Search Results

The Veraviewepocs Panoramic/Cephalometric X-ray Unit With Digital Image Function is an extraoral source X-ray unit that is used for dental radiographic examination and diagnosis of teeth, jaw, and oral structure by exposing an X-ray image receptor to ionizing radiation, with an optional cephalometric capability, and a digital imaging capability for taking both panoramic and cephalometric images.

The Veraviewepocs Panoramic/Cephalometric X-ray Unit With Digital Image Function is an extraoral source X-ray unit that is used for dental radiographic examination and diagnosis of teeth, jaw, and oral structure by exposing an X-ray image receptor to ionizing radiation, with an optional cephalometric capability, and a digital imaging capability for taking both panoramic and cephalometric images.

The provided text describes the 510(k) summary for the "J. Morita Manufacturing Corporation's Veraviewepocs Panoramic/Cephalometric X-ray Unit With Digital Image Function". However, this document does not contain specific acceptance criteria, performance data, or details of a study that directly proves the device meets acceptance criteria.

Instead, the document focuses on:

• Substantial Equivalence: It claims substantial equivalence to previously cleared predicate devices based on intended use, principle of operation, and technological characteristics.
• Compliance with Standards: It states that the device was tested and complied with UL2601-1 and IEC 60601-1, and will comply with 21 C.F.R. Subchapter J and successfully passed image quality testing.
• Software Validation: It mentions a software validation report describing development processes, requirements, hazard analysis, and certification of adherence to procedures.
• Biocompatibility: It addresses the use of biocompatible materials.

This 510(k) summary is a regulatory submission demonstrating substantial equivalence, not a detailed study report for meeting specific performance acceptance criteria. Therefore, most of the requested information cannot be extracted directly from the provided text.

Here is what can be inferred or stated based on the document:

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

• Acceptance Criteria: The document implies acceptance criteria are related to compliance with safety standards (UL2601-1, IEC 60601-1, 21 C.F.R. Subchapter J), successful software validation, and image quality testing. However, specific quantitative acceptance criteria (e.g., minimum resolution, SNR, DQE values, tolerance for geometric distortion) are not provided.
• Reported Device Performance: The document states the device "complied with the applicable requirements" for safety standards and "passed the image quality testing." No specific performance metrics or values are reported.

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

• Not provided. The document states "The modified Veraviewepocs was tested" and "passed the image quality testing," but gives no details about the sample size (e.g., number of images, number of patients, number of components tested) or the provenance of any data.

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)

• Not provided. The document does not mention the use of experts for establishing ground truth, as it is primarily focused on technical compliance and substantial equivalence rather than diagnostic performance evaluation by experts.

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

• Not provided. This information is typically relevant for studies involving human interpretation and consensus, which is not described here.

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

• No, an MRMC comparative effectiveness study was not done or reported. This device is an X-ray unit, not an AI-assisted diagnostic tool.

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

• Irrelevant/Not applicable. This device is an imaging hardware unit, not a standalone algorithm. The software mentioned is for controlling the device and processing the images, not for automated diagnostic interpretation.

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

• Not provided/Implicit through compliance standards. For "image quality testing," the ground truth would likely be defined by objective metrics and technical specifications (e.g., MTF, spatial resolution, contrast-to-noise ratio measured against phantoms or reference images) rather than medical interpretations like expert consensus or pathology. No details are given.

8. The sample size for the training set

• Not applicable. This device is a hardware X-ray unit with associated operational software, not a machine learning model that requires a "training set" in the conventional sense. The "software validation" refers to verifying that the software meets its specified requirements and functions correctly, not to training an AI model.

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

• Not applicable. See point 8.

Ask a specific question about this device

The Veraviewepocs Panoramic X-ray Unit with Cephalometric Capability that is the subject of this 510(k) is an extraoral source X-ray unit that is used for dental radiographic examination and diagnosis of teeth, jaw, oral structure, TM-joints and skull by exposing an X-ray image receptor to ionizing radiation.

The Veraviewepocs Panoramic X-ray Unit is an FDA-cleared extraoral source X-ray unit that it used for dental radiographic examination and diagnosis of teeth, jaw, and oral structure by exposing an X-ray image receptor to ionizing radiation (K#013955). The modified Veraviewepocs covered by this submission simply adds a cephalometric capability to the existing device. In addition to manual settings, the modified Veraviewepocs also has an "auto exposure" feature in the cephalometric mode. Exposure time is automatically adjusted depending on the patient's size, and the device is set at 80 kV and 10mA. A sensor behind the cephalometric cassette measures the amount of x- radiation, and the exposure is terminated once the accumulated x-radiation reaches a certain level.

The provided text describes a 510(k) summary for the J. Morita Manufacturing Corporation's Veraviewepocs Panoramic X-ray Unit with Cephalometric Capability. However, it does not contain specific acceptance criteria or a dedicated study section detailing performance metrics, sample sizes, expert qualifications, or ground truth establishment relevant to the device's diagnostic performance.

The document focuses on:

• Substantial Equivalence: Comparing the modified Veraviewepocs (with cephalometric capability) to predicate devices (Instrumentarium Corporation Imaging Division's Orthopantomograph OP100 and ORTHOCEPH OC 100).
• Technological Characteristics: Describing the added cephalometric feature and its "auto exposure" functionality.
• Safety and Compliance: Stating that the device complies with electrical safety standards (UL2601-1, IEC 60601-1), software validation, and biocompatibility for materials.
• Intended Use: Broadly for dental radiographic examination and diagnosis.

Therefore, I cannot populate the requested tables and information regarding acceptance criteria, device performance, study details, or ground truth as this information is not present in the provided text. The document primarily attests to regulatory compliance and substantial equivalence rather than a detailed clinical performance study.

Ask a specific question about this device

The Orthophos 3/3 Ceph/3 DS is an extraoral x-ray system intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The system allows for panoramic tomographic imaging and teleradiography.

The Orthophos 3/3 Ceph/3 DS is an extraoral x-ray system.

This appears to be a 510(k) clearance letter from the FDA for a dental X-ray system (Orthophos 3/3 Ceph/3 DS), issued in 1999. This type of document typically focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a robust study proving performance as one might find for a novel AI/software as a medical device (SaMD) cleared under a different pathway or with more recent guidance.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth types is not available within the provided text segments. The FDA 510(k) process primarily relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through a comparison of technological characteristics and intended use, rather than requiring extensive clinical performance studies with detailed acceptance criteria as would be expected for a novel AI device today.

To answer your questions based only on the provided text:

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

• Not Available. The document does not describe specific performance acceptance criteria for the Orthophos 3/3 Ceph/3 DS or report its performance against such criteria. It states that the device is "substantially equivalent" to predicate devices.

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

• Not Available. The document does not describe any specific test set, its sample size, or data provenance.

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)

• Not Available. The document does not describe the establishment of a ground truth for a test set.

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

• Not Available. The document does not describe any test set or adjudication method.

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

• Not Applicable / Not Available. This device is a traditional X-ray system, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not have been conducted. The document does not mention any MRMC studies.

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

• Not Applicable / Not Available. This device is hardware (an X-ray system), not a standalone algorithm. The document does not describe any standalone algorithm performance testing.

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

• Not Available. The document does not refer to ground truth data.

8. The sample size for the training set

• Not Available. The document does not describe any training set as this is an X-ray system, not an AI model.

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

• Not Available. The document does not describe any training set or its ground truth establishment.

In summary, the provided FDA 510(k) clearance letter for the Orthophos 3/3 Ceph/3 DS, being from 1999 and for a conventional X-ray device, does not contain the detailed performance study information typically required for modern AI/ML medical devices. The focus of this type of clearance is demonstrating substantial equivalence to a pre-existing device.

Ask a specific question about this device