(302 days)
The Portable X-ray System(Model:EXARO) is intended to be used by trained dentists and dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.
EXARO, 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, EXARO, 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 EXARO 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 EXARO produces sharp and clear images and prevents patients and dentists from radiation exposure with utilizing small dose of radiation.
The provided text is a 510(k) summary for the OSSTEM Implant Co., Ltd. Portable X-Ray System (Model: EXARO). It outlines the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific information regarding acceptance criteria, reported device performance in a table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about ground truth establishment for a study proving the device meets acceptance criteria.
The document focuses on regulatory compliance, specifically demonstrating that the EXARO system is substantially equivalent to a legally marketed predicate device (GENORAY Co.,Ltd.'s Portable X-Ray System, Model: PORT X II). This type of submission relies on showing that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate device.
The "Safety, EMC and Performance Data" section states:
"The compliance of EXARO will satisfy the applicable requirements of the Underwriters Laboratories Standard for Safety-UL/IEC 60601-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28 and IEC 60601-2-32. All required documents and reports will be submitted to the appropriate oversight agency to establish compliance with the applicable requirements. EMS test was performed by SGS Testing Korea Co., Ltd. for EXARO in accordance with Standard EN/IEC 60601-1-2. All test results were complied with the requirements."
And under "Safety and Effectiveness, comparison to Predicate":
"The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices."
To answer your request, based only on the provided text, I can state what is mentioned and what is explicitly not mentioned.
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: The document implies that the acceptance criteria are adherence to various international safety and performance standards (UL/IEC 60601-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, EN/IEC 60601-1-2 for EMC).
- Reported Device Performance: The document states, "All test results were complied with the requirements" for the EMC test and that "The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices." However, no specific numerical performance metrics are provided in a table format within this document.
2. Sample size used for the test set and the data provenance
- The document mentions "bench and clinical evaluation" but does not provide any details about the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- The document does not provide any information about the number or qualifications of experts used to establish ground truth for a test set.
4. Adjudication method for the test set
- The document does not provide any information about an adjudication method for a test set.
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
- The document describes a portable X-ray system, which is a hardware device for image acquisition, not an AI or software device for image interpretation. Therefore, no MRMC study with AI assistance would typically be applicable or described for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- As this is a hardware X-ray system, a standalone algorithm-only performance study is not applicable. The device's primary function is to generate X-ray images, not to interpret them autonomously.
7. The type of ground truth used
- The document does not specify the type of ground truth used for any evaluations. Given it's an X-ray system, ground truth for imaging performance might involve phantom studies, expert review of images, or correlation with clinical outcomes, but these details are not provided.
8. The sample size for the training set
- The document describes a hardware medical device and does not involve a "training set" in the context of machine learning algorithms.
9. How the ground truth for the training set was established
- As there is no mention of a training set, this information is not applicable and not provided.
In summary: The provided 510(k) summary focuses on demonstrating regulatory compliance and substantial equivalence to a predicate device through adherence to recognized safety and performance standards for an X-ray hardware system, rather than detailing a study with specific acceptance criteria and performance metrics for an AI-enabled diagnostic device. Therefore, much of the requested information, which is highly relevant for AI/software devices, is not present in this document.
§ 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.