
| Particulate Filtration Efficiency (per ASTM F2299-03) | Compliant - Pass | Compliant - Pass |
| Water Resistance: Impact Penetration (per AATCC 42) Level 1 Critical Zone | Pass AAMI/ANSI PB70 Requirements for Level 1 Protection. | Pass AAMI/ANSI PB70 Requirements for Level 1 Protection. |
| Flammability (16 CFR Part 1610) | No Flame Spread per 16 CFR Part 1610 | No Flame Spread per 16 CFR Part 1610 |
| Finished (Terminal) Product Sterilization Method | SAL 10-6 | SAL 10-6 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not explicitly state the sample sizes for each performance test. The data provenance is not specified, but the tests were performed by Stryker Instruments, indicating internal testing. The tests are prospective in nature, demonstrating the device's performance against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The tests performed are objective physical, chemical, and biological characterizations of the device material, evaluated against established industry and regulatory standards. Expert consensus for test results is not typically required in this context.
4. Adjudication method for the test set:
Not applicable. The tests involve objective measurements and comparisons to predefined acceptance criteria within established standards.
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. This is a medical device (surgical apparel) and not an AI-driven diagnostic or interpretative system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device (surgical apparel) and not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the performance tests outlined is defined by established industry standards, regulatory guidelines (e.g., 16 CFR Part 1610, AAMI/ANSI PB70), and ISO standards (e.g., ISO 9073-10, ISO 11135-1, ISO 10993-1). These standards provide objective criteria for evaluating the physical, mechanical, and biological properties of the surgical hood material.
8. The sample size for the training set:
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
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