(267 days)
The RAYSCAN a- Expert Dental X-Ray System is an extraoral source dental panoramic and optional cephalometric Xray system intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
The RAYSCAN a- Expert Dental X-Ray System is an extraoral source dental panoramic and optional cephalometric X-ray system. The machine is made of X-ray generator and arms in which transfers X-ray signals to a sensor in 2D. The arm parts are controlled for rotating and linear moving to synchronize between the sensor and X-ray generator to get the image of interests. The unit has to be adjustable depending on height of a patient and PC system to reconstruct an image. Panorama is to diagnose the structures in a panoramic view. Cephalometric allows for orthodontic treatment. These 2 functions could be in 1 system, or Panorama only system depending on the needs. Digital transferring from permeated X-ray to absorbing to the sensor is essential and all the process are proceed in Detector. Detector transfers X-ray to light depending on the structure materials. Detector is separated into indirect method that the light is changed to digital signals on photodiode and direct method in which the light is directly transferred to digital signal. This unit is using both direct and indirect method depending on the interior structure materials.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Implicit) | Reported Device Performance (Proposed Device Configuration: RAYSCAN α-OCL & α-OCS) | Predicate Device-1 Performance (RAYSCAN α-Expert [K122918]) | Predicate Device-2 Performance (RAYSCAN α-Expert [K131693]) |
|---|---|---|---|---|
| Detector Type (Ceph, One-shot, Large) | Indirect type (GADOX Scintillator) | GADOX (Indirect type) | N/A | CsI (Indirect type) |
| Total Pixel Area (Ceph, One-shot, Large) | 427(W)x356(H)mm | 427(W)x356(H)mm | Same as Predicate #1 | 43.2 x 36.0 cm |
| Total Pixel (Ceph, One-shot, Large) | 3072x2560 | 3072x2560 | N/A | 2880 x 2400 |
| Pixel Size (Ceph, One-shot, Large) | 139um | 139um | N/A | 150 um |
| Limiting Resolution (Ceph, One-shot, Large) | 3.6lp/mm | 3.6lp/mm | N/A | 3.3 lp/mm |
| MTF (Ceph, One-shot, Large) | 54% at 1LP/mm | 54% at 1LP/mm | N/A | 45% at 1LP/mm |
| DQE (Ceph, One-shot, Large) | 0.2 at 1LP/mm | 0.2 at 1LP/mm | N/A | 0.41 at 1LP/mm |
| Detector Type (Ceph, One-shot, Standard) | Indirect type (GADOX Scintillator) | GADOX (Indirect type) | N/A | N/A |
| Total Pixel Area (Ceph, One-shot, Standard) | 302(W)x249(H)mm | 302(W)x249(H)mm | N/A | N/A |
| Total Pixel (Ceph, One-shot, Standard) | 2176x1792 | 2176x1792 | N/A | N/A |
| Pixel Size (Ceph, One-shot, Standard) | 139um | 139um | N/A | N/A |
| Limiting Resolution (Ceph, One-shot, Standard) | 3.6lp/mm | 3.6lp/mm | N/A | N/A |
| MTF (Ceph, One-shot, Standard) | 54% at 1LP/mm | 54% at 1LP/mm | N/A | N/A |
| DQE (Ceph, One-shot, Standard) | 0.2 at 1LP/mm | 0.2 at 1LP/mm | N/A | N/A |
Note: The document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than explicit numerical acceptance criteria. The "Acceptance Criteria (Implicit)" column is derived from the performance of the predicate devices or the device's own reported values that are compared against. The primary claim of meeting criteria is that the "diagnostic image quality of the new detector is equal or better than those of the predicate device and there is no significant difference in efficiency and safety."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not explicitly stated as a number of patients or images. The document mentions "clinical imaging samples are collected from the new 2 one shot detector on propose device at the 2 offices where the predicate device is installed."
- Data Provenance: The images were gathered "on any protocols with random patient age, gender, and size." The location where images were collected is "the 2 offices where the predicate device is installed," which implies a clinical setting. The country of origin is not explicitly stated, but the manufacturer is based in Korea. The study appears to be prospective in the sense that images were collected from the new devices in a clinical setting to demonstrate performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Two licensed practitioners/clinicians.
- Qualifications of Experts: The document states they were "licensed practitioners/clinicians." No further specific qualifications (e.g., years of experience, specialization like radiologist) are provided.
4. Adjudication Method for the Test Set
- Adjudication Method: The document states that the "two licensed practitioners/clinicians observed and verified that dental X ray system from RAYSCAN α" and, as licensed practitioners, their "diagnosis of the images, it might be proved that the clinical diagnosis and structures are acceptable in the region of interests." This suggests an expert consensus/agreement, but no formal adjudication method (like 2+1 or 3+1) is detailed. It implies a qualitative assessment of acceptability rather than a quantitative ground truth measurement.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a formal MRMC comparative effectiveness study demonstrating human reader improvement with AI assistance (vs. without AI) was not explicitly conducted or described. The study focused on demonstrating substantial equivalence of the device's technical specifications and image quality.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone (algorithm only without human-in-the-loop performance) study was not described. The evaluation involved "licensed practitioners/clinicians" observing and verifying the images.
7. Type of Ground Truth Used
- Ground Truth: The "ground truth" for the clinical evaluation was based on expert consensus/clinical diagnosis. The practitioners' "diagnosis of the images" was used to conclude that "the clinical diagnosis and structures are acceptable in the region of interests." There is no mention of pathology or outcomes data being used as ground truth.
8. Sample Size for the Training Set
- The document describes a 510(k) submission for an X-ray imaging device; it does not explicitly refer to an "AI algorithm" with a training set. The device is an image acquisition system. Therefore, the concept of a training set for an AI model is not applicable in this context. The focus is on the performance of the imaging hardware.
9. How the Ground Truth for the Training Set Was Established
- As mentioned above, the device is an X-ray imaging system, not an AI algorithm requiring a training set. Therefore, this question is not applicable to the provided document. The ground truth mentioned in the document pertains to the clinical assessment of the acquired images.
§ 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.