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The ProVate Vaginal Support is indicated for the temporary, nonsurgical management of Pelvic Organ Prolapse in females.

The ProVate Vaginal Support is a vaginal ring pessary intended for the conservative nonsurgical, temporary management of Pelvic Organ Prolapse (POP) in females. The ProVate is a disposable, single use device intended to use for up to seven (7) days. The ProVate device is intended for prescription home use following a size fitting process performed by a health care professional. The device is supplied in its compact mode, within a disposable Applicator intended for the insertion of the device is expanded into its circular ring shape using the Applicator Plunger when inserting the device into the vagina. At the end of its use (up to 7 days), the patient pulls the Removal String which collapses the device into its compact configuration, facilitating easy removal. The device is then thrown away, and a new device can be inserted by the patient as needed. The ProVate includes additional components to facilitate insertion and removal of the device. The ProVate device is constructed to allow insertion into the vagina by the patient while the device is in a compact mode contained within a single use applicator. The ProVate device is expanded to its circular shape using the applicator when inserted into the vagina. Once inserted, the circular shape of the ProVate is comparable to that of the predicate device and the ring provides support to the prolapsed organs. To remove the device, the ProVate includes a removal string. Pulling on the string collapses the device to its compact state allowing for easier and more comfortable removal.

The ConTIPI Medical Ltd. ProVate Vaginal Support is a vaginal pessary intended for the temporary, nonsurgical management of Pelvic Organ Prolapse (POP) in females. The device's safety and effectiveness were evaluated through a series of bench tests and two clinical studies.

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of "acceptance criteria" against which specific device performance metrics are directly reported in a comparative format. However, the document outlines various tests conducted and their successful outcomes, indicating that the device met the performance and safety requirements. The performance data section provides indirect evidence of fulfilling acceptance criteria.

2. Sample Sizes and Data Provenance

The document describes two clinical studies:

• Prospective Safety Clinical Study:
  • Sample Size: Not explicitly stated but described as "statistically powered."
  • Data Provenance: Multicenter, randomized, cross-over study. The country of origin is not explicitly stated, but the manufacturer is based in Israel and the submission is to the U.S. FDA, suggesting potential international or U.S.-based study sites. The study design is prospective.
• Prospective Clinical Study to Evaluate Safety and Effectiveness:
  • Sample Size: Not explicitly stated but described as "statistically powered."
  • Data Provenance: One arm, multi-clinic prospective study. Country of origin not explicitly stated.

3. Number of Experts and Qualifications (for Ground Truth)

The document does not detail the number of experts or their specific qualifications for establishing ground truth within the clinical studies. For the clinical studies, vaginal examinations were conducted by physicians, who would serve as experts in assessing prolapse stages and adverse events. Specific qualifications (e.g., years of experience, specialization) are not provided.

• In the "Prospective Clinical Study to Evaluate Safety and Effectiveness," a "fitting process performed by a physician" is mentioned, indicating the involvement of medical professionals in determining appropriate device sizing and assessment.
• "Vaginal examinations and microbial evaluations were performed at the beginning and at the end of each usage phase" in the safety study, again implying medical expert assessment.

4. Adjudication Method

The document does not specify an adjudication method for the test set data (e.g., 2+1, 3+1 for resolving discrepancies). It is implied that clinical assessments were made by individual clinicians or study investigators.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned. The clinical studies focused on the performance of the device itself, either in comparison to a control device (for microflora) or against a baseline (for prolapse improvement), rather than on the impact of AI assistance on human readers.

6. Standalone Performance Study (Algorithm Only)

This device is a physical medical device (vaginal pessary), not a software or AI algorithm. Therefore, a standalone (algorithm only) performance study is not applicable and was not conducted.

7. Type of Ground Truth Used

The ground truth for the clinical studies was based on:

• Clinical Assessments: Vaginal examinations performed by physicians to assess prolapse stage (e.g., improvement by at least one stage, starting from stage 2 or 3 to stage 0 or 1).
• Microbial Evaluations: Laboratory analysis of vaginal microflora.
• Adverse Event Reporting: Clinical evaluation and reporting of adverse events.

This constitutes a combination of expert clinical assessment and laboratory data.

8. Sample Size for the Training Set

This question is not applicable. The ProVate Vaginal Support is a physical medical device, not an AI or machine learning model that requires a training set. The "training" in this context refers to the development and iterative testing of the device, which is informed by engineering principles, bench testing, and clinical feedback, rather than a data training set for an algorithm.

9. How Ground Truth for the Training Set was Established

This question is not applicable for the same reason as point 8. The device development process involves engineering specifications and preclinical/clinical data gathering, not the establishment of ground truth for an algorithmic training set.

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