(247 days)
The device is a permanently installed diagnostic x-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients.
The DRX-Evolution is a diagnostic x-ray system utilizing digital radiography (DR) technology. The DRX-Evolution is designed for horizontal and upright projection exams. The system consists of a high voltage x-ray generator, overhead tube crane with x-ray tube assembly, radiographic table with detector tray, Bucky image receptor on an upright wall stand, and x-ray controls containing a power distribution unit and operator PC (user interface).
This document describes the Carestream DRX-Evolution, a diagnostic x-ray system. The modifications to the device include firmware and mechanical changes to facilitate linear tomography exams, the addition of a new generator option, and software updates such as Bone Suppression and Pneumothorax Visualization.
Here's an analysis of the acceptance criteria and the studies that prove the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Functionality | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Overall Safety & Effectiveness | Device is as safe, as effective, and performs as well as or better than the predicate device. | "Predefined acceptance criteria were met and demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device." |
| Workflow, Performance, Function, Verification/Validation | Intended workflow, related performance, overall function, verification and validation of requirements for intended use, shipping performance, and reliability of the DRX-Evolution system (both software and hardware) are demonstrated. | "These studies demonstrated the intended workflow, related performance, overall function, verification and validation of requirements for intended use, shipping performance, and reliability of the DRX-Evolution system including both software and hardware requirements. Nonclinical test results have demonstrated that the device conforms to its specifications." |
| Linear Tomography Accuracy | Accurate movement of the x-ray tube head with respect to the image capture device. | "Test results using the tool phantom were as expected, demonstrating accuracy of the tube head movement with respect to the capture device." |
| Linear Tomography Diagnostic Quality | Linear tomography images acquired are of acceptable diagnostic quality. | "linear tomography images were generated using four different anthropomorphic phantoms (chest, hand, knee and pelvis). The images were evaluated by a board-certified radiologist for diagnostic quality. Results of this evaluation demonstrated that the linear tomography images acquired using the DRX-Evolution system are of acceptable diagnostic quality." |
| DRX 2530C Detector Image Quality | Equivalent or superior image quality to the DRX-1 Detector (predicate device). | "Results of these studies demonstrated equivalent or superior image quality to the DRX-1 Detector (predicate device)." |
| DRX-1C Detector Image Quality | Equivalent or superior image quality to the DRX-1 Detector (predicate device). | "Results of these studies demonstrated equivalent or superior image quality to the DRX-1 Detector (predicate device)." |
| DR Long Length Imaging Software Diagnostic Capability | Produced LLI images with statistically equivalent or better diagnostic capability to the predicate software. | "Results of the DR Long Length Imaging study demonstrated that the investigational software produced LLI images with statistically equivalent or better diagnostic capability to the predicate software." |
| Bone Suppression Software Effectiveness | Generates a companion image that, when presented to the physician along with the standard-of-care image, is rated substantially equivalent or improved as compared to that of the predicate product (standard-of-care image without the bone-suppressed companion image). | "Results of the Bone Suppression clinical study demonstrated that the software generates a companion image that, when presented to the physician along with the standard-of-care image, is rated substantially equivalent or improved as compared to that of the predicate product (standardof-care image without the bone-suppressed companion image)." |
2. Sample Size Used for the Test Set and Data Provenance
- Linear Tomography Accuracy (Bench Testing):
- Sample Size: Not explicitly stated, but it involved "a tool phantom" and "four different anthropomorphic phantoms (chest, hand, knee and pelvis)."
- Data Provenance: Bench testing, likely conducted internally by Carestream Health, Inc. The country of origin is not specified but the company is based in Rochester, New York, USA. This is retrospective for the purpose of regulatory submission.
- Detector Image Quality (Clinical Studies - DRX 2530C and DRX-1C):
- Sample Size: Not explicitly stated in this document ("Results of these studies demonstrated..."). These studies refer to K130464 for DRX 2530C and K120062 for DRX-1C, where detailed sample sizes would be found.
- Data Provenance: Clinical studies, in accordance with FDA guidance. Prospective studies are typical for such evaluations. The country of origin is not specified.
- DR Long Length Imaging Software Diagnostic Capability (Clinical Study):
- Sample Size: Not explicitly stated in this document ("Results of the DR Long Length Imaging study demonstrated..."). It refers to K130567 for more details.
- Data Provenance: Clinical study, likely prospective. The country of origin is not specified.
- Bone Suppression Software Effectiveness (Clinical Study):
- Sample Size: Not explicitly stated in this document ("Results of the Bone Suppression clinical study demonstrated..."). It refers to K133442 for more details.
- Data Provenance: Clinical study, likely prospective. The country of origin is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
-
Linear Tomography Diagnostic Quality (Bench Testing):
- Number of Experts: A single expert ("evaluated by a board-certified radiologist").
- Qualifications: "board-certified radiologist."
-
For other clinical studies (Detectors, LLI, Bone Suppression): The number and qualifications of experts are not detailed in this summary; they would be in the referenced 510(k) documents (K130464, K120062, K130567, K133442).
4. Adjudication Method for the Test Set
- Linear Tomography Diagnostic Quality: No formal adjudication method is described beyond a single board-certified radiologist's evaluation.
- For other clinical studies (Detectors, LLI, Bone Suppression): Adjudication methods are not detailed in this summary; they would be in the referenced 510(k) documents.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- No explicit MRMC comparative effectiveness study involving AI assistance for human readers is described in this document. The clinical studies mentioned for Bone Suppression and DR Long Length Imaging software compare the investigational software/images to a predicate or standard-of-care, but they don't explicitly state an "AI vs without AI assistance" MRMC study for improved human reader performance with an effect size.
- The Bone Suppression study mentions a "companion image that, when presented to the physician along with the standard-of-care image, is rated substantially equivalent or improved." This implies a reader study where human performance (or perception of image utility) is assessed with and without the software-generated companion image, but it does not specify an MRMC design or quantify an "effect size" in terms of improved diagnostic accuracy for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, standalone performance was evaluated for certain aspects:
- Linear Tomography Accuracy: The initial bench testing using a "tool phantom" evaluated the mechanical accuracy of the device's linear tomography function in a standalone manner (without human diagnostic interpretation), confirming "accuracy of the tube head movement."
- Image Quality Metrics: The statement that DRX-1C and DRX 2530C detectors "provide equal or superior image quality with respect to noise and spatial resolution at equivalent doses" suggests that standalone technical image quality metrics were assessed, and these would be algorithm-only or device-only measurements.
7. The Type of Ground Truth Used
- Linear Tomography Accuracy: The ground truth for mechanical accuracy was based on the "expected" results from a "tool phantom," implying known physical measurements or standards.
- Linear Tomography Diagnostic Quality: The ground truth was based on expert consensus/opinion by a "board-certified radiologist" regarding "acceptable diagnostic quality" of anthropomorphic phantom images.
- Detector Image Quality, DR Long Length Imaging Software, Bone Suppression Software: For these, the ground truth was generally based on comparison to a predicate device or standard-of-care, with evaluation typically performed by qualified experts (e.g., physicians for diagnostic capability). While not explicitly stated as "ground truth," the predicate/standard-of-care serves as the reference for equivalence or improvement claims.
8. The Sample Size for the Training Set
- The document does not explicitly state the sample size for any training sets.
- The software features (Bone Suppression, Pneumothorax Visualization) likely involved machine learning/AI models that would require training data. However, this information is not provided in the 510(k) summary. References to K133442 (Bone Suppression) might contain this information.
9. How the Ground Truth for the Training Set Was Established
- The document does not provide details on how ground truth for any training sets was established. Since training set details are absent, the method for establishing their ground truth is also not mentioned.
§ 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.