(57 days)
Snapshot is intended to be used by dentists and other qualified professionals for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures.
Snapshot is a digital intraoral sensor system that can be connected to a workstation PC via USB connection. The essential function and purpose of the system in a dental clinic is to capture intraoral digital dental x-ray images. The system can be used with general intraoral X-ray units. Snapshot utilizes existing designs and share parts with the predicate Sigma M sensor. The sensor is the same CMOS sensor as that of the predicate device. USB 2.0 High speed connection is used for image transfer to a PC. The basic system consists of Sensor, which is available in two sizes, Workstation software, Sensor holders and hygienic covers.
The provided document is a 510(k) summary for the Snapshot digital intraoral sensor system. It focuses on demonstrating substantial equivalence to a predicate device (Sigma M) rather than presenting a standalone study with acceptance criteria and performance data. Therefore, many of the requested details are not present in this document.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
This information is not available in the provided document. The 510(k) summary primarily focuses on demonstrating substantial equivalence based on design, composition, and function compared to a predicate device, rather than quantitative performance against specific acceptance criteria. It states: "As conclusion Snapshot is as safe, as effective, and performs as well as or better than the predicate device." This is a qualitative statement of equivalence, not a presentation of performance data against defined metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided document. There is no mention of a specific test set or data provenance for a performance study.
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)
This information is not available in the provided document. As there's no mention of a test set or a study conducted to establish performance metrics, there's no information on experts or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided document.
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
There is no indication that an MRMC comparative effectiveness study was done, or that the device involves AI assistance. The document describes a "digital intraoral sensor system" which is a hardware component for capturing X-ray images, not an AI-powered diagnostic tool. The focus is on the sensor's ability to capture images, not on assisting human readers with interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/available. The "Snapshot" is a digital intraoral sensor system, essentially a hardware component for image acquisition, not an algorithm that functions in a standalone capacity for diagnosis. Its purpose is to "capture intraoral digital dental x-ray images."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not available in the provided document, as no specific performance study with ground truth is detailed.
8. The sample size for the training set
This information is not available in the provided document. The device is a digital sensor, not a machine learning algorithm that requires a training set in the typical sense.
9. How the ground truth for the training set was established
This information is not available in the provided document, as it's not relevant to the described device type.
In summary:
The provided document is a 510(k) premarket notification that asserts substantial equivalence of the Snapshot device to a predicate device (Sigma M) based on design and functional similarities. It does not contain details about specific performance studies with acceptance criteria, test sets, or ground truth establishment, which are typical for studies evaluating diagnostic accuracy or AI software performance. The device is a hardware system for image capture, not an AI-driven diagnostic tool.
§ 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.