(90 days)
The MTI ST#1 Silicone Pessary is intended for prescription use to be used in the treatment of genuine stress urinary incontinence. It is not intended to be used while sleeping and thus must be removed on a daily basis before going to bed.
The MTI ST#1 Silicone Pessary is geometrically shaped such that when inserted in the patient's vagina, the urethra is aligned between the legs of the device and the bladder is fully supported, thus allowing the bladder to function normally.
The provided text is a 510(k) summary for the MTI ST#1 Silicone Pessary. It doesn't contain the detailed information necessary to answer all the questions regarding acceptance criteria and a study design for evaluating the device's performance in the way typically found for AI/imaging devices.
The document primarily focuses on demonstrating substantial equivalence to predicate devices. This means that instead of presenting novel performance data from an extensive study, the manufacturer is asserting their new device is as safe and effective as devices already on the market, by having similar technological characteristics and intended use.
Here's an attempt to answer your questions based on the available information, noting where data is not present in the document.
Acceptance Criteria and Device Performance
Since this is a substantial equivalence submission for a traditional medical device (not an AI/imaging device), the "acceptance criteria" are primarily related to biocompatibility and functional equivalence to predicate devices rather than specific performance metrics like sensitivity, specificity, or accuracy derived from a clinical efficacy study.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Non-irritating and non-toxic | Data demonstrates the device is nonirritating and nontoxic |
| Intended Use: Treatment of genuine stress urinary incontinence | Performs as intended for this use |
| Technological Characteristics: Similar to predicate devices | Has the same technological characteristics |
| Safety and Effectiveness: Equivalent to predicate devices | Concluded to be safe and effective for its intended use |
| Design: Geometrically shaped for bladder support and urethra alignment | Designed to align urethra and support bladder when inserted |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: The submission does not detail a specific "test set" or clinical study with a sample size for evaluating clinical performance against quantitative metrics. The evaluation relies on "Information on this and similar devices," which suggests a reliance on existing knowledge and biocompatibility testing rather than a new clinical trial for efficacy.
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 ground truth establishment by experts is described in this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: No adjudication method is described as there isn't a specific clinical test set requiring 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
- Not Applicable: This device is a physical medical device (a pessary), not an AI/imaging diagnostic tool. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this type of submission is primarily established through bench testing for biocompatibility and historical performance data on similar, legally marketed predicate devices. The claim is that because the device is technologically similar and biocompatiible, it will perform equivalently to the predicate devices, which are assumed to be safe and effective.
8. The sample size for the training set
- Not Applicable / Not Provided: This device is not an AI/ML model, so there is no training set in the typical sense.
9. How the ground truth for the training set was established
- Not Applicable: As above, there is no training set for an AI/ML model.
Summary of the Study Mentioned in the Document:
The document mentions a "Summary of Device Evaluation" where it states: "Information on this and similar devices demonstrates that the MTI ST#1 Silicone Pessary performs as intended. Biocompatibility data demonstrates that the device is nonirritating and nontoxic."
This indicates that the "study" demonstrating the device meets its (implied) acceptance criteria is based on:
- Biocompatibility testing: To ensure the material is non-irritating and non-toxic. The details of these tests (e.g., specific standards followed, number of samples) are not provided in this summary.
- Comparison to predicate devices: The primary justification is that the device has "the same technological characteristics" as the previously cleared DesChutes Medical Products, Inc. PelvX Incontinence Ring (K974116) and the Milex Silicone Gehrung with Knob Pessary. This comparison, along with general "Information on this and similar devices," serves as the basis for concluding safety and effectiveness, rather than a de novo clinical trial.
§ 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).