(30 days)
The AS-10 / CXDI-401RF is indicated for use in generating fluoroscopic and radiographic images of human anatomy for angiography, diagnostic, and interventional procedures. The device is intended to replace spot-film devices is also intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.
The AS-10 / CXDI-401RF is a solid state x-ray imager. It intercepts x-ray photons and the scintillator of the AS-10 / CXDI-401RF emits visible spectrum photons that illuminate an array of photo-detectors that create electrical signals. After the electrical signals are generated, it is converted to digital value.
The provided text describes a 510(k) premarket notification for a medical device, the AS-10 / CXDI-401RF, an x-ray imager. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance criteria through a detailed clinical study with acceptance metrics for a diagnostic device.
Therefore, the requested information cannot be fully extracted as it pertains to a diagnostic AI/CADe device, which this submission does not explicitly detail. This submission focuses on the safety and effectiveness of new imaging hardware (a flat panel detector) and its comparability to existing technology.
However, I can extract information related to the device's technical specifications and the non-clinical tests performed to demonstrate its equivalence.
Here's an attempt to answer based on the provided text, recognizing the limitations of the document's content for your specific questions:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the context of a diagnostic performance study with specific metrics (like sensitivity, specificity, or AUC) as one might find for an AI/CADe device. Instead, it compares the technical specifications and non-clinical performance of the AS-10 / CXDI-401RF to its predicate devices. The "performance" is implicitly demonstrated by showing that the new device's technical parameters are comparable to or improved upon the predicates and that it is safe and effective.
| Characteristic | Predicate Devices (CXDI-50RF K092439 & CSX-30 K162909) (Implicit "Acceptance Criteria" for Equivalence) | AS-10 / CXDI-401RF (Reported Device Performance) | Comparison to Predicates |
|---|---|---|---|
| Application | Fluoroscopy and Spot Radiology | Fluoroscopy and Spot Radiology | Identical |
| Technology | Flat panel detector: Scintillator and a-Si | Flat panel detector: Scintillator and a-Si | Identical |
| Scintillator | CsI(TI) | CsI(TI) | Identical |
| Pixel Pitch | 160 x 160 µm | 160 x 160 µm | Identical |
| Pixels | a) 2,208 x 2,688 (≈ 5.9 million) | ||
| b) 2,496 x 1,856 (≈ 4.6 million) | 2,688 x 2,688 (≈ 7.2 million) | Modified (Increased) | |
| Image Size | a) 350 x 430 mm | ||
| b) 399 x 297 mm | 430 x 430 mm | Modified (Increased) | |
| Overall Dimensions | a) 493 x 503 x 26 mm | ||
| b) 470 x 363 x 82.5 mm | 469 x 468 x 58 mm | Modified | |
| Weight | a) 5.7 kg | ||
| b) 19.0 kg | 13 kg | Modified | |
| Acquisition Mode (Binning) | a) Up to 15 fps (1x1) | ||
| b) Up to 30 fps (2x2) | Up to 15 fps (1x1) | ||
| Up to 30 fps (2x2) | |||
| Up to 30 fps (3x3) | Identical (1x1, 2x2), Modified (3x3 added) | ||
| DQE @ 1 µGy in 0 lp/mm, RQA5 | a) 0.6 | ||
| b) 0.79 | 0.75 | Modified | |
| Spatial Resolution [MTF@2cycle/mm, RQA5] | a) 0.3 | ||
| b) 0.22 | 0.28 | Modified | |
| A/D Conversion | a) 14-bit | ||
| b) 16-bit | 16-bit | Modified (from 14-bit to 16-bit for predicate a), Identical (for predicate b) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "non-clinical image comparisons involving flat panel display static and dynamic images taken with the new device and the predicate device CXDI-50RF." However, it does not specify a "sample size" in terms of number of patients or specific images, nor does it provide details on data provenance (country, retrospective/prospective). The testing focused on technical performance rather than clinical data sets.
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 provided. The non-clinical tests described focus on technical image quality and system performance rather than a diagnostic evaluation requiring expert readers to establish ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no expert human readers or adjudication process for diagnostic interpretations are 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. This submission is for new imaging hardware, not an AI/CADe device designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "non-clinical image comparisons," the "ground truth" would likely be objective measurements of image quality (e.g., DQE, MTF, noise characteristics) comparing the new device's output to the predicate device's output, rather than a clinical ground truth established by medical experts or pathology.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.