(170 days)
PORT-X IV is a portable X-ray system to be used by trained dental technicians as a mobile, extra oral x-ray source for producing diagnostic x-ray images using intra oral image receptors. It is intended for both adult and pediativ subjects.
The portable X-Ray system, PORT-X IV, 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. It is the X-ray equipment and uses it to diagnose the patient to acquire images. It also includes accessories, which are battery, recharging unit and hand switch.
The provided text is a 510(k) summary for the GENORAY Co., Ltd. PORT-X IV, a portable X-ray system. This document focuses on demonstrating substantial equivalence to a predicate device (Metabiomed, Inc. REXTAR X) rather than presenting a study to prove the device meets specific acceptance criteria for AI/algorithm performance. Therefore, many of the requested elements for an AI-based device's acceptance criteria and study are not applicable or cannot be extracted from this document.
However, I will extract what is available regarding general device performance and safety.
Here's the breakdown of the information based on the prompt and the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a table format for AI performance. Instead, it details performance standards and safety criteria for an X-ray device based on federal and international standards.
| Acceptance Criteria (Standards and Requirements) | Reported Device Performance (PORT-X IV) |
|---|---|
| Safety and General Performance Standards | |
| IEC 60601-1 Series (Electrical, mechanical, environmental safety and performance) | Complies with IEC 60601-1 Series. Electrical, mechanical, and environmental safety and performance testing performed. All test results were satisfactory. |
| IEC 60601-1-3 (Radiological protection) | Complies with IEC 60601-1-3. Radiological protection testing performed. All test results were satisfactory. |
| IEC 60601-2-65 (Specific requirements for dental X-ray equipment) | Complies with IEC 60601-2-65. Testing performed. All test results were satisfactory. |
| IEC 60601-1-2 (EMC testing) | EMC testing conducted in accordance with IEC 60601-1-2. All test results were satisfactory. |
| Radiation Control Provisions (21 CFR 1020.30 & 1020.31) | |
| Focal spot to skin distance: Longer than minimum length of 18 cm | Confirmed that the focal spot to skin distance was longer than the minimum length of 18 cm. |
| Minimum HVL (half-value layer): 1.5 mm | Confirmed that the minimum HVL was 1.5 mm. |
| Accuracy of loading factors (e.g., |
§ 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.