(27 days)
Identafi™ 3000 is intended to be used by qualified health-care providers to enhance the identification and visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer or premalignant dysplasia.
Identafi™ 3000 allows for conventional oral mucosal examination and excites the tissue with multispectral lights for direct visualization of the resulting natural tissue fluorescene and reflectance, and vasculature.
Identaff™ 3000 is also intended to be used by a surgeon to help identify diseased tissue around a clinically apparent lesion to aid in determining the appropriate margin for surgical excision.
Identafi™ 3000 eyewear is reusable filtered eyewear that is worn by a health care professional to enhance the visual effects of violet light during oral exam. Identafi™ 3000 eyewear bacbeen designed to allow transmission of 430-580 nm light.
The TRIMIRA™ IDENTAFI 3000® is a "AA" battery operated, hand-held, multispectral oral examination light used in conventional and specialized oral examination. Accessories outli oldi glasses and disposable mirrors.
The Identaff™ 3000, with multispectral identifi™ technology (patents pending), uses "AA" batteries to operate high-intensity LEDs to produce white, violet and amber light. These safe, visible lights allow health professional to perform Conventional Oral Examination (COE) using white ight, and specialized or enhanced visual examinations of tissue using violet and amber lights.
The Identafi™ 3000 violet light enhances normal tissue's natural fluorescence. Visual examination under violet light shows healthy tissues fluorescing blue (when using rose colored filtered glasses) while suspicious tissue appears dark because of its loss of fluorescence. Amber light enhances the withio suspicious assus app and makes visualization of the vasculature possible.
The direct visualization of fluorescent and reflective tissues is using the body's natural system to identify suspicious tissue quickly that may require further investigation.
The provided text is a 510(k) Summary for the TRIMIRA™ Identafi™ 3000 device. It describes the device's intended use and technological characteristics, and claims substantial equivalence to a predicate device. However, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for either test or training sets, as this information is not present in the provided text.
The document primarily focuses on establishing substantial equivalence to a predicate device (Trimira OCS 3000 K082603) based on similar intended use and technological characteristics (multispectral lights for visualizing tissue fluorescence and reflectance to identify oral tissue abnormalities). The claim of substantial equivalence implies that the device performs comparably to the predicate, but it does not detail any specific performance metrics or a study to demonstrate this.
§ 872.6350 Ultraviolet detector.
(a)
Identification. An ultraviolet detector is a device intended to provide a source of ultraviolet light which is used to identify otherwise invisible material, such as dental plaque, present in or on teeth.(b)
Classification. Class II.