(57 days)
The Portable X-ray System (Model: DIOX-602, PROX) is intended to be used by trained dentists and dental technicians as extraoral 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: DIOX-602, PROX) 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 of tooth 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 tooth and jaw, and makes X-ray images on receptor (chemical film or digital sensor).
The Portable X-ray System (Model: DIOX-602, PROX) is a diagnostic x-ray system, which is intended to be used by trained dentists and dental technicians as an extra-oral xray 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: DIOX-602, PROX) provides with sharp and clear images and keeps patients and dentists away from radiation using small dose of radiation.
The provided text is a 510(k) summary for the DIGIMED Portable X-Ray System. It primarily focuses on demonstrating substantial equivalence to a predicate device and outlines technical specifications rather than specific performance acceptance criteria or a detailed study proving the device meets them.
Therefore, many of the requested details, especially those related to AI algorithm performance, sample sizes for training/test sets, expert adjudication, and ground truth establishment, are not present in this document, as the device is an X-ray system, not an AI-powered diagnostic tool.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state numerical acceptance criteria or performance metrics for diagnostic accuracy in the way an AI algorithm study would. Instead, it relies on demonstrating substantial equivalence to an existing predicate device based on technical specifications and safety/EMC testing.
| Feature | Predicate Device (PORT-X II) Performance | Subject Device (DIOX-602, PROX) Performance | Acceptance Criteria (Implied) |
|---|---|---|---|
| Energy Source | 22.2V DC Li-Polymer battery | 24V DC Li-Polymer battery | Comparable rechargeable battery power |
| Exposure Time | 0.01-2.0 seconds | 0.01-1.6 seconds | Within clinically acceptable range for dental X-rays |
| Time Accuracy | ± (10%+1ms) | ± (10%+1ms) | Same accuracy as predicate device |
| mA | 2mA fixed | 2mA fixed | Same fixed current as predicate |
| kVp | 60kV fixed | 60kV fixed | Same fixed voltage as predicate |
| Wave Form | Constant Potential (DC) | Constant Potential (DC) | Same wave form as predicate |
| Safety & EMC | IEC 60601-1, -2-7, -2-28, -2-32 | IEC 60601-1, -2-7, -2-28, -2-32 | Compliance with international safety and EMC standards |
| Source to Skin Dist | 20cm | 20cm | Same distance as predicate (important for radiation dose) |
| Cone Diameter | 7cm | DIOX-602: 6.5cm, PROX: 6cm | Comparable beam limiting |
| User Interface | Exposure time: up, down. Selection buttons of parts of teeth, adult/child, film/sensor with display. | Exposure time: up, down. Two buttons for modes and selection of parts of teeth, adult/child, film/sensor with display. | Comparable user-friendly interface for dental practitioners |
| Exposure Switch | Control panel and remote controller | Control panel and remote controller | Same flexible control options |
| Intended Use | Extraoral x-ray source for diagnostic x-ray images using intraoral image receptors for adult/pediatric subjects. | Same | Same intended use as predicate |
Study Proving Device Meets Acceptance Criteria:
The document states: "The result of bench testing and clinical evaluation indicates that the subject device is as safe and effective as the predicate devices."
And "EMS testing was conducted by EMC Compliance Co., Ltd. for DIOX-602 and SGS Testing Korea Co., Ltd. for PROX in accordance with Standard EN/IEC 60601-1-2. All test results were satisfactory."
This indicates that the "study" was primarily bench testing for technical specifications and EMC (Electromagnetic Compatibility) testing to ensure compliance with relevant IEC standards (e.g., IEC 60601 series). A clinical evaluation was also performed, but no details are provided about its design, methodology, or results beyond the general statement of safety and effectiveness.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified. The "clinical evaluation" is mentioned, but no details on where or how the data was collected. Given the manufacturers are Korean, it's possible some data was from Korea, but this is speculative.
- Retrospective/Prospective: Not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- This information is not provided. As this is an X-ray hardware submission, not an AI diagnostic algorithm, the concept of "ground truth" derived from expert consensus on images is less central. The "clinical evaluation" would likely focus on image quality and safety, possibly involving dentists or technicians evaluating the images produced.
4. Adjudication Method:
- Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This is not an AI-assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.
6. Standalone (Algorithm Only) Performance:
- No. This is an X-ray hardware system, not an algorithm. Standalone algorithm performance is not relevant.
7. Type of Ground Truth Used:
- For the "clinical evaluation," the ground truth implicitly would be the diagnostic quality of the X-ray images produced by the device, evaluated by trained professionals, and compared to the images produced by the predicate device and the clinical needs of dentistry. This is not explicitly pathology or outcomes data but rather an assessment of image utility for diagnosis.
- For the technical and safety testing, the "ground truth" is adherence to the specified technical parameters (e.g., kVp, mA, exposure time accuracy) and compliance with international standards (IEC 60601 series) as verified by tests performed in certified labs.
8. Sample Size for the Training Set:
- Not applicable/Not specified. This device does not involve a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable/Not specified. As there is no AI component, there is no training set and therefore no ground truth established for it.
§ 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.