(48 days)
The intended use of the Progeny Imaging software is to act as a diagnostic imaging display of digitally acquired dental x-ray images. The software can also display images from intra oral video cameras.
The Progeny, Inc. Progeny Imaging Software is a diagnostic imaging display of digitally acquired dental x-ray images. The software can also display images from intra oral video cameras.
Here's an analysis of the provided text regarding the Progeny Imaging Software's acceptance criteria and study information.
It's important to note that this 510(k) summary is for a software display system and not an AI-powered diagnostic device. Therefore, many of the typical acceptance criteria and study components for AI medical devices (like sensitivity, specificity, reader studies, ground truth establishment using expert consensus or pathology) are not present or applicable in the provided document. The focus is on demonstrating substantial equivalence to existing predicate devices for image display functionality.
Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not contain a formal table of acceptance criteria with specific quantitative performance metrics like sensitivity, specificity, or AUC, as these types of metrics are typically associated with diagnostic algorithms or AI. Instead, the acceptance criteria are implicitly defined by demonstrating equivalence to predicate devices in terms of functionality and safety, as well as meeting product specifications and undergoing software testing.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Functional Equivalence: | |
| - Display Dental X-rays | Yes (Displays dental x-rays) |
| - Display Intra-oral images | Yes (Displays intra-oral images) |
| - PC Compatible | Yes (PC compatible) |
| - USB Support | Yes (Has USB support) |
| - Ethernet Support | Yes (Has Ethernet support - note: predicate devices did not have this, but it doesn't indicate non-equivalence) |
| - Operating System Compatibility | Windows XP compatible |
| - Display Resolution (SVGA equivalent or better) | SVGA |
| Safety and Effectiveness: | |
| - Meet product specifications | Verified |
| - Software design validation | Validated |
| - Performance validation | Validated |
| - Hazard analysis and risk assessment | Completed |
| - Same Indications for Use as Predicates | Yes |
Study Details (Based on the provided 510(k) summary)
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Sample size used for the test set and the data provenance:
The document does not specify a test set in the context of evaluating diagnostic performance from patient data. The "performance testing and verification to meet product specifications" would have involved testing the software against a variety of inputs and scenarios, but the number of images or cases used for this is not detailed, nor is the provenance of any data used for functional testing. Given it's a display software, such "test sets" would likely refer to various image formats, sizes, and simulated user interactions rather than a clinical dataset for diagnostic accuracy. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable / not provided. As it's a software display system, there is no "ground truth" in the diagnostic sense needed for clinical evaluation. The ground truth for functional verification would be whether the software correctly displays images as expected, which is determined by technical specifications, not expert clinical consensus. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable / not provided. No clinical ground truth adjudication method is mentioned or required for this type of device. -
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. This type of study is relevant for AI-powered diagnostic aids, which this device is not. The device is a display system, not an AI or diagnostic tool. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is not applicable in the context of diagnostic performance. The device is a standalone software component that displays images. Its "performance" is whether it correctly displays images, which is evaluated against its technical specifications, not clinical diagnostic metrics. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
As previously noted, the concept of clinical "ground truth" (e.g., from pathology or expert consensus) is not applicable to this device. The "ground truth" for the software's functionality would be its defined specifications (e.g., "display image A correctly," "allow zoom function B," etc.). -
The sample size for the training set:
This information is not applicable / not provided. This device is not an AI algorithm that undergoes training on a dataset. It is a software program developed to perform specific display functions. -
How the ground truth for the training set was established:
This information is not applicable / not provided. As explained above, there is no AI training set for this device.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.