(70 days)
The Naso-Laryngo-Pharyngoscope is indicated for visualization of the pharynx and larynx.
Not Found
I am sorry, but the provided text does not contain the information requested in your prompt. The document is an FDA 510(k) clearance letter for a device called "Naso-Laryngo-Pharyngoscope". It confirms that the device is substantially equivalent to previously marketed devices and lists its indications for use.
Crucially, it does not include any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, data provenance, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for training or testing sets. These details are typically found in a clinical study report or a technical summary, which is not provided here.
Therefore, I cannot populate the table or answer the specific questions about the study that proves the device meets acceptance criteria.
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.