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The EVS 4343W / EVS 4343WG / EVS 3643W / EVS 3643WG / EVS 3643WP Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

The EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP Detector is an indirect conversion device in the form of a square plate in which converts the incoming X-rays into visible light. This visible light is then collected by an optical sensor, which generates an electric charges representation of the spatial distribution of the incoming X-ray quanta. The charges are converted to a modulated electrical signal thin film transistors. The amplified signal is converted to a voltage signal and is then converted from an analog to digital signal which can be transmitted to a viewed image print out, transmitted to remote viewing or stored as an electronic data file for later viewing.

Here's a breakdown of the acceptance criteria and the study details for the DRTECH EVS detectors, based on the provided FDA 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the new devices (EVS 4343WP, EVS 3643WP) were primarily to demonstrate equivalent diagnostic capability to the predicate device (EVS 3643). This was assessed through clinical image evaluation, comparing image performance scores. For other device models and parameters (DQE, MTF), the acceptance typically involved being "basically equal or [better] than the predicate device."

Here's a table summarizing the comparison for key performance metrics:

Note: For DQE and MTF, the acceptance criterion implicitly means that the values should be close to or exceed the predicate's performance, indicating comparable or improved image quality metrics. The document states "basically equal or [better] than the predicate device." In some cases (e.g., EVS 4343W/EVS 3643W DQE vs. EVS 3643), the subject device values are slightly lower than the predicate, but this is presented within the context of "basically equal or [better] than" and ultimately deemed acceptable for substantial equivalence. For the GOS models, the subject devices showed improvement in DQE and MTF.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document mentions "8 positions of body parts (Chest PA, Cspine AP, C-spine LAT, L-spine LAT, Shoulder AP, Shoulder LAT, Extremities)" were selected for the clinical image evaluation. It does not explicitly state the number of images per body part or the total number of images in the test set. It also doesn't specify if these were real patient cases or phantoms.
• Data Provenance: Not explicitly stated. The manufacturer is based in the Republic of Korea, so the data could originate from there, but this is not confirmed. The study is described as a "clinical image evaluation." It's not specified if it's retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Described as a "single blind clinical image evaluation." This implies that the readers were blind to which device produced the image (subject vs. predicate). However, the specific method of consensus or individual scoring (e.g., 2+1, 3+1, none) among multiple readers is not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: The document describes a "single blind clinical image evaluation" to compare image performance. This sounds like a MRMC study, as it compares the image performance of multiple devices (subject vs. predicate) using human readers.
• Effect Size of Human Reader Improvement: The document states that "it is indicated that there is no significant difference of image performance between EVS 4343WP, EVS 3643WP and EVS 3643 as difference in the score is within one standard deviation." This implies equivalence rather than an improvement with AI vs. without AI assistance, as this is a comparison of X-ray detectors themselves, not an AI software. The study's focus was on the diagnostic capability of the new hardware, not an AI's impact on human performance. Thus, no effect size of human improvement with AI is provided.

6. Standalone Performance (Algorithm Only)

• This section does not involve an algorithm with standalone performance, as the device is a digital X-ray detector (hardware). The software (Econsolel) is mentioned and being the same as the predicate's, but the evaluation focuses on the hardware's image acquisition performance.

7. Type of Ground Truth Used

• Ground Truth: For the clinical image evaluation, the "ground truth" was established by comparing the "image performance" scores between the subject device's images and the predicate device's images. This is an expert consensus or subjective evaluation of image quality and diagnostic capability, rather than an objective pathology or outcomes data.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This document describes the evaluation of an X-ray detector, which is hardware, not an AI algorithm that would typically require a training set.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there is no mention of an AI algorithm training set.

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The EVS 4343A / EVS 4343AG / EVS 3643AG Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

The EVS 4343A / EVS 4343AG / EVS 3643A / EVS 3643AG is a flat-panel type digital X-ray detector that captures projection radiographic images in digital format within seconds, eliminating the need for an entire x-rav film or an image plate as an image capture medium. EVS 4343A / EVS 4343AG / EVS 3643A / EVS 3643AG differs from traditional X-ray systems in that, instead of exposing a film and chemically processing it to create a hard copy image, a device called a Detector is used to capture the image in electronic form.

The EVS 4343A / EVS 4343AG / EVS 3643A / EVS 3643AG Detector is an indirect conversion device in the form of a square plate in which converts the incoming X-rays into visible light. This visible light is then collected by an optical sensor, which generates an electric charges representation of the spatial distribution of the incoming X-ray quanta.

The charges are converted to a modulated electrical signal through thin film transistors. The amplified signal is converted to a voltage signal and is then converted from an analog to digital signal which can be transmitted to a viewed image print out, transmitted to remote viewing or stored as an electronic data file for later viewing.

The provided FDA 510(k) summary (K192400) for the DRTECH EVS 4343A, EVS 4343AG, EVS 3643A, and EVS 3643AG digital X-ray detectors focuses on demonstrating substantial equivalence to a predicate device (K162555). Therefore, the "acceptance criteria" discussed are primarily related to showing that the new devices perform as well as or better than the predicate, particularly in key physical performance metrics.

Here's an analysis of the acceptance criteria and the study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the predicate device's performance and the expectation that the new devices should meet or exceed these values for key metrics like DQE and MTF.

The document states: "it is proved that the DQE and MTF of predicated device and subject device are basically equal or worth than the predicate device." and "As a result, subject devices performance is equal or worth than the predicate device." However, the presented data shows that the subject devices exceed the DQE and MTF values of the predicate device, indicating superior performance in these measured aspects.

2. Sample Size Used for the Test Set and Data Provenance

The provided summary does not specify a sample size for a clinical test set involving patients or images. The "non-clinical data" discussed pertains to bench testing of the detector's physical performance (DQE, MTF, Resolution). Therefore, the concepts of "test set" in the context of clinical images, "country of origin," and "retrospective/prospective" are not applicable to the non-clinical performance evaluation described.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as the evaluation was a non-clinical, bench-top performance assessment of the device's physical imaging characteristics (DQE, MTF, resolution), not a clinical study requiring expert interpretation of medical images.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this 510(k) summary. The submission focuses on demonstrating substantial equivalence based on technical specifications and non-clinical performance, not on a comparison of human reader performance with or without AI assistance.

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

This is not applicable. The device is an X-ray detector, a hardware component that captures images. It does not contain an AI algorithm for image analysis in isolation (standalone) or for human-in-the-loop performance. Its "performance" refers to how well it acquires images, not how well it interprets them.

7. The Type of Ground Truth Used

The ground truth for the non-clinical performance evaluation (DQE, MTF, Resolution) would be based on physical phantom measurements and established international standards (e.g., IEC 62220-1) for characterizing X-ray detector performance. It is not expert consensus, pathology, or outcomes data, as those relate to clinical diagnostic accuracy.

8. The Sample Size for the Training Set

This 510(k) summary does not describe a training set. The device is a digital X-ray detector, which is a hardware component. There is no mention of machine learning or AI algorithms requiring a training set for this particular submission. The "study" here is a technical performance assessment of the detector itself.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as no training set for an AI algorithm is described.

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The EVS 4343 and EVS 4343G Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radio graphic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

The EVS 4343(G) is a wired flat-panel type digital X-ray detector that captures projection radiographic images in digital format within seconds, eliminating the need for an entire x-ray film or an image plate as an image capture medium. EVS 4343(G) differs from traditional X-ray systems in that, instead of exposing a film and chemically processing it to create a hard copy image, a device called a Detector is used to capture the image in electronic form.

The EVS 4343(G) Detector is an indirect conversion device in the form of a square plate in which converts the incoming X-rays into visible light. This visible light is then collected by an optical sensor, which generates an electric charges representation of the spatial distribution of the incoming X-ray quanta.

The charges are converted to a modulated electrical signal thin film transistors. The amplified signal is converted to a voltage signal and is then converted from an analog to digital signal which can be transmitted to a viewed image print out, transmitted to remote viewing or stored as an electronic data file for later viewing.

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that the acceptance criteria are based on equivalence to predicate devices (K142475 and K150766). The study aimed to demonstrate that the new detectors provide "images of equivalent diagnostic capability." While specific numeric acceptance thresholds are not explicitly stated, the performance metrics (DQE and MTF) are compared against the predicate devices.

Note regarding DQE: While the "Remark" column states "similarity," for EVS 4343, the DQE values are higher than both predicates, suggesting better performance. For EVS 4343G, the DQE at 1 lp/mm is lower than both predicates, and at 3 lp/mm, it is the same as K150766 but lower than K142475. The document concludes "similarity," indicating that these differences were deemed acceptable for substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

The document states that a "single-blinded concurrence study" was conducted to confirm "equivalent diagnostic capability" to the predicate devices. However, the sample size for the test set is not explicitly provided.

The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

The document does not specify the number of experts used or their qualifications for the single-blinded concurrence study. It only mentions that the study was conducted according to "CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices."

4. Adjudication Method for the Test Set:

The document mentions a "single-blinded concurrence study." This implies that readers were blinded to the source of the image (test device vs. predicate) and their readings were compared for agreement or concordance. However, the specific adjudication method (e.g., 2+1, 3+1, none) is not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document refers to a "single-blinded concurrence study" to assess "equivalent diagnostic capability," which suggests a type of reader study. However, it does not explicitly state that it was an MRMC comparative effectiveness study in the formal sense, nor does it provide an effect size of how much human readers improve with AI vs. without AI assistance. The device described is an X-ray detector, not an AI-powered diagnostic tool, so the concept of "AI assistance" is not applicable in this context.

6. Standalone Performance Study:

Yes, a standalone study of the algorithm's performance (in this case, the detector's physical performance) was done. The document explicitly includes "Summary of Non-Clinical Data" which reports the DQE (Detective Quantum Efficiency) and MTF (Modulation Transfer Function) values for the EVS 4343 and EVS 4343G devices. These are intrinsic performance characteristics of the detector itself, independent of human interpretation.

7. Type of Ground Truth Used:

For the non-clinical performance data (DQE, MTF), the ground truth is established through physical measurements and international standards (IEC 62220-1 for DQE).

For the "single-blinded concurrence study" assessing "equivalent diagnostic capability," the ground truth implicitly seems to be expert consensus on diagnostic capability comparing images from the new device against images from the predicate devices. However, the specific method for establishing this "ground truth" (e.g., if a definitive diagnosis was available for the cases used) is not detailed.

8. Sample Size for the Training Set:

The document does not provide information on a training set sample size. The EVS 4343(G) is an X-ray detector, a hardware device, not an AI algorithm that typically requires a large training dataset.

9. How Ground Truth for the Training Set Was Established:

As there is no mention of a "training set" for the device itself (being a hardware detector), this question is not applicable based on the provided document. The performance metrics (DQE, MTF) are physical properties measured according to established standards rather than "trained" by data.

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The EVS 4343 Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications

The EVS 4343 is a wired/wireless flat-panel type digital X-ray detector that captures projection radiographic images in digital format within seconds, eliminating the need for an entire x-ray film or an image plate as an image capture medium. EVS 4343 differs from traditional X-ray systems in that, instead of exposing a film and chemically processing it to create a hard copy image, a device called a Detector is used to capture the image in electronic form.

EVS 4343 consists of main components such as SSU, USB Switch Box and other accessories (Tether Interface Cable, Access Point, Hand Switch, Generator Interface Cable, LAN Cable, Interface cable, AC Power Code).

The provided text describes the DRTECH EVS 4343 Digital X-ray detector, which is a wired/wireless flat-panel digital X-ray detector intended for general radiographic diagnosis of human anatomy. It aims to replace film or screen-based radiographic systems in all general-purpose diagnostic procedures, excluding mammography applications.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" as a separate section with specific numerical thresholds for diagnostic equivalence beyond general performance metrics like DQE and MTF. Instead, it focuses on demonstrating substantial equivalence to a predicate device (E-WOO TECHNOLOGY Xmaru1717, K091090) through various comparisons and a clinical study confirming diagnostic capability.

However, we can infer some performance metrics and a general acceptance criterion of "diagnostic equivalence."

Note on DQE and MTF: The document states in Section 9: "The non-clinical performance testing constrains that the main physical values for comparison of X-ray devices like DQE and MTF are basically equal or better than the predicate device ranging 64.3% (predicate 18.8%) for MTF at 1.0lp/mm and 34.7% (predicate 36.2%) for DQE at 1.0lp/mm." While 34.7% is numerically lower than 36.2%, the statement implies it's still considered "basically equal or better" in the context of the overall assessment, or within an acceptable margin.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "a single-blinded concurrence study according to CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices was conducted." This implies cases or images were presented, but the number of cases is not provided.
• Data Provenance: Not specified. It's unclear if the data was collected retrospectively or prospectively, or the country of origin.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set

• Adjudication Method: Not specified. The study is described as a "single-blinded concurrence study," which suggests multiple readers participated, but the method for resolving disagreements or establishing expert consensus (e.g., 2+1, 3+1) is not detailed.

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

• MRMC Study: The document describes a "single-blinded concurrence study" comparing the EVS 4343's images to the predicate device for diagnostic capability. This implies a comparison between devices, likely with multiple readers, fitting parts of an MRMC design in terms of reader involvement. However, it is not a comparative effectiveness study of human readers with AI vs. without AI assistance. The EVS 4343 is a digital X-ray detector, not an AI-powered diagnostic assist tool. Therefore, the concept of "effect size of how much human readers improve with AI vs without AI assistance" is not applicable here.

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

• Standalone Performance: Not applicable. The EVS 4343 is a hardware device (X-ray detector) that produces images for human interpretation, not an algorithm that performs diagnosis independently. The performance metrics (DQE, MTF, Resolution) are intrinsic to the device's image acquisition quality, not an algorithm's diagnostic output.

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

• Type of Ground Truth: Not explicitly stated. For a "concurrence study" of diagnostic capability, the ground truth would likely be based on expert interpretation/consensus of the images, possibly referencing existing clinical diagnoses or follow-up, but the document does not elaborate.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is a digital X-ray detector (hardware), not an AI algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable, as this is a hardware device and not an AI algorithm requiring a training set.

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