(152 days)
The Uresta bladder support is indicated for use in adult women over 18 years of age who experience stress urinary incontinence (involuntary urine loss, such as a pee leak that occurs when you cough, laugh, sneeze or with some physical tasks).
Uresta® is a bell-shaped vaginal bladder support that is intended to support the urethra to help reduce leaks caused by stress urinary incontinence. It has a tapered tip for insertion into the vaginal introitus and a handle end to enable placement and removal. It may also be used with a water-based lubricant for easier insertion. Uresta® is available in five (5) sizes, ranging from 34 mm (size 2) to 52 mm (size 6). It can be inserted in the morning and removed at bedtime every day or used just for specific activities such as exercise and removed after the activity. Uresta® is molded from non-latex thermoplastic rubber and is provided non-sterile for single patient use.
This document is a 510(k) summary for the Uresta® vaginal pessary, seeking an Over-The-Counter (OTC) indication in addition to its existing Prescription (Rx) indication. The core of the submission revolves around demonstrating that the device can be appropriately self-selected and used by a lay user population for OTC use.
Based on the provided text, the specific details regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" are focused on the usability study conducted to support the OTC claim.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of quantitative acceptance criteria and specific numerical performance results for the usability study. Instead, it states the overall conclusion.
| Acceptance Criteria (Inferred from Study Purpose) | Reported Device Performance |
|---|---|
| Self-Selection: Patients can correctly determine if they meet the criteria to be an intended user based on package labeling. | "Women who were naïve to the device reviewed the external product packaging and determined if they met the criteria to be an intended user. The self-selection was confirmed via clinical diagnosis." |
(Implicitly, the performance was adequate to support the OTC claim, as the conclusion states patients can appropriately self-select.) |
| Labeling Usability & Independent Use: Intended users can understand the Instructions for Use (IFU) and independently insert and fit the device without guidance. | "Intended users then participated in a labeling usability simulated study in which they reviewed the Instructions for Use and independently inserted and fit the device without guidance."
"The results of the self-selection and usability study demonstrate that patients can self-select and use the device appropriately."
(Similar to self-selection, the performance was deemed appropriate.) |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not explicitly state the numerical sample size for the usability study. It refers to "women who were naïve to the device" and "intended users."
- Data Provenance: The document does not specify the country of origin. Given the context of a 510(k) submission to the FDA, it's highly implied to be a study relevant to the U.S. patient population. The study was prospective as it involved active participation of individuals in a simulated usability environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: The document mentions "clinical diagnosis" for confirming self-selection, implying healthcare professionals were involved in verifying eligibility. However, it does not specify the number of experts or their qualifications (e.g., specific medical specialties or years of experience).
- Qualifications: "Clinical diagnosis" suggests a qualified medical professional, but specific qualifications are not provided.
4. Adjudication method for the test set
The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth in the usability study. The "clinical diagnosis" for confirming self-selection suggests a direct clinical assessment rather than a multi-reader, multi-case review.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or relevant in this submission. This is a medical device (vaginal pessary), not an AI/software-as-a-medical-device (SaMD) that assists human readers in interpreting medical images or data.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical medical device (vaginal pessary), not an algorithm or AI system.
7. The type of ground truth used
The ground truth for the usability study essentially revolved around:
- Clinical Diagnosis: To confirm whether participants met the medical criteria for stress urinary incontinence after they self-selected based on packaging information.
- Observed Performance: Direct observation of participants' ability to interpret the Instructions for Use and successfully insert/fit the device independently.
8. The sample size for the training set
This question is not applicable. The "training set" concept is relevant for machine learning algorithms. This submission describes usability testing of a physical medical device, not an algorithm.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
§ 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).