(7 days)
This system is intended for use as a general radiography device for the head, chest, abdomen, spine, neck and limbs. This system is used for image acquisition, image display, and the transmission/output of images to external devices. Excluded indications include mammography, fluoroscopy and angiography.
This device is indicated as a general radiography device. It is capable of providing digital images of the head, neck, spine, chest abdomen and limbs by converting x-rays to digital images. Excluded indications include mammography, fluoroscopy and angiography studies.
The RADREX-I is a general purpose x-ray system that employs Solid State Imager(s), SSXI, which converts x-rays directly into electrical signals which can, after appropriate processing be displayed on LCD monitors or printed to a medical grade image printer. The system console is a PC based device that allows for work list management, image storage, image processing, image exporting and image printing. The system may be equipped with a table and/or vertical wall unit and is configurable with up to two x-ray tubes.
This 510(k) premarket notification is for the DRAD-3000E, RADREX-i, a general-purpose X-ray system. The document focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria for a new AI/algorithm. Therefore, much of the requested information regarding AI device performance, sample sizes, and ground truth establishment is not available.
Here's the breakdown of the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The document does not explicitly state specific quantitative acceptance criteria for device performance in the way an AI algorithm study would. Instead, the primary "acceptance criterion" for this 510(k) submission is substantial equivalence to the predicate device (Philips Medical Systems Bucky Vision - Digital Diagnost, K982795). This means the device must demonstrate comparable technological characteristics and intended use.
- Reported Device Performance: The document does not report specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy, or image quality scores from a study) for the DRAD-3000E, RADREX-i. The focus is on its functional description and safety compliance.
| Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance (Summary from submission) |
|---|---|
| Substantial Equivalence to Predicate | "This device employs similar materials and processes as found in the predicate device." |
| Intended Use | "general radiography device for the head, chest, abdomen, spine, neck and limbs. Used for image acquisition, image display, and the transmission/output of images to external devices." |
| Safety & Regulatory Compliance | "Designed and manufactured under Quality System Regulations (21 CFR § 820)." "In conformance with applicable parts of IEC 60601-1, IEC 60601-2-32, and IEC 60601-2-28." |
| Excluded Indications | "mammography, fluoroscopy and angiography." |
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable. This document describes a traditional X-ray system, not an AI algorithm requiring a test set for performance evaluation. Therefore, there is no mention of a test set sample size or data provenance in the context of an AI study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable. As this is not an AI algorithm, there is no ground truth establishment by experts for a test set described in this submission.
4. Adjudication Method for the Test Set:
- Not Applicable. No test set or adjudication method is described for this type of device submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This document does not describe an MRMC comparative effectiveness study. This type of study is typically conducted for diagnostic devices (especially AI-powered ones) to compare reader performance with and without the device's assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- No. This device is a hardware X-ray system, not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant and not described.
7. The Type of Ground Truth Used:
- Not Applicable. For this hardware device, the concept of "ground truth" in the context of diagnostic accuracy is not directly addressed within this 510(k) summary. The submission focuses on safety, functionality, and equivalence to a predicate.
8. The Sample Size for the Training Set:
- Not Applicable. As this is not an AI algorithm, there is no training set described.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. No training set ground truth establishment is described.
In summary, this 510(k) submission is for a conventional X-ray imaging system. The provided text does not contain information related to AI algorithm performance studies, acceptance criteria for such, sample sizes for training/test sets, ground truth establishment, or human reader studies. The primary goal of this submission is to demonstrate substantial equivalence to an existing predicate device based on device description, intended use, and conformance to safety standards.
§ 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.