(77 days)
The MirroScope™ System is indicated for use during dental examinations and procedures when a video image is desired.
The MirroScope™ System is an intraoral camera that is mounted on a customary mirror and complimentary imaging accessories. The System consists of the following main components:
- The MirroScope™: a handpiece comprised of a mirror (MirroLens), alignment of prisms and lenses, a miniature 1/4" CCD camera Remote Head Unit (RHU), located in the handle. The video signal from the RHU is transferred to the Camera Control Unit (CCU) located in a control box, via a lightweight cable. A set of six LED's illuminates the working area around the mirror. A disposable, single use protective sheath is provided to be mounted over the handpiece prior to each use, to ensure proper hygiene and to serve as a barrier cover.
- Two complementary packages, the PRO-200™ and the VIEW-300™, to provide either an overall solution or an add-on solution to the existing infrastructure. The PRO-200™ includes a Control Box (Camera Control Unit (CCU), Video Processing Unit (VPU), Power Supply Unit (PSU), RF Transmitter (Optional), Infrared Receiver (IRR), Docking station for MirroScope™), R-400 Infrared remote control, External AC/DC adaptor, Foot pedal (Optional), and RF Receiver (Optional). The VIEW-300™ includes a Control box (Camera Control Unit (CCU), Video Processing Unit (VPU), Power Supply Unit (PSU), 12.1" TFT screen and Converter, Infrared Receiver (IRR), Docking station for MirroScope™), R-400 Infrared remote control, External AC/DC adaptor, Accessories, and Foot pedal (Optional).
The provided text describes a 510(k) summary for "The MirroScope™ System", an intraoral camera. However, it does not contain the specific information requested about acceptance criteria and a study proving the device meets them.
The document primarily focuses on:
- Administrative details: Applicant information, contact person, date prepared, trade name, classification, product codes, and regulation numbers.
- Predicate devices: A list of previously cleared intraoral camera systems.
- Performance standards: A list of voluntary standards (IEC, EN, ISO) the device complies with, but these are general safety and compatibility standards, not performance criteria for its dental imaging function.
- Intended Use/Indications for Use: "The MirroScope™ System is indicated for use during dental examinations and procedures when a video image is desired."
- Device Description: Details about the MirroScope™ handpiece and its complementary packages (PRO-200™ and VIEW-300™).
- Substantial Equivalence: A statement asserting substantial equivalence to predicate devices and listing the types of testing performed to support this claim (electrical safety, EMC, software verification, performance testing, clinical images and use evaluation, hazard analysis).
The document mentions "Performance testing" and "Effective clinical images and use evaluation" as activities undertaken, but it does not provide any specific acceptance criteria (e.g., image resolution, clarity, color accuracy, or diagnostic accuracy) or the results of such studies. It does not present a table of acceptance criteria versus reported performance, nor does it detail the methodology, sample sizes, provenance, expert qualifications, or ground truth establishment for any performance study.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or the details of such a study based on the provided text. The document is too high-level and does not delve into the specifics of performance validation.
§ 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.