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510(k) Data Aggregation
(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., <70kVp +10%) | Accuracy of loading factors met essential performance requirements in accordance with IEC 60601-1 (e.g., <70kVp +10%). |
| Reproducibility of AIR KERMA | Reproducibility of AIR KERMA met essential performance requirements in accordance with IEC 60601-1. |
| Software Validation | Software Validation performed. All test results were satisfactory. (No specific metrics or acceptance criteria for software itself mentioned, beyond satisfactory outcome). |
| Clinical Evaluation | Clinical Evaluation performed. All test results were satisfactory. (No specific metrics or acceptance criteria for clinical efficacy beyond satisfactory outcome and substantial equivalence to predicate). |
| Overall Comparison | The performance test confirms that the device is as safe and effective as the predicate device (REXTAR X K132041). "EMC and performance data demonstrated that the PORT-X IV is as safe and effective as the predicate device." "All the test results were satisfied and the result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate device." "PORT-X IV is safe and effective as predicate device, and has no new indication for use." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "bench and clinical evaluation" and "performance testing" but does not specify a "test set" in terms of patient data or image datasets with a sample size for evaluating an algorithm. The testing described is related to the physical performance, safety, and electrical characteristics of the X-ray device itself.
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. This device is an X-ray generator, not an AI-powered diagnostic tool. Ground truth establishment by experts for image interpretation is not mentioned as part of its regulatory submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" here is compliance with established electrical, radiation, and safety standards for X-ray equipment.
8. The sample size for the training set
Not applicable. This device does not involve a training set for an AI algorithm.
9. How the ground truth for the training set was established
Not applicable.
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