(152 days)
The EDLENi sensor is an intra-oral x-ray sensor driven via CMOS technology indicated for the acquirement of intra-oral dental radiographs and intended for dental patients. The EDLENi will be handled via qualified dental and healthcare professionals in order to perform basic dental intra-oral x-ray imaging procedures. The sensors will be used to provide intra-oral radiographic images that ultimately diagnose general dental complications or abnormalities. The EDLENI sensor can be used in combination with positioning devices to facilitate alignment with the x-ray beam, or it may be positioned manually.
The EDLENi sensor is an electronic medical device used to acquire intra-oral radiographic images. The sensor can be operated by Radiologists, Dentists, Dental Assistants and other healthcare professionals, who are both trained and competent to take Dental X-ray radiographs. Intra-oral positioning of the sensor is accomplished by the use of dedicated intra-oral positioning devices that facilitate the accurate alignment of the x-ray beam. The sensor may also be aligned with the assistance of the patient. The EDLENi sensor is an indirect light converting digital x-ray detector. A scintillating device composed of Cesium Iodide (CsI) converts incident x-rays into visible light that is optically coupled to a light detection imager based on CMOS technology. The EDLENi allows for automatic detection of such incident x-rays in order to generate data. Software interprets this data into images used for dental applications. The EDLENi sensor supports USB 2.0 direct connectivity to personal computers and or laptops with dedicated electronics and a sensor software driver.
The provided document is a 510(k) Summary for the EDLENi Intra-Oral Sensor. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving the device meets specific acceptance criteria based on diagnostic performance. Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth types is not available in this document.
Here's an analysis of what can be extracted and what is not present:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy for specific clinical conditions). The primary acceptance criterion seems to be demonstrating substantial equivalence to predicate devices, particularly regarding safety and effectiveness, and compliance with relevant standards.
- Reported Device Performance: The document states, "Performance testing data according to the Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices have been provided to demonstrate substantial equivalence." However, the specific performance data itself (e.g., image quality metrics like spatial resolution, contrast resolution, DQE, noise) is not detailed in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified.
- The document explicitly states: "Clinical images were not provided; clinical images were not necessary to establish substantial equivalence based on the modifications of the device." This indicates that if performance testing involved image acquisition, it likely did so under phantom or laboratory conditions, not with patient data.
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. Since clinical images were not used, and the goal was substantial equivalence based on technical modifications rather than diagnostic performance, there was no need for expert ground truth establishment in a diagnostic context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication 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
- No, an MRMC study was not done. This document pertains to an intra-oral x-ray sensor, which is a hardware device for image acquisition, not an Artificial Intelligence (AI) or CAD software for diagnosis. Therefore, AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a sensor, not a standalone diagnostic algorithm. Its performance is related to image acquisition quality, which is then interpreted by human professionals.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable for diagnostic ground truth. The "ground truth" for the performance testing performed would likely revolve around objective technical measurements (e.g., measuring line pairs per millimeter for spatial resolution, signal-to-noise ratios, etc.) against expected or predicate device performance. This is not a clinical ground truth.
8. The sample size for the training set
- Not applicable. This device is a sensor and does not utilize a training set in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable.
Summary of available information:
- Device: EDLENi Intra-Oral Sensor
- Purpose of Submission: Demonstrate substantial equivalence to predicate devices for acquiring intra-oral dental radiographs.
- Key Argument for Substantial Equivalence: The only modifications compared to the predicate are the use of two new Hamamatsu CMOS sensors (instead of CCD) for readout, while maintaining the same detection material (Cesium Iodide).
- Performance Testing: "Performance testing data according to the Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices have been provided to demonstrate substantial equivalence." (Specific metrics are not detailed in this summary).
- Clinical Data: "Clinical images were not provided; clinical images were not necessary to establish substantial equivalence based on the modifications of the device."
- Safety and Effectiveness: Confirmed through compliance with IEC 60601-1-2 (Electromagnetic Compatibility), software design, verification, validation testing, and risk assessment.
§ 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.