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The DEXIS sensor is a USB- driven digital sensor which is intended to acquire dental intra- oral radiographic images. The DEXIS sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The DEXIS sensor can be used either in combination with special positioning devices to facilitate positioning and aligmment with the x-ray beam or it may also be positioned by hand with the assistance of the patient.

The DEXIS Sensors are an indirect converting x-ray detector, e.g. incident x-rays are converted by a scintillating material into (visible) light, this light is coupled optically to a light detection imager based on CMOS technology. The design of the sensor assembly supports the automatic detection of the incident x-rays to generate digital images for dental intra oral applications. The DEXIS Sensors support USB2.0 and USB 3.x connectivity to personal computers using a dedicated electronic assembly and a sensor software driver. The software and firmware for the subject device are similar to the software and firmware for the predicate device and both have a Moderate level of concern. The software performs only basic functions of image capture and transfer to a computer. The software does not perform any medical image manipulation such as image enhancements as these are expected to be performed in the dental viewing software(s) used in conjunction with the subject device.

The subject device DEXIS sensor refers to the dental intra-oral detector. The x-ray generator (an essential component for a fullyfunctional dental x-ray system) is not part of the submission.

The provided text is a 510(k) summary for the DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, and DEXIS IXS Size 2 Intraoral Sensor.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets and corresponding reported device performance values in a side-by-side format. However, it does state an important performance metric:

The document also implies that the device must conform to various international and FDA recognized consensus standards for medical electrical equipment, electromagnetic disturbances, usability, biological evaluation, risk management, and evaluation of imaging performance of dental X-ray. The conclusion states that non-clinical performance bench testing was conducted to determine conformance to these standards, implying successful adherence without providing specific numerical thresholds for each.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product."

Therefore, there was no clinical test set, sample size, or data provenance (country of origin, retrospective/prospective) for a study involving patients or real-world clinical data. The evaluation was based on non-clinical bench testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Since no clinical testing was performed, the concept of "ground truth" established by experts in the context of interpreting medical images from a test set does not apply. The performance was evaluated against technical specifications and standards using bench tests.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used that would require adjudication of expert interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted. The document explicitly states that clinical testing has not been conducted. This means there is no data on how human readers might improve with or without AI assistance, as the device is a dental intraoral sensor, not an AI-powered diagnostic tool for interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable in the typical sense of an AI algorithm. The device itself is an imaging sensor. The "algorithm" here refers to the internal processing of the sensor to acquire and transfer digital images, not an AI for diagnosis. The performance evaluation was of the sensor's technical capabilities (e.g., resolution, MTF).

7. Type of Ground Truth Used

For the non-clinical bench testing, the "ground truth" would be the known physical properties and characteristics being measured, as defined by the standards and specifications. For instance, the X-ray resolution was measured against a known standard or ideal resolution target.

8. Sample Size for the Training Set

Not applicable. The DEXIS sensor is a hardware device for acquiring images and is not an AI algorithm that undergoes a "training" phase with a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no training set for an AI algorithm.

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