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510(k) Data Aggregation
(28 days)
Portable X-ray System (Model: MiniX-V, Mini X-S)
The device 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 adults and pediatric subjects.
The portable x-ray system (Models: MiniX-V, MiniX-S) is an x-ray generating device which is mainly designed for dental examination. The device has an x-ray tube for generating x-rays, a high voltage transformer for generating high voltages, a high voltage rectification circuit for transforming and boosting AC voltage to mixed pulse voltage, a high voltage divide circuit for lowering high voltage to measure and calibrate high voltages, as well as a high voltage tube tank, a high frequency inverter circuit for generating high voltages, a control P.C.B for controlling, saving and displaying the data, a power P.C.B for supplying power to the circuit and apparatus in housing, user interface (LCD screen) and beam limiting part (x-ray emitting cone). The apparatuses above can be embedded in one or several cases, and except for the radiation opening in the x-ray system, all units are completely shielded by lead or high-density materials, protecting patients and users from unnecessary exposure of radiation. The package includes a remote control switch, a battery charger, and a backscatter shield. And the remote control switch can be used when the device is mounted on fixable stands as optional arms in user manual or digital camera tripods. Operating principle is that the high voltage electricity is getting into the x-ray tube and generates x-ray source. This x-ray source comes out from the emitting cone and goes through teeth and jaw of patient, and makes x-ray images onto image receptors as a chemical film or a digital sensor. Once the user enters the desired tube voltage data in the numerical value (%) by means of the user interface and press the x-ray exposure button, the system generates mixed pulse voltage (MiniX-V: 70kV max, MiniX-S: 60kV max) from the transformed and boosted AC voltage through high voltage generator. So the user is able to obtain x-ray images of patients' teeth and jaws from the image receptors, and diagnose about the images.
The provided FDA 510(k) summary for the DIGIMED Portable X-ray System (Models: MiniX-V, MiniX-S) states that "Clinical images were provided however they were not necessary in order to establish substantial equivalence with the predicate devices." and therefore, no acceptance criteria based on clinical performance or a study demonstrating the device meets such criteria is described.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (DIGIMED Portable X-Ray System, K152859) primarily through technical specifications and compliance with safety and performance standards. The only difference noted between the new device and the predicate is the "X-ray waveform" (mixed pulse versus constant potential (DC)).
However, based on the information provided, here's a breakdown of what can be inferred about the safety and performance evaluation:
1. Table of Acceptance Criteria and Reported Device Performance
Since clinical performance acceptance criteria are not mentioned as necessary for substantial equivalence, the "acceptance criteria" presented below are for technical and safety aspects, which are implied to be met for FDA clearance.
| Acceptance Criteria Category | Specific Criteria (Inferred from documentation) | Reported Device Performance |
|---|---|---|
| Output X-ray Parameters | ||
| kVp (MiniX-V) | Max 70kV | Max 70kV (Model MiniX-V) |
| kVp (MiniX-S) | Max 60kV | Max 60kV (Model MiniX-S) |
| mA | 2 mA fixed | 2 mA fixed |
| Exposure time | 0.01~2.0 seconds in 0.01 increments | 0.01~2.0 seconds in 0.01 increments |
| Time Accuracy | ± (10% + 1 ms) | ± (10% + 1 ms) |
| Half-value layer (MiniX-V) | 2.3 mm Al | 2.3 mm Al |
| Half-value layer (MiniX-S) | 2.0 mm Al | 2.0 mm Al |
| Safety Standards | ||
| EMI standards | EN60601-1-2, IEC60601-1-2, CISPR 11, IEC61000-3-2, IEC61000-3-3 | Complies |
| Performance standards | IEC 60601-1, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-65, IEC 62304 | Complies (Performance evaluation reports provided) |
| Radiation Safety | Compliance with "Radiation Safety Considerations for X-ray Equipment Designed for Hand-Held Use" | Assumed to comply as per FDA's review and clearance |
| Cybersecurity | Compliance with "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" | Assumed to comply as per FDA's review and clearance |
| General User Safety | All units completely shielded by lead or high-density materials to protect from unnecessary radiation | Device description states this |
| Mechanical/Physical | ||
| Size | 4.8" x 8.7" x 5.3" | 4.8" x 8.7" x 5.3" |
| Source to skin distance | 20 cm | 20 cm |
| Cone diameter | 5.3 cm | 5.3 cm |
| Backscatter protection | 6.3" dia. Pb-filled acrylic plastic scatter shield | 6.3" dia. Pb-filled acrylic plastic scatter shield |
| Duty Cycle | 1:60 | 1:60 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical "test set" in the sense of patient data used for diagnostic performance evaluation. The "test reports" mentioned are for compliance with technical, electrical, and safety standards (e.g., IEC standards, EMI standards). These typically involve laboratory testing of the device itself, not human subjects. Therefore, no sample size for a clinical test set or data provenance is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
As no clinical test set is described, this information is not applicable and therefore not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As no clinical test set is described, this information is not applicable and therefore not provided.
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 mentioned or performed. This submission is for an X-ray imaging device, not an AI-powered diagnostic tool. The document explicitly states: "Clinical images were provided however they were not necessary in order to establish substantial equivalence with the predicate devices." This implies that the review was focused on the device's technical specifications and safety profile, not its diagnostic efficacy compared to a predicate or with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was mentioned or performed, as this is a hardware device (X-ray system), not a software algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Since the primary evaluation was for technical/safety compliance and substantial equivalence to a predicate device, the "ground truth" would be established by validated testing equipment and adherence to recognized international standards (e.g., IEC, CISPR) and FDA guidance documents. For example, an oscillometer would measure the kVp output, and its reading would be the ground truth for that specification.
8. The sample size for the training set
Not applicable. This device is a portable X-ray system, not an AI model requiring a training set of images.
9. How the ground truth for the training set was established
Not applicable. This device is a portable X-ray system, not an AI model requiring a training set.
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