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The KRYSTAL-X WiFi 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 (which is a third party device, not part of Krystal-X WiFi), and placing an electronic sensor in the patients' mouth instead of conventional film. The sensor, upon radiation exposure, automatically captures instantaneously and transmits the images by WiFi to the computer. The computer and imaging software (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, and reduction of X-rav dosage. In no case, is it to be used directly by the patient. So, it is used exclusively in a healthcare specific environment. The WiFi device modification to our model Krystal-X in no way alters the indications for use of this device beyond what was originally approved in K053172.

Krystal-X WiFi is a wireless digital X-ray sensor for intraoral radiography.

This 510(k) submission primarily focuses on establishing substantial equivalence for the Krystal-X WiFi, a wireless digital X-ray sensor, by comparing it to previously cleared devices. It does not present a study with specific acceptance criteria and reported device performance in a robust fashion that would allow for a detailed answer to all your points.

The document states: "The proposed and the predicated devices are substantially equivalent." and "The only difference is the method of communication between the sensor and the computer from a wired to a wireless interface." This approach means that a new comprehensive study with acceptance criteria is typically not required if the changes are deemed minor and do not alter the fundamental safety and effectiveness of the device.

However, I can extract information related to what would be the context if such a study were present, based on the provided text.

Here's a breakdown of the requested information, indicating where the document lacks specific details:

1. Table of Acceptance Criteria and Reported Device Performance

This information is NOT PRESENT in the provided document. The 510(k) focuses on substantial equivalence based on similarity to predicate devices, not on a new, explicit study with defined acceptance criteria and performance metrics.

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

This information is NOT PRESENT in the provided document, as no specific performance study with a test set is detailed.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is NOT PRESENT in the provided document, as no specific performance study with ground truth established by experts is detailed.

4. Adjudication Method for the Test Set

This information is NOT PRESENT in the provided document, as no specific performance study with an adjudication method is detailed.

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

This information is NOT PRESENT in the provided document. The submission does not describe an MRMC study comparing human readers with and without AI assistance. The device itself (Krystal-X WiFi) is an imaging sensor, not an AI-assisted diagnostic tool.

6. Standalone Performance Study (Algorithm Only)

This information is NOT PRESENT in the provided document. The device is an image capture sensor, and the document clarifies that "The computer and imaging software (which is not provided by OWANDY) controls all aspects of image acquisition and image display, storage and printing." Therefore, a standalone algorithm performance study for this specific device would not be applicable or described here.

7. Type of Ground Truth Used

This information is NOT PRESENT in the provided document, as no specific performance study requiring ground truth is detailed. For intraoral imaging, ground truth for diagnostic accuracy would typically involve clinical diagnosis or potentially pathology if biopsies were taken, but this is not discussed here.

8. Sample Size for the Training Set

This information is NOT PRESENT in the provided document. The 510(k) submission does not describe any machine learning or AI component that would require a "training set."

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

This information is NOT PRESENT in the provided document, as there is no mention of a training set or AI/machine learning.

Summary of the 510(k) Approach in the Provided Document:

The 510(k) for Krystal-X WiFi relies on establishing "substantial equivalence" to previously cleared devices. This means that instead of conducting a new, full-scale performance study against specific acceptance criteria, the manufacturer argues that their device is safe and effective because it is fundamentally similar to devices already on the market.

Key aspects contributing to this argument are:

• Similar components and design: "The proposed and predicated devices use similar components and are similar in design, technical characteristics and mode of operation."
• Minor modification: The "only difference is the method of communication between the sensor and the computer from a wired to a wireless interface."
• Predicate devices: Comparison to (WDS X-RAY, ACCENT, CDR Wireless, KRYSTAL-X - an earlier wired version from the same company).
• No alteration to intended use: "The WiFi device modification...in no way alters the indications for use of this device beyond what was originally approved in K053172."

Therefore, the acceptance criteria and study details you requested for a new performance study are not applicable to how this particular 510(k) approval was likely achieved.

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