(122 days)
The BI IMAGE-X EVOLUTION device is an X-Ray generator designed for radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure in combination with an intraoral image receptor.
The device is designed to be used by dental professionals for radiographic examinations to assist with diagnosis of diseases of the teeth, jaw, and oral structure by exposing an x-ray image receptor to ionizing radiation. The x-ray source, a tube, is located outside the mouth. All three conventional types of intraoral receptors can be used with this device: analog x-ray film, digital phosphorous plates, and digital x-ray sensors. The Bi Image-X Evolution is a wall mounted device or can also be a floor model on a stand.
This document is a 510(k) Pre-market Notification for the BI IMAGE-X EVOLUTION, an extraoral X-ray system. The submission aims to demonstrate substantial equivalence to a predicate device, the Dental X-Ray Z70 (K122582).
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define "acceptance criteria" in the typical sense of quantitative performance thresholds for a diagnostic AI device (e.g., specific sensitivity, specificity, or AUC targets). Instead, it establishes substantial equivalence by comparing technological characteristics and adherence to safety standards.
Below is a table summarizing the technological comparison, which serves as the primary basis for demonstrating equivalence rather than meeting specific performance metrics for image analysis.
| Characteristic | Acceptance Criteria (Predicate Device K122582) | Reported Device Performance (Subject Device BI IMAGE-X EVOLUTION) |
|---|---|---|
| Intended Use | Extraoral X-ray system for dental radiographic examination and diagnosis of diseases of the teeth. | Extraoral X-ray generator that provides radiation for radiographic image formation for diagnosis. |
| Indications for Use | X-ray generator providing radiation for radiographic image formation for diagnosis. | Extraoral X-ray generator system for radiographic examinations to assist with diagnosis of diseases of the teeth, jaw, and oral structure in combination with an intraoral image receptor. |
| Electric Power Voltage | 120 VAC ± 10% or 230 VAC ± 10% | 108-132 VAC Monophase rectified |
| Rated Current | 9 A (120V) - 4A (230V) | 10A max (120V) |
| Type of Power Supply | 50/60 Hz | 50/60 Hz |
| kVp (kilovolt peak) | 70 kVp ± 10% | 70 kVp +/- 15% with 108-132 V |
| Exposure Time | 0.06 — 2.50 sec | 0.01-2.2 sec |
| Current to Tube | 7 mA ± 1.40 | 10 mA +/- 20% |
| Maximum Radiation Field | Ø 60 mm | Ø 60 mm |
| Focal Point | 0.8 mm x 0.8 mm (IEC 336) | 0.8mm (IEC366) |
| X-Ray Generator | AC - Alternate Current | AC - Alternate Current |
| Operator Exposure Control | Deadman Switch | Deadman Switch |
| Exposure Interval (Duty Cycle) | 1:60 | 1:32 |
| Minimum Distance SSD | 20 cm | 20 cm |
| Fuses | 10A 230V | 10A 250V |
| Operating Temperature Range | -20°C - + 55°C | -20°C - + 70°C |
| Fixed Arm | 27.56 inches (70 cm) | 27.56 inches (70 cm) |
| Standards of Conformity | EN 60601-1, EN 60601-2-28, EN 60601-2-54, EN 60601-1-3, EN 60601-1-2 | IEC 60601-1, IEC 60601-6, IEC 60601-3, IEC 60601-2-28, EN 60601-1-2 |
2. Sample Size Used for the Test Set and Data Provenance
This document describes an X-ray generator, not an AI/ML-driven diagnostic device that relies on a "test set" in the context of image analysis. Therefore, there is no mention of a test set sample size or data provenance related to image data. The "testing data reports" mentioned are for electrical, mechanical, and safety performance of the hardware.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. As this is not an AI/ML diagnostic device analyzing medical images, there's no "ground truth" established by experts in this context. The evaluation is based on technical specifications and compliance with standards.
4. Adjudication Method for the Test Set
Not applicable. There is no test set for image analysis requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document does not describe an MRMC study. The device is an X-ray generator aiming for substantial equivalence based on hardware and safety parameters, not on human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This is not an algorithm-only (AI) device. It is an X-ray generator.
7. The Type of Ground Truth Used
The "ground truth" in this context is adherence to recognized electrical and safety standards (IEC 60601 series, EN 60601 series, and 21CFR 1020.030, 1020.31). The testing involved physical measurements and evaluations against these objective standards by an independent laboratory.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is involved.
Summary of the Study and Evidence Presented:
The study presented to prove the device meets acceptance criteria is primarily a technical comparison and compliance testing to demonstrate substantial equivalence to the predicate device (Dental X-Ray Z70, K122582) and adherence to relevant safety and performance standards.
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Evidence Type:
- Technological Comparison: A detailed table (Table 5) comparing the subject device's specifications (e.g., kVp, mA, exposure time, focal point, power requirements) against those of the predicate device. The conclusion drawn is that the devices have "substantially similar technology characteristics."
- Performance Data: The submission includes "testing data reports" from an independent laboratory (Met Laboratories, Inc.) for:
- EMC and Electrical Safety: Conformance to IEC 60601-1 3rd Edition (including IEC 60601-1-6, 60601-1-3, 60601-2-28) and EN 650601-1-2.
- Radiation Performance Standards: Conformance to 21CFR 1020.030 and 1020.31 (presumably related to radiation output and limits for diagnostic X-ray systems).
- Software Verification and Validation: Performed by Radiotech, the manufacturer, and included in the submission. This indicates testing of the device's control software to ensure it functions as intended and safely.
- Risk Analysis: A risk assessment was performed, including recommendations for radiation exposure mitigation for users.
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Conclusion of the Study: "The subject and the predicate device have the same intended use and the same technological features. The BI IMAGE – X and the Dental X-Ray Z70 share the same principles of operation and use similar imaging firmware. The conclusion is that the subject device is as safe and effective as the predicate."
In essence, the "acceptance criteria" are implicitly met by demonstrating that the device is technically comparable to a legally marketed predicate and complies with established international and national safety and performance standards for X-ray equipment. No clinical studies or AI performance metrics are
mentioned because the device itself is an X-ray generator, not an imaging analysis tool.
§ 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.