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510(k) Data Aggregation
(192 days)
HYBRID C70 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 HYBRID C70, is an x-ray generating device which is designed for dental examination. The 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.
This document describes a 510(k) Pre-Market Notification for the HYBRID C70, an extra-oral x-ray system. The submission seeks to demonstrate substantial equivalence to a predicate device, the Rextar X (K132041).
Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for performance or clinical outcomes. Instead, it focuses on demonstrating technical safety and performance based on engineering specifications and adherence to recognized standards. The comparison table below highlights key technical specifications for both the subject device (HYBRID C70) and the predicate device (Rextar X).
| Feature / Criterion | HYBRID C70 (Subject Device) | Rextar X (Predicate Device) |
|---|---|---|
| Intended Use | Producing diagnostic x-ray for dental examination (diagnosis) before or after treatment for adults and pediatric subjects. Used by trained dentists and dental technicians. | Producing diagnostic x-ray for dental procedures (Bite wing, periapical, occlusal, panoramic) for adults and pediatric subjects. Used by trained dentists and dental technicians. |
| User Interface Display | LCD panel display (2.6 inch, FSTN LCD, 1/4 duty 1/3 BIAS) | LCD panel display (3.5 inch, BTN LCD, 1/4 duty 1/3 BIAS) |
| Exposure Switch | Exposure button on front cover or remote control switch | Exposure button on front cover |
| Source to Skin Distance (SSD) | 200 mm | 200 mm |
| Cone Diameter | 53 mm | 55 mm |
| Half-Value Layer (HVL) | Over 1.5 mmAl | Not identified |
| Exposure Time | 0.05~1.0 seconds in 0.01 increments | 0.01~1.3 seconds (43 steps) |
| Time Accuracy | ±(10% +1 ms) | ±(10% +1 ms) |
| kVp | 70 kV fixed | 70 kV fixed |
| mA | 2 mA fixed | 2 mA fixed |
| Focal Spot | 0.4 mm | 0.4 mm |
| Tube Type | Stationary | Stationary |
| Waveform | High Frequency DC | High Frequency DC |
| Energy Source | Rechargeable 14.8 V DC Lithium Polymer battery pack | Rechargeable 11.1 V DC |
| Dimension | 146(w) x 227(d) x 126(h) mm | 146(w) x 239(d) x 155(h) mm |
| Weight | 1.9 kg | 2 kg |
| EMI Standards | EN60601-1-2, IEC60601-1-2, CISPR 11, IEC61000-3-2, IEC61000-3-3 | EN60601-1-2, IEC60601-1-2 |
| Performance Standards | IEC 60601-1, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-65, IEC 62304 | IEC 60601-1, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32 |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "Clinical images were provided however they were not necessary in order to establish substantial equivalence with the predicate devices." This implies that no specific clinical "test set" for performance evaluation was rigorously analyzed or deemed necessary for the 510(k) clearance. The clearance was based on technical equivalence, safety, and performance standards testing.
Therefore, no sample size, data provenance, or details about and any specific clinical dataset are provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since no clinical test set was deemed necessary for establishing substantial equivalence, there is no mention of experts establishing a ground truth for such a set.
4. Adjudication Method for the Test Set
As no clinical test set was required for performance evaluation, no adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was performed or referenced in the provided text. The submission focuses on technical equivalence rather than demonstrating clinical improvement with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The HYBRID C70 is an extra-oral x-ray system, a device for acquiring diagnostic images, not interpreting them or providing AI-driven analysis. Therefore, a standalone (algorithm-only) performance study is not applicable to this type of medical device.
7. Type of Ground Truth Used
The primary "ground truth" for this 510(k) pertains to the technical specifications and performance metrics verified through laboratory testing and compliance with recognized standards (e.g., IEC 60601 series). The claim for image quality is implied by technical equivalence to the predicate device and the specified kVp and mA settings, which are standard for dental radiography. No specific clinical ground truth based on pathology or outcomes data was used to establish equivalence for diagnostic performance, as clinical images were not deemed necessary for the clearance.
8. Sample Size for the Training Set
As the HYBRID C70 is an x-ray generation device and not an AI-powered diagnostic system, there is no concept of a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Given that this is not an AI/ML device, this question is not applicable.
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