(70 days)
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.
The specific indications for use by pessary style are as follows:
Donut Pessary: Support of third degree prolapse, cystocele and rectocele.
Ring Pessary: Support of first or second degree prolapse. Ring with support can also be used on an accompanying cystocele.
Dish Pessary: Control of stress urinary incontinence and support of minor degrees of prolapse.
Oval Pessary: Support of first or second degree prolapse and accompanying cystocyle.
Shaatz Pessary: Support of first or second degree prolapse and accompanying cystocyle.
Mar-Land Pessary: Control of stress urinary incontinence and support of minor degrees of prolapse.
Hodge Pessary: Support of first to second degree prolapse, a cystocele, stress urinary incontinence and an incompetent cervix or uterine retroversion..
Gehrung Pessary: Support of cystocele and rectocele, as well as support of second to third degree prolapse.
Gellhorn Pessary: Support of second to third degree prolapse or procidentia.
Cube Pessary: Support of third degree prolapse, procidentia, cystocele, and rectocele.
Fitting Set: Used to determine the proper size of pessary for each patient.
Mentor EvaCare™ Vaginal Pessaries are manufactured from medical grade silicone elastomers and are available in the following styles:
Cube Pessarv
Dish Pessary
Gellhorn Pessary
Ring Pessary
Mar-Land Pessary
Hodge Pessary
Oval Pessary
Gehrung Pessary
Fitting Set
Cube Pessary with Drainage
Dish Pessary with Support
Gellhorn Pessary with Drainage
Ring Pessary with Support
Mar-Land Pessary with Support t
Hodge Pessary with Support
Shaatz Pessary
Donut Pessary
This document is a 510(k) summary for the Mentor EvaCare™ Vaginal Pessaries, submitted to the FDA in 1999. It details the device's substantial equivalence to previously cleared devices rather than presenting a study with specific acceptance criteria and performance metrics. Therefore, most of the requested information cannot be extracted from this document.
However, based on the provided text, here's what can be stated:
1. A table of acceptance criteria and the reported device performance:
This document does not specify quantitative acceptance criteria or report specific device performance metrics in the format of a table. It is a submission for substantial equivalence based on prior predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No test set or associated sample size, country of origin, or study design (retrospective/prospective) is mentioned for this 510(k) submission. The submission relies on biocompatibility testing of component materials and substantial equivalence to predicate devices, not on a new clinical study with a test set for performance evaluation.
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. No new clinical study with a test set and ground truth establishment by experts is described in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No new clinical study requiring an adjudication method for a test set 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:
Not applicable. This device is a silicone vaginal pessary, not an AI-assisted diagnostic tool, and therefore, no MRMC comparative effectiveness study involving AI or human readers would be relevant or discussed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. As noted above, this is a physical medical device, not an algorithm, so standalone performance testing in this context is irrelevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable. No new clinical study requiring ground truth establishment is detailed in this 510(k) submission for performance evaluation.
8. The sample size for the training set:
Not applicable. There is no mention of a "training set" as this device is not an AI/machine learning model.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set, there is no ground truth establishment for a training set discussed.
In summary: This 510(k) document is a regulatory submission for a physical medical device, the Mentor EvaCare™ Vaginal Pessary. It focuses on demonstrating substantial equivalence to predicate devices already on the market and mentions prior biocompatibility testing of materials. It does not describe a new clinical study involving acceptance criteria, performance metrics, test sets, training sets, or expert ground truth establishment as would be required for a novel diagnostic device or AI 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).