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Softseal Catheter (a uterine manipulator/injector) is used to access the uterine cavity for the injection and retention of contrast fluid (or gas) into the uterus to enable the visualization of the uterine cavity and fallopian tubes. This device is not for intrafallopian procedure. The following clinical indications are some of the applications:

1. Infertility
2. Menorrhagia
3. Dysmenorrhea Due to Uterine Synechia
4. Suspected Endometrial Polyp
5. Submucous Fibroid
6. Uterine Synechia (Asherman Syndrome)
7. Congenital Uterine Abnormality

Softseal HSG Catheter (a uterine manipulator/injector)

I am sorry, but based on the provided text, I cannot provide a description of the acceptance criteria and the study that proves the device meets them. This document is a 510(k) clearance letter from the FDA for a device called "Softseal HSG Catheter." It confirms that the device has been found substantially equivalent to a legally marketed predicate device.

The letter does not include:

• A table of acceptance criteria and reported device performance.
• Details of any specific study conducted to prove the device meets acceptance criteria. This type of information would typically be found in the 510(k) summary or detailed submission, not in the clearance letter itself.
• Sample size, data provenance, number of experts for ground truth, adjudication method, MRMC study results, or standalone algorithm performance. These are all details of a clinical or performance study, which are not present in this document.
• Training set information.

The document only states the device's indications for use and confirms its clearance based on substantial equivalence. It does not provide the underlying data or studies that established this equivalence.

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