(32 days)
The Perfect Shot Intra-Oral Camera is to be used by medical practitioners, usually dental hygienists, assistants or dentlats, to view the mouth of patients. It can explore the entire mouth and examine teeth or gum tissue for diagnostic purposes. It is distributed through dealers to medical practitioners.
The Perfect Shot is wireless, unlike other similar devices, allowing more freedom of movement by the user. It also contains voice activated instructions which enable the user to "freeze" a view on the monitor or take a picture and print) of the area being examined for reference at a later date by simply using voice instructions.
The product is designed to transmit a RF (radio frequency) signal to a receiver. This product can and will be used both intra and extra orally, which will allow a dentist to examine and display to the patient problem areas of concern or treatment that is required. The resolution capabilities of the CCD (Charge Coupled Device) is 640-480 lines.
The picture is transmitted to a monitor in the examination area for the patient to view , allowing the patient a better understanding of a potential problem and a better explanation of the prescribed solution.
Pictures that are captured may be printed for further review or for patient files. The Perfect Shot may also be attached to computers for digital storage or transmission to other computers.
The Perfect Shot Intra-Oral Camera is a wireless intra-oral camera that transmits an RF signal to a receiver. It has voice activated instructions to freeze a view or take a picture. It uses a CCD with 640-480 lines resolution. The picture is transmitted to a monitor and can be printed or attached to computers for digital storage or transmission.
The provided text is a 510(k) clearance letter from the FDA for the "Perfect Shot Intra-Oral Camera." This document does not contain information about acceptance criteria or a study proving the device meets those criteria.
The 510(k) process is based on demonstrating substantial equivalence to a legally marketed predicate device, not on meeting specific performance acceptance criteria from a new clinical study. The letter confirms that the FDA has reviewed the submission and determined that the device is substantially equivalent to pre-amendments devices, thereby allowing it to be marketed.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- MRMC comparative effectiveness study results.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This information would typically be found in a detailed predicate comparison or a separate clinical study report, neither of which is part of this 510(k) clearance letter. The document focuses on regulatory approval based on substantial equivalence.
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.