Search Results

The OpenSensorX Series 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.

OpenSensorX series are digital intra-oral sensors. 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 optional iRay intra-oral software application makes it easy to acquire, enhance, analyze, view and share images from the sensor. The major function of the OpenSensorX 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 OpenSensorX series has two device models, OpenSensor0001X and OpenSensor0002X.

The provided text does not contain detailed information about specific acceptance criteria and a study that proves the device meets those criteria in a structured format. The document is primarily a 510(k) summary for the OpenSensorX Series, focusing on establishing substantial equivalence to a predicate device. It describes general non-clinical studies and states that clinical data is not needed.

However, I can extract the non-clinical considerations from Section 9, which lists performance parameters tested against standard requirements to establish substantial equivalence. These can be interpreted as implicit acceptance criteria for maintaining equivalence with the predicate device.

Here's the information extracted and organized to best fit your request:

Acceptance Criteria and Device Performance

The "Nonclinical Considerations" section (Section 9.3) outlines various performance aspects that were tested to demonstrate substantial equivalence to the predicate device (DentiMax Digital X-ray Imaging System, K092547). While the specific acceptance values are not always explicitly stated (e.g., "meet standard requirements" or "assured the same as the predicate device"), the reported performance indicates that the OpenSensorX series meets or is substantially equivalent to the predicate for these criteria.

Study Details

The provided text describes non-clinical studies performed to establish substantial equivalence, rather than a clinical study or a comparative effectiveness study with human readers.

1. Sample size used for the test set and the data provenance: Not explicitly stated for each non-clinical test. The tests are described generally (e.g., "Electrical, mechanical, environmental safety and performance testing"). The product is an intraoral X-ray sensor; thus, the "test set" would refer to the physical devices themselves and the images generated by them under various conditions, rather than a dataset of patient images in the typical sense of AI/clinical studies. Data provenance is not specified beyond being "non-clinical."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The studies mentioned are primarily engineering and performance tests (e.g., electrical safety, EMC, sensor performance metrics). Ground truth, in this context, would be established by validated test equipment and standard measurement protocols.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to consensus methods for expert interpretation, which is not relevant for the described non-clinical performance and safety tests.

4. 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. The document explicitly states: "Clinical data is not needed to characterize performance and establish substantial equivalence." This indicates no clinical study, and therefore no MRMC study, was performed. The device is an image acquisition sensor, not an AI-assisted diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, in effect. The performance metrics (MTF, SNR, uniformity, etc.) are inherent characteristics of the device itself, measured objectively without human interpretation or intervention in the measurement process. The software component also underwent verification and validation tests independently.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical performance tests, the "ground truth" is based on established engineering standards, physical measurements, and comparison to the performance specifications of the predicate device. For biocompatibility, it's based on ISO 10993-1. For software, it's based on predefined requirements and design specifications.

7. The sample size for the training set: Not applicable. This device is an X-ray sensor, not an AI/ML algorithm that requires a training set in the conventional sense. The software mentioned (iRayDR) handles image acquisition, enhancement, analysis, and viewing, implying more traditional software engineering and validation rather than machine learning.

8. How the ground truth for the training set was established: Not applicable, as there is no mention of a training set for an AI/ML algorithm.

Ask a specific question about this device