(49 days)
THE DXIS® IS INTENDED FOR DENTAL RADIOGRAPHIC EXAMINATION AND DIOGNOSIS OF DISEASES OF THE TEETH, JAW AND ORAL STRUCTURE.
The Signet DXIS® System is designed to replace the film cassettes with a digital sensor in existing dental panoramic x-rav systems that are already on the market. It consists of a digital x-ray sensor. interface equipment, software, and adapters for specific dental x-ray systems. The DXIS® is installed by a Signet authorized technician on existing compatible dental x-ray systems. Software provided by Signet and a user supplied computer permit the images from the digital sensor to be recorded and displayed.
Here's a breakdown of the acceptance criteria and study information for the Signet DXIS® Digital X-ray Imaging System, based on the provided 510(k) summary:
This 510(k) summary (K983283) focuses on demonstrating substantial equivalence to predicate devices rather than proving a specific performance metric against a set of acceptance criteria through a dedicated study. For devices cleared under substantial equivalence, the primary "acceptance criterion" is that the new device is as safe and effective as existing legally marketed devices.
However, we can infer some "acceptance criteria" through the comparison with existing devices.
1. Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) for substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating similar technological characteristics and intended use to the predicate devices. The performance is reported in terms of features and capabilities matching or improving upon the predicates.
| Acceptance Criterion (Inferred from Predicate Comparison) | Reported Device Performance (DXIS®) |
|---|---|
| Ability to provide panoramic dental images | YES |
| Utilizes X-ray technology | YES |
| Replaces film cassettes in existing systems | YES |
| Performs digital processing of images | YES |
| Offers digital storage of images | YES |
| Provides hard copy (printing) capability | YES |
| Includes enhancement functions for images | YES |
| Utilizes a CCD acquisition sensor | YES (CCD DXIS Sensor) |
| Includes a computer interface board | YES |
| Includes acquisition software | YES (DXIS Acquisition Program) |
| Level of X-ray Radiation exposure comparable to or better than predicates | Up to 50% (of a baseline assumed to be comparable to or less than predicates like Trophy at 70%) |
| Panoramic Acquisition Board functionality (if applicable) | NO (but has a "Panoramic Correlator") |
| Panoramic Correlator functionality (if applicable) | YES (while Trophy has NO, implying a different approach to generating panoramic images) |
Note: The radiation exposure reduction (up to 50%) is a key performance characteristic highlighted, implying it meets or exceeds the predicate's performance in this aspect. For other features, the performance is simply "YES," indicating it possesses the characteristic.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not explicitly describe a specific "test set" or a performance study with a defined sample size to prove the device meets acceptance criteria in the way a clinical trial would. The submission focuses on a comparative analysis of technological characteristics to predicate devices.
Therefore, information on:
- Sample size used for the test set: Not specified.
- Data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified, as no such study is detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no specific "test set" and corresponding performance study with ground truth establishment is detailed, this information is not provided in the 510(k) summary.
4. Adjudication Method for the Test Set
As no specific "test set" is described for performance evaluation, an adjudication method is not applicable/not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not described in this 510(k) summary. The submission focuses on device characteristics and substantial equivalence, not reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
The DXIS® is a digital imaging system, not an AI algorithm for diagnostic interpretation. Its primary function is to acquire, display, store, and print digital X-ray images. Therefore, the concept of "standalone algorithm performance" (without human-in-the-loop) in the context of recent AI/ML medical devices does not directly apply to this device as described. Its performance is related to image quality, radiation dose, and functionality compared to film-based or other digital systems.
7. The Type of Ground Truth Used
As no specific performance study requiring ground truth is detailed, the type of ground truth used is not specified. The primary "ground truth" for this 510(k) is the established performance and safety of legally marketed predicate devices.
8. The Sample Size for the Training Set
The DXIS® is an imaging hardware and software system, not a machine learning model that requires a "training set" in the conventional AI sense. Therefore, "sample size for the training set" is not applicable and not specified.
9. How the Ground Truth for the Training Set Was Established
Since a "training set" in the context of AI/ML is not applicable to this device, how its "ground truth" would be established is not applicable/not specified.
§ 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.