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The UNIVERSAL-X digital system is used to provide instant digital images of human oral tissue and teeth without the use of a conventional x-ray film. It is used for diagnosis purpose, by dental practitioners.

This is achieved by using the conventional x-ray tube, and placing an electronic sensor in the patients mouth instead of conventional film.

The sensor , upon radiation exposure, automatically captures the images into a computer. The computer , which is not provided by OWANDY , controls all aspects of image acquisition and image display, storage and printing.

Additional software (after, and not part of, image capture software) is available on the market. They allow for enhancements such as zoom, contrasts controls, image inversion, and pseudo color renditions.

The main advantages of this digital imaging system are

• high definition ensuring high-value diagnostics
• interface allowing image processing in the PC

In no case, it has to be used directly by the patient. So, it is used exclusively in a healthcare specific environment.

The UNIVERSAL-X digital system is designed to collect instant images of human oral tissue and teeth without the use of a conventional x-ray film. It is used with a conventional X-ray tube and a Computer for dental radiographic imaging. The Universal-X is covered with a single use disposable sheath and positionned in the oral cavity opposite the tooth the dentists wishes to xray.

The dental X-ray tube (which is not part of Universal-X) is pointed at the sensor and activated.

The emitted radiation from the X-ray tube is detected by the sensor and transmitted as a data stream to the computer system that the device is connected to.

In no case, it has to be used directly by the patient. So, it is used exclusively in a healthcare specific environment.

The UNIVERSAL-X system consists of the following components : the sensor and its cable, a data box, and a PC with sensor adapter. The sensor body is made hermitically sealed shell which encapsulates a black and white CCD. The sensor attaches the processing unit via a 3 meters cable. The outer dimensions are approximately 42.77 X 28.40 mm with rounded edocs.

The datas/USB box relays the data to the computer for display. The data box is a 44.5 mm X 161.2 X 154 mm box with an USB cable connection.

The sensor, when exposed to radiation, captures image in the form of a charge pattern on its surface (CCD). The resulting electronic signals are digitised and sent to a computer for image presentation.

The provided text details a 510(k) summary for a dental imaging sensor, focusing on its substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a study to prove they are met. The document outlines the device's technical characteristics and intended use, asserting its equivalence to existing marketed devices (RVG TROPHY and RSV VISIODENT).

Based on the provided text, it is not possible to construct a table of specific acceptance criteria and detailed device performance metrics, nor can a formal study proving adherence to such criteria be fully described. The document is a regulatory submission for premarket notification, which largely relies on demonstrating substantial equivalence to predicates.

Here's an analysis of what information can be extracted and what is missing:

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

This information is not explicitly provided in the document. 510(k) summaries often do not include specific performance data against pre-defined acceptance criteria, especially for devices seeking clearance based on substantial equivalence. Instead, they typically assert that the device performs as well as or similarly to the predicate devices.

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

This information is not provided. The document makes no mention of a specific test set or data used to evaluate the UNIVERSAL-X. The basis of the submission is substantial equivalence to predicate devices, implying that their performance is the reference point.

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):

This information is not provided. As there's no mention of a specific test set with ground truth established, no details on experts or their qualifications are available.

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

This information is not provided.

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:

This information is not provided. The device is a digital imaging sensor, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.

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

This information is not provided. The device is hardware (a sensor) that captures images for human interpretation, not a standalone algorithm.

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

This information is not provided, as there's no mention of a specific test set requiring ground truth.

8. The sample size for the training set:

This information is not provided. The document describes a digital X-ray sensor, not a machine learning algorithm that typically requires a training set.

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

This information is not provided.

Summary of what is available from the text:

• Device: OWANDY UNIVERSAL-X Dental imaging sensor.
• Intended Use: "to provide instant digital images of human oral tissue and teeth without the use of a conventional x-ray film. It is used for diagnosis purpose, by dental practitioners."
• Predicate Devices: RVG TROPHY (K950532) and RSV VISIODENT (K031448).
• Basis for Clearance: Substantial equivalence to the predicate devices. The document highlights the technological similarities (X-ray sensitive solid-state imaging array (CCD), connection to digitizing electronics and computer interface, intended use with dental X-ray sources for capturing, evaluating, and storing images).
• Regulatory Class: Class II, Product Code MUH.
• Market History of Similar Devices: "Similar devices have been in use in the USA since 1989, and are now well accepted by dentists."

In conclusion, the provided text is a 510(k) summary demonstrating substantial equivalence for a dental imaging sensor. It does not contain the detailed performance study information with explicit acceptance criteria, sample sizes, ground truth establishment, or expert involvement as requested, because its regulatory pathway relies on comparison to already cleared predicate devices.

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