(51 days)
The EVA SELECT Digital Dental Imaging System is intended to be used with standard dental X-ray systems and computer stations for system operation, archive data storage, digital dental image input capture and enhancement, and patient data and support.
The EVA SELECT System (previously named the EVA System) has been modified to incorporate a new sensor component. The proposed EVA System is essentially identical in intended use and fundamental technology to the parent EVA Digital Dental Imaging System. The modifications are limited to changing the sensor from a proprietary design to a commercially available sensor which is already used in at least 2 devices with pre-market clearances (K112380 and K102456). As with the original EVA Sensor, the CMOS sensor when exposed to radiation uses a scintillator to indirectly capture the image in the form of a charge pattern on its surface. The resulting electronic output signals are digitized and sent to a computer via a USB interface. The images are then available for display on a computer monitor screen.
Here's an analysis of the provided text regarding the acceptance criteria and study for the EVA Select Digital Dental Imaging System:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list quantitative acceptance criteria in the typical sense for performance metrics like sensitivity, specificity, or image quality scores. Instead, the acceptance is based on demonstrating "substantial equivalence" to predicate devices, focusing on demonstrating that the new device is "as safe and effective" and offers "equal or better image quality." The technical characteristics table serves as a comparison against established devices.
| Acceptance Criteria (Implicit from Predicate Comparison) | Reported Device Performance (EVA SELECT) |
|---|---|
| Intended Use: For use with standard dental X-ray systems and computer stations for system operation, archive data storage, digital dental image input capture and enhancement, and patient data and support. | Meets: Intended use is identical to the original EVA Digital Dental Imaging System. |
| Number of Sensors: 2 Sizes (e.g., matching or exceeding predicate) | Meets: 2 Sizes. Both sizes match the pixel dimensions of the predicate Clear Vision and BelSensor Gold. |
| Sensor Sizes (mm): Comparable to or exceeding predicate devices (e.g., 19.95mm x 30.02mm, 36.00mm x 25.99mm) | Meets: 19.95 mm x 30.02 mm and 36.00 mm x 25.99 mm (matches Clear Vision and BelSensor Gold). |
| Pixel Size (μm): Comparable to or lower than predicate devices (indicating higher resolution potential) | Meets/Exceeds: 19 μm (improves upon original EVA's 30 μm, matches Clear Vision and BelSensor Gold). |
| Resolution (lp/mm): Theoretical and actual resolution comparable to or exceeding predicate devices. | Meets/Exceeds: 26.3 lp/mm (theoretical), 18.0 lp/mm (actual). Improves upon original EVA, matches Clear Vision and BelSensor Gold. |
| Technology: CMOS | Meets: CMOS (matches all predicates). |
| Scintillation: Comparable to predicate devices (e.g., CsI or GadOx) | Meets: CsI (improves upon original EVA's GadOx, matches Clear Vision and BelSensor Gold). |
| Interface with PC: USB | Meets: USB (matches all predicates). |
| Power Source: 5 V (USB) | Meets: 5 V (USB) (matches all predicates). |
| Gray Shades: 4096 | Meets: 4096 (matches all predicates). |
| Cable Length (m): Minimum or comparable to predicate devices | Meets: 3m (improves upon original EVA's 2m, matches Clear Vision and BelSensor Gold). |
| Electrical Safety and EMC: Compliance with IEC Standards. | Meets: Bench testing confirms compliance. |
| Risk Analysis and Software Validation: In accordance with FDA guidance. | Meets: Bench testing confirms compliance. |
| Image Quality: Clinical images demonstrate equal or better image quality compared to predicates. | Meets: Concluded by a qualified dentist. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated with a specific number of images or patients. The text mentions "Clinical images were acquired" and "Clinical images collected," implying a sample was used but without a quantitative count.
- Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or the country of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: "a qualified dentist" (singular).
- Qualifications of Experts: "qualified dentist." No further details on years of experience, specialization (e.g., oral radiologist), or any specific board certifications are provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable or not explicitly described. As only "a qualified dentist" evaluated the images, there's no mention of a multi-reader adjudication process (e.g., 2+1, 3+1). The evaluation appears to be a single expert's opinion.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. The submission does not describe an MRMC study comparing human readers with AI assistance versus without AI assistance. The focus is on the device's technical specifications and a single expert's assessment of image quality against predicates. The device itself is an imaging system, not an AI-assisted diagnostic tool in this context.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study Done
- Standalone Study Done: Not applicable in the context of an imaging system. This device is a digital dental imaging system (hardware and software for image capture and display), not an algorithm designed for standalone diagnostic performance. The "algorithm" here refers to image processing within the system for display, not an AI diagnostic algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for image quality was based on expert opinion/consensus (from a single "qualified dentist") comparing the EVA Select images to those acquired with predicate panels. It is not based on pathology reports or clinical outcomes data in this submission.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The device is a digital imaging system, and the submission describes its hardware and basic software functions (image capture, enhancement, display). There is no mention of a machine learning algorithm that would require a "training set" in the conventional AI sense. The device uses standard image processing techniques.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no mention of a training set for machine learning.
§ 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.