(55 days)
GenX-CR is a digital radiographic scanner for dental diagnostics intended for use by dentists and other qualified professionals.
This device is used to create and display digital images by scanning intraoral X-ray images stored in an Image Plate (or Phosphore Storage Plate).
GenX-CR scans a reusable phosphor storage plate (hereinafter referred to as "PSP") instead of an analog film to acquire high-quality digital radiographic images, digitally processes them, and displays images on the equipment's touch display screen and computer screen. It's a scanner. PSP is also known as IP (Image Plate)
After scanning the PSP, the image is saved in the device's internal memory, the scanned image can be checked in advance through the touch display, and the image stored in the PSP can be deleted and the PSP can be ejected. Scanned images can be directly transmitted to a computer or network via an Ethernet cable and are used in PortView, a dental diagnostic software package, and other diagnostic software.
GenX-CR is composed of mainly consists of PSP Scanner, PSP tray, power adapter and cable, Ethernet cable, PSP transfer box, PSP, PSP Protective Cover, Hygenic Bag, Dental PSP scanner control system software (Version: V2.2)
GenX-CR contains firmware that is part of the system. And we hereby certify that the level of concern for this software(PortView) and firmware(GenX-OP) is of Moderate level of concern. And It has not been cleared with other predicate devices but is the initial used in GenX-CR
Its compact design allows installation in space-constrained locations and minimizeds operating costs by using a low-cost, reusable PSP.
This FDA 510(k) summary for the GenX-CR device does not provided detailed information regarding specific acceptance criteria, a dedicated study proving device performance against those criteria, or most of the requested information about clinical studies.
Here's a breakdown of what can be gleaned and what is missing, based on the provided text:
1. Table of acceptance criteria and reported device performance:
The document includes a "Substantial equivalence chart" which compares various specifications and performance metrics of the proposed device (GenX-CR) to a predicate device (CRUXCAN(CRX-1000)). While this chart doesn't explicitly state "acceptance criteria," it implicitly uses the predicate device's performance as a benchmark for substantial equivalence.
| Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (GenX-CR) |
|---|---|
| Image File Format: TIFF / Raw Format | TIFF / Raw Format (Same) |
| Power Supply: 50/60 Hz, 100-240V~ | 50/60 Hz, 100-240V~ (Same) |
| X-ray Absorber: Imaging Plate | Imaging Plate (Same) |
| Image plate Size: Size 0: 22 x 31mm, Size 1: 24 x 40 mm, Size 2: 31 x 41mm, Size 3: 27 x 54 mm | Size 0: 22 x 31mm, Size 1: 24 x 40 mm, Size 2: 31 x 41mm, Size 3: 27 x 54 mm (Same) |
| Image Pixel Size: 25 um, 50 um | 25 um (High Resolution), 50 um (Standard Resolution) (Same) |
| Gray Scale level: 8 bit / 16 bit | 16 bit (Same as one option, higher than other) |
| Resolution: 14.0 lp/mm @ 25um | 12 lp/mm @ 25um (Similar, slightly lower than predicate but considered acceptable for substantial equivalence) |
| Imaging Plate Performance - DQE at 10% efficiency: 2.8 lp/mm | 2.8 lp/mm (Same) |
| Imaging Plate Performance - MTF at 3lp/mm: 35% | 35% (Same) |
| Laser safety classification: Class 1 laser product EN60825-1:2014 | Class 1 laser product EN60825-1:2014 (Same) |
2. Sample size used for the test set and the data provenance:
- Not explicitly stated for a clinical test set. The document mentions "Non-clinical validation testing has been performed to validate that GenX-CR conforms to the intended use, claims, user needs, effectiveness of safety measures, and instructions for use." However, it does not specify the sample size of images or patients used for this non-clinical validation.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided. The document states "Clinical testing was not necessary for the subject device, to demonstrate substantial equivalence." This implies no expert-based ground truth was established from a clinical study for the purpose of this 510(k).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. As no clinical study involving human readers and a test set for diagnostic accuracy is detailed, there is no mention of adjudication methods.
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, an MRMC comparative effectiveness study was not done. The device is a "digital radiographic scanner" that converts intraoral X-ray images from phosphor plates into digital images. It is not described as an AI-powered diagnostic assistance tool. The document explicitly states: "Clinical testing was not necessary for the subject device, to demonstrate substantial equivalence."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone diagnostic algorithm performance study was not done. The device itself is a scanner. Its performance is related to image quality metrics (resolution, DQE, MTF) and compliance with safety standards, rather than an diagnostic algorithm's ability to interpret images.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical validation, the "ground truth" would be against established engineering specifications, safety standards (IEC 60601 series), and the functional equivalence to the predicate device in terms of image capture and processing capabilities.
- There is no mention of ground truth established from expert consensus, pathology, or outcomes data, as no clinical diagnostic efficacy study was conducted for this submission.
8. The sample size for the training set:
- Not applicable/Not provided. The GenX-CR is described as a hardware device (scanner) with associated firmware and control software. There is no mention of a machine learning or AI component requiring a "training set" for diagnostic performance.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. As there is no mention of a training set for a diagnostic algorithm, the method for establishing its ground truth is not relevant here.
§ 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.