(28 days)
The DUO Sensors are USB driven intraoral sensors which are intended to acquire intraoral radiographic images. The DUO Sensors shall be operated by trained healthcare professionals, who are educated and competent to perform the acquisition of intraoral radiographs.
The DUO Sensors can be used either in combination with special positioning devices to facilitate positioning and alignment with the X-ray beam or they may also be positioned by hand with the assistance of the patient.
The DUO sensors are intended for any dental practice that uses X-ray equipment for intraoral diagnostic purposes. DUO sensors can be used by trained dental professionals for patients receiving intraoral X-ray examinations and procedures for capturing digital X-ray images. Captured digital X-ray images can be used for examinations and diagnostic purposes with the help of optional image analysis software. The optional image analysis software is not part of this submission. DUO sensors can be used with dental positioning devices and holders to assist with aligning an X-ray source beam with the sensor and anatomy.
The DUO sensors are USB-driven digital X-ray sensors designed for health care professionals who are already acquainted with the standard procedures for acquiring dental intraoral radiographs. Digital X-ray imaging is an aide for diagnosis and should always be confirmed by the doctor using appropriate additional diagnostic aides, professional judgment, and experience.
The DUO Sensors are indirect converting X-ray detectors. A scintillating material converts the incident Xrays into visible light, this light is coupled optically to a CMOS technology light detection imager, and then converted to digital data.
The design of the sensor assembly supports the automatic detection of incident X-rays to generate digital images for intraoral applications, once armed via a software command. The digital image created is immediately visible on the screen of a personal computer connected to the DUO sensor through the standard USB port. For DUO sensors to be used in a dental practice, an optional image analysis software will be necessary. Image analysis software is not part of the submission. DUO captured X-ray images are suitable for recognition of normal anatomical structures, dental pathologies, and abnormal conditions.
The DUO sensors support USB2.0 connectivity to computers using a dedicated electronic assembly and a sensor software driver. Functions of the DUO sensors are controlled by software drivers and utilities support sensor activation and settings.
The DUO sensors are manufactured with the same device firmware as the predicate device, Brasseler GEM.
This submission describes a dental digital X-ray sensor, DUO1 and DUO2, which is substantially equivalent to the predicate device, Brasseler GEM.
Here's the breakdown of the acceptance criteria and supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA submission for K241649 is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to a legally marketed predicate device rather than setting specific quantifiable acceptance criteria for novel claims. Therefore, the "acceptance criteria" here refer to demonstrating comparable performance to the predicate device (Brasseler GEM) for key technical aspects.
| Acceptance Criteria (Demonstrates Substantial Equivalence to Brasseler GEM) | Reported Device Performance (DUO1 and DUO2) |
|---|---|
| Mechanical/Physical Equivalence | |
| Sensor Exterior Sizes | DUO1: 36.36 mm x 24.53 mm (Same as Brasseler GEM) |
| DUO2: 41.80 mm x 30.48 mm (Same as Brasseler GEM) | |
| Sensor Imaging Sizes | DUO1: 30.26 mm x 20.32 mm (Same as Brasseler GEM) |
| DUO2: 36.08 mm x 26.25 mm (Same as Brasseler GEM) | |
| Overall Imaging Areas | DUO1: 615 mm² (Same as Brasseler GEM) |
| DUO2: 947.1 mm² (Same as Brasseler GEM) | |
| Clipped Corners | All with four clipped corners (Same as Brasseler GEM) |
| Housing Biocompatibility | IPx8 Equivalent ISO 10993-1 Biocompatible (Same as Brasseler GEM). Biocompatibility is based on the predicate device as materials/manufacturing are identical. SABIC resin used is the same as the predicate device. |
| Sterilization suitability | Not suitable for sterilization (Same as Brasseler GEM). Manufacturer recommends hygienic barrier. |
| Imaging Performance Equivalence | |
| Pixel Size | 19.5 μm (Same as Brasseler GEM) |
| Image Resolution (pixels) | DUO1: 1539 x 1026 pixels (1.70 M pixels) (Same as Brasseler GEM) |
| DUO2: 1842 x 1324 pixels (2.40 M pixels) (Same as Brasseler GEM) | |
| X-Ray Resolution (lp/mm) | 20 visible lp/mm (Predicate: 20+ visible lp/mm). The submission states both have a theoretical maximum resolution of 25 lp/mm. This is considered "Different" in the comparison table but is addressed as substantially equivalent in the "Meaningful Differences" section by clarifying theoretical maximums are the same. |
| Dynamic Range | 16,384:1 (Same as Brasseler GEM) |
| Technology (CMOS) | CMOS (Same as Brasseler GEM) |
| Scintillator Technology | Cesium Iodide (Same as Brasseler GEM) |
| MTF (Modulation Transfer Function) | Identical to Brasseler GEM (due to using the exact same sensor components from the same contract manufacturer). |
| DQE (Detective Quantum Efficiency) | Substantially equivalent to Brasseler GEM (determined by BAE Systems Imaging Solutions). |
| Electrical/Software Equivalence | |
| Operating System Compatibility | Microsoft Windows 10 and Windows 11 (Predicate: Windows 7 and 10). This indicates broader compatibility for later OS versions for DUO. |
| Interface to PC | USB 2.0, Type A (Same as Brasseler GEM) |
| Power Consumption | 0.8 Watts Max (Same as Brasseler GEM) |
| Electrical Rating | DC 5V, 350 mA max (Same as Brasseler GEM) |
| Cable Length | 0.6m and 1.9m (Predicate: 1.9m and 2.9m). Stated that cable length has no effect on performance. |
| Software Functionality | Functions controlled by software drivers and utilities support sensor activation and settings. Simple API for integration with existing FDA-cleared image capture/dental imaging software. |
| Clinical Performance | |
| Visual Assessment of Clinical Images | Performed similar or better than the predicate device (Brasseler GEM) as evaluated by US dentists. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The document refers to "clinical images captured with both the devices in a performance testing report which were evaluated by US dentists."
- Sample Size: The exact number of patients or images in the clinical performance test set is not specified in the provided text.
- Data Provenance: The images were evaluated by "US dentists." It is not explicitly stated whether the data was retrospective or prospective. Given the clinical image evaluation, it suggests real-world acquisition but the exact study design (e.g., controlled prospective collection vs. retrospective existing images) is not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: The document states that the clinical images "...were evaluated by US dentists." The exact number of dentists is not specified.
- Qualifications of Experts: The experts are described as "US dentists." Specific qualifications such as years of experience, subspecialty (e.g., board-certified oral and maxillofacial radiologists), or academic affiliations are not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: The document only states that images "were evaluated by US dentists." It does not describe any specific adjudication method (e.g., 2+1, 3+1 consensus, independent reads with no consensus).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- A formal MRMC comparative effectiveness study that quantifies improvements in human reader performance (e.g., AUC, sensitivity, specificity) with AI versus without AI assistance was not performed or described. The clinical performance testing involved dentists evaluating images from both devices, implying a comparative visual assessment, but not a controlled MRMC study in the context of AI assistance. The device itself is an intraoral sensor, not an AI diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- This device (DUO sensors) is a hardware component for acquiring images, not an AI algorithm for image analysis. Therefore, a standalone algorithm performance study is not applicable in the traditional sense. The submission states, "Image analysis software is not part of the submission" and "The optional image analysis software is not part of this submission."
7. Type of Ground Truth Used
- For the clinical performance testing, the ground truth was based on the visual evaluation and judgment of US dentists comparing images from DUO sensors to those from the predicate Brasseler GEM. This can be considered a form of expert consensus/reader judgment on image quality and diagnostic utility, but specific "ground truth" for disease presence/absence (like pathology or outcomes data) is not explicitly detailed as this is not an AI diagnostic device. The statement "DUO captured X-ray images are suitable for recognition of normal anatomical structures, dental pathologies, and abnormal conditions" implies the images were assessed for their ability to show such features.
8. Sample Size for the Training Set
- The provided text does not mention a training set for the DUO sensors. As this is a hardware device (sensor) and not an AI diagnostic algorithm, a "training set" in the context of machine learning is not applicable here. The device uses established CMOS and scintillator technologies and is compared against a predicate device.
9. How the Ground Truth for the Training Set Was Established
- Since there is no mention of a training set for an AI algorithm, the concept of establishing ground truth for a training set is not applicable to this submission.
§ 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.