(29 days)
RX DC x-ray unit is designed for use in the dental surgery to make endo-oral x-rays for diagnostic purposes. This equipment can be used to produce traditional x-rays developed using chemicals or, alternatively, it can be used with digital x-ray sensors.
The subject device RX DC, in the new 65/70 kV version, is an extraoral source dental X-ray system intended for intraoral imaging. The subject device is a device comprises a double mobile and articulate support arm. At the opposite ends of the arm are located, respectively:
- . A control unit equipped with wall plate, extension arm and wired/wireless control device;
- A tube head with x-ray tube; .
X-rays are produced using the high frequency and constant potential generators with a built in round collimator with the high frequency (HF) technology, X-ray emission at 70 kV and 8 mA (maximum power), and x-ray unit automatically calculates the best exposure time (from 0.02 s to 1.00 s) based on the selected tooth and patient size, as well as an adjustable arm allows for easy positioning. The system can be used either with conventional film or a digital imaging system. RX DC, 65/70 kV version, is manufactured by CEFLA S.C. and available in several versions, and it can be sold under different brands and commercial names for commercial needs, as well as with different type of installation, and also different types of maximum anode voltage (65 kV or 70 kV). To identify the different variants of the RX DC product, CEFLA S.C. designed a reference system to identify any variant via the REF code.
Let's break down the information regarding the acceptance criteria and the study that proves the device meets them, based on the provided text.
This document describes the 510(k) premarket notification for the RX DC dental X-ray unit. It focuses heavily on demonstrating substantial equivalence to predicate devices rather than setting specific, numerical acceptance criteria for a diagnostic performance study. The "acceptance criteria" here largely revolve around compliance with established standards and comparable physical measurements.
Here's the breakdown of the information you requested:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present a table with explicit numerical acceptance criteria for diagnostic accuracy, sensitivity, or specificity commonly associated with AI/CAD devices. Instead, the acceptance criteria are implicit in demonstrating compliance with safety and performance standards, and showing equivalent dosimetric output to a predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety and EMC Compliance: Device meets all requirements of the specified international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-65, IEC 62366). | "For all consensus standards here above all requirements have been met." (Section 7.A) This indicates full compliance with these safety, EMC, basic safety, essential performance, and usability standards. |
| Dosimetric Equivalence: The device emits a comparable quantity of X-ray dose to the predicate device (K080076) for various loading factors, patient sizes, and anatomical shapes. | "The test results demonstrated that RX DC, in the new 65/70 kV version, emits the same quantity of x-ray than the predicate device K080076." (Section 7.B) This indicates the device's radiation output is equivalent to the legally marketed predicate, meaning it performs similarly in terms of dose delivery. |
| Technological Equivalence: The device's technological characteristics (e.g., intended use, principle of use, generator type, anode material) are substantially similar to predicate devices. | The extensive comparison table in Section 6 demonstrates that the RX DC shares almost all key technological characteristics with K080076 and K120318, with minor differences (e.g., higher kV options, different arm lengths) that were addressed in subsequent tests. The software changes were validated to maintain the same performance. |
| Indication for Use Equivalence: The device is intended for the same diagnostic purposes as the predicate devices. | The "Indications for Use" for the subject device are identical to the predicate device K080076. (Section 5 and comparison table in Section 6). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of this 510(k) submission. There is no "test set" in the sense of a dataset for evaluating diagnostic performance (e.g., images for classification). The "tests" performed were non-clinical engineering and dosimetric tests.
- Data Provenance: The tests were conducted by CEFLA S.C. (the manufacturer) or their contracted labs. The company is based in Italy. The document doesn't specify if the dosimetric tests involved actual patient data or were conducted in a controlled laboratory environment with phantoms. Given the nature of dosimetric testing for X-ray units, it's highly likely to be laboratory-based and controlled.
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)
- This information is not applicable as there was no ground truth determination by experts for a diagnostic performance test set. The evaluation focused on physical and electrical device characteristics and dosimetric output.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable as there was no diagnostic performance test set requiring adjudication.
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, an MRMC comparative effectiveness study was not done. This submission is for an X-ray imaging device itself, not an AI/CAD system designed to assist human readers. The clinical utility is in producing the images, not in interpreting them.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, a standalone algorithm performance study was not done. This device is an X-ray unit, not a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- This information is not applicable as there was no diagnostic performance evaluation requiring ground truth. The "ground truth" equivalent for the dosimetric test would be the established and verified output of the predicate device.
8. The sample size for the training set
- This information is not applicable as there is no AI/machine learning component requiring a training set mentioned in this 510(k) summary.
9. How the ground truth for the training set was established
- This information is not applicable as there is no AI/machine learning component or training set mentioned.
§ 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.