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K Number
K230998
Device Name
Digital Wireless Intraoral X-Ray Sensor
Manufacturer
iRay Imaging Technology (Haining) Limited
Date Cleared
2023-10-20

(196 days)

Product Code
MUH
Regulation Number
872.1800
Type
Special
Panel
RA
Reference & Predicate Devices
K210312
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Digital Wireless Intraoral X-Ray Sensor (Pluto0002XW) 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.

Device Description

The Pluto0002XW Digital Wireless Intraoral X-Ray Sensor (Hereinafter referred to as Pluto0002XW) contains the digital intra-oral sensor. It features a 20um pixel pitch CMOS sensor with directly deposited CsI:Tl scintillator which ensures optimal resolution.

The major function of the Pluto0002XW is to convert the X-ray to digital image, with the application of high resolution X-ray imaging. Pluto0002XW 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 iRay intra-oral software (iRayDR) is part of the system, it is used to acquire, enhance, analyze, view and share images from the sensor.

AI/ML Overview

This FDA document, K230998, is a 510(k) summary for a Digital Wireless Intraoral X-Ray Sensor. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive performance studies against specific acceptance criteria for diagnostic efficacy. Therefore, much of the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in terms of clinical performance and AI-assistance aspects (e.g., MRMC studies, standalone AI performance) is not present as this device is a hardware component (X-ray sensor) and not an AI/ML-driven diagnostic software.

However, based on the provided text, we can glean information about the non-clinical studies performed to demonstrate safety and effectiveness for substantial equivalence.

Here's an attempt to answer your questions based solely on the provided text:

Acceptance Criteria and Device Performance (Non-Clinical)

The document does not present a table of acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) as it's not a diagnostic AI device or a comparative clinical study for human interpretation. Instead, the "acceptance criteria" can be inferred from the standards the device was tested against for safety, electromagnetic compatibility (EMC), wireless functionality, cybersecurity, and biocompatibility. The "reported device performance" is simply that the device "meet[s] the standard requirements" for these tests.

No explicit quantitative acceptance criteria or reported performance for diagnostic accuracy, sensitivity, or specificity are provided because this device is an imaging sensor, not a diagnostic algorithm that interprets images.

Study Details (Non-Clinical as reported in the 510(k) summary)

  1. A table of acceptance criteria and the reported device performance:

    Acceptance Criterion (Inferred from Standard Compliance)Reported Device Performance (Summary Statement)
    Electrical Safety (IEC/ES 60601-1, IEC60601-2-65)"All test results are meet the standard requirements."
    EMC Testing (IEC 60601-1-2)"All test results are meet the standard requirements."
    Wireless Functionality & Coexistence (ANSI IEEE C63.27-2017)"All test results are meet the standard requirements."
    Cybersecurity (Federal Food, Drug, and Cosmetics Act section 524B(b)(2))"...to provide a reasonable assurance that the subject device with its wireless capabilities are cybersecure."
    Biocompatibility (ISO10993-1)"the evaluation results and test result assured the safety the same as the predicate device."

  2. Sample sizes used for the test set and the data provenance:

    • Not applicable for clinical performance data. The document describes non-clinical engineering and safety tests. Thus, "sample size" would refer to the number of devices or test conditions, which are not specified in detail.
    • Data Provenance: Not specified, but generally, these tests are conducted in certified labs (often in the country of manufacture, China in this case, or by accredited third-party labs). The testing is prospective for the purpose of the 510(k) submission.

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • Not applicable. This relates to clinical diagnostic interpretation by experts, which is not evaluated for this hardware device.

  4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

    • Not applicable. This relates to clinical diagnostic interpretation.

  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

    • No, an MRMC study was not done. This device is an X-ray sensor, not an AI diagnostic tool. The document does not describe any human reader studies, with or without AI assistance.

  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • No, a standalone algorithm performance study was not done. This device is hardware.

  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

    • Not applicable for clinical diagnostic ground truth. For the non-clinical tests, the "ground truth" is compliance with the specified international and national safety and performance standards (e.g., IEC, ANSI IEEE, ISO).

  8. The sample size for the training set:

    • Not applicable. This pertains to AI/ML model training, which is not mentioned for this device.

  9. How the ground truth for the training set was established:

    • Not applicable. This pertains to AI/ML model training, which is not mentioned for this device.

In summary: The provided FDA document (a 510(k) summary) for the Digital Wireless Intraoral X-Ray Sensor focuses on demonstrating substantial equivalence through non-clinical performance and safety testing. It does not contain information related to clinical diagnostic performance, AI performance, or human-reader studies, as the device is a data acquisition component (X-ray sensor), not a diagnostic interpretation tool or AI software.

§ 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.