(121 days)
The Portable X-ray System (Model: BIOX) is intended to be used by trained dentists and dental technicians as extra-oral X-ray source for producing diagnostic X-ray images using intraoral image receptors. Its use is intended for both adult and pediatric subjects.
The Portable X-ray System (Model: BIOX) is portable dental X-ray system that operates on 24VDC supplied by a rechargeable Li-Polymer battery pack. The X-ray controls and power source are assembled into a single hand-held enclosure. The package includes battery charger. The Portable X-ray System generates and controls X-ray in order to diagnose teeth and jaw. It is composed of X-ray generator, controller and beam limiting device. Operating principle is that X-ray generated by high voltage electricity into X-ray tube, which penetrates teeth and jaw, and makes X-ray images on a receptor (chemical film or digital sensor). The Portable X-ray System (Model: BIOX) is a diagnostic x-ray system, which is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral image receptors. Its use is intended for both adult and pediatric subjects. This device includes a high frequency inverter that changes direct current to alternating current, X-ray tube, electrical protective devices, and other elements. The portable X-ray system (Model: BIOX) provides sharp and clear images and protects patients and dentists from leakage radiation by using a lead protective seal.
The provided document describes a 510(k) premarket notification for a medical device, the Portable X-Ray System (Model: BIOX). This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity for detecting a particular condition).
Instead, the acceptance criteria and proof provided relate to the device's technical specifications, safety, and performance as an X-ray source, ensuring it is as safe and effective as the predicate device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate device and compliance with various IEC standards. The "reported device performance" refers to the BIOX model's specifications.
| Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (BIOX Model) |
|---|---|
| Intended Use Equivalence | Intended to be used by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic X-ray images using intraoral image receptors. For both adult and pediatric subjects. |
| Energy Source | Rechargeable 24V DC Lithium polymer battery pack Or DC 24V Power Supply |
| Source to Skin Distance | 210 Cm |
| Cone Diameter | 6 Cm |
| Exposure Time Range | 0.01-1.6 seconds, 0.01 increments |
| Time Accuracy | ±(10% + 1ms) |
| mA (Tube Current) | 3mA fixed |
| kVp (Tube Voltage) | 60kV fixed |
| Wave Form | Constant Potential (DC) |
| Safety, EMC, and Performance Standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32 |
| User Interface | Exposure time: up, down select buttons of parts of teeth, adult and child, film and sensor with display |
| Exposure Switch | Control panel and remote controller |
| Tube Head Mounting | Yes |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical study in the form of a diagnostic image interpretation trial with a "test set" of patient data. The "tests" mentioned are:
- Bench testing
- Clinical evaluation (not detailed, but likely referring to a general assessment of functionality and safety, not a diagnostic accuracy study).
Therefore, there is no sample size for a test set of patient cases or information about data provenance in the context of diagnostic performance. The testing was focused on engineering and performance parameters 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
Not applicable. As no diagnostic accuracy study with a "test set" and "ground truth" for patient conditions was described, no expert consensus was established for such a purpose.
4. Adjudication method for the test set
Not applicable. There was no diagnostic accuracy study described that would require an adjudication method for case interpretations.
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
No MRMC comparative effectiveness study was done. The device is an X-ray source, not an AI-powered image analysis tool. Its purpose is to produce images, not to interpret them or assist human readers with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is an X-ray source, not an algorithm, and does not operate in a "standalone" or "human-in-the-loop" performance context related to AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not describe the establishment of ground truth for diagnostic purposes. The "ground truth" in this context is the physical and electrical performance parameters of the X-ray machine itself, which are verified through various engineering tests and compliance with recognized standards.
8. The sample size for the training set
Not applicable. Since this is an X-ray imaging device and not an AI algorithm, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for this purpose.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is described as a combination of:
- Bench Testing: This likely involved engineering tests to verify the device's electrical, mechanical, and radiation output specifications (e.g., kVp, mA, exposure time accuracy, radiation leakage).
- Clinical Evaluation: While not detailed, this would typically involve assessing the device's functionality, ease of use, and ability to produce clinically usable images in a practical setting. This is distinct from a diagnostic accuracy study.
- Compliance with Standards: The device was tested and found to comply with a series of international standards:
- UL/IEC 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment)
- IEC 60601-1-3 (Collateral Standard: General requirements for radiation protection in diagnostic X-ray equipment)
- IEC 60601-2-7 (Particular requirements for the safety of high voltage generators of diagnostic X-ray generators) - likely a typo in the original document, often 2-7 is related to X-ray tubes
- IEC 60601-2-28 (Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis)
- IEC 60601-2-32 (Particular requirements for the safety of associated equipment of X-ray equipment)
- EN/IEC 60601-1-2 (Electromagnetic compatibility - Requirements and tests)
The conclusion states that "The result of bench testing and clinical evaluation indicates that the subject device is as safe and effective as the predicate devices." This implies that the BIOX device met the safety and performance benchmarks set by the predicate device and the relevant international standards.
§ 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.