Search Results

The Handheld Dental X-ray System, model XVbeam2000, is indicated for use only by a trained and qualified dentist or dental technician as an extraoral X-ray source to produce diagnostic X-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.

The subject device Handheld Dental X-ray System, model XVbeam2000, is a battery-operated, portable extraoral X-ray source system that is designed to generate X-rays to produce diagnostic quality intraoral X-ray images utilizing intraoral image receptors. The device can be used with three receptor types: film, digital intraoral X-ray sensors, and phosphor plates. The subject device is designed for use in a dental office or similar environments (hospital ward etc.) where appropriate safeguards are implemented. The subject device XVbeam2000 is an X-ray device with a DC generator. The handheld device features a main body (X-ray tube head), rechargeable battery (handset), charger, and charger AC/DC power supply. A beam-limiting cone is incorporated within the device. Internal and external shielding provide sufficient radiation protection to allow the clinician to remain in the operatory with the patient. The power is supplied by a rechargeable Lithium-Ion battery core pack built into a handset. This facilitates portability of the device.

The provided text is a 510(k) summary for a medical device (XVbeam2000 Handheld Dental X-ray System). This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device, not a study proving the device meets specific acceptance criteria through clinical trials or performance studies that would typically generate the requested information.

Therefore, the requested information about acceptance criteria for device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not explicitly available in the provided document. The document focuses on demonstrating substantial equivalence through non-clinical performance testing and compliance with recognized standards.

However, I can extract the information that is present and note where the requested information is not provided.

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing and Compliance with Standards)

The document states that "The test results show that all of the performance specifications have met the acceptance criteria. Verification and validation testing of the device was found acceptable to support the claim of substantial equivalence."

While specific numerical acceptance criteria and reported device performance for individual metrics are not tabulated, the document generally indicates that the device met the requirements of several FDA-recognized consensus standards for medical electrical equipment and X-ray systems.

Here's a table summarizing the general approach taken, as specific performance criteria and reported values are not detailed in the provided text:

Ask a specific question about this device

The digital intraoral X-ray sensors XVD2121 Plus, XVD2530 are intended for any dental practice that uses X-ray equipment for intraoral diagnostic purposes. Each can be used by trained dental professionals for patients receiving intraoral X-ray examinations and produces digital images that can be displayed and archived digitally.

The subject device digital intraoral X-ray sensor, XVD2121 Plus or XVD2530, is used as X-ray receptor to acquire dental X-ray radiographic images in clinical entities. The subject device doesn't emit X-rays. The X-rays are to be generated from X-ray dental machine, a separate device. The subject device can be used by trained dental professionals for patients receiving intraoral X-ray imaging examinations and produces digital images that can be displayed, and archived digitally. To acquire X-ray intraoral radiographic image, first the X-rays are to be generated from the X-ray dental machine and passing through human teeth and surrounding anatomy; then the attenuated X-ray beams are detected by the sensor and subsequently converted into digital data that are to be transmitted to the software (computer). The imaging data are then stored in DICOM format images that can be displayed on the monitor and viewed by dentists.

The subject device digital intraoral X-ray sensor consists of sensor, adaptor, cable, and software (computer or laptop NOT part of the device).

The intraoral sensor detects the incident X-rays and converts X-rays into digital signal or data. The sensor consists of tiny silicon chip-based pixels and their associated electronics encased in a plastic housing. The intraoral sensor is small, thin, flat, rigid rectangular box, usually black in color and similar in size to intraoral film packets. Sensors vary in thickness from about 5 to 7 mm. Sensor is cabled to allow data to be transferred directly from the mouth to the computer (software) via the USB port.

When used clinically the sensor shall be covered with a protective plastic barrier envelope for infection control purposes. New sheath is required for each new patient and must be disposed of after patient use. One usually slide the sensor into the sheath to provide a secure barrier around the sensor. The protective cover sheath is disposable and is a separate device, NOT a part of this device.

To acquire the intraoral X-ray radiographic images, the sensor (with sheath) is placed inside the mouth as X-ray receptor. First the X-rays are to be generated from the dental X-ray generating machine outside of the mouth. The X-rays pass through and are attenuated by tooth/teeth and surrounding anatomy; the attenuated X-rays are detected by the sensor and then converted into digital data that are to be transmitted to the software (computer).

The digital data are then stored in DICOM format image that can be displayed on the monitor and viewed by dentists. The key clinical feature of intraoral sensor is the rapid availability of the image after exposure. The sensor is utilized as X-ray receptor, and does NOT emit X-rays. The X-ray generating equipment is a separate device. NOT a part of subject device.

The physical size of model XVD2530 is 31.5mm * 38.5mm, while that of model XVD2121 Plus is 26.5mm * 32mm. The effective imaging area of model XVD2530 is 29.5mm * 24.6mm, while that of model XVD2121 Plus is 20.0mm * 19.8mm. The differences between model XVD2121 Plus and model XVD2530 are the physical sizes and effective imaging areas. Otherwise model XVD2121 Plus and model XVD2530 are exactly same device. Different size is offered to better fit with size of oral cavity of individual patient and different anatomic region, such as posterior teeth or anterior teeth.

The provided text describes a 510(k) summary for a medical device cleared by the FDA, primarily focusing on proving its substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria in a typical clinical trial sense.

This document is a premarket notification (510(k)) to the FDA, which generally focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. This is different from a Post-Market Approval (PMA) application, which typically requires rigorous clinical trials to demonstrate safety and effectiveness for a novel device.

Therefore, the information regarding specific acceptance criteria and detailed study results that "prove the device meets acceptance criteria" for clinical performance, as one might expect from a full clinical trial, is limited or not present in the provided text. The testing described is primarily non-clinical performance testing to verify functionality and safety, and bench testing for image quality and electrical safety, to support substantial equivalence.

Based on the provided text, here's an attempt to answer your questions:

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

The document does not provide a specific table of "acceptance criteria" for clinical performance. Instead, it lists technical specifications and performance characteristics compared to a predicate device. The general "acceptance criteria" are implied to be that the device performs functionally and safely at a level comparable to the predicate device and meets relevant industry standards.

Here's a table primarily extracting the technical specifications and reported characteristics that would serve as a proxy for performance criteria in this context of a 510(k) submission, comparing the subject device to the predicate:

The Study Proving Acceptance Criteria:

The document explicitly states: "Clinical data is NOT required for a finding of substantial equivalence." (Section 13). Therefore, the "study" proving the device meets acceptance criteria regarding clinical performance is not a full-scale clinical trial.

Instead, the "study" is a series of non-clinical performance testing (bench testing, phantom tests, system validation/verification), electrical safety, EMC, and software testing, as described in sections 8, 9, 10. The goal of these tests is to demonstrate that the device performs functionally and safely in a manner comparable to the predicate device and meets recognized consensus standards.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated as a number of patient cases or images for clinical evaluation, because no clinical study was performed. The "test set" pertains to the non-clinical and bench testing. For phantom tests and system validation, the "sample size" would refer to the number of tests performed on the physical devices/software, but these quantities are not specified in the summary.
• Data Provenance: The document does not specify the country of origin for the non-clinical test data. It is implied to be from the manufacturer's own testing facilities.
• Retrospective or Prospective: Not applicable, as there was no clinical data collection of patient images described. The non-clinical testing would be prospective (tests conducted at the time of device development).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable, as there was no clinical study involving expert readers to establish ground truth for a test set of patient images.
• Qualifications of Experts: N/A.

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

• Adjudication Method: Not applicable, as there was no clinical study involving multiple readers and adjudication of findings.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The device described is an intraoral X-ray sensor (hardware), not an AI-powered diagnostic tool for image interpretation. Therefore, the concept of "human readers improving with AI assistance" is not relevant to this device's submission.

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

• Standalone Performance: Not applicable in the context of an "algorithm only" performance, as this device is a hardware sensor, not a standalone AI algorithm. The image quality and technical specifications (e.g., spatial resolution, low contrast resolution, gray scale) can be considered "standalone" performance characteristics of the hardware and its associated software for image acquisition and display. These were evaluated through non-clinical bench testing.

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

• Type of Ground Truth: For the non-clinical performance testing, the "ground truth" would be established by physical measurements against known standards (e.g., phantom test results, resolution charts, electrical safety parameters) and engineering specifications. There is no mention of clinical ground truth (e.g., expert consensus, pathology) for patient data, as no clinical study was conducted.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is a hardware sensor. While it has embedded software, the document describes it as a "hardware-based device that incorporates software" (Section 10). There is no indication of a machine learning or AI component that would require a "training set" of data in the typical sense for a clinical imaging algorithm.

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

• How Ground Truth for Training Set was Established: Not applicable, as there is no mention of an algorithm requiring a training set in the document.

Ask a specific question about this device