(37 days)
The Portable HDX Intraoral X-ray unit is intended for use only by a qualified/trained dentist or dental technician on both adult and pediatric subjects for taking diagnostic extraoral dental x-rays using intraoral image receptors.
Portable HDX Intraoral X-ray is a portable dental x-ray system that operates on 120 VAC (+/-10%), 60 Hz, and 240 VAC (+/-10%), 50 Hz line AC power. The system uses Constant Emission Power (CEP) which allows for minimum exposure time and can be either mounted to a tripod or can be hand held.
The "Portable HDX Intraoral X-ray" device is a portable dental x-ray system. The study for this device primarily focuses on demonstrating substantial equivalence to a predicate device (MinXray HF70D) rather than meeting specific performance criteria through a standalone study. The acceptance criteria and testing are based on regulatory and government performance standards for X-ray systems.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Acceptance Criterion | Portable HDX Intraoral X-ray (Reported Performance) | Predicate Device (MinXray HF70D) |
|---|---|---|
| Intended Use | Extraoral dental x-ray with intraoral receptors (for adult and pediatric subjects) | SAME |
| Energy Source | 120V 50 Hz or 240V Hz AC | 120V 50-60 Hz AC |
| Size (Body) | 5.5" H x 8.25 W x 8" D | 5.8" H x 4.8" W x 7.9" D |
| Size (Cone) | 2.75" Dia. x 5.75" L | 2" Dia. x 6" L |
| Weight | 11.7 lbs. | 10.4 lbs. |
| User Interface | Up-down buttons for exposure time selections with display. | Up-Down pushbuttons for three kVp selections and exposure time selection with indicators. |
| Exposure Times | 0.01 – 2.00 seconds in 0.01 increments | 0.02 - 1.98 seconds in 99 steps |
| mA | 7 mA | 10 mA |
| kVp | 65 kVp | 60, 65, 70 kVp |
| Performance Standard | 21 CFR 1020.30, United States Government Specifications SP0200-96-R-8076 (NSN 6525-01-425-5216) | 21 CFR 1020.30 |
| Electrical Safety | UL 2601, CSA 601-M90, EN 6061-1:1990+A1+A2 | UL 2601, IEC 6061-1 |
The acceptance criteria are implicitly defined by compliance with the listed performance standards and demonstration of comparable performance to the predicate device across various technical specifications. The reported device performance is presented as its specifications, which are compared to those of the predicate device. The conclusion is that the new system is "as safe and effective" as the predicate based on bench and user testing against these standards.
2. Sample Size Used for the Test Set and Data Provenance
The document states that "bench and user testing" was performed. However, the specific sample sizes for the test set (e.g., number of tests, number of users, number of images) are not provided. The provenance of the data (e.g., country of origin, retrospective or prospective) is also not specified, beyond mentioning "bench and user testing" against US government specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The study design described does not involve a ground truth established by experts in the typical sense of diagnostic accuracy studies (e.g., radiologists interpreting images). Instead, it relies on compliance with engineering and safety standards for the device itself.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided in the document. The testing described is against performance standards and specifications, not an assessment of diagnostic performance requiring adjudication of interpretations.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an X-ray imaging system, not an AI-powered diagnostic tool, so evaluation of human reader improvement with AI assistance is not relevant to this filing.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation of an "algorithm only" (without human-in-the-loop performance) was not done. This device is a hardware system; there is no mention of an algorithm being evaluated in this context. The standalone performance evaluation referred to here would be the device's adherence to relevant technical standards (e.g., radiation output, exposure accuracy), which was indeed assessed through "bench and user testing."
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" in the diagnostic accuracy sense (like pathology or expert consensus for image interpretation) is not directly applicable to this submission. The "ground truth" or reference standard used here is the adherence to established technical performance and safety standards for X-ray devices, specifically 21 CFR § 1020.30 (Performance Standards for Diagnostic X-Ray Systems and Their Major Components) and United States Government Specifications SP0200-96-R-8076. These standards define acceptable parameters for the physical operation and safety of the X-ray system.
8. The Sample Size for the Training Set
A "training set" is not applicable to this type of device. The Portable HDX Intraoral X-ray is a physical medical device, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for this device.
§ 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.