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Purelmage™ Sterile Ultrasound Transmission Gel is intended for use as the coupling medium for ultrasound procedures where sterility of the ultrasound transmission gel is preferred. The PureImage™ Sterile Ultrasound Transmission Gel is intended for use with imaging procedures only. As such it is indicated for use with transabdominal or transvaginal ultrasound diagnostic procedures.

PureImage™ Sterile Ultrasound Transmission Gel

The provided document is a 510(k) premarket notification letter from the FDA regarding a sterile ultrasound transmission gel. This type of document does not contain the information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth for an AI/device performance study.

Ultrasound transmission gels are Class II medical devices used as a coupling medium for ultrasound procedures. Their regulatory clearance focuses on aspects like sterility, biocompatibility, and acoustic properties to ensure they perform their intended function without causing harm or interfering with the ultrasound signal. The evaluation typically involves:

• Sterility testing: To ensure the gel is free from viable microorganisms.
• Biocompatibility testing: To ensure the gel does not cause adverse biological reactions when in contact with the body.
• Acoustic impedance testing: To ensure the gel effectively transmits ultrasound waves between the transducer and the patient's skin.
• Viscosity and pH testing: To ensure the gel has appropriate physical characteristics for its intended clinical use.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This means the device was cleared based on substantial equivalence to existing devices, not necessarily on a novel performance study proving its diagnostic accuracy in the way an AI algorithm for image interpretation would be evaluated.

Therefore, I cannot extract the requested information from this document. The document describes a traditional medical device clearance, not an AI or diagnostic performance study.

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