Search Results

The MedNet LOCATOR, INC., pediatric myringotomy tube is to be used by ear, nose and throat physicians for insertion into the eardrum for the purpose of ventilating and/or draining the middle ear in the case of mild to chronic otitis media which causes earache and discomfort for the patient.

Myringotomy Tube - Pediatric

This letter is a 510(k) clearance for a Myringotomy Tube - Pediatric device and does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document states:

• The device is a "Myringotomy Tube - Pediatric" (K972126).
• It is for "insertion into the eardrum for the purpose of ventilating and/or draining the middle ear in the case of mild to chronic otitis media which causes earache and discomfort for the patient."
• The FDA has determined the device to be "substantially equivalent" to devices marketed prior to May 28, 1976. This means it has met the regulatory requirements for clearance based on its similarity to an already approved device, rather than through a direct study demonstrating its performance against specific acceptance criteria.

Therefore, I cannot provide the requested information from this document. It does not include:

• A table of acceptance criteria or reported device performance.
• Sample sizes for test sets or data provenance.
• Information on experts for ground truth establishment or adjudication methods.
• Details on MRMC comparative effectiveness studies or standalone algorithm performance.
• Specific types of ground truth used.
• Sample sizes for training sets or how ground truth for training sets was established.

Ask a specific question about this device

The MedNet Locator, INC., bobbin with tab myringotomy tube is to be used by ear, nose and throat physicians for insertion into the eardrum for the purpose of ventilating and/or draining the middle ear in the case of mild to chronic otitis media which causes earache and discomfort for the patient.

Myringotomy Tube - Bobbin with Tab

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details (like sample size, data provenance, expert qualifications, adjudication methods), or any comparative effectiveness studies.

The document is a 510(k) clearance letter from the FDA for a "Myringotomy Tube - Bobbin with Tab." It primarily states that the device is substantially equivalent to legally marketed devices and can therefore be marketed. It also includes the stated "Indications For Use" for the device.

Therefore, I cannot provide the requested information.

Ask a specific question about this device

The MedNet LOCATOR, INC., bobbin myringotomy tube is to be used by ear, nose and throat physicians for insertion into the eardrum for the purpose of ventilating and/or draining the middle ear in the case of mild to chronic otitis media which causes earache and discomfort for the patient.

Myringotomy Tube - Bobbin

The provided documents are a 510(k) premarket notification letter from the FDA and the associated "Indications For Use" statement for a medical device. These documents do not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested.

The FDA letter (K971943) simply states that the "Myringotomy Tube - Bobbin" device is substantially equivalent to legally marketed predicate devices and can proceed to market. The "Indications For Use" defines the intended use of the device.

Therefore, I cannot provide a response to your request, as the necessary information is not present in the given text.

Ask a specific question about this device