(79 days)
The Digital Intra-Oral X-Ray Imaging System (Pluto0002X) is used in conjunction with dental Radiography in medical units. The product is used for dental X-ray examination and the diagnosis of structural diseases. The product is expected to be used in hospitals and clinics, operated and used by trained professionals under the guidance of doctors. This device is not intended for mammography and conventional photography applications.
This device is suitable for providing dental radiography imaging for both adult and pediatric.
The PlutoX Digital Intraoral X-Ray Imaging System (Hereinafter contains Pluto0001X and Pluto0002X) is the digital intra-oral sensor. It features a 20um pixel pitch CMOS sensor with directly deposited CsI:Tl scintillator which ensures optimal resolution. An easy to use hi-speed direct USB interface enables a simple connection to a PC without need for an additional control box.
The iRay intra-oral software (iRayDR) is part of the system, it is used to acquire, enhance, analyze, view and share images from the sensor. Based on how the operation of the software associated with device function affects the patient or operator, and the effect may be direct or indirect, we hereby certify that the level of concern for our product, use the software 1.0207 version is Moderate. It has not been cleared with other predicate devices but is the initial used in PlutoX.
The major function of the PlutoX series is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. This detector is the key component of intra-oral DR system, enables to complete the digitalization of the medical X-ray imaging with the intra-oral DR system software.
The provided text describes the 510(k) premarket notification for the PlutoX Digital Intraoral X-Ray Imaging System and does not contain detailed acceptance criteria for a specific study, nor does it present the results of a study designed to prove the device meets such criteria.
The "Nonclinical study" section (pg. 8 & 9) lists several performance characteristics that were evaluated for the PlutoX series and states that "the results have shown that the PlutoX series are substantially equivalent to the predicate devices on the Market (K090458)". However, it does not explicitly define acceptance criteria as quantitative thresholds for these characteristics, nor does it provide the reported performance values in a table. It only mentions that the test results "meet the standard requirements" for various electrical, mechanical, environmental safety, EMC, and biological evaluations.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: The document does not provide a specific table with quantitative acceptance criteria and corresponding reported performance for image quality metrics. It only lists parameters that were evaluated for substantial equivalence.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a device performance study and not a diagnostic AI study requiring expert ground truth in this context.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes the PlutoX system as a digital intraoral X-ray imaging system, which implies the output is an image for human interpretation, not an AI algorithm acting in a standalone diagnostic capacity.
- The type of ground truth used: Not applicable, as this primarily concerns physical performance characteristics of an imaging device rather than diagnostic accuracy against a ground truth diagnosis.
- The sample size for the training set: Not applicable, as this is related to physical device performance testing, not an AI model's training set.
- How the ground truth for the training set was established: Not applicable.
The document focuses on demonstrating substantial equivalence to a predicate device (GXS-700 from Gendex Dental Systems) based on technological characteristics and non-clinical performance evaluations, not on meeting specific clinical or diagnostic acceptance criteria through a clinical study. It explicitly states, "Clinical data is not needed to characterize performance and establish substantial equivalence."
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.