(129 days)
The Portable X-ray System (Model: DXR-1) 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.
DXR-1, a portable dental X-ray system, operates on 25.2V DC supplied by a rechargeable Li-Polymer battery pack. The X-ray tubehead, controls and power source are assembled into a single hand-held enclosure. The package includes a battery charger. The potable X-ray system, DXR-1, being composed of X-ray generator, controller, and beam limiting device is designed to diagnose tooth and jaw through generated and controlled X-ray. The mechanical principle of DXR-1 starts from the generation of X-ray by high voltage electricity, which in turn penetrates tooth and jaw area after flowing through X-ray tube and produces X-ray images on X-ray receptors (i.e. chemical film or digital sensor) This device contains a high frequency inverter that converts direct to alternating current, X-ray tubehead, electrical protective devices, and other elements. The DXR-1 produces sharp and clear images and prevents patients and dentists from radiation exposure with utilizing small dose of radiation.
Here's an analysis of the provided text regarding the acceptance criteria and study for the EXARO Co., Ltd. Portable X-Ray System (Model: DXR-1):
It's important to note that the provided text is a 510(k) summary for a medical device submitted to the FDA. This type of document primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing detailed clinical study results in the same way a publication for a novel device would. Therefore, much of the requested information (like specific sample sizes for test sets, number of experts for ground truth, or details of multi-reader studies) is not present in this document. The "study" mentioned is primarily a bench and clinical evaluation comparing the new device to a predicate device.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the DXR-1 are generally implied by its demonstrated "substantial equivalence" to the predicate device, the GENORAY Co., Ltd. PORT-X II. The study aims to show that the DXR-1 is as safe and effective as the predicate. The table below outlines the key technical specifications and safety/performance standards, indicating where the DXR-1 either matches or falls within acceptable comparative ranges of the predicate.
| Acceptance Criteria (Implied by Predicate) | DXR-1 Reported Device Performance | Notes |
|---|---|---|
| Rechargeable Power Source: 22.2V DC Lithium Polymer battery pack | Rechargeable 25.2V DC Lithium Polymer Battery pack | Similar technology, slightly higher voltage in DXR-1. |
| Exposure Time: 0.01-2.0 seconds, 0.01 increments | 0.01-1.6 seconds, 0.01 increments | Similar range, DXR-1 has a slightly shorter maximum exposure time. |
| Time Accuracy: ±(10%+1ms) | ±(10%+1ms) | Matches predicate. |
| Heat Capacity: 8.5 KHU | 8.5 KHU | Matches predicate. |
| Power Output: 100 W | 180 W | DXR-1 has higher power output. This would typically be seen as an improvement, provided it doesn't negatively impact safety or image quality and remains within accepted radiation dose limits for its intended use. |
| mA: 2mA fixed | 2mA fixed | Matches predicate. |
| kVp: 60kV fixed | 60kV fixed | Matches predicate. |
| Focal Spot: 0.8 mm | 0.8 mm | Matches predicate. |
| Wave Form: Constant Potential (DC) | Constant Potential (DC) | Matches predicate. |
| Safety, EMC, Performance Standards (IEC 60601-1series) | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32 | DXR-1 is stated to comply with the same standards as the predicate. |
| Source to skin distance: 20cm | 20cm | Matches predicate. |
| Cone Diameter: 7cm | 6 cm | DXR-1 has a slightly smaller cone diameter. This may influence beam coverage but typically would be assessed for its impact on image capture and radiation protection. |
| User Interface: Exposure time controls, tooth/adult/child/film/sensor selection | Exposure time controls, tooth/adult/child/film/sensor selection | Matches predicate functionally. |
| Exposure switch: Control panel and remote controller | Control panel and remote controller | Matches predicate. |
| Tubehead mounting: Yes | Yes | Matches predicate. |
| Intended Use: Extra-oral X-ray source for diagnostic images using intraoral receptors for adult and pediatric subjects. | Intended to use 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. | Matches predicate. |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a distinct "test set" sample size for a clinical study in the typical sense (e.g., number of patients or images). The "bench and clinical evaluation" is mentioned, implying some form of testing, but detailed clinical reader study parameters are not disclosed.
- Data Provenance: Not specified in the provided text. It's common for submission data to be from the manufacturer's home country (Korea in this case) or internal studies, but this is not explicitly stated for the clinical evaluation. The document is for a 510(k) submission, not a scientific publication, so such detail is often omitted if not directly required for substantial equivalence.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. For a 510(k) of this nature, clinical "ground truth" might be implied by comparison to the predicate device's established performance, or by standard clinical diagnostic practices, rather than a formal expert consensus study for the specific device under review.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the document.
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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, this was not a MRMC study. The device described is a portable X-ray system, not an AI-powered diagnostic tool. The document details the hardware (X-ray generator, tubehead, controls) and its performance characteristics, not an algorithm's diagnostic capabilities or reader improvement with AI assistance.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, this is not applicable. The DXR-1 is an X-ray imaging device itself, not an algorithm that performs a standalone diagnosis. Its performance would be evaluated based on image quality, radiation output, safety, and functionality, not a diagnostic algorithm's accuracy.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The document implies that the ground truth for the "clinical evaluation" would be standard diagnostic X-ray image quality criteria, potentially judged by dental professionals, against images produced by the predicate device or against clinically acceptable diagnostic images. However, the specific method (e.g., "expert consensus" or direct comparison to "pathology") is not specified. For an X-ray device, image quality and the ability to produce diagnostic images sufficient for clinical decision-making are the primary "ground truth" goals.
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The sample size for the training set:
- Not applicable / not provided. This device is a hardware system, not a machine learning model, so there is no "training set" in the AI sense.
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How the ground truth for the training set was established:
- Not applicable. As above, there is no AI training set for this hardware device.
§ 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.