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WAVELEWATH MULTI - PURPOSE ULTRASO UND GEL IS INTENDED TO BE USED AS A Coupling MEDUAL FOR ULTRASOUND TRANSMISSION.

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The provided FDA 510(k) document for "Wavelength Multi-Purpose Ultrasound Gel" is a clearance letter, not a study report or a detailed submission containing acceptance criteria and performance data. Therefore, it does not contain the specific information requested regarding device performance, study details, sample sizes, ground truth establishment, or expert qualifications.

The letter explicitly states that the FDA has "reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your bocurely be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This means the device was cleared based on its substantial equivalence to an already legally marketed device, not necessarily through a new de novo study with acceptance criteria and performance metrics.

Therefore, I cannot provide the requested information from the provided text.

To answer your questions, I would need access to the actual 510(k) submission document or a detailed study report for the "Wavelength Multi-Purpose Ultrasound Gel" that outlines its performance testing.

However, I can extract the following relevant information from the provided document:

• Trade/Device Name: Wavelength Multi-Purpose Ultrasound Gel
• Regulation Number: 21 CFR 892.1570
• Regulation Name: Diagnostic Ultrasound transducer (This is the regulation for the device the gel is used with, not directly the gel itself, but indicates its intended context.)
• Product Code: 90 ITX
• Indications For Use: "Wavelength Multi-Purpose Ultrasound Gel is intended to be used as a coupling medium for ultrasound transmission."

In a typical 510(k) submission for a device like an ultrasound gel, "acceptance criteria" and "device performance" would primarily revolve around:

• Physical and Chemical Properties: Viscosity, pH, acoustic impedance, absence of air bubbles, stability over time, microbial purity, cytotoxicity, skin irritation, and sensitization.
• Acoustic Transmission: Demonstration that the gel effectively transmits ultrasound waves without significant attenuation or interference. This would typically be compared to a predicate device.

The study that "proves the device meets the acceptance criteria" would likely be a series of bench tests and possibly biocompatibility studies comparing the gel's properties to those of a legally marketed predicate ultrasound gel. However, the details of such tests are not present in this clearance letter.

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