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510(k) Data Aggregation
(29 days)
RiX70 DC X-ray Unit is designed for use in 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 is RiX70 DC X-rav Unit and it is an extraoral source dental x-ray system intended for intraoral imaging. The subject device is a device comprised of 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 control . device.
- A tube head with x-ray tube.
X-ravs are produced using the high frequency and constant potential generators with a built in round collimator with the high frequency (HF) technology. X-rav emission at 70 kV and 7 mA (maximum power), and the xray unit automatically calculates the best exposure time (from 0.01 s to 2.00 s) based on the selected tooth and patient size, as well as an adjustable arm that allows for easy positioning. This device may also be adjusted manually to the user's specific radiographic technique.
The system can be used either with conventional film or a digital imaging system.
The RiX70 DC is available in two configurations: a wall-mount configuration and a floor-standing configuration, and provides for three selections of kVp: 60kVp, 65kVp, and 70kVp.
This submission is for an X-ray unit, which is hardware, not an AI/ML device. Therefore, the questions related to AI/ML device performance and testing (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable.
Here's an analysis of the provided document focusing on the acceptance criteria and study for the RiX70 DC X-ray Unit:
Acceptance Criteria and Study for RiX70 DC X-ray Unit
The provided document describes the substantial equivalence determination for the RiX70 DC X-ray Unit to a predicate device (RX DC). The acceptance criteria primarily revolve around meeting recognized performance standards and demonstrating similar technological characteristics and safety profiles to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is an X-ray unit and not an AI/ML device, the acceptance criteria are based on compliance with electrical, safety, and performance standards. The "reported device performance" reflects the device's conformity to these standards and its characteristics compared to the predicate.
| Acceptance Criteria Category | Specific Criteria (Applied to RiX70 DC) | Reported Device Performance |
|---|---|---|
| Indications for Use / Intended Use | Must be substantially equivalent to predicate device. | Same as Predicate:- Designed for use in dental surgery to make endo-oral x-rays for diagnostic purposes.- Can be used with traditional x-rays (chemicals) or digital x-ray sensors.- Designed for acquisition of intraoral images of teeth, jaw, and mouth structure for diagnostic purposes. |
| Device Description | Similar core function as the predicate device (extraoral source dental x-ray system for intraoral imaging). | Similar to Predicate:- Double mobile and articulate support arm.- Control unit with wall plate, extension arm, wired control device.- Tube head with x-ray tube.- High frequency and constant potential generators with built-in round collimator.- High frequency (HF) technology.- Automatically calculates exposure time based on selected tooth and patient size, or adjustable manually.- Can be used with conventional film or digital imaging.- Available in wall-mount and floor-standing configurations.- 60kVp, 65kVp, and 70kVp selections. |
| Technological Characteristics | Similar operating principles, key components (X-ray tube, HV generator, anode material), and safety features. Any differences must be well-justified and proven equivalent. | Mostly Same/Similar to Predicate:- Principle of use: X-ray tube (Same)- HV generator: High frequency, Constant potential (Same)- Anode material: Tungsten (Same)- Focal spot size: 0.4mm (IEC 60336/1993) (Same)- Leakage radiation: < 0.25 mGy/h (@ 1 m) (Same)- Exposure times control: Microprocessor controlled (Same)- Exposure modes: Preset loading factors or manual mode (Same)- Selectable parameter: Patient type, anatomical position, film type (Similar - predicate listed patient type/anatomical position, implicit film type for both)- Patient type: Adult-Child (Same)- Tooth type: Molar, Premolars, Incisors/canines, Bite wing (Same)- Film type: Photo-stimulated plate or sensor (Same)- Installation configuration: Wall-mounted standard version (Same), Subject has additional Stand mobile version (Similar - additional option)- X-ray emission control: Wired control (Different - predicate had remote control)- Tube voltage (kV): 60, 65, 70 kV (Different - predicate had 60 kV only)- Tube current (mA): 7 mA fixed (Similar - predicate had 7 mA, 3.5 mA)- Exposure time: 0.02 sec-2 sec (R' so steps) (Different - predicate had 0.01 sec - 1 sec (in R 20 steps))- X-ray tube & Anode angle: 16° (Similar - predicate had 12.5°)- Focus film distance: Standard round (fix): 200 mm (8"), Standard rectangular (removable): 45x35mm (Different size - predicate had Short round (fix): 200 mm (8"), Long rectangular (removable): 300mm (12"))- Diameter of x-ray beam cone: Short round (fix): Ø 60 mm (Different size - predicate had Short round (fix): Ø 60 mm, Long rectangular (removable): Ø 45x35mm, Round (removable): Ø 55 mm) |
| Performance Standards | Must comply with relevant national and international electrical, safety, and medical device standards. | Compliant:- IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) (Medical electrical equipment - General requirements for basic safety and essential performance)- IEC 60601-1-6:2010 (Medical electrical equipment - General requirements for basic safety and essential performance - Collateral standard: Usability)- IEC 62366: 2007 (Medical devices - Application of usability engineering to medical devices)- IEC 60601-1-3:2008 (Second Edition) (Medical electrical equipment - General requirements for basic safety and essential performance - Collateral standard: Radiation protection in diagnostic X-ray equipment)- IEC 60601-2-65:2012 (Medical electrical equipment - Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment)- IEC 60601-1-2:2007 (EMC) (Medical electrical equipment - Electromagnetic compatibility - Requirements and tests)- IEC 62304 (Medical device software: Software Life Cycle Processes)- ISO 14971 (Medical devices - Application of risk management to medical devices)Outcome: All requirements met. CB certificate obtained. |
| Software/Firmware | Must be developed and tested according to appropriate risk levels (e.g., Moderate Level of Concern) and relevant software standards. | Compliant:- Software/Firmware quality activities conducted for a Moderate Level of Concern.- Activities for conformance with IEC 62304. |
| Risk Analysis | Must identify and mitigate risks associated with the device's use, particularly radiation exposure. | Compliant:- Risk management performed according to ISO 14971.- Addressed radiation exposure to the user under mobile operating conditions.- Recommendations for safety precautions (e.g., personnel monitoring, protective equipment) in the user manual. |
Study Proving Device Meets Acceptance Criteria:
The study to prove the device meets acceptance criteria is primarily a non-clinical performance study focusing on bench testing and compliance with recognized standards.
- Type of Study: Non-clinical (bench testing, standards compliance, comparison to predicate).
- Methodology:
- Direct Comparison with Predicate Device: A detailed comparison of technological characteristics (Table 5.1) was performed to demonstrate substantial equivalence in terms of intended use, indications for use, and technological features. Differences were noted and implicitly deemed not to raise new questions of safety or effectiveness.
- Compliance Testing to Recognized Standards: The device underwent rigorous testing to ensure conformity with various IEC and ISO standards related to medical electrical equipment safety, electromagnetic compatibility (EMC), radiation protection, usability, and software lifecycle processes.
- Risk Analysis: A risk management process was conducted in accordance with ISO 14971.
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: Not applicable in the traditional sense for an AI/ML model's test set. For an X-ray unit, the "sample" would be the device itself subjected to various tests outlined by the standards. These tests are typically performed on a limited number of units (e.g., one or a few production units) to demonstrate design and manufacturing compliance. The document does not specify the exact number of units tested but implies that tests were performed on the "subject device."
- Data Provenance: Not applicable in the context of clinical data provenance for an AI/ML model. The "data" here refers to test results from a lab environment. The CB certificate from IMQ Italy indicates the testing body and country of origin for the compliance testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not applicable. This is not an AI/ML device requiring expert ground truth for image interpretation. The "ground truth" for an X-ray unit is its ability to meet engineering specifications and safety standards as measured by calibrated equipment and assessed by qualified test engineers and regulatory bodies.
4. Adjudication Method for the Test Set:
- Not applicable. There is no subjective interpretation or consensus-building on image findings. Compliance is determined by objective measurements against predefined thresholds in standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC study was not done. This device is an X-ray unit, which produces images, it does not interpret them with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is an X-ray unit, not an AI/ML algorithm. Its "standalone performance" is its ability to generate X-rays within specified parameters and meet safety standards.
7. The Type of Ground Truth Used:
- Engineering Specifications and Recognized International Standards: The "ground truth" for this device is compliance with the objective electrical, mechanical, radiation, and software safety requirements defined in the listed IEC and ISO standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-65, IEC 62304, IEC 62366, ISO 14971). The device's performance metrics (like leakage radiation, focal spot size, tube voltage, current, exposure time) are compared against the requirements and specifications, some of which are standardized.
8. The Sample Size for the Training Set:
- Not applicable. This is an X-ray unit, not an AI/ML device that requires training data.
9. How the Ground Truth for the Training Set was Established:
- Not applicable.
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