(23 days)
ODI HD Dental Sensor is intended to be used by dentists and other qualified professionals for providing diagnostic x-ray radiographs of dentition, jaws and other oral structures.
The ODI HD Dental Sensors are electronic medical device intra-oral radiographic images. The sensor can be operated by Radiologists, 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 sensor may also be aligned with the assistance of the patient. The ODI HD Dental Sensors is an indirect light converting digital x-ray detector. A scintillating device composed of Cesium lodide (Csl) converts incident x-rays into visible light that is optically coupled to a light detection imager based on CMOS technology. The ODI HD Dental Sensors allow for automatic detection of such incident x-rays in order to generate data. Software interprets this data into images used for dental applications. The ODI HD Dental Sensors support USB 2.0 direct connectivity to personal computers and or laptops with dedicated electronics and a sensor software driver. The subject device does not control the generator, it is only a receiver. The X-ray system and the software used are not a part of this submission.
This document, K190234, is a 510(k) Premarket Notification for a dental sensor. The key argument for substantial equivalence relies on the fact that the device (ODI HD Dental Sensor) is essentially identical to a previously cleared predicate device (Apex Dental Sensor K163282), with the main components sourced from the same supplier. Therefore, the "study" proving the device meets the acceptance criteria is primarily a comparison to the predicate device and adherence to relevant electrical and performance standards.
Here's the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by the technical specifications and performance characteristics of the predicate device, as well as adherence to recognized international standards for medical electrical equipment and X-ray detectors. The device performance is demonstrated by its identical (or highly similar) specifications to the predicate and its conformity to these standards.
| Acceptance Criteria (Implicitly based on Predicate & Standards) | Reported Device Performance (ODI HD Dental Sensor) |
|---|---|
| General | |
| Classification and Product Code (Class II, 21 CFR 872.1800, MUH) | Class II, 21 CFR 872.1800, MUH |
| Common Name (Intraoral Digital X-ray Sensors) | Intraoral Digital X-ray Sensors |
| Classification Name (Extraoral source X-ray system) | Extraoral source X-ray System |
| Classification Panel (Dental) | Dental |
| Intended Use (Providing diagnostic x-ray radiographs of dentition, jaws and other oral structures) | Providing diagnostic x-ray radiographs of dentition, jaws and other oral structures. |
| Indications for Use (Radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure) | Intended to be used by dentists and other qualified professionals for providing diagnostic x-ray radiographs of dentition, jaws and other oral structures. |
| Number of Sensors (2 sizes) | 2 sizes (S11684-12, S11685-12) |
| Cable Length (2m) | 2m |
| Pixel Size (20 x 20 µm) | 20 x 20 µm |
| Resolution (20 Lp/mm typ) | 20 Lp/mm typ |
| Technology (CMOS chip + optical fiber plate + Csl scintillator) | CMOS chip + optical fiber plate + Csl scintillator |
| Sensor Active Area (Size 1: 600mm², Size 2: 884mm²) | Size 1: 600mm², Size 2: 884mm² |
| Principles of Operation (X-ray → scintillator → fiber optic → CMOS → electronics → PC) | X-ray (radiation) => scintillator (convert to light) => fiber optic (filtering) => CMOS (convert to digital) => electronics => PC (capture & display image) |
| Connection to Imaging Practice PC (USB 2.0 Interface) | USB 2.0 Interface |
| Software-Image Management (Apteryx XrayVision) | Apteryx XrayVision |
| Sensor Board (All control electronics directly integrated on CMOS sensor chip) | All control electronics directly integrated on CMOS sensor chip |
| Sensor Input Voltage & Current (USB2.0 (5V, 4.25min)) | USB2.0 (5V, 4.25min) |
| Operating Temperature (0°C~+35°C) | 0°C~+35°C |
| Electrical Safety Standards | |
| IEC 60601-1 (Electrical) | AAMI ES 60601-1:2005/(R) 2012 (found to be equivalent to predicate's IEC 60601-1-1) |
| IEC 60601-1-2 (EMC) | IEC 60601-1-2 Edition 3-2007 |
| IEC 62220-1 (Performance) | IEC 62220-1:2015 – Determination of the Detective Quantum Efficiency Detectors used in Radiographic Imaging (found to be equivalent to predicate's 62220-1) |
| IEC 60529 (Performance - IP Code) | IEC 60529:2001 - Degrees of Protection Provided by Enclosures (IP Code) |
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 explicitly states: "Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterizes all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on the ODI HD Dental Sensors."
Therefore, there was no "test set" in the sense of a clinical dataset used for performance evaluation that would require a sample size or data provenance details. The evaluation was based on engineering and performance testing against standards and comparison to a predicate device.
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. As stated above, no clinical data or test set requiring a ground truth established by experts was used. The focus was on engineering performance and substantial equivalence to a predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as 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 MRMC study was done. This device is a dental X-ray sensor, not an AI-powered diagnostic tool. The submission is for hardware that captures the image, not software that assists in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device (dental sensor), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical test set requiring ground truth was used. The "ground truth" for this submission are the established technical specifications and performance characteristics of the predicate device and the relevant international standards.
8. The sample size for the training set
Not applicable. This device is a passive sensor, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
§ 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.