(144 days)
The RAYSCAN α- Expert Dental X-Ray System is an extraoral source dental panoramic and optional cephalometric X-ray system intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
Modified RAYSCAN α- Expert is designed for panoramic scanning of teeth, jaw and oral cavity, used to create and control the X-ray beam. And as a dental digital panoramic X-ray system with X-ray located on outer part of the oral cavity, includes the Cephalometric scanning function, as an option, for acquiring images of the head. The modifications are as following: Hardware: Added option CEPH sensor (Scan type). In addition to the one-shot type CEPH sensor of original device (K122918), the modified device offers an additional Scan type CEPH sensor. Updated Software including: Additional protocol for new CEPH sensor (Scan type): Lateral wide Additional PANO protocols: Segmentation (Individual Tooth), Bitewing, and Orthogonal RAYSCAN α- Expert offers digital imaging with or without the optional One-shot type & Scan type cephalometric attachment. Detector Options: Base: RAYSCAN α-P: PANO Option: RAYSCAN α-OC: PANO+One-shot CEPH Option: RAYSCAN α-SC: PANO+SCAN CEPH The system includes processing, and archiving "SMARTDent "software(Optional)
The provided text describes a 510(k) submission for the RAYSCAN α-Expert, primarily focusing on modifications to an existing device (K122918). The modifications include adding a "Scan type CEPH sensor" and new PANO protocols. The submission argues for substantial equivalence to the predicate device.
Here's an analysis of the acceptance criteria and study information provided:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., sensitivity, specificity, accuracy thresholds). Instead, the performance specification comparison table largely establishes that the modified device either has the same specifications as the predicate device or additional specifications for the new "Scan type" cephalometric function. The implicit acceptance criterion is that the new components perform either equivalently to the existing components or to a satisfactory level for their intended function.
| Parameter | Acceptance Criteria (Implicit from Predicate & New Features) | Reported Device Performance (Modified K131693) |
|---|---|---|
| Common Name | Same as Predicate: Dental panoramic and cephalometric X-ray system | Dental panoramic and cephalometric X-ray system |
| Indications for use | Same as Predicate: For dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. | The RAYSCAN α- Expert Dental X-Ray System is an extraoral source dental panoramic and optional cephalometric X-ray system intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. |
| Performance Specification | Panoramic, One-shot type Cephalometric (optional), Additional Scan type Cephalometric (optional) | Panoramic |
| Cephalometric(optional) |
- One_shot type
- Scan type |
| Detector type | α-OC: PANO+One-shot CEPH (option), α -P : PANO, Additional α -SC: PANO+SCAN CEPH (option) | α-OC: PANO+One-shot CEPH (option)
α -P : PANO
α -SC: PANO+SCAN CEPH (option) |
| Detector Type (detail) | Pano: Flat panel X-ray sensor, Ceph(Optional): Flat panel X-ray sensor [One-shot type], Additional CdTe Direct flat panel sensor[Scan type] | Pano: Flat panel X-ray sensor
Ceph(Optional) - Flat panel X-ray sensor [One-shot type]
- CdTe Direct flat panel sensor[Scan type] |
| Focal size | Same as Predicate: 0.5mm | 0.5mm |
| X-ray Voltage | Same as Predicate: 6090kVp | 6090kVp |
| X-ray Current | Same as Predicate: 417mA | 417mA |
| Total Filtration | Same as Predicate: 2.6 mm Al equivalent | 2.6 mm Al equivalent |
| Magnification | Pano: 1.31, Ceph[One-shot type]: 1.13, Additional Ceph[Scan type]: 1.11 | Pano: 1.31
Ceph[One-shot type]: 1.13
Ceph[Scan type]: 1.11 |
| Scan time | Pano: 14sec, Ceph[One-shot type]: 0.3sec3.0sec, Additional Ceph[Scan type]: below 18sec | Pano: 14sec3.0sec
Ceph[One-shot type]: 0.3sec
Ceph[Scan type]: below 18sec |
| Applicable Standards | Compliance with IEC 60601-1, -1-1, -1-3, -2-7, -2-28, -2-32, -1-2 | All listed IEC standards met. |
| Software Functionality | Modified device performs as intended with no adverse impact from hardware/software changes. | "Software verification testing and validation testing was performed to confirm that the modified device performed as intended and that changes made to the hardware and software had no adverse impact on the functionality of the system. All tests met requirements demonstrating that the modified device performed as expected." |
| Non-clinical/Clinical Safety | Equivalence to predicate regarding safety and effectiveness, especially for new Scan type CEPH sensor. | Safety & effectiveness reports for the added Scan type cephalometric sensor provided separately. "Non-clinical & Clinical considerations according to FDA Guidance 'Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices' were performed. All test results were satisfactory." "expert review of image comparisons for both devices" concluded substantial equivalence. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on the sample size for any clinical or non-clinical test sets, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective nature of data). It mentions "safety & effectiveness reports for the added Scan type cephalometric sensor is provided separately" and "report regarding non-clinical & clinical consideration for the added Scan CEPH sensor is provided separately," suggesting such details would be found within those separate documents.
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)
The document mentions an "expert review of image comparisons for both devices" as part of the basis for concluding substantial equivalence. However, it does not specify:
- The number of experts.
- The qualifications of those experts (e.g., specific medical specialty, years of experience, board certifications).
- How "ground truth" was established, only that images were compared.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method (e.g., 2+1, 3+1) used for establishing ground truth or resolving discrepancies among experts. It only mentions an "expert review of image comparisons."
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
There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done, nor is there any mention of comparing human readers with AI assistance versus without AI assistance. The device in question is an X-ray system, not primarily an AI-driven interpretation tool. The software updates are for new protocols and sensor types, not for diagnostic assistance features requiring such a study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This submission is for an X-ray imaging system, not an algorithm meant for standalone diagnostic performance. Therefore, a standalone algorithm-only performance study is not applicable and not mentioned. The "performance" refers to the imaging system's ability to produce images according to specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document only states that an "expert review of image comparisons" was conducted. It does not explicitly define how ground truth was established beyond this expert review (e.g., whether it involved expert consensus, comparison to a gold standard like pathology, or outcomes data). For an imaging device, "ground truth" often refers to the image quality parameters and features being correctly discernible and meeting technical specifications.
8. The sample size for the training set
The document does not provide any information regarding a training set sample size. This is consistent with the nature of the submission, which focuses on device modifications and substantial equivalence to a predicate, rather than a novel AI algorithm requiring separate training and test sets. Software verification and validation are mentioned, but not in the context of machine learning training.
9. How the ground truth for the training set was established
Since no training set is mentioned in the context of machine learning or AI, there is no information on how its ground truth would have been established. The "ground truth" in this context pertains to the functional and safety performance of the hardware and software components based on engineering tests and expert image review.
§ 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.