Search Results

Medical Interporous is a soaking treatment for the reduction of odor causing microorganisms on dentures and orthodontic retainers.

Not Found

I am sorry, but based on the provided document, there is no information available regarding acceptance criteria or a study proving the device meets said criteria.

The document is a letter from the FDA to Bonyf AG concerning their 510(k) premarket notification for the "MEDICAL INTERPOROUS" device. It primarily states that the FDA has reviewed the submission and determined that the device is "substantially equivalent" to legally marketed predicate devices.

The letter explicitly mentions:

• Trade/Device Name: MEDICAL INTERPOROUS
• Regulation Name: OTC Denture Cleanser
• Regulatory Class: I
• Product Code: NUX
• Indications for Use: "Medical Interporous is a soaking treatment for the reduction of odor causing microorganisms on dentures and orthodontic retainers."

However, it does not contain any details about:

• Specific performance acceptance criteria (e.g., a certain percentage reduction in microorganisms).
• Any studies conducted to demonstrate the effectiveness of the device.
• Sample sizes for test or training sets.
• Data provenance.
• Expert involvement in establishing ground truth.
• Adjudication methods.
• MRMC studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.

This type of FDA letter for a Class I device (OTC Denture Cleanser) usually focuses on substantial equivalence to existing predicate devices, meaning the device is similar enough in intended use, technology, and safety/effectiveness to a legally marketed device that it doesn't require a Pre-Market Approval (PMA) application with extensive clinical trial data. Detailed performance studies are often not mandated to the same extent as for Class II or III devices for 510(k) clearance.

Ask a specific question about this device