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

The DEXIS sensor is 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 sensor supports USB 2.0 and USB 1.1 connectivity to personal computers using a dedicated electronic assembly and a sensor software driver.

The provided text is a 510(k) Summary for the DEXIS Sensor, a digital X-ray device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them. It doesn't detail:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a "test set."
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study, or effect size of human improvement with AI.
6. Standalone performance of an algorithm without human-in-the-loop.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a study.
8. Sample size for a training set.
9. How ground truth for a training set was established.

Instead, the document asserts substantial equivalence by comparing the DEXIS Sensor's characteristics and intended use to two legally marketed predicate devices: Schick Technologies, CDR (K072134) and Suni Medical Imaging, Inc., SuniRay II Digital Radiographic System (K070219).

The key comparison points in the "Substantial Equivalence" table are:

• Indications for Use: All three devices are for acquiring dental intra-oral radiography images, to be operated by healthcare professionals.
• Number of Sensors: DEXIS Sensor has 1, CDR has 3, SuniRay II has 2.
• Sensor Size (mm): DEXIS is 30 x 39; CDR has sizes 31 x 22, 37 x 24, 43 x 30; SuniRay II has sizes 39.5 x 26, 43.5 x 31.5.
• Technology: All three use CMOS.
• Interface to PC: All three use USB.
• Dynamic Range: DEXIS Sensor has 16,384:1; both predicates have 4096:1. (The DEXIS Sensor exceeds the predicate devices in this specification, which is generally considered a positive attribute.)
• Sensor Cable Length (m): DEXIS is 2.8; CDR is 2; SuniRay II is 1.

The conclusion drawn in the document is that the DEXIS Sensor is "substantially equivalent in intended use and technical characteristics" to the predicate devices. This type of submission does not typically include the detailed clinical study information requested.

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