(48 days)
PaX-Primo is a digital panoramic dental X-ray imaging system that uses a CMOS detector for a real time digital image acquisition. It is intended for producing diagnostic X-ray radiographic images of skull, dentition, and oral smictures of the patient population targeting men. women and children. The device is operated and used by physicians. dentists and X-ray technologists.
PaX-Primo diagnostic equipment is a dental panoramic X-ray system which consists of X-ray generator, X-ray controller, X-ray beam limiting device, image process unit and exposure switch. This device utilizes a high voltage generator to generate X-ray by inputting energy to the anode and the cathode. The X-ray is exposed on the oral maxillofacial area of a patient before reaching CMOS digital sensor. The CMOS sensor converts resulting X-ray into clectrical charge. The clectrical pattern is further converted to voltage and a digital signal which is interpreted by a computer to produce a digital image.
Based on the provided text, the device in question is the Vatech Co., Ltd. PaX-Primo, a digital panoramic dental X-ray imaging system. The submission focuses on demonstrating substantial equivalence to a predicate device (PaX-P&P) rather than establishing novel performance criteria through extensive clinical studies.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not present explicit acceptance criteria in the form of numerical thresholds for clinical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" are implied to be the characteristics of the predicate device, and the "reported device performance" are the corresponding characteristics of the PaX-Primo, showing them to be "the same" or "similar."
| Characteristic | Acceptance Criteria (Predicate Device: PaX-P&P) | Reported Device Performance (Proposed Device: PaX-Primo) | Met/Not Met (Based on "Same" or "Similar" claim) |
|---|---|---|---|
| Indications for Use | Producing diagnostic X-ray radiographic images of skull, dentition, and oral structures. Operated by physicians, dentists, and X-ray technologists. | Producing diagnostic X-ray radiographic images of skull, dentition, and oral structures. Operated by physicians, dentists, and X-ray technologists. | Met (Claimed as "same") |
| Performance | Panoramic | Panoramic | Met (Claimed as "same") |
| Power source | 110V/230V~, 50/60Hz | 110V/230V~, 50/60Hz | Met (Claimed as "same") |
| X-ray tube | D-051 (Toshiba) | D-051 (Toshiba) | Met (Claimed as "same") |
| Focal spot size | 0.5 mm | 0.5 mm | Met (Claimed as "same") |
| Total filtration | 2.8 mm Al | 2.8 mm Al | Met (Claimed as "same") |
| Tube voltage | 50 – 80 kVp | 50 – 80 kVp | Met (Claimed as "same") |
| Tube current | 2 – 10 mA | 2 - 10 mA | Met (Claimed as "same") |
| Nominal magnification | 1.3 | 1.3 | Met (Claimed as "same") |
| Exposure time | Min. 6.6 sec, Max. 13.2 sec | Min. 6.5 sec, Max. 13.5 sec | Met (Claimed as "similar" in range) |
| DICOM compatibility | Compatible | Compatible | Met (Claimed as "same") |
| X-ray beam | Fan beam | Fan beam | Met (Claimed as "same") |
| Detector Type | CCD | CMOS | Not Directly Comparable (Different technology, but deemed "similar" in overall function for X-ray acquisition) |
| Pixel size | 0.096 mm | 0.100 mm | Met (Claimed as "similar" - minor difference) |
| Active area | 146x6 mm | 150.4x6 mm | Met (Claimed as "similar" - minor difference) |
| Safety and EMC | Compliance with IEC 60601-1, -1-1, -1-3, -2-7, -2-28, -2-32, and IEC 60601-1-2 | All test results were satisfactory. | Met |
Study Proving Acceptance Criteria:
The study that proves the device meets the acceptance criteria is primarily a substantial equivalence comparison to the predicate device, supplemented by non-clinical testing for safety and performance standards.
2. Sample size used for the test set and the data provenance:
The document does not specify any clinical test set for evaluating the PaX-Primo's performance against specific diagnostic criteria or a ground truth. The acceptance is based on engineering specifications and comparison to the predicate.
The document mentions "Non-clinical & Clinical considerations according to FDA Guidance for the Submissions of 510(k)'s for Solid State X-ray Imaging Devices" was performed, but no details on specific clinical data, sample size, or provenance of such data are provided. This typically means the reliance is on the equivalence of technical specifications rather than new clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided as there is no described clinical test set with a ground truth established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided as there is no described clinical test set requiring adjudication.
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:
An MRMC study was not conducted and is not mentioned in the provided text. The device is a digital X-ray imaging system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is an X-ray imaging system, not an algorithm, and its output is intended for human interpretation. No standalone algorithm performance is discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not provided as there is no described clinical test set with a ground truth. The "ground truth" for the device's acceptability is essentially its technical specifications matching or being equivalent to those of the predicate device, as well as meeting relevant safety standards.
8. The sample size for the training set:
This information is not provided. The device is a hardware imaging system. If any internal calibration or image processing algorithms were developed, details about their training sets are not included here. Given the 2010 submission date, sophisticated deep learning models requiring large training sets were less common for this type of device.
9. How the ground truth for the training set was established:
This information is not provided as there is no described training set.
§ 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.