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This device is for use in adult women, over 18 years of age, who experience involuntary urine loss with physical activity (stress urinary incontinence).

The uresta™ Pessary has been modified to be manufactured using an alternate non-latex thermoplastic elastomer rubber. No other changes have been made to the device.

The EastMed Inc. uresta™ Pessary (K083769) is a vaginal pessary designed for adult women experiencing stress urinary incontinence. This 510(k) pertains to a modified version of the device, where the only change is the manufacturing material (an alternate non-latex thermoplastic elastomer rubber).

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

The document does not provide details on sample size, test set, or data provenance (e.g., country of origin, retrospective/prospective) for any specific study. The 510(k) focuses on demonstrating substantial equivalence based on a material change to an already cleared device.

3. Number of Experts and Qualifications:

The document does not mention the use of experts to establish ground truth for any test set. Given the nature of the submission (material change), such an assessment might not have been deemed necessary.

4. Adjudication Method:

The document does not describe any adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention an MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. This device is a physical medical device, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance:

The concept of "standalone performance" for an algorithm is not applicable here, as the uresta™ Pessary is a physical device, not an algorithm.

7. Type of Ground Truth Used:

The document implies that the ground truth for establishing safety of the new material was based on biocompatibility testing standards and results. No other form of "ground truth" (like pathology or outcome data) is mentioned in relation to the material change.

8. Sample Size for Training Set:

The document does not provide any information regarding a training set sample size. As a physical medical device, the concept of a "training set" in the context of an algorithm or machine learning model is not relevant.

9. How Ground Truth for Training Set Was Established:

The document does not address how ground truth for a training set was established, as there is no mention of a training set or an algorithm in this 510(k) submission.

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