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The Yoni.Fit® Bladder Support is intended for the temporary management of urine leakage caused by stress urinary incontinence (SUI) in women, 18 years and older.

The Yoni.Fit® Bladder Support is a vaginal pessary prescribed by a physician for single patient use for the temporary management of stress urinary incontinence. The device is intended for a single 30-day duration per patient. It can be worn for up to 12 hours in a 24-hour period and is reusable after washing with warm water and mild. oil-free soap. The device is a single-patient. multi-use medical device that will be provided non-sterile and requires reprocessing prior its first and subsequent uses. The rim of the Yōni.Fit® Bladder Support applies pressure aqainst the urethra and bladder neck to support the bladder and urethra. The Yōni.Fit® Bladder Support is available in each of the following sizes: 34mm (Size 2), 42mm (Size 3), 42mm (Size 3), 45mm (Size 3.5), 48mm (Size 4), and 52mm (Size 5). The Yoni.Fit® Bladder Support is made of injection molded silicone (non-latex rubber) with no color additives.

Each package of the Yoni.Fit® Bladder Support comes with the following:

• 3 reusable Yōni.Fit® Bladder Supports for sizing .
• . Cleaning brush
• Storage case ●
• Instructions for Use ●

The provided text describes the 510(k) summary for the Yoni.Fit® Bladder Support, a vaginal pessary intended for the temporary management of urine leakage caused by stress urinary incontinence (SUI) in women. While it details clinical performance data, it does not explicitly present a table of acceptance criteria with reported device performance in the format requested. However, based on the provided information, we can extract the relevant details to construct a response.

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

The document does not explicitly state pre-defined acceptance criteria for the clinical study. Instead, it describes its primary effectiveness endpoint and the achieved results. We can infer the "acceptance criteria" from the goal of the study – to show a statistically significantly higher responder rate compared to the control.

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

• Sample Size (Clinical Study):

  • Total participants enrolled and randomized: 58 (31 Yōni.Fit® and 27 control)
  • Participants completing treatment phase: 56
  • Participants continuing to open label phase: 54
  • Participants completing 30 days of safety follow-up: 42
  • Participants completing 6 weeks of safety follow-up: 38
  • Participants with completely missing efficacy data (considered non-responders for analysis): 4 (2 Yōni.Fit®, 2 control)

• Data Provenance:

  • Country of Origin: Three US sites.
  • Study Type: Prospective, randomized, comparator-controlled, single blinded, multicenter crossover study.

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)

The study evaluates the effectiveness of a medical device for stress urinary incontinence using patient-reported outcomes (questionnaires) and objective measurements (12-hour pad weights, voiding diaries). The "ground truth" for efficacy is based on objective measurement of urine leakage (pad weights) and patient-reported symptoms, not expert interpretation of diagnostic images or pathology. Therefore, there is no mention of experts establishing ground truth in the context of diagnostic interpretation. The study was conducted by medical professionals, and participants were diagnosed with SUI by both a cough supine test and a history of SUI.

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

The document does not describe an adjudication method for establishing ground truth, as the primary effectiveness endpoint was based on quantitative measurements (pad weights) and participant questionnaires. Medical staff and investigators would have managed data collection and study conduct, but there's no mention of a specific adjudication panel for results.

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 performed. This type of study is typically relevant for AI/CADe (Computer-Aided Detection/Diagnosis) devices where human readers interpret medical images with and without AI assistance. The Yoni.Fit® Bladder Support is a physical medical device, not a software or AI diagnostic tool.

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

No, a standalone (algorithm only) performance study was not done. As mentioned, the Yoni.Fit® Bladder Support is a physical device inserted by the patient (after physician fitting/prescription) for direct therapeutic effect, not a standalone algorithm.

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

The ground truth for the clinical effectiveness study was based on:

• Outcomes Data: Primarily objective measurements of urine leakage (average 12-hour pad weights) and patient-reported outcomes from questionnaires.
• Clinical Diagnosis: Participants were diagnosed with SUI by a cough supine test and a history of SUI prior to enrollment.

8. The sample size for the training set

The document describes a clinical study to evaluate the safety and effectiveness of the device, which serves as a pivotal study for regulatory approval. It does not mention a "training set" in the context of machine learning, as this is a physical medical device and not an AI/ML algorithm.

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

As there is no mention of a training set for an AI/ML algorithm, this question is not applicable based on the provided document. The clinical study was designed to test the device's performance against a control, not to train an algorithm.

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The Revive bladder support is intended for temporary management of urine leakage caused by stress urinary incontinence (SUI) in women, 18 years and older.

The Revive bladder support reduces bladder leaks in women who are suffering from SUI by preventing or reducing unwanted urinary leakage. Use of the device is applicable for women who experience leakage when laughing, coughing, exercising, sneezing, etc. The device is not intended to treat women with urge incontinence. The shape of the Revive bladder support is designed to fit in the vaginal tract, and there is no sizing required. The device fits most users. The device can be worn daily for up to 12 hours. The Revive bladder support can be reused (and cleaned) for up to 31 times. Each packaged Revive bladder support device comes with the following:

• · 1 Reusable Bladder Support
• · 1 Reusable Applicator
• · 1 Month Strings Supply
• · Travel Case
• · Instructions for Use

The provided document describes the Revive™ Reusable Bladder Support, intended for temporary management of urine leakage caused by stress urinary incontinence (SUI) in women aged 18 and older. While the document details the device's characteristics, non-clinical tests, and a clinical study, it does not explicitly state quantified acceptance criteria for device performance. Instead, it reports observed performance outcomes from a clinical study and states that the device was effective, well-tolerated, and safe.

Therefore, for the acceptance criteria table, I will use clinically meaningful improvements reported in the study as the "acceptance criteria" based on the reported "met" performance.

Here's the information based on the provided text:

1. Table of acceptance criteria and the reported device performance

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

• Test Set (Clinical Study): The exact number of participants is not explicitly stated, but it refers to "participants" throughout the clinical study summary. Based on the percentages provided for efficacy results (53% of participants, 71% of participants), an N value for the clinical study is not given.
• Data Provenance: The study was a "multicenter study," implying data from multiple locations, but specific countries are not mentioned. It was an "interventional" study, indicating a prospective design where participants underwent a baseline phase and a treatment phase with the investigational product.

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

• The document states that "All adverse events were reviewed by a third-party adjudicator for consistent reporting and classification using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0."
• The number and qualifications of this "third-party adjudicator" or any other experts establishing ground truth for efficacy measures are not specified in the provided text.

4. Adjudication method for the test set

• For adverse events, a "third-party adjudicator" reviewed events for consistent reporting and classification. No specific adjudication method like "2+1" or "3+1" is mentioned, just that a single (implied) third-party individual or entity performed the review.
• For efficacy outcomes (pad weight gain, leakage episodes, quality of life), no adjudication method 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, an MRMC comparative effectiveness study involving human readers and AI assistance was not mentioned. The device is a physical medical device (bladder support), not an AI algorithm. The closest comparison is the statement: "The percentage of responders is greater as compared to the predicate device," but this is a direct comparison of the device's performance against historical data/reports of a predicate device, not an MRMC study.

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

• Not applicable. This device is a physical medical device, not an algorithm.

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

• Clinical Outcomes Data: The ground truth for efficacy was based on direct clinical measurements and patient-reported outcomes from the intervention:
  • Pad weight gain reduction (quantitative measure).
  • Leakage reduction (number of leakage episodes per day, quantitative measure).
  • Improvement in quality of life analysis (patient-reported outcome).
• Safety Data: Adverse events, vaginal swabs, and urinalysis results served as ground truth for safety.
• Laboratory Testing: Biocompatibility data (cytotoxicity, sensitization, irritation, pyrogenicity, genotoxicity, chemical characterization) and Staphylococcus aureus growth/TSST-1 production tests provided ground truth for material safety.
• Engineering/Mechanical Test Data: Removal string retention, pessary extraction, string tensile strength, and pessary removal retraction forces provided ground truth for physical performance.

8. The sample size for the training set

• Not applicable. This device is a physical medical device, not an AI/machine learning algorithm that requires a training set. The clinical study was for evaluation of the device as a whole.

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

• Not applicable. As above, there was no "training set" in the context of an AI/ML algorithm.

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