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Gynethotics pessaries are removable devices placed in the vaginal cavity to provide a nonsurgical alternative for the treatment of pelvic organ prolapse and to relieve the symptoms of pelvic relaxation with or without urinary incontinence in adults.

Gynethotics Ring Pessary is indicated for use in cases of mild (Stage I) pelvic organ prolapse.

Gynethotics Ring with Support Pessary is indicated for use in cases of mild (Stage I) pelvic organ prolapse.

Gynethotics Ring with Knob Pessary is indicated for use in cases of mild (Stage I) pelvic organ prolapse, and stress urinary incontinence.

Gynethotics Ring with Support and Knob is indicated for use in cases of mild (Stage I) pelvic organ prolapse, and stress urinary incontinence.

Gynethotics Incontinence Ring Pessary is indicated for use in cases of stress urinary incontinence.

Gynethotics Marland Pessary is indicated for use in cases of mild (Stage I) and moderate (Stage II) pelvic organ prolapse, and stress urinary incontinence.

Gynethotics Marland with Support Pessary is indicated for use in cases of mild (Stage I) and moderate (Stage II) pelvic organ prolapse, and stress urinary incontinence.

Gynethotics Gellhorn Pessary is indicated for use in cases of mild (Stage I) to severe (Stage III or procidentia) pelvic organ prolapse.

Gynethotics Cube Pessary is indicated for use in cases of moderate (Stage II) to severe (Stage III or procidentia) pelvic organ prolapse.

Gynethotics pessaries are vaginal pessaries made from silicone that are inserted into the vagina to function as a supportive structure of the vagina, uterus, bladder and/or rectum to manage and treat the symptoms of pelvic floor dysfunction, such as pelvic organ prolapse and incontinence. Gynethotics pessaries come in four general shapes, including: Ring, Gellhorn, Marland, and Cube. Each shape comes in a range of configurable features and dimensions.

The provided text is a 510(k) Summary for the Gynethotics™ Pessary, a medical device. It does not describe a study involving an AI or software device that classifies, diagnoses, or assists human readers with medical images or data. Therefore, I cannot extract the information required to populate the fields related to acceptance criteria and study designs typically associated with such devices (e.g., sample size for test set, number of experts, MRMC studies, ground truth establishment, etc.).

The document focuses on demonstrating substantial equivalence of the Gynethotics™ Pessary, a physical vaginal pessary, to predicate devices through:

• Indications for Use Comparison: Showing similar intended medical applications (pelvic organ prolapse, stress urinary incontinence).
• Technological Characteristics Comparison: Highlighting that the device is made of similar materials (silicone) and has comparable dimensions to predicates, with differences not raising new safety/effectiveness questions.
• Performance Data (Bench/Lab Testing): Including mechanical testing (folding, bend, cord detachment, etc.) and biocompatibility testing (cytotoxicity, sensitization, irritation, etc.), TSST-1 risk assessment, cleaning validation, and packaging validation.

Therefore, it is impossible to provide the requested information based on the provided text. The information pertains to the regulatory submission for a physical medical device, not a diagnostic AI/software tool.

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