(88 days)
The ADC Dental is indicated for use to provide diagnostic quality images to aid in physician or dentist diagnosis. The ADC Dental is intended to be used in extraoral dental and maxillofacial imaging applications.
The ADC Compact Plus, the predicate device, is a computed radiography imaging system. Instead of screens and photographic film for producing the diagnostic image, the ADC Compact system utilizes an "imaging plate," a plate coated with photo-stimulatable storage phosphors that are sensitive to X-rays and capable of retaining a latent image. This imaging plate is inserted into a device that scans it with a laser and releases the latent image in the form of light which is converted into a digital bit stream. The bit stream of image data is stored locally and can also be stored in the PACS network in DICOM format.
The ADC Dental is identical in hardware and software to the ADC Compact Plus. The only difference is in a data file provided that is accessed by the (unchanged) software, where preselected image processing parameters are paired with typical dental exposure Rather than entering the exposure parameters by exam type. parameters manually, as would be the case for dental/maxillofacial exams using the ADC Compact Plus, the user would simply select the exam type and patient age, and the proper image processing parameters would be selected automatically and applied to "developing" the image.
Here's an analysis of the provided text regarding the ADC Dental device, focusing on acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific numerical acceptance criteria were not explicitly defined, nor were precise quantitative performance metrics reported. The submission focuses on demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Provide diagnostic quality images to aid in physician and dentist diagnosis. | "found to be preferred to traditional imaging techniques." |
| Intended for use in extraoral dental and maxillofacial imaging applications. | Indicated for and intended to be used in these applications. |
| Substantially equivalent to predicate devices (ADC Compact Plus and Schick Technologies CDR-Pan Model 4700). | "The ADC Dental is identical in hardware and software to the ADC Compact Plus." "The only difference is in a data file provided that is accessed by the (unchanged) software, where preselected image processing parameters are paired with typical dental exposure." "The ADC Dental has the same (identical) technological characteristics as the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document only mentions "a clinical environment."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications: "physician and dentist." Specific qualifications (e.g., number of years of experience, specialization) are not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done? No. The document states, "The ADC Dental was tested in a clinical environment and it was found to be preferred to traditional imaging techniques." This is a general statement, not indicative of a formal MRMC study with a comparative effectiveness analysis of human readers with vs. without AI assistance. The device itself is a digital imaging system, not an AI-assisted diagnostic tool in the modern sense.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study Done? No. The device is an imaging system, not an algorithm meant for standalone diagnosis. Its function is to produce images for human interpretation. The "only difference is in a data file provided that is accessed by the (unchanged) software, where preselected image processing parameters are paired with typical dental exposure ... the user would simply select the exam type and patient age, and the proper image processing parameters would be selected automatically and applied to 'developing' the image." This describes automated image processing, not a diagnostic algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: Implied to be based on expert preference ("found to be preferred to traditional imaging techniques") for "diagnostic quality images." It does not explicitly state pathology confirmation or direct outcomes data.
8. Sample Size for the Training Set
- Sample Size: Not applicable. The device is a computed radiography system, not a machine learning model that requires a training set in the conventional sense. The "data file" mentioned for image processing parameters would likely be based on expert knowledge and empirical testing rather than an algorithmic training process on a large dataset.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment: Not applicable. As mentioned above, there isn't a "training set" in the context of an AI/ML model for this device. The image processing parameters in the data file would have been established through expert-defined settings and optimization for dental/maxillofacial imaging, likely drawing on established radiographic principles and empirical adjustments.
§ 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.