(20 days)
The CareView 1800L detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This product is not intended for mammography applications.
CareView 1800L is a kind of cassette size digital X-ray flat panel detectors which have 434mm×434mm imaging area. The device communicates by wired communication feature (Giga-bit Ethernet communication mode by connecting the power box).
The device intercepts X-ray photons and then the scintillator emits visible spectrum photons that illuminate an array of photo detectors (a-Si) that create electrical signals. After the electrical signals are generated, it is converted to a digital value and an image will be displayed on the monitor.
The detector should be integrated with an operating PC and an X-ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic.
Generally, CareView 1800L is the same as the cleared product, CareView 1500L except the dimension. The dimension of CareView 1800L is 460mm x 15mm, while the CareView 1500L is 384mm x 460mm x 15mm.
This document, K153492, is a 510(k) Premarket Notification for the CareView 1800L X-ray Flat Panel Detector. It's a submission to the FDA seeking substantial equivalence to a legally marketed predicate device, not a study demonstrating new acceptance criteria or device performance beyond what is required for substantial equivalence.
Therefore, the document does not contain the requested information regarding acceptance criteria and a study proving the device meets those criteria in the typical sense of a clinical trial or performance study. Instead, it focuses on demonstrating that the new device, CareView 1800L, is substantially equivalent to a previously cleared device, CareView 1500L (K153058), based on technical specifications and established safety/EMC standards.
Here's a breakdown of what can be inferred or is missing from the provided text based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present a table of acceptance criteria or reported device performance in the context of a new performance study. It uses the predicate device's performance as a benchmark for substantial equivalence.
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance (CareView 1800L) |
|---|---|
| Intended Use Equivalence: Digital imaging solution for general radiographic diagnosis of human anatomy, replacing film/screen systems, not for mammography. | Met: Intended use is identical to predicate. |
| Technological Equivalence: |
- X-ray Absorber: Csl Scintillator
- Readout Mechanism: Thin Film Transistor
- Grayscale: 16 bit, 65536 grayscale
- Pixel Pitch: 154µm
- Spatial Resolution: Min. 3.3 line pair/mm
- Communications: Gigabit Ethernet
- Imaging Plate: Carbon Fiber Plate
- Cooling: Air cooling
- Power Supply: DC +24 V, Max.1 A
- Power Consumption: Max. 24 W
- Operating/Storage Conditions: (Specified ranges for Temp, Humidity, Atmospheric pressure) | Met: All listed technological characteristics are identical to the predicate device, with the exception of imaging matrix size and effective imaging area, which are a direct consequence of the larger physical dimension. These differences are deemed not to affect substantial equivalence. |
| Safety and EMC Standards: Compliance with IEC/ES 60601-1 (Electrical safety) and IEC/EN 60601-1-2 (EMC). | Met: "Electrical, mechanical, environmental safety and performance testing according to IEC/ES 60601-1 was performed, and EMC testing was also conducted in accordance with IEC/EN 60601-1-2. All test results are satisfactory." |
| Image Quality (Implied by technological equivalence and intended use): Image quality equivalent to predicate device. | Implied Met: The document states, "The difference of dimension doesn't affect the technological parameters and clinical images." This suggests image quality is considered equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This document describes a substantial equivalence determination based primarily on technical specifications and compliance with standards, not a specific clinical performance test set with human subjects or images for evaluation.
- Data Provenance: Not applicable in the context of a "test set" for performance evaluation. The data presented is about the device's technical specifications and compliance with international safety and EMC standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. No "ground truth" establishment by experts for a test set is mentioned in this submission. The determination of substantial equivalence relies on comparing technical specifications and intended use against a predicate device.
4. Adjudication Method for the Test Set
- Not applicable. There is no test set or adjudication method described in this document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a MRMC comparative effectiveness study was not done or reported in this 510(k) summary. The document focuses on demonstrating substantial equivalence, not comparative effectiveness with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is an X-ray flat panel detector, a hardware component for imaging. "Algorithm only" or "standalone performance" in the context of AI or image processing algorithms typically refers to software, not directly to this type of hardware. The performance is assessed by its physical and technical characteristics in capturing X-ray images, as well as its compliance with safety standards.
7. The Type of Ground Truth Used
- Not applicable. The concept of "ground truth" (expert consensus, pathology, outcomes data) is not relevant to this 510(k) submission, which evaluates substantial equivalence of a hardware device based on technical specifications and safety standards rather than diagnostic accuracy against a disease state.
8. The Sample Size for the Training Set
- Not applicable. This device is hardware (an X-ray flat panel detector), not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this hardware device.
§ 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.