(42 days)
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
| Acceptance Criteria (Inferred from reported study outcomes) | Reported Device Performance (from Clinical Study) | Met? |
|---|---|---|
| Efficacy: | ||
| >50% improvement in pad weight gain | 53% of participants showed >50% improvement | Yes |
| >50% reduction in leakage episodes | Average 56.7% reduction in leakage episodes | Yes |
| Clinically meaningful reduction in leakage episodes, pad weight gain, or both | 71% of participants achieved this | Yes |
| Safety: | ||
| Low incidence of serious adverse events | No serious adverse events reported | Yes |
| Minimal significant negative changes in vaginal microflora | Only one participant had yeast cells (asymptomatic) | Yes |
| Minimal significant negative changes in urinary tract health | Two participants screened positive in urinalysis (asymptomatic) | Yes |
| Non-cytotoxic | Non-cytotoxic | Yes |
| Non-sensitizer | Non-sensitizer | Yes |
| Non-irritant (vaginal) | Non-irritant | Yes |
| Non-pyrogenic | Non-pyrogenic | Yes |
| Non-mutagenic | Non-mutagenic | Yes |
| Does not enhance growth of Staphylococcus aureus | Did not promote or enhance bacterial growth | Yes |
| Does not increase production of TSST-1 | Did not promote or enhance toxin production | Yes |
| Functional: | ||
| Meets specified dimensions | Product dimensions confirmed to meet specifications | Yes |
| String retention force within specifications | Confirmed to meet specification | Yes |
| Pessary extraction force within specifications | Confirmed to meet specification | Yes |
| String tensile strength within specifications | Confirmed to meet specification | Yes |
| Pessary removal retraction force within specifications | Confirmed to meet specification | Yes |
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.
§ 884.3575 Vaginal pessary.
(a)
Identification. A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia.(b)
Classification. Class II (performance standards).