(91 days)
The PORT-X II Portable X-Ray system is intended to be used by trained dentists and dental technicians as an extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.
PORT-X II is a portable dental X-ray system that operates on 22.2VDC supplied by a rechargeable Li-Polymer battery pack. The X-ray tubehead, X-ray controls, and power source are assembled into a single hand-held enclosure. The package includes spare batteries, a battery charger. This equipment generates and controls X-ray in order to diagnose of hand, tooth and jaw. It is composed of X-ray generator, controller and beam limiting device.
The provided 510(k) summary for the GENORAY Co., Ltd. Portable X-Ray System (PORT-X II) primarily focuses on establishing substantial equivalence to a predicate device and demonstrating compliance with safety and performance standards rather than presenting a detailed study with specific acceptance criteria related to diagnostic accuracy or clinical effectiveness. Therefore, many of the requested criteria for a study proving device performance are not explicitly available in the provided text.
Here's an analysis based on the information given, and where information is missing, it will be noted.
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) or device performance related to image quality or clinical outcomes. Instead, it focuses on compliance with established safety and electrical standards.
| Acceptance Criteria (Derived from Compliance) | Reported Device Performance |
|---|---|
| Compliance with UL/IEC 60601-1 (General medical electrical equipment safety) | Will comply (stated intention) |
| Compliance with IEC 60601-2-7 (Medical electrical equipment - X-ray generators for diagnostic use) | Will comply (stated intention) |
| Compliance with IEC 60601-2-28 (Medical electrical equipment - Diagnostic X-ray source assemblies) | Will comply (stated intention) |
| Compliance with IEC 60601-2-32 (Medical electrical equipment - X-ray equipment for general use) | Will comply (stated intention) |
| Compliance with EN/IEC 60601-1-2(2001) (EMC for medical electrical equipment) | All test results were satisfactory (by EMC Compliance Co., Ltd.) |
| Leakage Current of External Body meets IEC 60601-1 requirement | Should be satisfied (stated design feature) |
| X-ray Shooting Controller: Dead Man Type function | Shooting of X-Ray and continuous shooting should not be operated without opening Dead Man Controller (stated design feature) |
| Buzzer sound during radiation shooting, off when stopped | Buzzer makes sound during shooting, turned off when stopped (stated design feature) |
2. Sample sized used for the test set and the data provenance
The document does not describe a clinical test set for evaluating the diagnostic performance of the device or human reader performance. The testing mentioned relates to electrical safety and EMC compliance, not clinical data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set with ground truth established by experts is described.
4. Adjudication method for the test set
Not applicable, as no clinical test set with ground truth requiring adjudication is described.
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. This device is a portable X-ray system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a portable X-ray system, not an algorithm.
7. The type of ground truth used
For the safety and performance evaluations mentioned, the "ground truth" is adherence to established international standards (e.g., IEC 60601 series, EN/IEC 60601-1-2). These are engineering and electrical standards, not medical ground truth like pathology or outcomes data.
8. The sample size for the training set
Not applicable. This device is a hardware X-ray system, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.