(99 days)
The Apex Dental Sensors is intended to be used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures.
The Apex Dental Sensors is an electronic medical device used to acquire 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 x-ray beam. The sensor may also be aligned with the assistance of the patient. The Apex Dental Sensors is an indirect light converting digital x-ray detector. A scintillating device composed of Cesium Iodide (Csl) converts incident x-rays into visible light that is optically coupled to a light detection imager based on CMOS technology. The Apex 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 Apex 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.
The provided document is a 510(k) premarket notification for a medical device called "Apex Dental Sensors". The purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device, QuickRay HD Intraoral Sensor (K151926).
The document does not describe a study involving patient data, expert evaluation, or MRMC comparative effectiveness to establish the device's performance in a clinical context or against specific acceptance criteria related to diagnostic accuracy. Instead, the performance data presented focuses on engineering and safety standards to show that the new device performs equivalently to its predicate.
Therefore, many of the requested items (sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or cannot be extracted from this specific 510(k) summary.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria provided are primarily based on equivalence to the predicate device and conformity to various engineering and safety standards. There are no clinical performance acceptance criteria (e.g., sensitivity, specificity for detecting a specific disease) reported in this document.
| Parameter | Acceptance Criteria (Equivalent to Predicate / Standard Conformance) | Reported Device Performance |
|---|---|---|
| General | ||
| Intended Use | Equivalent to Predicate | Radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure |
| Indications for Use | Equivalent to Predicate | Intended to be used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures. |
| Classification (Class, Panel) | Equivalent to Predicate | Class II, Dental Panel |
| Common Name | Equivalent to Predicate | Intraoral Digital x-ray Sensor |
| Product Code | Equivalent to Predicate | MUH |
| Regulation Number | Equivalent to Predicate | 21 CFR 872.1800 |
| Classification Name | Equivalent to Predicate | Extraoral source x-ray System |
| Key Features | ||
| Number of Sensors | Equivalent to Predicate | 2 |
| Cable Length | Equivalent to Predicate | 2m |
| Pixel Size | Equivalent to Predicate | 20 x 20μm |
| Resolution | Equivalent to Predicate | 20 Lp/mm typ (S11684-12) |
| Technology | Equivalent to Predicate | CMOS chip +optical fiber plate + CsI scintillator |
| Matrix dimensions (Active Area) | Equivalent to Predicate | 600mm² (Size 1), 884mm² (Size 2) |
| Principles of Operation | Equivalent to Predicate | X-ray (radiation) => scintillator (convert to light) => fiber optic (filtering) => CMOS (convert to digital) => electronics => PC (capture & display image) |
| Software-Image Management | Equivalent to Predicate (Apteryx XrayVision) | Apteryx XrayVision |
| Sensor Board | Equivalent to Predicate (control electronics integrated on CMOS chip) | All control electronics directly integrated on CMOS sensor chip |
| Sensor Input Voltage | Equivalent to Predicate (5V) | USB2.0 (5V, 4.25min) |
| Operating Temperature | Equivalent to Predicate (0°C to 35°C) | 0°C ~ +35°C |
| Other Requirements / Standards | ||
| Recommended PC Requirements | Comparable to Predicate | Processor: Intel 1.2GHz or above, Memory: 1G+, Hard disk: 40G+, Interface: USB 2.0, Display: 1024x758+, OS: Windows XP, IEC 60950-1:2005 compliant PC. |
| Connection to Imaging PC | Equivalent to Predicate (USB 2.0) | USB 2.0 Interface |
| Electrical Safety | Conformance to IEC 60601-1-1 | Conforms to AAMI ES 60601-1:2005/(R) 2012 |
| EMC | Conformance to IEC 60601-1-2 | Conforms to IEC 60601-1-2 - Edition 3-2007, IEC 61326-1 |
| Performance Imaging | Conformance to IEC 6220-1 | Conforms to IEC 6220-1:2003 (Determination of DQE) |
| Dental X-ray Equipment | Conformance to IEC 60601-2-65 | Conforms to IEC 60601-2-65:2012 |
| FDA Guidance | Conformance to Solid State X-ray Imaging Devices guidance | In compliance with FDA guidance document (Solid State X-ray Imaging Devices) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes a premarket notification based on technical and performance equivalence to a predicate device and adherence to industry standards, not a clinical study with a test set of patient data. Therefore, this information is not applicable and not provided.
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 no clinical test set requiring expert ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set is described.
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. This device is an intraoral digital x-ray sensor, a hardware component for image acquisition, not an AI-powered diagnostic software. Therefore, an MRMC study related to AI assistance for human readers is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware sensor, not an algorithm, so standalone AI performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical study requiring ground truth is described. The "ground truth" in this context is the predicate device's established performance and the requirements of various engineering and safety standards.
8. The sample size for the training set
Not applicable. This is a hardware device; thus, there is no AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI model.
§ 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.