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The WDS X-POD and ZEN-X Digital X-Ray Sensors are intended to capture intraoral digital images when exposed to X-Rays. The process is automatic and transmits the digital image to a personal computer by wireless Bluetooth connection or by USB link. Additional legally marketed components such as conventional X-ray tubes and image capture software that are currently available commercially can be used with the WDS X-POD and ZEN-X Digital X-Ray Sensors.

The X-POD is comprised of the X-POD X-Ray sensitive digital sensor, with cable and connector, to be connected to a hand-held unit. X-POD X-ray Digital Sensor is a CMOS Sensor that receives the X-Ray image and converts it into an electronic format. The X-POD hand-held unit receives the X-ray images from the sensor and stores them on an secure digital card. It includes a color display with touch-screen capability. The display allows the user to check if the X-ray was correctly positioned on the image. It also includes an electronic board which allows the X-POD sensor to communicate with the PC through USB® and Bluetooth® links, and controls the display including the on-board circuits for charge control and monitoring the rechargeable battery. The X-POD handheld unit also includes an SD card to store the images. A Wall mount Battery Charger is used for recharge of the internal battery, or to operate the hand-held unit when the battery level is under a minimum value. The battery charger provides 9VDC, 1.5A. The rechargeable battery pack supplies the electricity to the electronic board and the sensor. The battery compartment is enclosed by a screwmounted panel and can only be replaced by qualified technicians (service). The battery charger is used for fast recharge of the internal battery, or to operate the hand-held unit when the battery level is under a minimum value. The battery charger provides 9VDC, 1.5A. The ZEN-X Sensor consists of the following components which are described in detail below: . ZEN-X Intraoral Sensor - ZEN-X interface . - CD-ROM with software, driver, and manuals . The ZEN-X intraoral sensor receives the X-ray image and converts it to an electronic format. The data from the X-ray image is transmitted from the sensor to the PC through the interface. The image data sent by the X-ray sensor is converted by the interface circuit into standard logic levels for the electronic circuit board to process the image data. The USB interface controls the flow of data and commands between the ZEN-X Interface and the computer. The ZEN-X Interface controls the timing and functions of the image data conversion and transmission.

Here's an analysis of the provided text regarding the acceptance criteria and study for the WDS X-POD and ZEN-X Digital X-Ray Sensors:

Based on the provided text, a formal study demonstrating performance against specific acceptance criteria is not explicitly described. The submission is a Special 510(k), which focuses on modifications to an existing predicate device (WDS Digital X-Ray Sensors, K061114) and argues for substantial equivalence based on design verification and design validation activities rather than a new clinical performance study with predefined acceptance criteria.

The key points from the document are:

• Modification: The primary modification is changing the sensor from a CCD to a CMOS sensor to improve functional performance (more images, ease of use).
• Safety and Effectiveness: "The appropriate design verification and design validation activities were conducted to address the potential risks identified in the Risk Analysis. These activities (discussed in Section 10.2) included electrical safety testing and electromagnetic compatibility testing to ensure that all design requirements were fulfilled. The results confirm that the modified X-POD and ZEN-X are safe and effective for capturing of digital X-ray images."
• Substantial Equivalence: The argument for substantial equivalence is based on the same intended use, principles of operation, and similar overall design, with the differences being "minor and raise no new issues of safety or effectiveness."

Therefore, I cannot populate most of the requested fields because the document does not contain information about a traditional performance study comparing specific acceptance criteria to device performance.

Here's a table summarizing what can be inferred or what is explicitly missing:

Acceptance Criteria and Device Performance for WDS X-POD and ZEN-X Digital X-Ray Sensors

Study Details (Based on available information):

1. Sample size used for the test set and the data provenance: Not explicitly stated. The submission refers to "design verification and design validation activities" and "potential risks identified in the Risk Analysis," but does not detail a specific test set of images or patients.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as a dedicated performance study with expert ground truth establishment for a test set is not described. The evaluation relies on technical testing rather than clinical interpretation.
3. Adjudication method for the test set: Not applicable.
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: Not applicable. This device is a digital X-ray sensor, not an AI-powered diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is an image acquisition component.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the technical tests (electrical safety, EMC), the "ground truth" would be compliance with the respective standards. For image performance, if any objective measures were taken, they are not detailed. It is not based on clinical ground truth like pathology or expert consensus of diagnostic findings.
7. The sample size for the training set: Not applicable. This device is a hardware component and does not involve AI/machine learning training sets.
8. How the ground truth for the training set was established: Not applicable.

Summary of what the document implies about meeting requirements:

The device is not proven to meet acceptance criteria through a clinical performance study with defined metrics. Instead, its safety and effectiveness (and thus, its ability to function acceptably) are inferred through:

• Technical Testing: Electrical safety testing and electromagnetic compatibility testing were performed to confirm compliance with design requirements.
• Substantial Equivalence to Predicate: The core argument is that the new devices are "substantially equivalent" to a previously cleared device (WDS Digital X-Ray Sensors, K061114) because the changes (switching from CCD to CMOS) are considered minor and improve performance without raising new safety or effectiveness concerns. The assumption is that if the predicate device was safe and effective, and the changes are minor and enhance function, the new device will also be safe and effective.

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The Cefla MyRay Hyperion is intended for use in producing panoramic-ray images of the maxillofacial region. It is used for the examination of teeth, the jaw, and oral structures.

The MyRay Hyperion is a panoramic dental X-ray system which consists of a telescopic column, an overhead frame with a horizontal arm where an X-ray source and collimator and an X-ray image detector are mounted, and a console with a keyboard and display. The device includes a patient positioning system that consists of two handles which the patient grasps during exposures, a bite block, a frame for holding the head in the proper position and alignment with laser guide lights. The x-ray source and collimator generate a fan shaped x-ray beam which is projected through the patient's skull by the rotation of the imaging unit. The x-ray image detector allows reconstruction of the diagnostic image, storage of the image in the buffer memory, and transfer of the image to an external PC (not provided by Cefla).

Here's an analysis of the provided text regarding the Cefla MyRay Hyperion, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for the Cefla MyRay Hyperion, a dental panoramic X-ray system. This type of device is an imaging modality. The typical "acceptance criteria" and "studies" you're asking about (e.g., performance metrics like sensitivity/specificity, comparison to ground truth, reader studies) are primarily relevant for AI/CAD devices that provide diagnostic interpretations or assistance.

For a standard X-ray imaging system like the Cefla MyRay Hyperion, the "acceptance criteria" are generally related to its ability to produce clear, diagnostically acceptable images and its functional characteristics meeting established safety and performance standards for medical devices. The "study" for such a device is typically a demonstration of substantial equivalence to existing predicate devices, focusing on technical specifications, image quality, and safety rather than a clinical efficacy trial with human readers.

Therefore, many of your requested points will not be directly applicable or explicitly stated in this type of submission.

Acceptance Criteria and Device Performance for Cefla MyRay Hyperion

Based on the provided 510(k) summary, the device's "acceptance criteria" for regulatory clearance are primarily demonstrating substantial equivalence to predicate devices in terms of intended use, operational characteristics, and technological characteristics, as well as meeting general safety and performance standards. The "study" proving this is the 510(k) submission itself, which compares the new device to established predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Description: This 510(k) pertains to a medical imaging device itself, not an AI or diagnostic software. Therefore, there isn't a "test set" in the sense of a dataset of images used to evaluate diagnostic performance. The "test" for this device involved comparing its technical specifications and image acquisition capabilities to legally marketed predicate devices.
• Provenance: Not applicable in the context of diagnostic performance data. The device was manufactured in Italy.

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

• Not Applicable (N/A): For a panoramic X-ray machine itself, "ground truth" as it applies to diagnostic accuracy of an AI algorithm is not relevant. The device's "ground truth" is its ability to produce images that are physically accurate representations of the maxillofacial anatomy, which is assessed through engineering testing and comparison to functional specifications, not expert consensus on diagnostic findings.

4. Adjudication Method for the Test Set

• N/A: No "adjudication method" for diagnostic interpretation of a test set was performed as this is an imaging device, not a diagnostic AI.

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

• No: An MRMC comparative effectiveness study was not done. These studies are typically conducted for AI/CAD systems to demonstrate improvement in human reader performance with aid. This submission is for an imaging acquisition device.

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

• N/A: This is an imaging device, not a standalone diagnostic algorithm. Its "performance" is its ability to acquire images, not to interpret them without human intervention.

7. Type of Ground Truth Used

• Physical and Technical Specifications: The "ground truth" for this device's evaluation is primarily its adherence to established engineering, safety, and performance specifications for dental panoramic X-ray systems, as well as its ability to produce images comparable in quality to predicate devices. This includes measurements of factors like focal spot size, kVp output, detector characteristics, and image resolution.

8. Sample Size for the Training Set

• N/A: The concept of a "training set" is relevant for machine learning algorithms. This is a medical device for image acquisition, not an AI algorithm, so no training set was used.

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

• N/A: As there's no training set, this question is not applicable.

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