(51 days)
The HyperLight Portable X-ray Unit is a diagnostic X-ray system which is intended to be used by trained dentists and dental technicians as an extra-oral X-ray source for producing diagnostic x-ray images using intra-oral receptors. Its use is intended for both adults and pediatric subjects.
Intended as extraoral x-ray sources to be used with intraoral image receptors for diagnostic imaging by dentists or dental technicians.
HyperLight Portable X-ray Unit of Changzhou Sifary Medical Technology Co., Ltd., is a handheld x-ray device. The technology of portable x-ray devices was originally developed in the 1950s and was originally designed to be used in situations where there was no access to fixed x-ray units. With new technological possiblities arising, the use of portable handheld devices are becoming more mainstream.
The subject device is designed for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure by exposing an x-ray image receptor to ionizing radiation. The x-ray source, a tube, is located inside the handheld device. All three conventional types of intraoral receptors can be used with this device-analog x-ray film, digital phosphorous plates, and digital x-ray sensors. The intraoral x-ray detectors are not part of the subject device. The functions of the HyperLight Portable device are supported by software. The software package is of Moderate level of concern and it's not based on the predicate system.
This device is used in general dentistry and is supplied with an internal timer to control the duration of the x-ray source to the patient. The handheld x-ray device is a choice model to assist doctors with special need patients, nursing home patients in the office that cannot be easily moved, as well as other special situations. The choice of an x-ray generator is a matter of functional utility in the dental operatory and personal preference by the medical professional.
This document is a 510(k) premarket notification for a medical device (HyperLight Portable X-ray Unit). It does not contain information about an AI/ML algorithm or a study related to its performance against acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device (MobileX Portable X-ray System) based on technical characteristics, indications for use, and non-clinical performance data (electrical safety, EMC, software validation, biocompatibility, usability, risk assessment, and clinical comparison).
Therefore, I cannot provide the requested information about acceptance criteria, study details for an AI/ML algorithm, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided text.
The document discusses the following:
1. A table of acceptance criteria and the reported device performance:
- The document provides a "Comparison of Technological Characteristics with Predicate" table, which acts as a comparison against a predicate device, not against specific quantitative acceptance criteria for an AI/ML algorithm.
- It lists characteristics like size, source to skin distance, cone diameter, user interface, backscatter radiation protection, exposure switch, electrical information (exposure time, time accuracy, mA, kVp, waveform, total filtration), and performance standards.
- For example, for "Exposure time," the subject device's reported performance is "0.02 ~ 2.0 seconds in .01-.40s increments (20 steps)" compared to the predicate's "0.01 ~ 1.3 seconds in 0.01 or 0.05 increments." This is a comparison, not an acceptance criterion with a pass/fail threshold.
2. Sample sized used for the test set and the data provenance:
- Not applicable. The document describes non-clinical performance data, primarily engineering and safety tests, and a comparison to a predicate device. There is no mention of a test set with patient data for an AI/ML algorithm, nor data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No AI/ML algorithm performance study is described that would require expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No AI/ML algorithm performance study is described.
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:
- Not applicable. No MRMC study or AI assistance for human readers is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. No AI algorithm is the focus of this 510(k) submission. The device is a portable X-ray unit.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. There is no AI/ML algorithm requiring ground truth from clinical data. The "ground truth" for this submission are
established engineering standards (e.g., IEC standards for electrical safety, EMC, etc.) and the characteristics of the predicate device.
8. The sample size for the training set:
- Not applicable. No AI/ML algorithm training is mentioned.
9. How the ground truth for the training set was established:
- Not applicable. No AI/ML algorithm training is mentioned.
In summary, this document is a regulatory submission for a physical medical device (X-ray unit) based on substantial equivalence, not an AI/ML device requiring clinical performance validation against acceptance criteria.
§ 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.