(25 days)
The DIGITAL RADIOGRAPHY CXDI-CS01 provides digital image capture for conventional film/screen radiographic examinations. This device is intended to capture, for display, radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
The DIGITAL RADIOGRAPHY CXDI-CS01 (hereinafter referred to as CXDI-CS01) is a solid-state x-ray imager. The CXDI-CS01 is a series of detectors, and in the predicate device (K203849) consists of the CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710C Wireless, CXDI-810C Wireless, and CXDI-410C Wireless.
The CXDI-CS01 intercepts x-ray photons, and the scintillator emits visible spectrum photons that illuminate an array of photodetectors that create electrical signals. After the electrical signals are generated, the signals are converted to digital values. The digital values are sent to the PC via a wired or wireless connection, converted to images with the CXDI Control Software, and then displayed on the PC/monitors. The PC/monitors used with the CXDI-CS01 are not a part of this submission.
The subject of this Special 510(k) submission is a change to the CXDI-CS01 to add the DIGITAL RADIOGRAPHY CXDI-Pro (hereinafter referred to as CXDI-Pro) series and the DIGITAL RADIOGRAPHY CXDI-Elite (hereinafter referred to as CXDI-Elite) series detectors to the CXDI-CS01 series of detectors. In addition, the CXDI-Pro and CXDI-Elite components and features (Bluetooth connection and the Built-in AEC Assistance) have been added to the CXDI-CS01. The CXDI Control Software has been updated from V2.19.0.7 to V3.10.2.2 to add the Intelligent NR function (cleared under K212269), update the GPU driver, add several minor functional changes, and fix bugs. Together, these changes make up the CXDI-CS01.
The provided text is a 510(k) summary for a medical device called "DIGITAL RADIOGRAPHY CXDI-CS01". It describes the device, its intended use, and its similarities to a predicate device. However, it explicitly states that clinical testing was not necessary for this submission due to minor differences from the predicate device. Therefore, the document does not contain any information about acceptance criteria, device performance from a clinical study, sample sizes, ground truth establishment, or expert involvement for a clinical study.
The document only discusses bench testing to demonstrate conformance with performance standards and safety standards.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
This information is not available in the provided text. The document refers to conformance with various standards (e.g., IEC 60601-1) but does not provide specific acceptance criteria or reported performance data for these standards in a tabular format. The table provided in the 510(k) summary compares technological characteristics with the predicate, such as DQE, pixel pitch, and spatial resolution, but these are characteristics of the device, not performance benchmarks against acceptance criteria from a study demonstrating clinical effectiveness.
Technological Characteristics Comparison (from the provided text, not acceptance criteria/performance from a clinical study):
| Characteristic | Proposed Device Performance | Predicate Device Performance |
|---|---|---|
| Scintillator | CsI(Tl) | CsI(Tl) |
| Pixel Pitch | CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710C Wireless, CXDI-810C Wireless, CXDI-410C Wireless, and CXDI-Elite: 125μm. CXDI-Pro: 140 μm. | CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710C Wireless, CXDI-810C Wireless, CXDI-410C Wireless: 125μm. |
| Spatial Resolution | CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710C Wireless, CXDI-810C Wireless, and CXDI-410C Wireless: 35% [MTF@2lp/mm]. CXDI-Pro and CXDI-Elite: 45% [MTF@2lp/mm]. | CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710C Wireless, CXDI-810C Wireless, CXDI-410C Wireless: 35% [MTF@2lp/mm]. |
| DQE | CXDI-702C Wireless: 58% [@0.5 lp/mm, 1 mR]. CXDI-402C Wireless: 58% [@0.5 lp/mm, 3.5 uGy]. CXDI-710C Wireless, CXDI-810C Wireless, and CXDI-410C Wireless: 60% [@0 lp/mm, 4 uGy]. CXDI-Pro: 58% [@0.5 lp/mm, 3.5 uGy]. CXDI-Elite: 67% [@0.5 lp/mm, 3.5 uGy]. | CXDI-702C Wireless: 58% [@0.5 lp/mm, 1 mR]. CXDI-402C Wireless: 58% [@0.5 lp/mm, 3.5 uGy]. CXDI-710C Wireless, CXDI-810C Wireless, and CXDI-410C Wireless: 60% [@0 lp/mm, 4 uGy]. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available. The document explicitly states: "Clinical testing is not necessary for the current submission, based on the minor differences from the predicate device. Adequate detector bench testing should be sufficient to demonstrate that the subject detector CXDI-CS01 works as intended."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available due to the absence of a clinical study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available due to the absence of a clinical study.
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
This information is not available. The device is a "Solid State X-Ray Imager" and its primary function is digital image capture. There's no mention of AI assistance for human readers in the document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not available. The device is a digital radiography system, not an AI algorithm, and no clinical performance studies are mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not available due to the absence of a clinical study.
8. The sample size for the training set
This information is not available. There is no mention of an AI algorithm requiring a training set in this submission.
9. How the ground truth for the training set was established
This information is not available due to the absence of a training set as no AI algorithm is detailed in this submission.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.