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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 3643 and EVS 3643G 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 3643(G) 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 3643(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 3643(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.

The provided text describes the acceptance criteria and a study conducted for the EVS 3643 and EVS 3643G Digital X-ray detectors.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions a "single-blinded concurrence study" and "Clinical images were provided". However, it does not specify the sample size for the test set (number of images or cases).

The data provenance is also not explicitly stated regarding country of origin or whether it was retrospective or prospective. It only notes that the study was conducted "according to CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices."

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

The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical study. It refers to a "concurrence study," implying multiple readers, but provides no details.

4. Adjudication method for the test set

The document mentions a "single-blinded concurrence study," but does not describe the specific adjudication method used (e.g., 2+1, 3+1, none). The term "concurrence" suggests agreement among observers, but the process 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

The study described is a "single-blinded concurrence study" comparing the new x-ray detectors (EVS 3643G) to predicate devices to establish equivalent diagnostic capability. It is not an MRMC comparative effectiveness study evaluating the improvement of human readers with AI assistance. The device itself is a digital X-ray detector, not an AI-powered diagnostic tool. Therefore, there is no mention of effect size related to human reader improvement with AI.

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

The device is a digital X-ray detector, which captures images. It is not an algorithm that performs a diagnostic task independently. Therefore, a standalone algorithm-only performance study is not applicable to this device. The non-clinical data focuses on inherent device performance characteristics like DQE, MTF, and Resolution.

7. The type of ground truth used

The document states that the "concurrence study" confirmed that the new x-ray detectors "provide images of equivalent diagnostic capability." This implies that the ground truth for the clinical images was established through expert consensus on diagnostic capability, rather than pathology or specific disease outcomes.

8. The sample size for the training set

The document does not mention a training set or its sample size. This device is a hardware component (digital X-ray detector) and not a machine learning algorithm that requires a training set for model development.

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

As there is no mention of a training set, the method for establishing its ground truth is also not applicable.

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The EVS 3643 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 3643 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 3643 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 3643 consists of main components such as SSU. USB Switch Box, Battery Pack, Battery charger and other accessories (Tether Interface Cable, Hand Switch, Generator Interface Cable, LAN Cable, Interface cable, AC Power Code).

EVS 3643 should be integrated with an operating PC and an X-Ray generator.

Here's a breakdown of the acceptance criteria and study information for the EVS 3643 device, based on the provided document:

Acceptance Criteria and Reported Device Performance

Note: The document states that the EVS 3643 is functionally identical and shares similar performance to the predicate device (EVS 4343) with minor differences in these specified metrics, which are presented as the acceptance criteria against which the new device was compared. The conclusion is that the EVS 3643 "meets the acceptance criteria and is adequate for this intended use."

Study Information

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

   • The document mentions "Clinical images were provided," but does not explicitly state the specific sample size of images used in the clinical study.
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The study was conducted as a "single-blinded concurrence study," which implies it was likely a prospective collection for this specific study, but the source of the images themselves is not detailed.

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

   • The document states a "single-blinded concurrence study" was conducted. It does not specify the number of experts or their qualifications (e.g., years of experience, specific board certifications) used to establish ground truth or evaluate diagnostic capability.

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

   • The document describes a "single-blinded concurrence study." This typically implies that reader evaluations are compared to a predetermined ground truth, or to evaluations by other readers, but it doesn't specify an adjudication method like "2+1" or "3+1." The phrase "concurrence study" suggests agreement among observers or with a known reference, but the precise adjudication process is not detailed.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not explicitly described.
   • The study was a "single-blinded concurrence study" to confirm "equivalent diagnostic capability to the predicate devices," not to measure human performance improvement with AI assistance. The device itself is an X-ray detector, not an AI interpretation tool.

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

   • Yes, performance metrics such as DQE, MTF, and Resolution were evaluated for the device itself (EVS 3643) and compared to the predicate device (EVS 4343) in a "comparison test." This represents standalone performance. The clinical study also implicitly assesses the standalone image quality produced by the detector.

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

   • For the clinical "concurrence study," the ground truth was based on the premise of "equivalent diagnostic capability to the predicate devices." This implies that the images produced by EVS 3643 were deemed to provide equivalent information that would lead to the same diagnosis as those from the predicate device or a recognized standard, likely established by expert review ("concurrence"). The specific method of establishing this diagnostic ground truth (e.g., expert consensus on specific findings, long-term outcomes) is not further detailed.

7. The sample size for the training set:

   • The document does not describe the use of a training set for an AI/algorithm system. The device is a digital X-ray detector, and the description focuses on its hardware and imaging characteristics, not on machine learning model development. Therefore, a training set for an AI model is not applicable here.

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

   • As there's no mention of a training set for an AI/algorithm, there's no information on how its ground truth was established.

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