(79 days)
Digital intraoral X-ray Imaging System, models i-Sensor H2, are used in conjunction with dental Radiography in medical units. The product is used for dental X-ray examination, the diagnosis of structural diseases of teeth, jaws and mouth. The product is expected to be used in hospitals and clinics, operated and used by trained professionals under the guidance of doctors.
This device is not intended for mammography and conventional photography applications.
This device is suitable for providing dental radiography imaging for both adult and pediatric.
The Digital intraoral X-ray Imaging System, models i-Sensor H1 and i-Sensor H2, are the digital intra-oral sensor. It features a 20um pixel pitch CMOS sensor with directly deposited CsI:Tl scintillator which ensures optimal resolution. An easy to use hispeed direct USB interface enables a simple connection to a PC without need for an additional control box. The optional intra-oral software application makes it easy to acquire, enhance, analyze, view and share images from the sensor. The major function of i-Sensor H1 and i-Sensor H2 are to convert the X-ray to digital image, with the application of high resolution X-ray imaging. This detector is the key component of intra-oral DR system, enables to complete the digitalization of the medical X-ray imaging with the intra-oral DR system software.
The provided text is a 510(k) summary for a Digital Intraoral X-ray Imaging System. It describes non-clinical testing performed to establish substantial equivalence to a predicate device. However, it explicitly states that clinical data is not needed to characterize performance and establish substantial equivalence. Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria based on human-in-the-loop performance or diagnostic accuracy.
The document focuses on non-clinical performance characteristics to demonstrate substantial equivalence through technical specifications and comparison to the predicate device.
Here's a breakdown of the requested information based on the provided text, highlighting where information is not present due to the nature of the submission:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria for diagnostic performance against a ground truth and reported device performance against those criteria. It does list several non-clinical tests and states that "All test results are meet the standard requirements." and "the results have shown that the i-Sensor H1 & i-Sensor H2 are substantially equivalent to the predicate devices". These statements imply that the acceptance criteria for these non-clinical tests were that the device's performance met the relevant standard requirements or was equivalent to the predicate.
Here are the non-clinical tests mentioned and the general statement of their performance:
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Meet IEC/ES 60601-1 and IEC60601-2-65 for Electrical, mechanical, environmental safety and performance | All test results meet standard requirements |
| Meet IEC 60601-1-2 for EMC testing | All test results meet standard requirements |
| Safety evaluation according to ISO10993-1 for materials in contact with oral mucosa | Evaluation results and test results assured the safety the same as the predicate device |
| Substantially equivalent to predicate for Dose to output signal transfer function, Signal to noise ratio, uniformity, Defect, Minimum triggering dose rate, Modulation transfer function (MTF), Spatial resolution, Low contrast resolution and Image Acquisition time | Results showed substantial equivalence to the predicate devices |
| Software (Ai-Dental) classifies hazards, defines requirements/design specifications, and passes test cases | All specification pass all the test cases and complies the intended design specification |
| Pediatric capabilities and labeling requirements considered | Related information shown in User's manual |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical test set or data from human subjects was used. The submission states, "Clinical data is not needed to characterize performance and establish substantial equivalence." This implies no test set of patient data was used for diagnostic performance evaluation.
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)
Not applicable. No clinical test set was used, and thus no expert ground truth establishment for diagnostic purposes was performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set was used.
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
Not applicable. The device is a "Digital Intraoral X-ray Imaging System" (hardware), not an AI-assisted diagnostic software. No MRMC study was mentioned or performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an "algorithm only" performance. Since the device is a hardware imaging system, this isn't directly applicable in the sense of a diagnostic algorithm's standalone performance. The non-clinical tests (e.g., MTF, spatial resolution) demonstrate the inherent image quality capabilities of the device itself, which could be considered its "standalone" performance characteristics as an imaging system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests: The "ground truth" was established by engineering standards, physical measurements, and comparison to the predicate device's established performance specifications. For instance, spatial resolution would be measured against a known standard.
8. The sample size for the training set
Not applicable. The provided document details a hardware device. If there is a "software Ai-Dental" mentioned, it seems to be an image acquisition/enhancement software rather than a diagnostic AI that would require a training set in the typical sense (for supervised learning on disease detection). The document discusses the software's compliance with design specifications and test cases, not its training data.
9. How the ground truth for the training set was established
Not applicable, as there's no mention of a diagnostic AI algorithm requiring a training set.
§ 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.