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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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