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510(k) Data Aggregation
(275 days)
The device is intended to be used by trained dental technicians as a portable and a mobile, extra-oral X-ray source. This can help producing diagnostic x-ray images by using with various intra-oral image detectors. This x-ray image can be used for dental examination (diagnosis) before or after treatment. Its use is intended for both adult and pediatric subjects.
The portable x-ray system (Model: DHX-70H, XTG-70H), is an x-ray generating device which is designed for dental examination. Each device has an x-ray tube for generating x-ray, a high voltage transformer for generating high voltage, 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, an LCD display for saving and displaying the x-ray exposure setting, a power P.C.B with super capacitors for supplying power to the circuit and apparatus in housing, 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 patient and operator 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 optional stands or digital camera tripods.
The provided document is a 510(k) summary for the DHX-70H and XTG-70H portable X-ray systems. It primarily focuses on demonstrating substantial equivalence to a predicate device (Rextar X) based on technological characteristics and compliance with safety and performance standards. It explicitly states that clinical images were provided but "were not necessary in order to establish substantial equivalence." This implies that a clinical study with detailed acceptance criteria for device performance was not a requirement for this 510(k) clearance based on clinical effectiveness.
Therefore, based on the provided document, I cannot fulfill all parts of your request. Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for clinical device performance (e.g., diagnostic accuracy, sensitivity, specificity). Instead, it focuses on technical specifications and compliance with safety and performance standards. The "performance" mentioned refers to adherence to these technical specifications and standards, not clinical outcomes.
| Acceptance Criterion (Technical & Safety Standards Compliance) | Reported Device Performance (as stated in document) |
|---|---|
| EMI standards: EN60601-1-2, IEC60601-1-2, CISPR 11, IEC61000-3-2, IEC61000-3-3 | Complies, test reports provided |
| Performance standards: IEC 60601-1, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-65, IEC 62304 | Complies, test reports provided |
| Time Accuracy: ± (10% + 1 ms) | Meets criterion (listed as part of comparison with predicate) |
| kVp: 70 kV fixed | Meets criterion (listed as part of comparison with predicate) |
| mA: 2 mA fixed | Meets criterion (listed as part of comparison with predicate) |
| Focal spot: 0.4 mm | Meets criterion (listed as part of comparison with predicate) |
| Half-value layer (HVL): Over 1.5 mmAl | Meets criterion (listed as part of comparison with predicate) |
| Source to skin distance (SSD): 200 mm | Meets criterion (listed as part of comparison with predicate) |
| Exposure time: 0.05~1.0 seconds in 0.01 increments | Meets criterion (listed as part of comparison with predicate) |
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 explicitly states that "Clinical images were provided however they were not necessary in order to establish substantial equivalence with the predicate devices." This indicates that a formal clinical test set with a specific sample size and provenance was not required or used for regulatory clearance based on clinical performance evaluation. The evaluation was primarily based on technical specifications and compliance with recognized standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Since a clinical study for establishing device performance against a ground truth was not deemed necessary for this 510(k) clearance (as per point 2), there is no information about experts or ground truth establishment in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as a clinical test set requiring adjudication was not reported as part of the substantial equivalence determination for clinical performance.
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
Not applicable. The device is an X-ray source, not an AI-powered diagnostic tool. No MRMC study or AI assistance evaluation is mentioned or relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is hardware (an X-ray source), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. As a clinical performance study with established ground truth was not detailed as a requirement for this 510(k) clearance, there's no mention of the type of ground truth used.
8. The sample size for the training set
Not applicable. The device is a hardware X-ray system, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as it's not a machine learning algorithm.
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