(145 days)
N1 is a dental portable X-ray imaging system that captures radiographic images for dental diagnosis using intraoral imaging sensors. Only trained and qualified dental practitioner or radiologist shall use N1 to diagnose and treat diseases related to the teeth, jaws, and/or other oral structures in adults and children.
N1 is a portable dental X-ray imaging device powered by a rechargeable lithium polymer battery pack. It generates X-rays optimized for dental examinations (on teeth, etc.). The N1's X-ray generator equipped with an X-ray tube consists of control unit, user interface, X-ray aperture (collimator), a back-scatter shielding glass, and remote irradiation switch. The x-ray detectors (digital detectors or analog film) are not accessories for use with the N1. N1 is a product designed to diagnose the conditions of teeth through X-irradiation using its intraoral imaging sensors. Software is included for operation and configuration of the N1. It is of Moderate level of concern and it's not based on the predicate software.
The provided FDA 510(k) summary for the N1 device (K232012) does not contain information regarding acceptance criteria or a study that proves the device meets specific performance criteria beyond general safety and electrical compliance.
The document states:
- "No clinical studies are submitted." (Page 5, Section 8)
- "We performed the applicable non-clinical tests in the FDA guidance document for solid state x-ray detectors. The digital detectors used for testing are not part of the subject device." (Page 5, Section 7)
- "Software validation and verification test, EMC/Electrical Safety tests, and performance tests were conducted and the test results support that the subject device is substantially equivalent to the predicate device." (Page 5, Section 7)
- The conclusion mentions some differences in specifications but states, "there was no significant difference in the safety / performance of the product, and it was confirmed that the Portable dental X-ray imaging device had better performance than the equivalent device in some specifications." (Page 6, Section 9) This implies a comparison to a predicate device, but no specific performance metrics or acceptance criteria are detailed.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving those criteria are met from this document. The submission focuses on demonstrating substantial equivalence to a predicate device primarily through non-clinical testing (electrical safety, EMC, software verification/validation) and comparing technical specifications, rather than reporting on a clinical or performance study with defined acceptance criteria for diagnostic accuracy or effectiveness.
§ 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.