(31 days)
The device is indicated for use in obtaining diagnostic images to aid the physician with diagnosis. The system can be used to perform radiographic imaging of various portions of the human body, including the skull, spinal column, extremities, chest, abdomen and other body parts. The device is not indicated for use in mammography.
The DRX-Compass System is a general purpose x-ray system used for acquiring radiographic images of various portions of the human body. The system consists of a combination of components including various models of high voltage x-ray generators, control panels or workstation computers, various models of patient support tables, wallmounted image receptors/detectors for upright imaging, a ceiling mounted tube support, x-ray tube, and collimator (beam-limiting device).
The DRX-Compass can be used with digital radiography (DR) and computed radiography (CR) receptors. Systems equipped with DR or CR receptors can also be configured to include a workstation computer that is fully integrated with the x-ray generator.
The modified (subject) device, DRX-Compass, is the previously cleared Q-Rad System stationary x-ray system which has been modified as follows:
- New marketing names DRX-Compass and DR-Fit will be used depending upon regional marketing strategies.
- Implementation of a new wall stand that provides options for automated vertical motion and vertical to horizontal manual tilt (90 degrees).
- Implementation of a different Overhead Tube Crane (OTC): This OTC is ceiling suspended and provides x-y movement capability for the tube head with respect to the detector. The tube head is capable of three options for alignment with the image acquisition device (detector) as follows: 1) manual alignment by moving the x-ray tube support, 2) manual alignment using the "tube-up/tube-down" switch on the tube support, or 3) automatic alignment using the "Auto Position" switch to activate motors on the tube support in x, y, z, and alpha directions
- Focus 35C and Focus 43C Detectors are added as additional optional detector selections for customers ordering a DRX-Compass system.
- X-Ray Generator: Several Carestream designed generators are available with the system depending on power requirements and regional configurations. These generators are functionally identical to the generators currently offered for sale with the Q-Rad System.
This looks like a 510(k) summary for a medical device called DRX-Compass, an X-ray system. The document does not contain the acceptance criteria or results of a study (like an AI model performance study) that would typically involve statistical metrics, ground truth establishment, or expert reviews.
Instead, this document describes:
- Device Name: DRX-Compass
- Regulatory Information: Product Code, Regulation Number, Class, etc.
- Predicate Device: Q-Rad System (K193574)
- Device Description: Components of the DRX-Compass system, including generator models, patient support tables, wall-mounted receptors, ceiling-mounted tube support, X-ray tube, and collimator. It also mentions the new additions/modifications compared to the predicate device (new marketing names, new wall stand, different Overhead Tube Crane (OTC), added detectors, and available generators).
- Indications for Use: Obtaining diagnostic images for various body parts.
- Substantial Equivalence: The primary claim is that the DRX-Compass is substantially equivalent to the predicate Q-Rad System, stating that modifications do not raise new issues of safety and effectiveness.
- Discussion of Testing: It briefly mentions "non-clinical (bench) testing" to evaluate performance, workflow, function, verification, and validation, and that "Predefined acceptance criteria were met." However, it does not specify what those acceptance criteria were or how they were met in terms of specific performance metrics. It's focused on demonstrating equivalence to the predicate device, not on proving performance against a detailed set of criteria that would typically be described for an AI/CAD device.
Therefore, based only on the provided text, I cannot extract the detailed information requested in the prompt. The document is a regulatory submission summary, not a clinical or performance study report.
If this were a submission for an AI/CAD device, the "Discussion of Testing" section would typically elaborate on a clinical study including:
- A table of acceptance criteria and the reported device performance: This would list metrics like sensitivity, specificity, AUC, etc., and the target performance values.
- Sample size used for the test set and the data provenance: Details on number of cases, patient demographics, and origin of data.
- Number of experts used to establish the ground truth for the test set and their qualifications: Information about the radiologists/pathologists.
- Adjudication method: How disagreements among experts were resolved.
- Multi-reader multi-case (MRMC) comparative effectiveness study: If conducted, the effect size (e.g., improvement in reader performance with AI).
- Standalone performance: The algorithmic performance without human intervention.
- Type of ground truth used: e.g., pathology, clinical follow-up.
- Sample size for the training set: Number of cases used for model development.
- How the ground truth for the training set was established: Similar to the test set, but for the training data.
In summary, the provided document does not contain the information requested because it pertains to a traditional X-ray system's substantial equivalence claim, not the performance evaluation of an AI/CAD (Computer-Aided Detection/Diagnosis) algorithm.
§ 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.