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TVUS/HSG-Cath™ is intended for intracervical injection of saline into the uterus for enhanced transvaginal ultrasonography (TVUS), also known as saline infusion sonography (SIS). TVUS/HSG-Cath may also be used for the delivery of contrast media into the female reproductive tract for diagnostic examination of the uterus and fallopian tubes.

TVUS (SIS) with saline infusion:

• persistent abnormal or dysfunctional uterine bleeding .
• suspected myometrial or intraluminal abnormalities (e.g., . fibroids or polyps)
• . thickened or irregular endometrium
• recurrent pregnancy loss t
• pre- and post-operative assessment of uterine pathology . HSG with contrast media:
  • unexplained infertility .
  • recurrent pregnancy loss

Not Found

The provided document is a 510(k) summary for the TVUS/HSG-Cath™ Saline/Contrast Media Infusion Catheter. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a device meets specific performance criteria through a standalone study with acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria studies, such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or their data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone (algorithm-only) performance studies.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Instead, the 510(k) summary (specifically Section 9 from the first page) indicates that the device's substantial equivalence is based on its similarity in intended use, indications for use, and technological characteristics to a predicate device, the "H/S Elliptosphere Catheter, (K013972) ACKRAD Laboratories, Inc."

The document details the intended use and indications for use of the TVUS/HSG-Cath™, which are consistent with the predicate device. For devices seeking 510(k) clearance, the primary "proof" that the device is safe and effective is its substantial equivalence to a legally marketed predicate device, not typically a de novo clinical study against specific performance acceptance criteria like those outlined in the request.

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