Search Results

The Care View 1800Le 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.

The CareView 1800Le detector is a class of digital X-ray flat panel detector that has an imaging area of 430mm×430mm. The detector communicates by a wired connection (Giga-bit Ethernet communication mode via connecting the power box). The detector functions by intercepting X-ray photons. Then the scintillator emits visible spectrum photons that illuminate an array of photo detectors (a-Si) that create electrical signals. The electrical signals are then digitally converted to display an image on the monitor. The detector should be connected to a computer and X-ray generator to digitize X-ray images and transfer radiography diagnostics. The x-ray generator, an essential part of a full x-ray system, is not part of the subject medical device. The software that supports the functions of the digital detector CareView 1800Le is unchanged from the predicate. Generally, CareView 1800Le is the same as the cleared product, CareView 1800L except the pixel size. The pixel size of CareView 1800Le is 140 μm, while the CareView 1800L is 154 μm.

The provided text describes a 510(k) summary for the CareView 1800Le X-ray Flat Panel Detectors. This document explicitly states that the device is "substantially equivalent" to a predicate device (CareView 1800L). Substantial equivalence means that the new device is as safe and effective as a legally marketed predicate device, and does not require a full safety and effectiveness evaluation as would be needed for a PMA.

Therefore, the study performed to "prove the device meets the acceptance criteria" is a non-clinical study to demonstrate substantial equivalence to a predicate device. There are no acceptance criteria in the sense of specific clinical performance metrics (e.g., sensitivity, specificity for disease detection) because this is a 510(k) for an X-ray detector, not a diagnostic AI algorithm.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and reported device performance

The acceptance criteria are implicitly that the proposed device (CareView 1800Le) performs comparably to the predicate device (CareView 1800L) across key technical specifications, and that any differences do not raise new questions of safety or effectiveness. The reported device performance is a direct comparison of technical specifications.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes non-clinical testing rather than a study with a test set of patient cases. The testing focused on technical specifications (e.g., spatial resolution, MTF, DQE). The sample size for these technical measurements is not specified in the summary, but it would typically involve multiple measurements of the device itself under controlled conditions according to relevant standards. There is no information on data provenance relating to patient data as it's not a clinical study in that sense.

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)

Not applicable. This is not an AI diagnostic device that requires expert-established ground truth on medical images. The measurements of performance metrics like MTF and DQE are objective physical measurements of the detector's imaging capabilities, established through standard metrology.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is not a clinical study involving human readers or interpretation of results that would require an adjudication method.

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

No. This is not an AI device that assists human readers. It is an X-ray flat panel detector.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, in a sense. The "standalone" performance here refers to the physical and technical performance of the X-ray detector itself. The summary outlines the technical specifications (e.g., pixel pitch, spatial resolution, MTF, DQE) that characterize the device's standalone imaging capabilities. This is the primary subject of the "Nonclinical and clinical considerations" section, which compares these specifications to the predicate device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable in the context of clinical ground truth for disease. The "ground truth" here is the actual physical performance of the device as measured against established engineering and physics standards for X-ray detectors (e.g., line pair patterns for spatial resolution, standardized test objects for MTF/DQE).

8. The sample size for the training set

Not applicable. This device does not employ a machine learning algorithm that requires a training set of data.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this device.

Ask a specific question about this device

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.

• 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.

Ask a specific question about this device