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RCT600 is CBCT and panoramic x-ray imaging system with cephalometric. Which is intended to radiographic examination of the dento-maxillofacial, sinus and TMJ structure for adult and pediatric patients. 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.

RCT600 provides 3D computed tomography for scanning hard tissues such as bone and teeth. By rotating the C-arm, which houses a high-voltage generator, an X-ray tube and a detector on each end, CBCT images of dental maxillofacial structures are obtained by recombining data scanned from the same level at different angles. Functionalities include panoramic image scanning for obtaining images of whole teeth, and a cephalometric option for obtaining cephalometric images.

The RCT600 device, for which K243903 is the 510(k) number, is a Computed Tomography X-Ray System used for radiographic examination of dento-maxillofacial, sinus, and TMJ structures. It also includes cephalometric imaging, specifically wrist images for growth and maturity assessment for orthodontic treatment.

The acceptance criteria are implicitly defined by the safety and effectiveness information provided in the 510(k) summary, specifically by demonstrating substantial equivalence to the predicate device, RCT700 (K213226). The testing performed aims to prove that despite some differences (deletion of one-shot Ceph option, different scan Ceph detector, changes in magnification, and scan times), the RCT600 maintains similar safety and effectiveness characteristics.

Here’s a breakdown of the information requested based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are based on demonstrating performance similar to the predicate device (RCT700, K213226) and meeting recognized international standards for medical electrical equipment and X-ray imaging devices.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document mentions "Sample clinical images" were submitted for each imaging dental modality and that features were "clinically tested." However, it does not specify the number of cases or patients used in the clinical imaging test set.
• Data Provenance: The document does not explicitly state the country of origin of the data. It mentions "Clinical images were gathered from all detectors of the RCT600 system." The applicant is Ray Co., Ltd., based in SOUTH KOREA. Given the context, it is reasonable to infer the data either originated from or was managed by the manufacturer. The study is prospective, as it involved gathering clinical images with the new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• Number of Experts: "A licensed practitioner" (singular) reviewed the sample clinical images.
• Qualifications of Experts: The expert was an "independent, licensed practitioner/clinician DDS/ABOMR."
  • DDS stands for Doctor of Dental Surgery, indicating a dental professional.
  • ABOMR stands for American Board of Oral and Maxillofacial Radiology, indicating specialization in dental and maxillofacial radiology. No years of experience are specified.

4. Adjudication Method for the Test Set

The document states, "A licensed practitioner reviewed the sample clinical images and deemed them to be of acceptable quality for the device intended use." This indicates a single-reader review without an explicit adjudication process defined for multiple readers.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. The document describes a "clinical testing" where sample images were reviewed by a single licensed practitioner to confirm diagnostic quality. There is no mention of human readers improving with or without AI assistance, as this is an imaging device, not an AI diagnostic algorithm.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• This question is not directly applicable to the RCT600, as it is an X-ray imaging system, not an AI diagnostic algorithm. The "performance" being evaluated implicitly includes the algorithm within the imaging device that processes and reconstructs the images. The focus is on the imaging system's ability to produce diagnostically acceptable images for human interpretation. The clinical evaluation verifies the diagnostic quality of the images produced by the device, which is an assessment of its standalone imaging performance.

7. The Type of Ground Truth Used

The ground truth for the clinical image review was based on expert consensus (from the singular licensed practitioner) regarding the "acceptable quality for the device intended use" of the sample clinical images.

8. The Sample Size for the Training Set

The document does not specify a sample size for a training set. The device being described is an X-ray imaging system, not a machine learning algorithm that typically requires a separate training set. The "software" component mentioned underwent validation, but no details of training data for the software's inherent functions (e.g., image reconstruction algorithms) are provided, as these are typically validated through engineering and bench testing rather than a separate clinical "training set" in the context of device clearance.

9. How the Ground Truth for the Training Set was Established

As no explicit training set for an AI algorithm is mentioned, the concept of ground truth establishment for a training set is not applicable in the context of this device's submission description. The software validation relies on risk analysis and compliance with FDA guidance documents rather than a specific clinical training dataset and ground truth for learning.

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