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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 Vaginal Tactile Ultrasound Imager obtains high-resolution mapping of pressures, ultrasound images and assesses the strength of pelvic floor muscles within the vagina. It is used in a medical setting to acquire the pressures, ultrasound images and store the corresponding data. It also provides visualization, analysis tools and information. The real time data as well as the analysis information can then be viewed with an intention of assisting in the diagnosis and evaluation. The device is intended for use by physicians, surgeons and medically trained personnel.

The Vaginal Tactile Ultrasound Imager (TIUSv) acquires ultrasound images and tactile images (pressure maps) from within the vagina and assesses the strength of pelvic floor muscles within the vagina. The device provides data on the pressures applied to vaginal walls along with the probe location to visualize pelvic floor support structures, and to record pelvic floor muscle contraction. The TIUSv software provides measurement, imaging, and reporting tools. The acquired data and the analysis results provided by TIUSv software can be used by a physician for quantitative biomechanical assessment of the vagina and pelvic floor conditions. The TIUSv probe is equipped with 96 pressure (tactile) sensors, 192 ultrasound transducers, an orientation sensor (accelerometer), temperature sensors, and micro-heaters. During the clinical procedure, the probe is used to acquire dynamic ultrasound images and pressure responses from the vaginal walls under applied loads. The TIUSv examination procedure includes data collection from all segments of the vagina. Real-time data are sampled from the probe sensors via the interface electronics. The TIUSv software displays the acquired data in real time. The resulting pressure maps (tactile images) of the vagina integrate all the acquired pressure and positioning data for each of the pressure sensing elements. The TIUSv records the dynamic contraction for pelvic floor muscle(s). The probe surfaces that contact the vaginal walls are preheated to human body temperature. The TIUSv supports physician data analysis by means of a playback function, which replays a stored session using previously recorded data instead of the real time data. The TIUSv also provides data and graphs such as pressure applied to the probe and location, resting pressures, muscle contraction pressures and calculated pressure gradients.

The FDA 510(k) clearance letter for the Vaginal Tactile Ultrasound Imager (TIUSv) (K231875) (pages 0-10) indicates that the device's performance was evaluated through various tests, but it does not provide a detailed study proving the device meets specific acceptance criteria for its diagnostic capabilities (e.g., accuracy in assessing pelvic floor muscle strength or identifying abnormalities using ultrasound).

Instead, the documentation focuses on:

• Bench testing for measurement accuracy of pressure, temperature, and orientation.
• Safety and engineering compliance (biocompatibility, electrical safety, EMC, cleaning/disinfection validation).
• Software verification and validation.
• Comparison to a predicate device (Vaginal Tactile Imager K142355) and a reference device (Acuson Ultrasound System) to establish substantial equivalence.

While the document states, "The real-time data as well as the analysis information can then be viewed with an intention of assisting in the diagnosis and evaluation," it does not present clinical study results from human subjects to establish the device's diagnostic performance relative to acceptance criteria in terms of sensitivity, specificity, accuracy, or its impact on human reader performance.

Therefore, the following sections will be based on the information provided in the document, acknowledging the absence of clinical diagnostic performance data.

Acceptance Criteria and Reported Device Performance

As specific diagnostic performance acceptance criteria from a clinical study are not provided, the table below focuses on the measurement performance acceptance criteria that were met through bench testing.

1. Table of Acceptance Criteria and Reported Device Performance (Measurement)

2. Sample Size for the Test Set and Data Provenance

The provided document details various engineering and bench tests, along with software verification and validation. It does not describe a 'test set' in the traditional sense of a clinical dataset of patients assessed by the device for diagnostic performance. The performance data presented (e.g., pressure accuracy, ultrasound resolution) are derived from bench testing as indicated in Section 6, "OVERVIEW OF THE PERFORMANCE DATA." Therefore, there is no patient-specific sample size, country of origin, or information on retrospective/prospective data collection for diagnostic efficacy evaluation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since the document focuses on bench testing and engineering verification, no experts were used to establish ground truth for a clinical test set. The "ground truth" for the reported measurement accuracies (pressure, temperature, orientation) would have been established using precisely calibrated instruments and phantom models during laboratory bench testing.

4. Adjudication Method for the Test Set

As there was no clinical "test set" requiring human interpretation or diagnosis, no adjudication method was used or described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported in this documentation. The clearance is based on substantial equivalence to a predicate device, and engineering/bench testing, not on clinical efficacy beyond what is needed to demonstrate equivalence.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The document does not describe a standalone performance study of an AI algorithm in the context of diagnostic accuracy. The device provides "visualization, analysis tools and information" to assist physicians, suggesting a human-in-the-loop use case. The reported performance metrics are for the device's physical measurement capabilities, not an AI algorithm's diagnostic output.

7. Type of Ground Truth Used

For the reported measurement performance (e.g., pressure, temperature, orientation accuracy, ultrasound resolution), the ground truth was established through calibrated reference instruments and defined test conditions during bench testing and engineering verification. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for diagnostic accuracy in patient populations.

8. Sample Size for the Training Set

The document does not mention any training set size, as it does not describe an AI/machine learning model whose diagnostic performance was evaluated from a clinical dataset. The software verification and validation refer to general software development practices (e.g., IEC/EN 62304), not the training of a predictive model.

9. How the Ground Truth for the Training Set Was Established

As no training set is described for an AI/machine learning model, there is no information on how ground truth was established for such a set.

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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 Perifit Care+ is a perineometer designed to treat stress, mild-moderate urge and mixed urinary incontinence in women, by strengthening of the pelvic floor muscles through exercise. This device provides biofeedback via smart phone technology.

Perifit Care+ is indicated for an adult female.

The Perifit Care+ device consists of a rigid probe covered in a silicone sheath that is temporarily inserted into the vagina. Sensors located under the sheath measure the strength of the user's pelvic floor muscles. This information is then transmitted wirelessly to a smartphone application in order to provide real-time feedback to the user. It is a single patient, reusable device to be supplied over-the-counter.

The provided document is a 510(k) summary for the Perifit Care+ device. It outlines the device's indications for use, technological characteristics, and comparison to a predicate device (Perifit K221476) to establish substantial equivalence.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in the format of specific thresholds for performance metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device (Perifit K221476) through similarity in indications for use, technological characteristics, and safety testing.

The "reported device performance" is largely described through the completion of various non-clinical performance tests, indicating the device met the standards for safety and functionality, rather than achieving specific quantitative performance metrics against a defined acceptance criterion.

However, based on the provided text, we can infer some "acceptance criteria" from the testing performed and the comparison to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each non-clinical performance test (e.g., number of units dropped, number of users for the questionnaire). It also does not explicitly state the provenance (country of origin, retrospective/prospective) for these tests, except that they were conducted to a standard (e.g., ISO, IEC). User testing via a questionnaire is mentioned, implying a human subject component, but details are absent.

This type of information is usually detailed in the full 510(k) submission, not typically in the public summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The studies described are primarily non-clinical, involving engineering and materials testing, and software validation, rather than clinical studies requiring expert ground truth for diagnostic accuracy. The "user testing through a questionnaire" is a form of user experience or usability testing, not typically a "ground truth" establishment in a diagnostic context.

4. Adjudication Method for the Test Set

Since there's no mention of a diagnostic accuracy study or establishment of "ground truth" by experts, an adjudication method (like 2+1 or 3+1) is not applicable and not mentioned in this summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a MRMC comparative effectiveness study was not done. The Perifit Care+ is a patient-operated perineometer providing biofeedback, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output with or without AI assistance. The effectiveness is primarily linked to the patient's own exercise and biofeedback, not an external reader's interpretation.

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

The device is a perineometer that provides biofeedback for pelvic floor muscle exercise via a smartphone app. Its "performance" is based on its ability to accurately sense muscle contractions and transmit that data, along with the functionality of the app itself. The software verification and validation (and "sensor behavior testing") would assess its standalone performance in these aspects. There's no "algorithm only" performance reported in the sense of an AI model making a diagnosis or prediction without human input, as this is not the nature of the device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests, the "ground truth" would be established by:

• Engineering specifications and standards: For mechanical, electrical, and sensor performance (e.g., a drop test either meets or fails a predetermined physical integrity standard).
• Reference materials/methods: For biocompatibility testing (e.g., cell cultures, animal models for irritation).
• Software requirements and design specifications: For software V&V (the software performs as designed and meets requirements).
• User feedback/comprehension: For the user questionnaire (users correctly understand labeling and operation).

There is no mention of ground truth established by expert consensus, pathology, or outcomes data related to diagnostic accuracy, as it's not a diagnostic device.

8. The Sample Size for the Training Set

This information is not provided and is generally not applicable in this context. The device is not an AI/ML model that is "trained" on a dataset in the conventional sense for making diagnostic predictions. Its software includes an application and embedded firmware, which are developed and validated against requirements, not "trained."

9. How the Ground Truth for the Training Set Was Established

As there's no mention of a "training set" in the context of machine learning, this information is not applicable and not provided. Software "ground truth" would be established by its adherence to design specifications and user requirements during the development and validation phases.

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The Perifit is a perineometer designed to treat stress, mild-moderate urge and mixed urinary incontinence in women, by strengthening of the pelvic floor muscles through exercise. This device provides biofeedback via smart phone technology.

Perifit is indicated for an adult female.

The Perifit device consists of a rigid probe covered in a silicone sheath that is temporarily inserted into the vagina. Sensors located under the sheath measure the strength of the user's pelvic floor muscles. This information is then transmitted wirelessly to a smartphone application in order to provide real-time feedback to the user. It is a single patient, reusable device to be supplied over-the-counter.

The Perifit is a perineometer designed to treat stress, mild-moderate urge, and mixed urinary incontinence in women by strengthening pelvic floor muscles through exercise. It provides biofeedback via smartphone technology. The Perifit is indicated for adult females and is available over-the-counter.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document does not specify a separate "test set" in the context of clinical performance data in the typical sense of evaluating diagnostic accuracy or treatment efficacy with patient outcomes. The performance data focuses on device safety, electrical safety, biocompatibility, software validation, and mechanical durability, which are typically evaluated through engineering tests and specific standards.

• Biocompatibility: The ISO 10993 tests would involve specific biological samples or animal models depending on the sub-part (e.g., cell cultures for cytotoxicity, animal models for sensitization/irritation/toxicity). The sample sizes for these specific tests are not detailed.
• Mechanical Tests: The number of devices subjected to mechanical drop and durability testing is not specified.
• Sensor Behavior/User Comprehension: A "questionnaire" was used, but the sample size of users and data provenance (e.g., country of origin, retrospective/prospective) for this survey are not stated.

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

This information is not applicable or provided in the document. The document describes a 510(k) submission for a perineometer, which is a biofeedback device, not an AI/ML diagnostic or prognostic tool that would typically involve expert-established ground truth for a test set. The "ground truth" for this device relates to its adherence to safety and performance standards (e.g., biocompatibility standards, electrical safety standards, mechanical performance).

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

Not applicable. The document does not describe a clinical study requiring adjudication of expert interpretations or diagnoses.

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. The Perifit is a perineometer for pelvic floor muscle exercise and biofeedback, not an AI-assisted diagnostic or interpretation system that would involve human "readers" or an MRMC study.

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

Not applicable. The Perifit is a physical device that works with a smartphone app for biofeedback. Its performance is intrinsically linked to user interaction and physical measurements. It is not an algorithm that operates "standalone" in a diagnostic or interpretive capacity.

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

The "ground truth" for the Perifit's performance is its compliance with established engineering and safety standards and its ability to provide biofeedback, rather than a clinical ground truth like pathology or expert consensus on a diagnosis.

• Biocompatibility: ISO 10993 standards define the "ground truth" for material biological safety.
• Electrical Safety: IEC 60601 standards define the "ground truth" for electrical safety.
• Software Validation: FDA guidance and IEC 62304 define the "ground truth" for software quality and safety.
• Mechanical Performance: Internal specifications and durability testing protocols define the "ground truth" for mechanical integrity.
• Functionality (Biofeedback): The device's ability to accurately sense pelvic floor muscle contractions and transmit them to the app for user feedback is the functional ground truth, demonstrated through sensor behavior testing.

8. The sample size for the training set:

Not applicable. The device is not an AI/ML model that undergoes "training" in the traditional sense. The development and verification process involves engineering design, testing against standards, and software validation.

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

Not applicable. As there is no "training set" for an AI/ML model, there is no ground truth established for such a set.

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The leva Pelvic Health System is intended for:

1. Strengthening of the pelvic floor muscles;
2. Rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed and mild to moderate urgency urinary incontinence (including overactive bladder) in women;
3. Rehabilitation and training of weak pelvic for the first-line treatment of chronic fecal incontinence (>3month uncontrolled passage of feces) in women.
   This device interacts with the user via smart phone technology.

The leva Pelvic Health System ("leva PHS" or "leva System") is a prescription intra-vaginal device designed to allow the user to rehabilitate and strengthen their pelvic floor muscles ("PFM") as well as allow them to monitor their progress during pelvic floor muscle training ("PFMT"). The leva system is designed to wirelessly facilitate PFMT in women and to transmit real-time performance data through a dedicated mobile application that has been downloaded onto the patient's mobile device. The leva system is designed to be used vaginally and is intended to be used repeatedly by a single patient.

The provided text describes clinical studies for the Renovia leva Pelvic Health System, but it does not specifically mention acceptance criteria or a study designed to universally "prove the device meets acceptance criteria" for a diagnostic or AI-driven system.

Instead, the document details two clinical studies (REN-17 and REN-19) that support the expanded indications for use of the device, particularly for fecal incontinence. These studies serve to demonstrate the device's safety and effectiveness for its intended use, thereby establishing substantial equivalence to a predicate device.

Here's an analysis based on the information provided, tailored to address the points in the prompt, with a strong caveat that the traditional "acceptance criteria" and "study proving it meets acceptance criteria" framework, as typically applied to diagnostic AI, is not explicitly present here. The studies focus on clinical effectiveness and safety rather than specific technical performance metrics of an AI algorithm.

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

The document does not present explicit "acceptance criteria" in the format of a diagnostic performance target (e.g., sensitivity > X%, specificity > Y%). Instead, the studies aim to demonstrate clinical improvement and non-inferiority/superiority in patient-reported outcomes for fecal incontinence. The performance is measured by changes in clinical scores.

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

• REN-17 (Single-arm study for primary effectiveness):
  • Test set (Effectiveness Analysis): 26 participants
  • Test set (Safety Analysis): 27 participants
  • Data provenance: United States only, prospective.
• REN-19 (RCT Subset Analysis for fecal incontinence symptoms):
  • Test set (Effectiveness/Safety Analysis): 92 participants (44 in leva-02 arm, 48 in control arm).
  • Data provenance: United States only, prospective (subset of a larger RCT).

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

This information is not provided in the document. For this type of device (pelvic floor muscle training biofeedback), the "ground truth" is typically established by patient-reported outcomes (like St. Mark's Score, CRADI-8, CRAIQ-7), which are subjective measures of symptoms and quality of life, rather than objective assessments requiring expert interpretation of raw data. The device provides biofeedback, and the clinical studies assess the impact of that biofeedback on patient outcomes.

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

This information is not provided and is generally not applicable to studies relying primarily on validated, self-reported patient questionnaires for primary endpoints. The CRADI-8 and CRAIQ-7 are validated patient-reported symptom scales. St. Mark's Score is also a validated questionnaire completed by the patient, though occasionally a clinician might administer it.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The leva Pelvic Health System is a biofeedback device for pelvic floor muscle training, not an AI-driven diagnostic imaging or interpretation tool that assists human readers. The clinical studies compare its effectiveness in improving clinical outcomes (like fecal incontinence symptoms and quality of life) against standard care (unassisted Kegel exercises) or against baseline, but not in the context of an AI-assisted diagnostic workflow involving human readers.

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

This question is not applicable in the traditional sense for this device. The device itself is a "human-in-the-loop" system by design, providing real-time biofeedback to the user during exercises. Its "performance" is measured by its impact on clinical outcomes when used by patients, not by an algorithm's isolated diagnostic accuracy. The text states that the device transmits biofeedback to an app, and the previous 510(k) comparison indicates the "Principle of Operation" is "Provides indication of relative position of pelvic floor muscle contraction using accelerometers." This refers to its sensing capabilities. The clinical studies assess the overall effect of using this system (device + app + patient interaction) on health outcomes.

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

The ground truth for effectiveness was established using patient-reported outcomes data from validated questionnaires:

• St. Mark's Score (Vaizey) for fecal incontinence severity (REN-17).
• FIQoL (Fecal Incontinence Quality of Life) for different aspects of quality of life (REN-17).
• CRADI-8 (Colorectal-Anal Distress Inventory, Short Form) for fecal incontinence symptoms (REN-19 subset).
• CRAIQ-7 (Colorectal-Anal Impact Questionnaire Short Form) for condition-specific quality of life (REN-19 subset).

Fecal incontinence diagnosis itself was based on pre-defined screening criteria reported by participants.

8. The sample size for the training set

The document does not specify a training set sample size because the reported studies (REN-17 and REN-19) are clinical trials designed to assess the device's efficacy and safety in human subjects, not to train a machine learning model. While the device certainly has internal software and algorithms that might have been developed using some data, these clinical studies are distinct from the paradigm of "AI training sets."

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

As there is no explicit "training set" described in the context of AI model development, this question is not directly applicable. If one were to consider the broader development cycle of the device, the "ground truth" for the device's biofeedback mechanism (e.g., accurately reflecting pelvic floor muscle contraction) would have been established through engineering validation and verification testing, likely comparing accelerometer data to known movements or potentially against electromyography (EMG) or pressure-based perineometry, but this is not detailed in the provided clinical study summaries. The clinical studies use actual patient outcomes as their measure of effectiveness.

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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 leva Pelvic Health System is intended for:

1. Strengthening of the pelvic floor muscles;

2. Rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed and mild to moderate urgency urinary incontinence (including overactive bladder) in women.

This device interacts with the user via smart phone technology.

The leva Pelvic Health System ("leva System") is a prescription intra-vaginal device designed to allow the user (or woman) to rehabilitate and strengthen their pelvic floor muscles (PFM) as well as allow them to monitor their progress during pelvic floor muscle training (PFMT). The leva system is designed to wirelessly facilitate PFMT in women and to transmit real-time performance data through a dedicated mobile application that has been downloaded onto the patient's mobile device. The leva system is designed to be used vaginally and is intended to be used repeatedly by a single patient.

The leva PHS consists of a probe, storage case, associated batteries, and the Renovia Digital Health App (App). Thermoplastic elastomer (TPE) was used as the material overlay for the electronics and six accelerometers are contained within the probe. Additional electronics are contained in the storage case to transmit data wirelessly between the device and the App.

The provided text describes a 510(k) premarket notification for the "leva Pelvic Health System." It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (K192270, leva Pelvic Digital Health System) based on technological characteristics and non-clinical testing.

Crucially, this document does NOT contain information about a study proving the device meets specific performance acceptance criteria related to its clinical efficacy or accuracy using AI. It mainly discusses hardware, firmware, and software changes, and non-clinical testing (biocompatibility, software/firmware design verification, manufacturing testing). Therefore, I cannot fulfill most of the requested information about acceptance criteria for device performance, clinical study design, expert ground truth, or MRMC studies, as these types of details are not present in the provided 510(k) summary.

The device is a perineometer that provides an indication of the relative intensity of pelvic floor muscle contraction using accelerometers. Its intended use is for strengthening, rehabilitation, and training of weak pelvic floor muscles for the treatment of stress, mixed, and mild to moderate urgency urinary incontinence.

Here's what can be extracted from the provided text:

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

  • Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity, or improvement thresholds for a specific clinical outcome). The "acceptance" discussed is related to demonstrating substantial equivalence through non-clinical testing.
  • Reported Device Performance: The document states that "Biocompatibility testing demonstrated that the subject device, leva Pelvic Health System, is as safe and effective, and performs as well as the predicate device, leva Pelvic Digital Health System." It also mentions "Software and firmware design verification testing" and "Manufacturing testing protocol verification" were done to ensure the device continues to meet requirements for substantial equivalence. However, specific performance metrics or thresholds are not provided.

• 2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

  • Not provided. The document focuses on non-clinical testing (biocompatibility, software verification, manufacturing testing) and does not describe a clinical test set with human subject data.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

  • Not applicable/Not provided. No clinical test set with ground truth established by experts is described in this document.

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

  • Not applicable/Not provided. No clinical test set requiring adjudication is described.

• 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:

  • No. This document does not describe an AI-assisted device or an MRMC study. The device provides "indication of relative intensity of pelvic floor muscle contraction using accelerometers" and transmits data to a mobile app for user monitoring and guidance. It does not appear to employ AI for diagnostic or assistive interpretation requiring human reader studies.

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

  • Not applicable/Not provided. The device's primary function is to measure muscle contraction and provide data to the user via an app for rehabilitation purposes, not to provide an automated diagnosis or interpretation in a "standalone" fashion as might be expected from a typical AI algorithm in medical imaging.

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

  • Not specified/Not applicable to a clinical study. The "ground truth" implicitly referred to is safety and performance equivalence to the predicate device, demonstrated through non-clinical tests (biocompatibility, software/firmware design verification, manufacturing testing).

• 8. The sample size for the training set:

  • Not applicable/Not provided. This document does not pertain to the development or validation of an AI model with a training set.

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

  • Not applicable/Not provided. No AI model training set is discussed.

Summary of available information regarding the device itself:

• Trade/Device Name: leva Pelvic Health System
• Regulation Number: 21 CFR §884.1425
• Regulation Name: Perineometer
• Regulatory Class: II
• Product Code: HIR
• Intended Use:
  1. Strengthening of the pelvic floor muscles.
  2. Rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed, and mild to moderate urgency urinary incontinence (including overactive bladder) in women.
• Principle of Operation: Provides indication of relative intensity of pelvic floor muscle contraction using accelerometers.
• Key changes from predicate (minor modifications):
  • Hardware (adhesive, PCB/PCBA, battery vendor, labeling)
  • Embedded software (firmware: performance improvement, communications, diagnostic, bug fixes)
  • Mobile Application Software (bug fixes, content updates like educational videos)
  • Manufacturing and Risk Analysis updates
• Testing performed to support substantial equivalence (non-clinical):
  • Biocompatibility (ISO 10993-1, -5, -10)
  • Software and firmware design verification testing
  • Manufacturing testing protocol verification

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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 Intimate Rose Kegel Exercise System is indicated for the strengthening of the perineal pelvic floor muscles by providing resistance to an individual's voluntary contractions of these muscles. It seeks to correct, through exercise, low tone in the pelvic floor, which can cause or contribute to health issues including urinary incontinence and sexual dysfunction.

The Intimate Rose Kegel Exercise System is a pelvic floor exercise device for use in strengthening the pelvic floor musculature. It is a reusable, over-the-counter device that is comprised of 6 progressively heavier and color-coded silicone weights. An Intimate Rose Kegel Exercise System weight is inserted into the vagina and is held in place by contracting the pelvic floor muscles. The weight of the Intimate Rose Kegel Exercise System device provides resistance as it is lifted with each contraction of the pelvic floor muscles. When utilized correctly, the device will move upward and inward when the user contracts her pelvic floor muscles. The body's angle while exercising controls the level of resistance.

This document is a 510(k) Summary for a medical device called the "Intimate Rose Kegel Exercise System." It describes the device, its intended use, and compares it to a legally marketed predicate device.

Based on the provided text, the device in question (Intimate Rose Kegel Exercise System) is a physical, non-AI-powered medical device. Therefore, the questions regarding acceptance criteria and studies related to AI/software performance (such as sample size for test sets/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment) are not applicable to this specific device submission.

This document focuses on establishing substantial equivalence for a physical device, primarily through non-clinical performance testing (biocompatibility, reprocessing, mechanical performance), rather than an AI/software-driven diagnostic or therapeutic device.

If the request was intended for an AI-powered device, the provided text does not contain the information necessary to answer the questions.

Ask a specific question about this device