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The CooperSurgical Milex pessaries are intended to provide support to pelvic organs when inserted in the vagina.

The following Indications for Use are associated with each of the following pessary styles:

Milex® Shaatz Folding Pessaries:
Shaatz pessary is indicated for temporary, nonsurgical management of pelvic organ prolapse in Stage I and Stage II prolapse, complicated by a mild cystocele.

Milex® Gellhorn Pessaries:
Gellhorn pessary is indicated for temporary, nonsurgical management of pelvic organ prolapse in Stage III prolapse or procidentia.

Milex® Ring Folding Pessaries:
Milex Ring Pessary is indicated for use as removable structures placed in the vagina to treat uterine prolapse, including cystocele and rectocele, as well as stress urinary incontinence in women.

Milex® Pessaries are intended for adult women as Obstetrical and Gynecological medical devices. Milex® Pessaries are distributed in a non-sterile condition made from silicone. The Milex Pessaries are available in a variety of styles, each having a range of sizes that is inserted into the vagina to function as a supportive structure of the uterus, bladder and rectum. All pessaries are produced in a like fashion, utilizing injection molding of liquid silicone rubber. The Milex Pessaries are manufactured in pink for single patient use.

This submission includes the following designs of Milex Pessaries: Shaatz Pessary, Gellhorn Pessary (Short and Long Stem), and Ring Folding Pessaries (Ring without support, Ring with support, Ring with knob without support, Ring with knob with support).

Based on the provided FDA 510(k) Clearance Letter and 510(k) Summary for CooperSurgical Milex® Pessaries, it's clear that this submission is for a medical device (vaginal pessaries) and NOT an AI/software device.

Therefore, many of the questions related to acceptance criteria, MRMC studies, standalone algorithm performance, ground truth establishment, and training/test sets for AI models do not apply to this specific clearance.

The "acceptance criteria" for this physical device are primarily based on demonstrating substantial equivalence to a predicate device through:

• Identical/Similar Indications for Use: Showing that the new device is intended for the same medical purposes as the predicate.
• Similar Technological Characteristics: Demonstrating that the materials, design, and fundamental principle of operation are comparable or that any differences do not raise new questions of safety or effectiveness.
• Performance Data (Bench Testing/Biocompatibility): Providing evidence that the device performs as intended and is safe for its intended use, typically through non-clinical testing.

Here's how to address the questions given the nature of the device:

1. A table of acceptance criteria and the reported device performance

For a physical device like a pessary, "acceptance criteria" are typically defined by demonstrating substantial equivalence to a predicate device and meeting established performance and safety standards through non-clinical testing. The "reported device performance" refers to the results of these tests and the comparison to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not specify a "sample size" for a clinical test set in the way one would for an AI model or a clinical trial. The performance data is based on biocompatibility testing of the device material, which involves laboratory tests with specific biological samples (e.g., cell cultures, animal models for implantation/toxicity studies) rather than patient data.
• Data Provenance: Not applicable in the context of clinical patient data for this type of device. The data provenance would refer to the testing laboratories and their adherence to ISO standards for biocompatibility. The summary states "testing performed by CooperSurgical" and references international ISO standards.

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. This device is a physical medical device, not an AI or imaging diagnostic tool that relies on expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. As above, this is for a physical device, not an AI model requiring human adjudication of results.

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 is for a physical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Ground truth for this device is established through adherence to international consensus standards for medical device biocompatibility (ISO 10993 series) and engineering performance standards for physical characteristics like dimensions, durability, and material properties. It's not based on clinical "outcomes data" or "expert consensus" in the diagnostic sense, but rather on meeting pre-defined safety and performance benchmarks.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

• Not applicable. This is not an AI/ML device.

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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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