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510(k) Data Aggregation
(148 days)
DVAS (DVAS-M, DVAS-W)
DVAS is an extra-oral source x-ray system to be used by trained dentists and dental technicians as an extra-oral x-ray source for producing diagnostic dental radiographic examination and diagnosis of teeth, jaw, and other oral structures using intra-oral image receptors. It is intended for both adult and pediatric subjects.
DVAS, the extra-oral source x-ray system for dentistry is the standard X-ray equipment used to acquire intraoral images of patients during dental diagnosis such as dental caries, periodontal diseases, dental root fracture, and other oral and dental pathologies. DVAS is used to provide anatomic X-ray images of a patient at hospitals or dental clinics using a cone for X-ray exposure. The doctor or dentist can check the acquired X-ray images with chemical films or a PC monitor. DVAS can be used Digital I/O Sensor, Image plate (CR), Film as a Image receptor. The image receptors are not part of this submission.
The provided text is a 510(k) summary for the DVAS (DVAS-M, DVAS-W) extra-oral source x-ray system. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a standalone study with specific acceptance criteria and performance metrics for the device itself in a clinical setting.
Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance (e.g., sensitivity, specificity, or reader improvement) is not present in the provided document. The document primarily addresses engineering and regulatory compliance.
However, I can extract information related to safety, EMC, performance data comparison, and software validation, which are forms of acceptance criteria for a medical device.
Here's a breakdown of the available information based on your request, highlighting what is implicitly or explicitly stated regarding "acceptance criteria" and "proof":
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of clinical performance acceptance criteria (e.g., specific sensitivity or specificity thresholds) because it is a 510(k) submission focused on substantial equivalence to a predicate device, not clinical efficacy trials for novel AI algorithms.
However, it does describe compliance with various standards and successful completion of validation testing as its "performance criteria" for regulatory clearance.
| Acceptance Criterion (Implicit/Explicit) | Reported Device Performance (Proof) |
|---|---|
| Engineering Bench Testing & Verification/Validation (General) | DVAS successfully completed verification and validation testing per GENORAY quality system and engineering bench testing. All test results were satisfactory. |
| Safety and Electrical Compliance (IEC 60601-1, -1-2, -1-3, -2-65) | The system has been tested and is compliant with IEC 60601-1 (General requirements for basic safety and essential performance), IEC 60601-1-2 (Electromagnetic disturbances - Requirements and tests), IEC 60601-1-3 (General requirements for radiation protection in diagnostic X-ray equipment), and IEC 60601-2-65 (Particular requirements for the basic safety and essential performance of dental extra-oral x-ray equipment). |
| Radiation Control Compliance (21 CFR 1020.30, 1020.31) | DVAS complies with all applicable 21 CFR performance standards: 21 CFR 1020.30 (Electronic products; general) and 21 CFR 1020.31 (Radiological safety for diagnostic x-ray systems and their major components). |
| Software Validation (FDA Guidance: "Software Contained in Medical Devices") | Software was validated according to the FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical devices" and "Guidance for the content of premarket submissions for management of cyber security." Results demonstrated that all executed verification tests were passed. |
| Pediatric Information in Labeling (FDA Guidance: "Pediatric Information for X-ray Imaging Device Premarket Notifications") | The system has reflected pediatric information in the labeling according to the FDA Guidance "Pediatric Information for X-ray Imaging Device Premarket Notifications," dated November 28, 2017, as DVAS can be used in both adult and pediatric populations. |
| Non-clinical Validation Testing for Intended Use/Claims | Non-clinical validation testing has been performed to validate that DVAS conforms to its intended use, claims, user needs, effectiveness of safety measures, and instructions for use. The bench tests indicate that the new device is as safe and effective as the predicate device. |
| Substantial Equivalence to Predicate Device | Based on comparison information (similar functions, electronic features, indications for use, patient type, mechanical configuration, X-ray field size, target material, electrical power, focal spot, and applied standards), the device is deemed safe and effective as the predicate device and has no new indication for use, therefore it is substantially equivalent to the predicate device (RIX 70 DC, K182206) and reference device (PORT-X IV, K172810). |
2. Sample size used for the test set and the data provenance
The document does not mention a "test set" in the context of clinical images or patient data for evaluating a diagnostic algorithm. The testing described is primarily engineering and regulatory compliance testing, not a clinical performance study involving diagnostic accuracy metrics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical test set needing expert ground truth establishment is mentioned in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set needing adjudication is mentioned.
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 is mentioned. This device is an X-ray system (hardware), not an AI diagnostic algorithm, so such a study would not be relevant for this type of submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is an X-ray system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the engineering and regulatory compliance tests, the "ground truth" would be the specifications and requirements of the relevant standards (e.g., IEC 60601 series, 21 CFR 1020.30/31).
8. The sample size for the training set
Not applicable. This document does not describe the development or testing of an AI algorithm that would require a training set of data.
9. How the ground truth for the training set was established
Not applicable. No training set for an AI algorithm is mentioned.
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