Search Results

Digital intraoral X-ray Imaging System, models i-Sensor H2, are used in conjunction with dental Radiography in medical units. The product is used for dental X-ray examination, the diagnosis of structural diseases of teeth, jaws and mouth. 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 Digital intraoral X-ray Imaging System, models i-Sensor H1 and i-Sensor H2, are 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 hispeed direct USB interface enables a simple connection to a PC without need for an additional control box. The optional intra-oral software application makes it easy to acquire, enhance, analyze, view and share images from the sensor. The major function of i-Sensor H1 and i-Sensor H2 are 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 is a 510(k) summary for a Digital Intraoral X-ray Imaging System. It describes non-clinical testing performed to establish substantial equivalence to a predicate device. However, it explicitly states that clinical data is not needed to characterize performance and establish substantial equivalence. Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria based on human-in-the-loop performance or diagnostic accuracy.

The document focuses on non-clinical performance characteristics to demonstrate substantial equivalence through technical specifications and comparison to the predicate device.

Here's a breakdown of the requested information based on the provided text, highlighting where information is not present due to the nature of the submission:

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

The document does not present a formal table of acceptance criteria for diagnostic performance against a ground truth and reported device performance against those criteria. It does list several non-clinical tests and states that "All test results are meet the standard requirements." and "the results have shown that the i-Sensor H1 & i-Sensor H2 are substantially equivalent to the predicate devices". These statements imply that the acceptance criteria for these non-clinical tests were that the device's performance met the relevant standard requirements or was equivalent to the predicate.

Here are the non-clinical tests mentioned and the general statement of their performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No clinical test set or data from human subjects was used. The submission states, "Clinical data is not needed to characterize performance and establish substantial equivalence." This implies no test set of patient data was used for diagnostic performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical test set was used, and thus no expert ground truth establishment for diagnostic purposes was performed.

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

Not applicable. No clinical test set was used.

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

Not applicable. The device is a "Digital Intraoral X-ray Imaging System" (hardware), not an AI-assisted diagnostic software. No MRMC study was mentioned or performed.

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

This refers to an "algorithm only" performance. Since the device is a hardware imaging system, this isn't directly applicable in the sense of a diagnostic algorithm's standalone performance. The non-clinical tests (e.g., MTF, spatial resolution) demonstrate the inherent image quality capabilities of the device itself, which could be considered its "standalone" performance characteristics as an imaging system.

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

For the non-clinical tests: The "ground truth" was established by engineering standards, physical measurements, and comparison to the predicate device's established performance specifications. For instance, spatial resolution would be measured against a known standard.

8. The sample size for the training set

Not applicable. The provided document details a hardware device. If there is a "software Ai-Dental" mentioned, it seems to be an image acquisition/enhancement software rather than a diagnostic AI that would require a training set in the typical sense (for supervised learning on disease detection). The document discusses the software's compliance with design specifications and test cases, not its training data.

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

Not applicable, as there's no mention of a diagnostic AI algorithm requiring a training set.

Ask a specific question about this device

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:

1. 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.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. 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.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not mentioned.
6. 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.
7. 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.
8. 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.
9. 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."

Ask a specific question about this device

The Planmeca Dixi is a Digital Intraoral X-ray Imaging System, which is an accessory to Intraoral X-ray devices, i.e. extraoral source x-ray systems with intraoral image receptors. It is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The Dixi is using intraoral x-ray sensor technique, with images displayed on a monitor, and image manipulation, archiving and communication are performed via a computer.

The Planmeca Dixi is a Digital Intraoral X-ray Imaging System, which is an accessory to Intraoral X-ray devices, i.e. extraoral source x-ray systems with intraoral image receptors. The Dixi is using intraoral x-ray sensor technique, with images displayed on a monitor, and image manipulation, archiving and communication are performed via a computer.

I am sorry, but the provided text from the FDA letter and the "Indications for Use" enclosure from Planmeca OY, while related to regulatory approval for a dental X-ray system, does not contain the specific information required to answer your request regarding acceptance criteria and a detailed study proving device performance.

The documents focus on:

• The FDA's decision of substantial equivalence for the Planmeca Dixi system to a predicate device.
• The general regulatory class and applicable regulations.
• The intended use of the device for dental radiographic examination and diagnosis.

There is no mention of:

• Specific acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy).
• Details of a study conducted to prove the device meets such criteria.
• Sample sizes, data provenance, expert qualifications, or ground truth methodologies for any performance study.
• Information about MRMC studies, standalone algorithm performance, or training set details.

Therefore, I cannot generate the table or provide the detailed answers to your numbered points based on the provided text.

Ask a specific question about this device