(205 days)
For the temporary management of stress urinary incontinence in women
The device is a single use vaginal pessary, inserted into the vagina, by the user, using a tampon-like applicator. The device is composed of a high density polyethylene core, a nonwoven overwrap, and a withdrawal cord. The overwrap helps to facilitate ease of insertion and removal. The device is removed by a withdrawal cord made from tampon withdrawal cord material. Upon removal, the device is disposed of in a trash receptacle. The pessary is a single-use device. It is designed for daily use up to 12 hours in 24 hours. The device is available in one size and is sold over-the-counter.
This document details the premarket notification for the "Always/Tampax bladder supports" device. However, it does not contain information about the acceptance criteria or a study proving the device meets specific performance acceptance criteria related to its primary function of managing stress urinary incontinence (SUI).
Instead, the document focuses on:
- Substantial Equivalence: Demonstrating that the device is substantially equivalent to a legally marketed predicate device (Improve Bladder Supports/TIPI OTC K131198). This is the primary goal of a 510(k) submission.
- Safety and Efficacy Studies: Two clinical studies (a safety study and an efficacy and safety study) were conducted to support the device's safety and effectiveness. However, these studies evaluated the device's performance in general terms (e.g., well-tolerated, minimal effect on vaginal wall, statistically significant and clinically meaningful improvement in symptoms, able to self-administer appropriately) rather than against specific, quantifiable performance acceptance criteria for SUI management.
- Non-Clinical Tests: These tests focused on design verification (e.g., applicator force, withdrawal cord strength, core stiffness, dimensions) and biocompatibility (cytotoxicity, sensitization, irritation, genotoxicity, systemic toxicity, local effects after implantation, TSS risk). These are about the device's physical and biological properties.
- Label Comprehension and Self-Selection: A study to ensure users understand the labeling and can self-select the product appropriately for an OTC device.
Therefore, many of the requested items cannot be answered directly from the provided text as the information is not present in the content.
Based on the provided text, here is what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
As stated above, the document does not explicitly define specific, quantitative acceptance criteria for the device's performance related to SUI management (e.g., "reduce SUI episodes by X%" or "reduce pad weight by Yg"). The clinical studies conclude that the device was effective and safe, and provided a "statistically significant and clinically meaningful improvement" in SUI symptoms and pad weight gain, but without defining a specific benchmark for "improvement" as an acceptance criterion.
The non-clinical tests (e.g., cytotoxicity, withdrawal cord strength) do have implied acceptance criteria (e.g., "non-cytotoxic," "not broken or detached") but these are for device safety and integrity, not the clinical performance in managing SUI.
| Acceptance Criteria (Explicitly stated for performance) | Reported Device Performance (Related to SUI management) |
|---|---|
| Not explicitly defined in terms of SUI management metrics within the provided text for acceptance against a specific threshold. | "statistically significant and clinically meaningful improvement in the symptoms that were most important to each woman, whether it was a reduction in SUI episode frequency, a reduction in pad load, or both." |
| "Well-tolerated" / "Safe" | "device was well-tolerated, with no serious AEs." |
| "majority of the AEs that were observed were 'mild' and spontaneously resolved." | |
| "minimal effect on the vaginal wall and surrounding structures." | |
| "Appropriate self-administration" | "women were able to appropriately... self-administer the device." |
2. Sample Size Used for the Test Set and Data Provenance
- Efficacy and Safety Study (Clinical Tests):
- Sample Size: Not explicitly stated. The text mentions it was a "single-arm, open label, multi-center, 4-week efficacy study."
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies were "multi-center." They are prospective as they are described as "studies performed" to evaluate the device.
- Safety Study (Clinical Tests):
- Sample Size: Not explicitly stated. Described as "A randomized, 2-arm (pad control), single-blind (vaginal examiner), multi-center, 3-month safety study."
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies were "multi-center." They are prospective.
- Label Comprehension and Self-Selection Study:
- Sample Size: Not explicitly stated. It describes "Three cohorts were tested: 1) A population of women... ages 18 and older; 2) A population of women... ages 18 and older with low literacy; 3) A population of women... ages 65 and older."
- Data Provenance: Not explicitly stated (e.g., country of origin). Likely prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document for any of the clinical studies. The clinical studies evaluated patient-reported outcomes (SUI episode frequency, pad weight gain) and physician observations (vaginal examinations), but there is no mention of "ground truth" being established by a panel of experts. The safety study explicitly mentions a "single-blind (vaginal examiner)," implying a single expert for certain assessments in that study, but their qualifications are not provided.
4. Adjudication Method for the Test Set
- This information is not provided in the document. The studies are described as clinical trials with various designs (randomized, single-blind, open label), but no details on adjudication processes for outcomes are mentioned.
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 was not done. This device is a physical, over-the-counter vaginal pessary for SUI management, not an AI-based diagnostic or assistive software. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not applicable. As mentioned above, the device is a physical medical device, not an algorithm or AI software. There is no algorithm to perform in a standalone capacity.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- For the clinical efficacy study, the "ground truth" or primary outcome measures appear to be patient-reported outcomes data (SUI episode frequency, reduction in pad weight gain) and possibly clinical observation data from vaginal examinations.
- For the safety study, the "ground truth" or outcome measures were adverse events, physical examinations, visual vaginal examinations, clean catch urine collection, and vaginal swabbing.
- For the non-clinical tests (e.g., biocompatibility), the ground truth is derived from standardized test methods and their defined pass/fail criteria (e.g., ISO standards, specific observable reactions). For example, "non-cytotoxic" and "non-irritating" serve as the ground truth.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set. The clinical studies mentioned are for evaluation of the device itself, not for training an algorithm.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As above, there is no AI/ML algorithm or training set for this device.
§ 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).