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This product is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.

RadiForce RX850 is a color LCD monitor for viewing medical images including those of mammography. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles. With the matrix size (or resolution) of 4,096 x 2,160 pixels (8MP), the RX850 is an alternate replacement for traditional dual head 5MP display installations.

Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used.

Model variations with cosmetic differences are distinguished by characters attached to the name of the base model "RX850" such as "RX850-AR", a model with an Anti-Reflective film lamination.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX850 based on the OC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS and its subset, RadiCS LE, are included in this 510(k) submission as an accessory to the RadiForce RX850.

The provided document describes the FDA 510(k) premarket notification for the EIZO RadiForce RX850 and RX850-AR 8MP Color LCD Monitor. It does not provide the kind of study detailed in the request. The main point of the document is to demonstrate "substantial equivalence" to a predicate device, not to showcase the device's performance against specific acceptance criteria through a clinical or reader study in the way requested.

Here's an analysis of why the requested information cannot be fully provided based on the given text and what information is available:

1. Table of acceptance criteria and reported device performance:

The document lists several "bench tests" performed on the RadiForce RX850. While these are performance measurements, they are not presented as "acceptance criteria" with specific pass/fail thresholds in a table format that can be directly compared to a reported device performance. The conclusion states: "The test results showed that the RadiForce RX850 has display characteristics equivalent to those of the predicate device, RadiForce GX540 except some items, each of which was determined that it would not affect observer's performance. Besides, the display characteristics of the RadiForce RX850 meet the pre-defined criteria when criteria are set." This implies that internal criteria were met but they are not explicitly detailed in the document.

Therefore, a table cannot be fully constructed as requested. However, the types of performance tests conducted are:

2. Sample size used for the test set and the data provenance:

• Sample size: Not applicable or not provided. This document describes a monitor, not an AI or diagnostic algorithm tested with a dataset of cases. The "test set" here refers to the monitor itself undergoing various display performance measurements.
• Data provenance: Not applicable. The tests are on the device's display characteristics, not on a medical image dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The "ground truth" here is the physical performance of the monitor as measured by various technical standards and instruments, not clinical diagnoses made by experts.

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

• Not applicable. As described above, this is about device performance, not clinical interpretation.

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 a medical display device, not an AI algorithm. There is no mention of an MRMC study or AI assistance.

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

• No. This is a medical display device, not an algorithm.

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

• The "ground truth" for the device's technical performance is established through defined measurement methodologies and technical standards (e.g., DICOM GSDF, AAPM TG18 guideline).

8. The sample size for the training set:

• Not applicable. This is not an AI algorithm that requires a training set.

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

• Not applicable.

Summary:

The provided text is an FDA 510(k) clearance document for a medical display monitor. It focuses on demonstrating "substantial equivalence" of the new monitor to a legally marketed predicate device through technical bench tests, ensuring that the new device's display characteristics do not negatively impact safety or effectiveness. It does not involve clinical studies with patient data, AI algorithms, or human reader performance evaluation, which are the typical contexts for the detailed questions about acceptance criteria, ground truth, and reader studies.

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This product is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.

RadiForce RX850 is a color LCD monitor for viewing medical images including those of mammography. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles. With the matrix size (or resolution) of 4.096 x 2.160 pixels (8MP), the RX850 is an alternate replacement for traditional dual head 5MP display installations. Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used. RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX850 based on the OC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS and its subset, RadiCS LE, are included in this 510(k) submission as an accessory to the RadiForce RX850.

Here's an analysis of the provided text regarding the EIZO RadiForce RX850 monitor's acceptance criteria and studies:

Product: EIZO RadiForce RX850 8MP Color LCD Monitor

Study Reference: K140702 (510(k) Summary)

Acceptance Criteria and Reported Device Performance

The document does not explicitly list acceptance criteria in a quantitative table. Instead, it states that "the display characteristics of the RadiForce RX850 meet the pre-defined criteria when criteria are set" and that the "test results showed that the RadiForce RX850 has display characteristics equivalent to those of the predicate device, RadiForce RX840-MG except 2 items, each of which was determined that it would not affect observer's performance."

Based on the performance testing section, the acceptance criteria are implicitly tied to the performance metrics outlined by the AAPM Task Group 18 (TG18 guideline) and specific measurements related to display characteristics. The "reported device performance" is essentially that it met these implicit criteria and demonstrated equivalence to the predicate.

While quantitative acceptance criteria are not presented in a table with reported performance, the document lists various performance aspects that were tested. These can be inferred as the targets for acceptance.

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

The document describes bench tests performed on the RadiForce RX850 monitor. These tests assess the physical and photometric properties of the display device itself, not image data analysis from patients. Therefore, the concept of "test set" in terms of patient data or clinical cases is not applicable here. The "sample size" would refer to the number of RadiForce RX850 units tested, which is not specified but implicitly at least one unit.

The manufacturer, EIZO Corporation, is based in Japan, so the testing would have been conducted there or by their representatives. This is not a study involving patient data, so "retrospective or prospective" provenance is not relevant.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As this is a technical bench test of a display device, clinical "ground truth" established by medical experts is not relevant. The ground truth for these tests would be the measured physical properties of the display against established technical standards (like DICOM GSDF or TG18 guidelines). There is no mention of experts establishing a ground truth for a test set of images.

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

Not applicable. There is no test set of clinical cases requiring adjudication. The performance is measured against technical specifications and guidelines.

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

Not applicable. This submission is for a medical display monitor, not an AI-powered diagnostic algorithm. No MRMC study was performed or is relevant to this device.

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

Not applicable. This is a hardware monitor, not an algorithm. Standalone algorithm performance is not relevant.

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

The "ground truth" for the performance testing is based on established technical guidelines and standards for medical displays. Specifically, the AAPM Task Group 18 (TG18 guideline) for display performance assessment and DICOM GSDF (Grayscale Standard Display Function) are mentioned as references. These are objective, quantifiable standards for display characteristics.

8. The sample size for the training set

Not applicable. This is a hardware monitor, not a machine learning model. There is no "training set."

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

Not applicable. As there is no training set for a machine learning model, the establishment of ground truth for such a set is not relevant.

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