(87 days)
The ESX is an extraoral source of X-rays, intended to be used for producing diagnostic dental radiographs for treatment of disease of the teeth, jaw and oral structures.
ESX is an extraoral source dental X-ray system intended for intraoral imaging. It consists of X-ray generator, X-ray controller, beam limiting device, operation panel and mechanical arm. The X-ray controller allows for accurate exposure control, and an adjustable mechanical arm allows for easy positioning. The system can be used either with conventional film or a digital imaging system.
The provided text describes a 510(k) submission for the ESX Dental Extraoral Source X-ray System. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study that proves the device meets specific acceptance criteria through performance metrics.
Therefore, many of the requested categories cannot be directly filled from the provided text as the type of study described (focused on electrical, mechanical, and safety standards) does not involve performance metrics like accuracy, sensitivity, or specificity for diagnostic tasks, nor does it typically involve human readers or ground truth established by experts in the same way an AI/CAD device would.
Here's what can be extracted and inferred from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (as described/implied) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 | All test results satisfactory. |
| Mechanical Safety | Compliance with IEC 60601-1 | All test results satisfactory. |
| Environmental Safety | Compliance with IEC 60601-1 | All test results satisfactory. |
| Performance Safety | Compliance with IEC 60601-1 | All test results satisfactory. |
| Specific Performance Standards | Compliance with IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32 | All test results satisfactory. |
| EMC (Electromagnetic Compatibility) | Compliance with IEC 60601-1-2 | All test results satisfactory. |
Note: The document doesn't provide numerical performance metrics (e.g., accuracy, sensitivity, specificity) for a diagnostic task, as this is an X-ray system, not a diagnostic aid or AI/CAD device. The "performance" refers to the system's ability to operate safely and within technical specifications for an X-ray generator.
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable or not provided in the context of this 510(k) summary. The testing described (electrical, mechanical, safety, EMC) typically involves testing the physical device components and system functionality against established engineering standards, rather than evaluating diagnostic performance on a dataset of patient images. Therefore, "test set" and "data provenance" as applied to diagnostic image analysis are not relevant here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable or not provided. For this type of device (an X-ray system), the "ground truth" for the testing performed relates to established engineering standards (e.g., whether the device outputs the correct voltage, meets insulation requirements, operates safely). It does not involve human experts establishing ground truth for diagnostic image interpretation.
4. Adjudication Method for the Test Set
This information is not applicable or not provided. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human experts when establishing ground truth for diagnostic decisions. Since the testing here is against engineering and safety standards, such adjudication methods are not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done for this submission. This type of study is relevant for evaluating the impact of AI/CAD devices on human reader performance, which is not the purpose of this submission for an extraoral X-ray system.
6. If a Standalone (Algorithm Only Without Human-in-the-loop Performance) Was Done
This information is not applicable. The ESX is an X-ray system, not a diagnostic algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for the testing described in this submission is comprised of established engineering standards and regulatory requirements (e.g., IEC 60601 series standards). The testing verifies that the device's electrical, mechanical, and radiation output characteristics meet these predefined safety and performance specifications. It does not involve expert consensus, pathology, or outcomes data for diagnostic accuracy.
8. The Sample Size for the Training Set
This information is not applicable or not provided. The ESX is a physical X-ray system and does not involve AI or machine learning algorithms that require a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As the device does not employ AI or machine learning, there is no training set and therefore no ground truth establishment for a training set.
§ 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.