(73 days)
RCT800 is CBCT and panoramic x-ray imaging system with cephalometric.
Which is intended to radiographic examination of the dento-maxillofacial, sinus, TMJ, Airway for diagnostic support for adult and pediatric 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.
RCT800 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 does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of diagnostic accuracy or effect size with AI assistance. The document is a 510(k) summary for the RCT800, a dental CBCT and panoramic x-ray system, comparing it to a predicate device.
The document discusses safety and effectiveness information and performance (imaging performance) testing according to certain standards, but these tests are primarily related to the physical and technical specifications of the imaging system and its components (like X-ray generation, detectors, electrical safety, EMC, software validation, etc.), rather than an evaluation of its diagnostic capabilities or comparative effectiveness with human readers.
Here's an analysis of the provided sections based on your request, highlighting the missing information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists various parameters of the proposed device and compares them to the predicate device. However, these are technical specifications (e.g., detector type, FOV, X-ray voltage, pixel size, scan time) and not diagnostic acceptance criteria (e.g., sensitivity, specificity for a particular condition).
| Parameter | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|---|
| Indications for Use | Same as predicate device #1 | RCT800 is CBCT and panoramic x-ray imaging system with cephalometric. Intended for radiographic examination of the dento-maxillofacial, sinus, TMJ, Airway for diagnostic support for adult and pediatric patients. Model scan option. Cephalometric image also includes wrist to obtain carpus images for growth and maturity assessment for orthodontic treatment. Operated by dentists or other legally qualified healthcare professionals. (Same as predicate) |
| Performance (Imaging Performance) | Satisfies designated tolerance for parameters required for imaging properties and patient dosage. | "All test results were satisfactory." (General statement, no specific diagnostic performance metrics) |
| FXDD-1012CHA Detector Performance | Similar to FXDD-0606CA (predicate device's detector) | "Based on Non-Clinical Test results of FXDD-1012CHA for the subject device, is similar to that of the FXDD-0606CA for the Predicate device. All test results were satisfactory." |
| Electrical, Mechanical, Environmental Safety | Compliance with IEC 60601 series and IEC 60601-1-2 (EMC). | Tests performed, results satisfactory. |
| Software Validation | Compliance with FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices". | Documentation provided, level of concern "moderate" identified, difference does not affect safety/effectiveness. |
| Bench Testing | Satisfy designated tolerance for parameters describing functionalities related to imaging properties and patient dosage. | "All test results were satisfactory." |
| Non-clinical Considerations | Compliance with FDA Guidance "submissions of 510(k)'s for Solid State X-ray Imaging Devices". | Conducted, results satisfactory. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Clinical imaging samples are collected from the new detector on propose device at the 2 offices where the predicate device is installed". It also states these images were "gathered from the new detector installed with RCT800 on any protocols with random patient age, gender, and size."
- Sample Size: The exact number of clinical imaging samples or "patients" is not specified.
- Data Provenance: The images were collected at "2 offices," implying real-world clinical settings. The location (country) is not specified, but the applicant and manufacturer are from Korea. The data collection seems to be prospective in the sense that the images were taken with the new detector for evaluation, but it's not a formal prospective clinical trial for diagnostic performance. It's described as "Clinical considerations were conducted according to FDA Guidance 'Format for Traditional and Abbreviated 510(k)s, section 20'".
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: "two licensed practitioners/clinicians observed and verified that dental X ray system from RCT800."
- Qualifications: "licensed practitioners/clinicians." No specific details on their specialty (e.g., radiologist, dentist, orthodontist) or years of experience are provided.
4. Adjudication Method for the Test Set:
Not applicable or not described in the context of diagnostic performance. The two practitioners "observed and verified" the images, but there's no mention of a formal adjudication process (e.g., 2+1, 3+1 consensus) for establishing ground truth for diagnostic accuracy.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. The document does not describe any study comparing human readers with AI assistance versus without AI assistance. The RCT800 is an imaging system, and the filing is for its substantial equivalence to a predicate imaging system, not for an AI diagnostic aid.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not applicable. The RCT800 is an imaging device, not an AI algorithm. Its performance is as an imaging system.
7. The Type of Ground Truth Used:
For the "clinical imaging samples," the ground truth seems to be implicitly expert diagnosis/interpretation. The document states, "As licensed practitioners or clinician diagnoses of the images, it might be proved that the clinical diagnosis and structures are acceptable in the region of interests." This suggests that the practitioners visually assessed the images for diagnostic acceptability and structural clarity, rather than comparing them to a definitive pathological diagnosis or outcomes data.
8. The Sample Size for the Training Set:
Not applicable for this type of device and submission. The RCT800 is a hardware imaging system, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
§ 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.