(251 days)
Qraypen is to be used as an intraoral video source and is indicated for individuals who may benefit from the addition of video images in intraoral dental examinations.
Qraypen, a Dental Intraoral Camera, provides digital color images of intraoral anatomy during oral health examinations by dentists or dental sub-specialists. The output of the images can be shown through a computer monitor. This product is designed only for the use in dentistry and may only be used by trained medical personnel. The Qraypen is not made as a caries detection device. Therefore, Qraypen is not claimed as a caries detection device.
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(1) Main components of Oraypen
Oraypen is a hand-held device that consists of Oraypen Handpiece, Cradle, Cradle screw, USB 2.0 Cable, Adapter, and User manual. The Qraypen is connected to a compatible Windows PC and power supply by USB 2.0 type cable. -
(2) Design features
- a) An intraoral camera that is capable of both blue and white LED color imaging
- b) Integral LED that allows the color of light to be changed
- c) Automatic focusing
- d) Compatible with any viewer program that meets the standards of USB video device class (UVC) 1.0 or higher
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(3) Three modes are available:
- a) White light mode: Qraypen captures images with white LED color light
- b) Blue light mode: Oraypen captures images with blue LED color light
- c) Orange light mode: Qraypen captures images with white and Blue LED color light in succession
The provided text is a 510(k) summary for the AIOBIO Co., Ltd. Qraypen, a Dental Intraoral Camera. This document focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria, device performance metrics, or the study design for proving these criteria.
Therefore, I cannot provide the requested information, including the table of acceptance criteria and reported device performance (1), sample size and data provenance (2), number and qualifications of experts for ground truth (3), adjudication method (4), multi-reader multi-case study details (5), standalone performance (6), type of ground truth used (7), training set sample size (8), or how the training set ground truth was established (9).
The document primarily discusses:
- Device Description: What the Qraypen is, its components, design features, and technical specifications (blue and white LED imaging, automatic focusing, compatibility with UVC viewers).
- Indications for Use: Used as an intraoral video source for dental examinations.
- Comparison to Predicate Device (CDR-CAM): Highlights similarities in indications for use, target population, anatomical sites, environment of use, intended users, design, focus range, light source, camera connection, system components, portability, and standards met. It also notes differences like power supply, focus type, imager type, principle/method of operation, software, and disinfection methods.
- Summary of Non-Clinical Performance Testing: Lists compliance with various standards for Electromagnetic Compatibility (EMC), Electrical Safety, Software Verification and Validation, Photobiological Safety, and Cleaning and Disinfection Validation. It also mentions bench testing for barrier sleeves but without specific performance metrics.
- Biocompatibility Testing: Stated that no biocompatibility testing was conducted because the device does not directly or indirectly contact the patient's body, as a disposable sleeve covers the camera.
The document does not provide any quantitative performance data such as sensitivity, specificity, accuracy, or any metrics that would constitute "acceptance criteria" and "reported device performance." It also doesn't detail any clinical studies, reader studies, or how ground truth was established for performance evaluation with respect to diagnostic accuracy or other performance parameters.
§ 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.