Search Results

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 health care professionals.

The system's purpose is RCT800, a 3D computed tomography scanner for scanning hard tissues like bones and teeth. By rotating the c-arm, which is embedded with an all-in-one x-ray tube and a detector on each end, CBCT images of the dental maxillofacial area can be attained by recombining data from the same level that is scanned from different angles. Additionally, the system includes a panoramic image scanning function for attaining images of the whole teeth, a cephalometric scanning option for attaining a cephalic image, and a Model Scan option for attaining a dental model CBCT image.

The provided text describes the 510(k) summary for the Ray Co., Ltd.'s RCT800 device. While it mentions various tests and compliance with standards, it does not explicitly provide a table of acceptance criteria and reported device performance in the typical format of a clinical study report with specific metrics and thresholds. Instead, it states that "All test results were satisfactory" for performance (imaging performance) testing conducted according to IEC 61223-3-4 and IEC 61223-3-7.

It also mentions "Clinical images were provided" and that "A licensed practitioner reviewed the sample clinical images and deemed them to be of acceptable quality for the intended use," but it doesn't detail a formal clinical study with specific acceptance criteria beyond subjective expert opinion.

Therefore, much of the requested information regarding the study that proves the device meets the acceptance criteria in a quantifiable manner (e.g., statistical significance, specific performance numbers) is not present in the provided document. The document primarily focuses on demonstrating substantial equivalence to a predicate device through technical similarities, bench testing, and compliance with general safety and performance standards.

However, based on the provided text, I can infer and extract some information:

Acceptance Criteria and Device Performance (Inferred from compliance statements)

Since the document states that "All test results were satisfactory" for imaging performance tests and that a licensed practitioner found clinical images to be of "acceptable quality for the intended use," the implied acceptance criteria were met. However, the specific quantitative criteria are not listed.

Table 1: Implied Acceptance Criteria and Reported Device Performance

Study Details (Based on the provided text)

1. Sample sizes used for the test set and the data provenance:

   • Test Set (Clinical Images): The document states "Clinical imaging samples were collected from new detectors on the proposed device at the two offices where the predicate device was installed for the clinical test images. These images were gathered from all detectors installed with RCT800 using protocols with random patient age, gender, and size."
     • Specific Number: Not specified. It indicates "samples" and "images gathered from all detectors," implying a collection across multiple patient demographics, but no numerical count is provided.
     • Provenance: Clinical images obtained from "two offices where the predicate device was installed." The country of origin is not explicitly stated for these clinical images, but the applicant (Ray Co., Ltd.) is from SOUTH KOREA, so it is plausible these were collected within South Korea or countries where the predicate device was installed.
     • Retrospective/Prospective: Not explicitly stated, but the mention of collecting "new detectors" and "random patient age, gender, and size" suggests some form of prospective or concurrent collection for evaluation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: "Two licensed practitioners/clinicians" clinically tested and approved the features. "A licensed practitioner reviewed the sample clinical images." It's unclear if these refer to the same "two" or one specific "licensed practitioner."
   • Qualifications: "Licensed practitioners/clinicians." No further details on their years of experience, subspecialty (e.g., specific type of radiologist/dentist), or formal board certifications are provided.

3. Adjudication method (e.g., 2+1, 3+1, none) 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 intended use." This suggests a qualitative assessment, but no formal adjudication method (like 2+1 consensus) is described. It implies that the single or (if two practitioners were involved) potentially un-adjudicated opinion of the expert(s) served as the "truth."

4. 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:

   • No MRMC study was mentioned. The document focuses on demonstrating that the device itself produces images of acceptable quality for human interpretation, not on the improvement of human readers with AI assistance. This device is a source of images (an X-ray system), not an AI algorithm for image analysis.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The device is a medical imaging system (CT/panoramic/cephalometric X-ray system), not an AI algorithm for image analysis. Therefore, the concept of "standalone performance" for an algorithm does not apply in the context of this device. The performance refers to the image acquisition capabilities of the system itself.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For clinical image quality, the ground truth was expert opinion/assessment by "licensed practitioners/clinicians" who deemed the images "of acceptable quality for the intended use."
   • For bench testing, the ground truth was based on compliance with standards (e.g., IEC 61223-3-4, IEC 61223-3-7) and "designated tolerance" parameters.

7. The sample size for the training set:

   • This device is an X-ray imaging system. It takes images (presumably raw data) and reconstructs them into clinically useful images using reconstruction algorithms such as FBP (Filtered Back Projection) (as mentioned for the predicate device). The document does not describe the use of machine learning that would require a "training set" in the conventional AI sense. If any internal algorithms are adaptable or "learn," details are not provided. The phrase "training set" is typically applicable to AI/ML devices, which this is not identified as in the provided text.

8. How the ground truth for the training set was established:

   • Not applicable, as no training set (for AI/ML) is mentioned or implied for this device.

Ask a specific question about this device

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.

Here's an analysis of the acceptance criteria and study information for the RCT800 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria for the imaging performance, but rather indicates that the device's performance was compared to its predicate and found satisfactory. The performance specifications are primarily focused on the operational parameters of the X-ray system.

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

• Sample Size for Test Set: The text states, "Clinical images were provided these images were not necessary to establish substantial equivalence based on the modifications to the device but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended." It also mentions, "These images were gathered from the all detector installed with RCT800 on any protocols with random patient age, gender, and size." A specific numerical sample size (e.g., number of patients or images) is not provided.
• Data Provenance: The images were collected "at the 2 offices where the predicate device is installed." The text does not specify the country of origin but states the manufacturer (RAY Co., Ltd.) is from the Republic of Korea. It is implied to be prospective as the images were gathered for the purpose of this submission and involve "random patient age, gender, and size" on newly installed devices, rather than being pulled from existing archives.

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

• Number of Experts: "Two licensed practitioners/clinicians."
• Qualifications of Experts: "Licensed practitioners/clinicians." No specific experience level (e.g., "10 years of experience") is provided, but being "licensed" implies a baseline qualification for medical interpretation.

4. Adjudication Method for the Test Set

The text states, "A licensed practitioner reviewed the sample clinical images and found them to be of acceptable quality for the intended use." It does not describe a formal adjudication method (like 2+1 or 3+1 consensus). It appears to be a single reviewer's assessment, which might suggest a less rigorous adjudication than a multi-reader consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described or presented in the provided text. The study focused on demonstrating substantial equivalence to a predicate device through technical specifications, bench testing, and a review of clinical images by a practitioner, rather than measuring reader performance with and without AI assistance. The device is an X-ray imaging system, not an AI diagnostic tool that assists human readers.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable in the context of an X-ray imaging device. The RCT800 is an imaging system, not an AI algorithm intended for standalone diagnosis. Its performance is evaluated on its ability to produce images of acceptable quality for human interpretation.

7. Type of Ground Truth Used

The ground truth for the clinical images was established by expert judgment/review by "licensed practitioners/clinicians." The practitioners assessed the "acceptable quality for the intended use" of the images. This is not pathology, or direct outcomes data, but rather an assessment of diagnostic utility from the images.

8. Sample Size for the Training Set

The provided text focuses on the performance of the imaging device itself and its comparison to a predicate, not on an AI algorithm that would require a distinct training set. Therefore, a training set sample size is not applicable or mentioned in this context. The "software" mentioned (RAYSCAN) is for viewing and managing images, not for AI-based analysis requiring a training dataset.

9. How Ground Truth for the Training Set Was Established

As no training set for an AI algorithm is mentioned, the method for establishing its ground truth is not applicable or described.

Ask a specific question about this device

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).

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.

Ask a specific question about this device

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 describes the regulatory clearance of a medical device (RCT800), focusing on its substantial equivalence to predicate devices rather than a detailed study proving it meets specific acceptance criteria in the context of AI performance. Therefore, the information needed to fully answer the request, particularly regarding AI performance, ground truth establishment, expert qualifications, and sample sizes for training/test sets in an AI context, is largely absent.

It appears the RCT800 is a dental X-ray system (CBCT, panoramic, cephalometric) and not explicitly an AI-powered diagnostic device from the provided documentation. The "software" mentioned is for image generation, patient data management, and inquiry, with a moderate level of concern, suggesting it functions as control and viewing software rather than an AI-driven interpretation system.

However, I can extract and infer some information based on the request and the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission focused on substantial equivalence for an imaging device, the "acceptance criteria" are generally aligned with demonstrating that the new device performs as safely and effectively as legally marketed predicate devices, and meets relevant performance standards.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size:
  • Clinical Images: "random patient age, gender, and size" were used to gather clinical images from the new detector installed with RCT800. The number of patients or images is not specified.
  • Non-Clinical Performance: Test results for the new detectors (FXDD-0606CA, 1717SCC) were compared to predicates. This likely involved quantitative testing on phantoms or test objects, not patient data in the same sense as clinical images. The sample size for these non-clinical tests is not specified, but typically involves a defined set of measurements.
• Data Provenance: The new detector was installed at "2 offices where the predicate device is installed." This suggests prospective data collection (images gathered from newly installed RCT800 units in a clinical setting). The country of origin is not explicitly stated for the clinical data, but the manufacturer is in the Republic of Korea.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: "two licensed practitioners/clinicians."
• Qualifications of Experts: "licensed practitioners/clinicians." No specific specialization (e.g., radiologist, dentist) or years of experience are provided, but the context of "dental X-ray system" strongly implies dental professionals.

4. Adjudication method for the test set

• The text 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 an assessment of diagnostic acceptability by the two practitioners. An explicit "adjudication method" (like 2+1 or 3+1) is not detailed; it's more of a verification of intended function rather than a formal ground truth consensus process for diagnostic accuracy.

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

• No, an MRMC comparative effectiveness study involving AI assistance was not described. The submission is for an imaging device itself, not an AI-powered diagnostic aid. The device helps acquire images; it does not independently interpret them or assist human readers in interpretation beyond providing the images.

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

• No, a standalone algorithm performance study was not described. This device is an X-ray system; it requires a human operator to acquire images and human practitioners to interpret them. The "software" mentioned supports device operation and image viewing, not autonomous diagnostic interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For the clinical observations, the "clinical diagnosis and structures are acceptable in the region of interests" by "licensed practitioners or clinician diagnoses." This suggests expert diagnostic opinion as the basis for evaluating image acceptability. It does not refer to pathology or outcomes data.
• For non-clinical performance (e.g., image quality, dose), the ground truth would be physical measurements against established standards (IEC norms) or direct comparison to the physical properties/output of the predicate devices.

8. The sample size for the training set

• Not applicable / Not provided. The RCT800 is an X-ray imaging system, not an AI model requiring a training set in the conventional sense. The software mentioned is for control, patient data management, and image generation, not for learning from a training set to make diagnoses.

9. How the ground truth for the training set was established

• Not applicable. As a non-AI imaging device, there is no "training set" or "ground truth for the training set" in the context of machine learning model development.

Ask a specific question about this device