(114 days)
The VoiceMaster is to be used in patients after a Laryngectomy who would like to restore their vocal abilities.
This device is an indwelling voice prosthesis, with a one-way ball valve, designed to fit into a tracheo-esophageal fistula.
The provided text does not contain information about acceptance criteria or a study proving device performance against such criteria. The document is a 510(k) summary for a medical device (VoiceMaster Prosthesis) and the FDA's clearance letter for it.
The 510(k) summary:
- Identifies the product (VoiceMaster Prosthesis) and its intended use (restoring vocal abilities after a laryngectomy).
- Compares it to predicate devices (Groningen Voice Prosthesis, Panje Voice Prosthesis, Provox Voice Prosthesis), highlighting similarities in body design and material, and a difference in valve design (ball valve vs. slit/flap valves).
The FDA clearance letter:
- Confirms the device is substantially equivalent to legally marketed predicate devices.
- States that the device can be marketed.
Therefore, I cannot provide the requested information in the table format or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert involvement, as this information is not present in the provided text.
To answer your request, a different type of document (e.g., a clinical study report, a detailed performance testing protocol, or a more comprehensive premarket submission) would be required.
§ 874.3730 Laryngeal prosthesis (Taub design).
(a)
Identification. A laryngeal prosthesis (Taub design) is a device intended to direct pulmonary air flow to the pharynx in the absence of the larynx, thereby permitting esophageal speech. The device is interposed between openings in the trachea and the esophagus and may be removed and replaced each day by the patient. During phonation, air from the lungs is directed to flow through the device and over the esophageal mucosa to provide a sound source that is articulated as speech.(b)
Classification. Class II (special controls). The device, when it is a voice amplification device, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.