(382 days)
The VISTEO digital system is used to provide instant digital images of human oral tissue and teeth without the use of a conventional x-ray film. It is used for diagnosis purpose, by dental practitioners.
This is achieved by using the conventional x-ray tube, and placing an electronic sensor in the patient's mouth instead of conventional film.
The sensor, upon radiation exposure, automatically captures the images into a computer.
The computer, which is not provided by OWANDY, controls all aspects of image acquisition and image display, storage and printing.
Additional software (after, and not part of, image capture software) is available on the market. They allow for enhancements such as zoom, controls, image inversion, and pseudo color renditions.
The main advantages of this digital imaging system are :
- high definition ensuring high-value diagnostics
- interface allowing image processing in the PC
In no case, it has to be used directly by the patient. So, it is used exclusively in a healthcare specific environment.
The VISTEO system consists of the following components: the sensor and its cable, a USB/data box, with sensor adapter. The sensor body is made hermitically sealed shell which encapsulates a black and white CMOS chip. The sensor attaches the USB/data box (processing unit) via a 1 meter removable cable.
The sensor, when exposed to radiation, captures image in the form of a charge pattern on its surface (CMOS). The resulting electronic signals are digitised and sent to a computer for image presentation.
According to the 2 different models, there are two possible sizes:
D001 model (size 1): the outer dimensions are approximately 1.5 x 1.0 x 0.3 inches (38,9 x 24,9 x 7,4mm) with rounded edges.
D002 model (size 2): the outer dimensions are approximately 1.7 x 1.2 x 0.3 inches (42.9 x 30.9 x 7,4mm) with rounded edges.
The USB/data box relays the data from to the computer for display. The data box is a 5.4 x 1.8 x 0.7 inches (13.8x 1.8 x 0.7 cm) box with an USB cable connection.
Positioner accessories : 2 bite blocks (bitewing and endo) + 1 aiming ring
The provided 510(k) summary for the VISTEO device does not contain a specific study proving the device meets particular acceptance criteria in terms of diagnostic performance or accuracy. Instead, the submission focuses on substantial equivalence to a predicate device (UNIVERSAL-X, K053172) based on technological characteristics and intended use.
Here's an analysis of what is and isn't available in the document regarding acceptance criteria and performance:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of acceptance criteria for diagnostic performance outcomes (e.g., sensitivity, specificity, image quality metrics) or any reported device performance against such criteria. The focus is on demonstrating that the VISTEO device functions similarly to its predicate in capturing digital dental X-ray images.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified for diagnostic performance or image quality. | Not reported as per a specific study with defined metrics. |
| (Implicit) Image Acquisition and Display Functionality | "The VISTEO digital system is used to provide instant digital images of human oral tissue and teeth..." and "...high definition ensuring high-value diagnostics." (These are descriptive statements, not quantified performance criteria.) |
2. Sample Size Used for the Test Set and Data Provenance:
No specific test set or associated sample size for evaluating clinical performance (e.g., diagnostic accuracy) is mentioned. The submission describes the device's components and its function in capturing images but does not detail a study where these images were evaluated against a ground truth.
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Since no test set for evaluating diagnostic performance is described, there's no mention of experts used to establish ground truth or their qualifications.
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set:
Not applicable, as no test set for clinical performance evaluation is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No MRMC study is mentioned in the provided text. The submission focuses on substantial equivalence based on technological characteristics and intended use, not on comparative effectiveness for diagnostic tasks.
- MRMC Study: No.
- Effect Size (AI vs. without AI assistance): Not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The VISTEO is a hardware device (sensor) that captures raw image data. It interfaces with a computer for display and storage. The document explicitly states: "Additional software (after, and not part of, image capture software) is available on the market. They allow for enhancements such as zoom, controls, image inversion, and pseudo color renditions." This indicates that the VISTEO itself is not an "algorithm" as typically referred to in AI/ML, but rather an imaging sensor. Therefore, a standalone algorithm performance study is not relevant to this device's description.
- Standalone Study: Not applicable (device is a sensor, not an algorithm).
7. The Type of Ground Truth Used:
Not applicable, as no study evaluating diagnostic performance against a ground truth is described.
- Type of Ground Truth: Not specified.
8. The Sample Size for the Training Set:
The device is an imaging sensor, not an AI/ML algorithm that requires a training set. Therefore, there is no mention of a training set or its sample size.
- Sample Size (Training Set): Not applicable.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as the device does not involve a training set for an AI/ML algorithm.
Summary of 510(k) Approach for VISTEO:
The 510(k) submission for VISTEO is based on demonstrating substantial equivalence to an existing legally marketed predicate device (OWANDY UNIVERSAL-X, K053172). This approach typically relies on comparing the new device's technological characteristics and intended use to the predicate, rather than conducting new clinical performance studies with specific acceptance criteria and ground truth evaluations.
- Technological Characteristics Comparison: The document highlights the change from CCD technology in the predicate to CMOS technology in VISTEO, but asserts that both are X-ray sensitive solid-state imaging arrays.
- Intended Use Comparison: Both devices are stated to be for digital dental radiography, intended for diagnosis by dental practitioners.
The FDA's clearance (K093105) indicates that they agreed the VISTEO device is substantially equivalent to the predicate, implying that it is as safe and effective as the predicate without requiring new clinical performance data.
§ 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.