(59 days)
The DT-703 is a portable dental X-ray system that captures radiographic images for dental diagnosis using intraoral imaging sensors. Only trained and qualified dental practitioner or radiologist shall use DT-703 to diagnose and treat diseases related to the teeth, jaws, and/or other oral structures in adults and children.
DT-703 is a handheld X-ray system powered by a rechargeable Li-ion polymer battery pack. DT-703 is an extra source X-ray generating device that is mainly designed for dental examination (on teeth, etc.). DT-703 is composed of X-ray generator with X-ray tube including device controller, power controller, user interface, beam limiting part, backscatter shielding glass, and optional remote exposure switch. DT-703 is designed to diagnose teeth and jaw through X-ray irradiation using an intra-oral image receptor. DT-703 is controlled by software (firmware) and the software level of concern is Moderate. The x-ray image detector (an integral part of a complete dental diagnostic system) is not part of the DT-703 X-ray device.
The provided text describes a 510(k) premarket notification for the DT-703 dental X-ray system. It details the device's characteristics, intended use, and comparison to a predicate device (KaVo NOMAD Pro 2). However, it explicitly states:
"Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product."
Therefore, I cannot provide information on acceptance criteria and a study that proves the device meets clinical acceptance criteria, a multi-reader multi-case (MRMC) study, or standalone performance, because no clinical studies were performed. The submission relies solely on non-clinical (engineering and safety) testing and comparison to a predicate device.
Here's a breakdown of what can be extracted or inferred based on the provided text, while acknowledging the explicit lack of clinical performance data:
Clinical Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The document explicitly states that "Clinical testing has not been conducted on this product." Therefore, there are no acceptance criteria related to clinical performance, nor any clinical study to prove the device meets such criteria.
The substantial equivalence determination for this device (DT-703) is based on non-clinical test data that characterize performance, and a comparison of its technological characteristics, intended use, and principle of operation to a legally marketed predicate device (KaVo NOMAD Pro 2).
Non-Clinical Acceptance Criteria and Supporting Information
While no clinical acceptance criteria or studies are presented, the submission implies acceptance criteria based on compliance with various electrical, safety, and electromagnetic compatibility (EMC) standards.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Criteria (from standards compliance) | Reported Device Performance (Compliance Claim) |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1:2005, AMD 1:2012 | Complies with IEC 60601-1:2005, AMD 1:2012 |
| Electrical Safety (US Equivalent) | Compliance with AAMI ES60601-1:2005/(R)2012 And A1:2012 | Complies with AAMI ES60601-1:2005/(R)2012 And A1:2012 (Implied by equivalence to predicate) |
| EMC (EMI/EMS) | Compliance with IEC 60601-1-2: Ed. 4.1 | Complies with IEC 60601-1-2: Ed. 4.1 |
| Radiation Protection | Compliance with IEC 60601-1-3 Edition 2.1 2013-04 | Complies with IEC 60601-1-3 Edition 2.1 2013-04 |
| Dental X-Ray Specific Safety | Compliance with IEC 60601-2-65 Edition 1.0 2012-09 | Complies with IEC 60601-2-65 Edition 1.0 2012-09 |
| Risk Management | Compliance with ISO 14971 Third Edition 3 2019 | Complies with ISO 14971 Third Edition 3 2019 |
| Battery Safety | Compliance with IEC 62133 Edition 2.0 2012-12 | Complies with IEC 62133 Edition 2.0 2012-12 |
| Design/Performance Equivalence to Predicate | Similar intended use, indications, technological characteristics, principle of operation, and acceptable performance compared to KaVo NOMAD Pro 2 (K173319). | DT-703 found substantially equivalent to KaVo NOMAD Pro 2. Key characteristics like X-ray tube (70 kV, 3 mA vs 60 kVp, 2.5 mA), battery (22.2 V Li-ion 1.0 Ahr vs 21.6 V Li-ion 1.7 Ahr), exposure time range (0.02-0.5s vs 0.02-1.0s), and physical dimensions are presented for comparison. |
| Software Concern Level | Moderate | Software level of concern declared as Moderate. (Implicitly met by review) |
| Radiation Safety (Handheld) | Follows "Radiation Safety Considerations for X-ray Equipment Designed for Hand-Held Use, issued December 24, 2008" | Utilized FDA Guidance (implied compliance). |
2. Sample sized used for the test set and the data provenance:
- Sample Size: The document does not specify sample sizes for individual non-clinical tests (e.g., how many units were subjected to electrical safety testing). The assumption is that standard engineering testing practices were followed, which typically involve a limited number of test units to demonstrate compliance with standards.
- Data Provenance: The testing was "performed in accordance with the following international standards." This indicates the tests were likely conducted in a controlled laboratory environment, presumably by or for the manufacturer (ECOTRON Co., Ltd, based in South Korea) or a certified testing body. The data is non-clinical, related to product design and safety specifications.
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 question is not applicable as the document explicitly states "Clinical testing has not been conducted on this product" and relies on non-clinical data. Therefore, no medical experts (like radiologists) were involved in establishing "ground truth" for a test set in the conventional sense of a clinical study. The "ground truth" for non-clinical testing refers to compliance with established engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable as clinical testing, which would involve reader adjudication, was not performed.
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. The device (DT-703) is a conventional dental X-ray system, not an AI-powered image analysis tool. The submission states, "Clinical testing has not been conducted on this product."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone performance study was done in the context of an algorithm or AI. The device is a hardware X-ray system. The "performance" assessment refers to its compliance with safety and electrical standards, not the diagnostic accuracy of an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" is defined by the specifications within the international standards (e.g., acceptable leakage current, proper radiation shielding, electromagnetic compatibility limits, battery performance). The device either meets these predefined technical criteria or it does not. There is no biological or diagnostic "ground truth" involved.
8. The sample size for the training set:
- This question is not applicable. The device is a hardware X-ray system, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- This question is not applicable as no training set for an AI/ML algorithm 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.