(61 days)
RCT700 is CBCT and panoramic x-ray imaging system with cephalometric. Which is intended to radiographic examination of the dento-maxillofacial, sinus, TMJ, Airway and ENT structure for diagnostic support for adult and pediatic patients. And a model scan is included as an option. Cephalometric image is also includes wrist to obtain carpus images for growth and maturity assessment for orthodontic treatment. The device is to be operated and used by dentists or other legally qualified heath care professionals
RCT700 is 3D computed tomography for scanning hard tissues like bone and teeth. By rotating the c-arm which is embedded with high voltage generator all-in-one x-ray tube and a detector on each end, CBCT images of dental maxillofacial is attained by recombining data from the same level that are scanned from different angle. Panoramic image scanning function for attaining image of whole teeth, cephalometric scanning option for attaining cephalic image, and Model Scan option for attaining dental model CBCT image are included.
The provided text describes the updated RCT700 device, a dental panoramic/tomography and cephalometric X-ray system, and compares it to two predicate devices (K182614 and K192737). The 510(k) summary focuses on demonstrating substantial equivalence rather than a detailed study proving novel acceptance criteria for a new AI component. The acceptance criteria and the study conducted are primarily focused on maintaining safety and effectiveness comparable to the predicate devices.
Here's the breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly tied to the performance specifications of the predicate devices and general regulatory standards for medical imaging devices. The "reported device performance" refers to the new device (RCT700) meeting these established specifications.
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate Devices and Standards) | Reported Device Performance (RCT700) |
|---|---|---|
| X-ray Current (Min.) | 4mA (from predicate) | Changed to 1mA (This represents a design change, and its safety/effectiveness is justified by non-clinical testing and comparison to standards) |
| Irradiation Time (One shot Ceph) | Not explicitly stated, but "changed" from predicate | Changed (details not provided, but deemed acceptable via non-clinical testing) |
| Electrical Safety | Compliance with IEC 60601-1: 2005/AMD1:2012(3.1 Edition) | Performed, results satisfactory |
| Protective Provisions against X-radiation | Compliance with IEC 60601-1-3: 2008/AMD1:2013(Second Edition) | Performed, results satisfactory |
| Usability | Compliance with IEC 60601-1-6:2010(Third Edition) | Performed, results satisfactory |
| Dental X-ray Equipment Specific | Compliance with IEC 60601-2-63: 2012/AMD1:2017(First Edition) | Performed, results satisfactory |
| EMC Testing | Compliance with IEC 60601-1-2: 2014(Edition 4.0) | Performed, results satisfactory |
| Software Validation | Compliance with FDA "Guidance for the Content d Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" | Validated, deemed substantially equivalent with a "moderate" level of concern. |
| Imaging Performance | Compliance with IEC 61223-3-4 and IEC 61223-3-5 | Performed, all test results satisfactory |
| Non-clinical Performance | No significant difference compared to predicate device using the same detector | Demonstrated, as the subject device uses the same detector as the predicate. |
| Clinical Image Quality | Acceptable quality for intended use | Sample clinical images reviewed by a licensed practitioner and found acceptable. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a numerical sample size for the test set used for non-clinical or clinical evaluations.
- Test Set Description: "Bench testing" and "Performance (Imaging performance) testing" were conducted. "Clinical images were provided," and "clinical imaging samples are collected from the all detector on propose device at the 2 offices where the predicate device is installed."
- Data Provenance: The general context of the submission implies that the testing was conducted by the manufacturer (RAY Co., Ltd.) in REPUBLIC OF KOREA. The clinical images were collected from "2 offices where the predicate device is installed," suggesting a retrospective collection for evaluation purposes, though this isn't explicitly stated as purely retrospective vs. prospectively gathered for the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: "two licensed practitioners/clinicians" for clinical testing. For the review of clinical images, "A licensed practitioner reviewed the sample clinical images."
- Qualifications of Experts: "licensed practitioners/clinicians." No specific experience level (e.g., "radiologist with 10 years of experience") is provided.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method like 2+1 or 3+1 for resolving discrepancies in expert opinions. It states that "A licensed practitioner reviewed the sample clinical images and found them to be of acceptable quality," suggesting a single-reader assessment for acceptance of image quality. For the "two licensed practitioners/clinicians" for clinical testing, the method of their "approval" is not detailed.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, an MRMC comparative effectiveness study involving human readers and AI assistance was not conducted or described.
- AI Effect Size: The document does not describe AI functionality or an AI component that would require such a study or an effect size. The device is an imaging system, and its software (RayScan) is described as "viewing software programs" and supporting "image generate function," which is not characterized as AI for diagnostic assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. The device is a physical X-ray imaging system, not a standalone algorithm. The software (RayScan) is integrated into the device for image generation and viewing.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the clinical image quality evaluation, the "ground truth" was established by the subjective assessment of "licensed practitioners" determining if the images were of "acceptable quality for the intended use." This aligns with expert opinion/assessment of image quality rather than objective ground truth like pathology or outcomes data.
8. The Sample Size for the Training Set
Not applicable. This document describes a medical device (an X-ray system) and its associated software (for image acquisition and viewing), not a machine learning or AI algorithm that would typically require a separate training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no mention of a machine learning or AI algorithm requiring a training set in this submission.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.