(259 days)
The RAYSCAN a- P, SC, OCL, OCS panoramic X-ray imaging system with Cephalostat is an extra-oral source X-ray system, intended for dental radiographic examination of the teeth, jaw, and oral structures, to include panoramic examinations and implantology and for TMJ studies and cephalometry. Images are obtained using the standard narrow beam technique.
RAYSCAN α-Expert (RAYSCAN α-P, SC, OCL, OCS) provides panoramic for scanning teeth, jaw and oral structures. By rotating the C-arm, which houses a high-voltage generator, an all-in-one Xray tube and a detector on each end, panoramic images of oral and maxillofacial structures are obtained byrecombining data scanned from different angles. Functionalities include panoramic image scanning for obtaining images of whole teeth, and a Cephalometric scanning option for obtaining Cephalic images.
The provided text describes a 510(k) premarket notification for the "RAYSAN α-Expert" dental X-ray system. The submission affirms its substantial equivalence to a predicate device, K142058. While it outlines several tests conducted to support this claim, it does not provide explicit acceptance criteria in a table format nor does it detail a specific study with quantitative performance metrics for a direct comparison against such criteria.
Here's a breakdown of the information that can be extracted, and where there are gaps regarding the requested specifics:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with corresponding device performance metrics. Instead, it states that "All test results were satisfactory" for performance (imaging performance) testing conducted according to IEC 61223-3-4. It also mentions that "a licensed practitioner reviewed the sample clinical images and deemed them to be of acceptable quality for the intended use." This indicates a subjective assessment of image quality rather than quantitative performance against defined acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document mentions that "images were gathered from all detectors of RAYSCAN α-Expert using protocols with random patient age, gender, and size" and that "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." However, it does not specify the exact number of images or patients in the clinical test set.
- Data Provenance: The images were collected "at the two offices where the predicate device was installed for the clinical test images." The manufacturer is Ray Co., Ltd. located in South Korea. It's implied these are prospective clinical images gathered for the purpose of the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: "The clinical performance of RAYSCAN α-Expert were clinically tested and approved by two licensed practitioners/clinicians."
- Qualifications of Experts: They are described as "licensed practitioners/clinicians." No specific details such as years of experience, specialization (e.g., radiologist, dentist), or board certification are provided.
4. 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." It implies individual review, but does not specify any formal adjudication method (e.g., whether the two practitioners independently reviewed images and consensus was reached, or if there was a third adjudicator in case of disagreement).
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 MRMC comparative effectiveness study is mentioned. This device is an X-ray imaging system, not an AI-assisted diagnostic tool for humans, so this type of study would not be applicable. The comparison is between the new device's image quality and the image quality of the predicate device.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an X-ray imaging device, not an algorithm. Therefore, "standalone (algorithm only)" performance is not applicable. The device's primary function is image acquisition.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the clinical image quality assessment appears to be expert opinion/consensus (from two licensed practitioners) regarding whether the images were "of acceptable quality for the intended use." There's no mention of pathology or outcomes data for establishing ground truth.
8. The sample size for the training set
The document mentions software validation, but this X-ray system is not described as an AI/ML device that requires a distinct "training set" in the context of machine learning model development. This question is not directly applicable to the type of device described.
9. How the ground truth for the training set was established
As the device is not described as involving an AI/ML model with a training set, this question is not directly applicable. The software mentioned is for saving patient and image data, inquiries, and image generation, and was validated according to FDA guidance for software in medical devices, not specific AI/ML training.
Summary of what is present and what is missing:
- Acceptance Criteria/Performance Table: Not provided in the requested format. General statement of "satisfactory" test results and "acceptable quality."
- Test Set Sample Size & Provenance: Sample size not quantified. Provenance is South Korea, likely prospective.
- Number & Qualification of Experts: Two licensed practitioners/clinicians. No further qualification details.
- Adjudication Method: Not specified.
- MRMC Study: Not applicable.
- Standalone Performance: Not applicable.
- Type of Ground Truth: Expert opinion on image quality.
- Training Set Sample Size: Not applicable (not an AI/ML device in this context).
- Training Set Ground Truth: Not applicable.
§ 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.