(30 days)
The MobileX Portable X-ray System 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 receptors. Its use is intended for both adults and pediatric subjects.
Intended as extraoral x-ray sources to be used with intraoral image receptors for diagnostic imaging by dentists or dental technicians.
MobileX Portable X-ray System of Denterprise International, Inc., is a handheld xray device. The technology of this device was originally developed in Korea more than a decade ago and global production is still concentrated in that country.
The subject device is designed for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure by exposing an x-ray image receptor to ionizing radiation. The x-ray source, a tube, is located inside the handheld device. All three conventional types of intraoral receptors can be used with this device-analog x-ray film, digital phosphorous plates, and digital x-ray sensors.
This device is used in general dentistry and is supplied with an internal timer to control the duration of the x-ray source to the patient.
The software is designed for a button operated device to be used by a user and a display window to be observed by the user. The software is for controlling the operation of the hardware according to the user operation that is required for this device. This software is new but this type of software is common for use in the handheld x-ray systems.
The provided document is a 510(k) summary for the MobileX Portable X-ray System, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy.
Therefore, the requested information regarding acceptance criteria and a study proving their fulfillment, especially concerning diagnostic performance (e.g., sensitivity, specificity), cannot be fully extracted from this document. The document describes non-clinical performance data confirming safety and effectiveness compared to the predicate, primarily through engineering and regulatory standards rather than a clinical multi-reader, multi-case study or standalone algorithm performance.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic task). Instead, it focuses on adherence to engineering and regulatory standards, and technological equivalence to a predicate device.
| Acceptance Criteria Category | Criterion Description (Based on Regulatory Standards & Predicate Equivalence) | Reported Device Performance (MobileX Portable X-ray System) |
|---|---|---|
| Electrical Safety & EMC | Must conform to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-65, IEC 62304, IEC 62366, IEC 6100-3-2, IEC 6100-3-3, ISO 14971 standards. | All tests were performed in accordance with ISO standards recognized by FDA. Conformity with all standards was determined by the device manufacturer, Remedi Co., Ltd., Korea. Electrical test performed by KCTL, Inc. Laboratories, Inc., Korea. Device successfully passed. |
| Software Validation | Software must be validated, adhering to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software has a Moderate Level of Concern. | Software validation was performed. Details are provided within the Software Validation Report (not included here). The software is for controlling hardware operation according to user input. |
| Biocompatibility | Materials in contact with patient must be biocompatible. | Biocompatibility testing was performed. |
| Usability | Device must be safe and effective for its intended use by trained personnel. Adherence to human factors principles. | Usability testing was performed. |
| Risk Assessment / Radiation Leakage | Must conform to EN 60601-1-3:2010 (sub-clause 12.2, 12.4, 13.4) and IEC 60601-2-65 (sub-clause 203.12.2, 203.12.3, 203.12.4). Must meet 21 CFR 1020 Subchapter J, 21 CFR 1020.30, 21 CFR 1020.31. | Test of leakage radiation according to specified EN & IEC standards was performed. The device passed, and test methods were verified. Claims adherence to 21 CFR 1020 "Performance Standards for Ionizing Radiation Emitting Products," 21 CFR 1020.30 "Diagnostic x-ray systems and their major components," and 21 CFR 1020.31 "Radiographic Equipment." |
| Performance Characteristics (X-ray Tube) | Equivalence to predicate (MiniX-V) on key parameters (mA, kVp, waveform, duty cycle). | mA: 2mA fixed (Same as predicate). kVp: 70kVp fixed (Same as predicate). Waveform: Constant Potential (DC) (Same as predicate). Duty Cycle: 1:60 (Same as predicate). Exposure Time: 0.01 ~ 1.3 seconds (Predicate: 0.01 ~ 2.0 seconds). Time Accuracy: ±(10% +1 ms) (Same as predicate). These differences are considered minor and do not raise new safety/effectiveness issues. |
| Intended Use / Indications for Use | Same as predicate device (MiniX-V). | Intended as extraoral x-ray sources for diagnostic imaging by dentists/dental technicians using intraoral receptors for adults and pediatric subjects (Same as predicate). |
| Technological Characteristics (Overall) | Substantially similar to predicate device, with minor differences not raising new safety/effectiveness issues. | Similar design principles, user interface, tube-head mounting, energy source. Minor differences in physical size, source-to-skin distance, cone diameter, exposure time range, and specific performance standards addressed (subject device has additional tests). These are deemed minor. |
2. Sample Size for Test Set and Data Provenance
The document explicitly states "Clinical data was not needed to support substantial equivalence."
The "Non-Clinical Performance Data" section lists various engineering and regulatory tests. These tests are generally performed on a small number of engineering samples or prototypes of the device itself rather than a "test set" of patient data.
- Sample Size for Test Set: Not applicable in the context of clinical or diagnostic performance on patient data, as no such study was conducted or reported. For engineering tests (e.g., electrical safety, radiation leakage), the "sample size" typically refers to the number of devices tested, which would be very small (e.g., 1-several units).
- Data Provenance: Not applicable for patient data. Engineering tests were performed in Korea (manufacturer: Remedi Co., Ltd., Korea; electrical test: KCTL, Inc. Laboratories, Inc., Korea). These are non-patient, non-clinical tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as no clinical "test set" of patient data requiring expert-established ground truth for diagnostic performance evaluation was used. The evaluation focused on engineering compliance and equivalence.
4. Adjudication Method for the Test Set
This information is not applicable as no clinical "test set" requiring adjudication of ground truth was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an X-ray source (hardware), not an AI-powered diagnostic software. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done. This is an X-ray device, not a diagnostic algorithm.
7. The type of ground truth used
This information is not applicable in the context of diagnostic performance (e.g., expert consensus, pathology, outcomes data), as no such study was performed. The "ground truth" for the device's performance was its adherence to established engineering standards (e.g., IEC, ISO, CFR) and demonstration of equivalent physical and technical characteristics to the predicate device.
8. The sample size for the training set
This information is not applicable. This is a hardware device submission, not an AI/Machine Learning algorithm that requires a "training set" of data.
9. How the ground truth for the training set was established
This information is not applicable as there was no training set.
§ 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.