(109 days)
The FireCR Dental imaging system is indicated for capturing, digitization and processing of intra oral x-ray images stored in imaging plate recording media
The FireCR Dental is Computed Radiography Reader which produces the X-ray diagnostic image in digital format instead of using traditional screens and film. This device utilizes reusable X-ray storage phosphor plate (Imaging Plate) that is sensitive to X-ray and stores latent image when it is exposed to X-ray. After X-ray exposure to the X-ray storage phosphor plate, X-ray storage phosphor plate is scanned by means of laser in the device. Latent image in the X-ray storage phosphor plate is released in a form of light by laser scanning. Then the light is collected and converted into a form of digital image. The signal processing is made to the digital image data such as the digital filtering, the gain & offset correction and flat fielding. The image can then be viewed on a computer workstation, adjusted if necessary, then stored locally, sent to an archive, printed or sent to PACS system. After acquisition of latent image from the X-ray storage phosphor plate, it is erased thoroughly to be reused.
Here's a breakdown of the acceptance criteria and study information for the FireCR Dental Imaging System (K131442), based on the provided text:
Acceptance Criteria and Device Performance
The provided document compares the FireCR Dental to a predicate device, DIGORA Optime, across various technical specifications. The acceptance criteria seem to implicitly be substantial equivalence to the predicate device in key performance metrics.
| Acceptance Criteria / Performance Metric (Predicate) | Reported Device Performance (FireCR Dental) | Met (Y/N) |
|---|---|---|
| Intended Use | Dental Computed Radiography System for producing digital X-Ray images for dental radiography (intra oral) purposes. | This device is a Dental Computed Radiography System and intended for use in producing digital X-Ray images for dental radiography (intra oral) purposes. |
| Physical Characteristics | ||
| Overall Dimensions | Reader: 190 x 200 x 383mm | Reader: 185 x 100 x 293mm |
| Imaging Area | Size 0, 1, 2, 3, 4c (Specific dimensions for each size as listed) | Size 0, 1, 2, 3, 4c (Specific dimensions for each size as listed) |
| Effective Pixel Pitch | 35um, 64um | 35um, 64um |
| Spatial Resolution | 14.3 lp/mm @ 35um, 7.8 lp/mm @ 64um | 14.3 lp/mm @ 35um, 7.8 lp/mm @ 64um |
| Image Matrix | Specific dimensions for each IP size at 64um and 35um | Specific dimensions for each IP size at 64um and 35um |
| Weight | 9.8kg | 4.7kg |
| Imaging Device | High Sensitivity Photo Multiplier Tube (s-PMT) | High Sensitivity Photo Multiplier Tube (s-PMT) |
| Operational Characteristics | ||
| Operating Condition | Temperature: 10 - 40 °C, Humidity: 30 - 90% RH | Temperature: 15 - 30°C, Humidity: 15% - 95% RH |
| Power Requirements | 100 - 240V, 50/60Hz | 100 - 240V, 50/60Hz |
| Methods of Exposure | Register Patient -> X-ray Exposure | Register Patient -> X-ray Exposure |
| X-ray Absorber | Imaging plate | Imaging plate |
| Functional Characteristics | ||
| Output Data | DICOM 3.0 Compatible | DICOM 3.0 Compatible |
| DQE @ 10% eff. | 2.4 lp/mm | 2.6 lp/mm |
| MTF @ 3 lp/mm | 32% | 34% |
| Defect Compensation | By Calibration | By Calibration |
| Dynamic Range Image | 14bit | 16bit |
| Processing | DICOM 3.0 Compliant | DICOM 3.0 Compliant |
| DICOM Compatibility | DICOM 3.0 Compliant | DICOM 3.0 Compliant |
Conclusion on Acceptance Criteria: The FireCR Dental is deemed to meet acceptance criteria by demonstrating substantial equivalence to the predicate device, with some technical specifications (like DQE, MTF, and Dynamic Range) showing slight improvements. The overall conclusion is that its performance is equivalent to the predicate.
Study Information
The document describes a "Clinical Study" and non-clinical/performance testing.
1. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The text mentions "As a result of Clinical Study, FireCR Dental is considered that Image quality is equivalent to the Predicate Device." This implies a patient-level or image-level comparison, but the number of cases or patients is not provided.
- Data Provenance: Not explicitly stated, but the "Clinical Study" implies human data. The location of the study (e.g., country of origin) is not mentioned. It is unclear if the data was retrospective or prospective.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated how many "dentists" were involved.
- Qualifications of Experts: Described as "dentists." No further details on their experience (e.g., years of experience, specialization) are provided.
3. Adjudication method for the test set:
- Adjudication Method: Not explicitly stated. The text says "The rating was considered equivalent by dentists," which suggests a consensus or comparison approach, but the specific method (e.g., majority vote, independent review with arbitration) is not detailed.
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:
- MRMC Study: No. This device is a Computed Radiography Scanner System, not an AI-assisted diagnostic tool. The "clinical study" focused on comparing the image quality of the new device to a predicate device, as evaluated by dentists, rather than on reader performance with or without AI assistance.
- Effect Size of AI: Not applicable, as this is not an AI device.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, in a sense. The comparison of technical specifications (DQE, MTF, Spatial Resolution, Dynamic Range) between the FireCR Dental and the predicate device can be considered standalone performance assessments of the device's imaging capabilities. However, this isn't a "standalone algorithm" performance as the device's primary function is image acquisition, not autonomous diagnosis. The device's output (digital images) is intended for human interpretation.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth Type: Expert opinion/evaluation by "dentists" on image quality, implicitly against the predicate device's image quality. The statement "FireCR Dental is considered that Image quality is equivalent to the Predicate Device" suggests a comparison where the predicate's image quality serves as the reference, and the dentists' ratings are the mechanism for assessing equivalence. It's not based on pathology or outcomes data.
7. The sample size for the training set:
- Training Set Sample Size: Not applicable. This device is a Computed Radiography scanner, which processes X-ray signals into digital images. It does not use machine learning or AI that would require a "training set" in the conventional sense for training an algorithm.
8. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no mention of a training set or AI model being developed for this device. The device's "processing" involves digital filtering, gain & offset correction, and flat fielding, which are standard image processing techniques not typically "trained" on labeled ground truth data.
§ 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.