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The Portray System is an extraoral X-ray source (intraoral X-ray system for producing diagnostic dental radiographs of the teeth, jav, and other oral structures. The system provides 2D imaging for diagnostic purposes and 3D imaging as an adjunctive tool.

The Portray System, an extraoral X-ray source (intraoral X-ray detection) dental X-ray system, is a nanotechnology-based 2D and 3D extraoral imaging system offering high resolution X-ray image quality and diagnostic accuracy. The 3D image provides a layer-by-layer virtual dissection of the oral cavity when viewed as Tomosynthesis. Alternatively, when viewed as Synthetic 2D, the image provides a rotatable representation of a 2D image taken from the same point in space. 3D images are to be used only as an adjunct to 2D image analysis.

The Portray System is comprised of the following components:

• Computer ●
• User Interface Software ●
• High voltage Electronics ●
• Wall-mount ●
• Articulating Arm .
• X-ray Source Array (Tube) .
• . X-ray Shielding
• X-ray Collimator ●
• Detector Holder ●
• . Intraoral X-ray Detector

The Portray Detector Holder and off-the-shelf detector sleeve are accessories to the Portray System and the sole patient contacting components.

The Portray system will be available in a single, wallmounted configuration.

The Portray system software will support interoperability with electronic patient records and storage of X-ray images in a persistent database located on a Local Area Network (LAN).

The provided document does not contain information about acceptance criteria, reported device performance in a table, or a study specifically designed to demonstrate the device meets acceptance criteria. The document is a 510(k) summary for the Portray System, focusing on demonstrating substantial equivalence to a predicate device.

However, based on the non-clinical performance data section, some aspects relevant to performance evaluation are mentioned. I will extract those that relate to specific quantifiable characteristics typically associated with acceptance criteria, even though explicit "acceptance criteria" values are not stated.

Here's an attempt to structure the information based on your request, identifying what is available in the document and what is not:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly provide a table of acceptance criteria with corresponding reported device performance values. Instead, it lists technical specifications and compares them to a predicate device, noting their substantial equivalence without providing specific performance data for the Portray System against predefined acceptance thresholds.

For example, for "Focal spot size," it states the Portray System's size is 0.7 and the predicate's is 0.4, and then concludes substantial equivalence because the Portray device meets "internal requirements and requirements specified in IEC 61223-3-4 on image resolution." However, the actual thresholds or the Portray System's specific resolution performance are not 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 applicable. The document states, "Assessment of Clinical Data: No clinical data was required to demonstrate substantial equivalence." The non-clinical performance testing does not specify "test sets" in the context of clinical studies 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 applicable, as no clinical data or ground truth establishment by experts for image interpretation is mentioned. The testing was non-clinical performance data (e.g., electrical safety, electromagnetic compatibility, image quality metrics).

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

Not applicable, as no clinical data or expert adjudication is discussed.

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. The document does not describe the Portray System as an AI-assisted device for image interpretation, nor does it mention any MRMC studies. The 3D imaging is stated to be an "adjunctive tool."

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

Not applicable, as the Portray System is an X-ray system for image acquisition, not an algorithm for image analysis per se. Its 3D imaging capability is an "adjunctive tool," indicating it's intended to supplement human review of 2D images.

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

Not applicable, as no clinical studies requiring a ground truth for diagnostic accuracy were performed or reported. Non-clinical performance assessments would use physical measurement standards and established engineering tests (e.g., measuring focal spot size, linearity of air kerma).

8. The sample size for the training set

Not applicable. The document does not describe any machine learning or AI components that would require a training set.

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

Not applicable, as there is no mention of a training set or machine learning components.

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