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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 2430W and EVS 2430GW 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 2430(G)W 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 2430(G)W 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 2430(G)W 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.

This document describes the regulatory submission for the DRTECH Corporation's EVS 2430W and EVS 2430GW Digital X-ray detectors. The submission aims to demonstrate substantial equivalence to a predicate device (EVS 3643, EVS 3643G, K162552).

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than defining explicit acceptance criteria with specific thresholds for each parameter. Instead, it compares the performance of the modified device (EVS 2430W, EVS 2430GW) to the predicate device (EVS 3643, EVS 3643G). The acceptance is implicitly based on the new devices showing "basically equal or higher" physical values for key X-ray device comparison metrics.

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

• Sample Size: Not explicitly stated as a number of cases or images. The document mentions "Clinical images were provided" and "study confirmed that the x-ray detectors EVS 2430(G)W provide images of equivalent diagnostic capability." The specific number of images or patients in the clinical image test set is not provided.
• Data Provenance: Not explicitly stated. The study was a "single-blinded concurrence study according to CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices." This typically implies a controlled setting, but the origin (e.g., country, type of clinic) of the raw images or data used is not mentioned. It is a clinical test to demonstrate clinical effectiveness. Whether it's retrospective or prospective is also not stated clearly for this "clinical image evaluation."

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

• Number of Experts: Not specified. The document states it was a "single-blinded concurrence study." This implies that expert readers (e.g., radiologists) were involved in evaluating the images, but their number is not provided.
• Qualifications of Experts: Not specified. While the context (radiographic diagnosis) implies radiologists would be the experts, their specific qualifications (e.g., years of experience, subspecialty) are not mentioned.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not explicitly stated. The term "concurrence study" implies that multiple readings were compared for agreement, but the specific adjudication method (e.g., 2+1, 3+1, majority vote, etc.) is not detailed. The "single-blinded" aspect means the readers were unaware which images came from the test device versus the predicate.

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

• Was an MRMC study done? A "single-blinded concurrence study" was conducted to confirm "equivalent diagnostic capability" to the predicate. This is a type of comparative effectiveness study. However, it's not explicitly framed as an "MRMC study" in the sense of a statistical design aimed at measuring observer performance gains. It's more of a qualitative assessment of equivalence.
• Effect size of human readers with AI vs. without AI assistance: Not applicable. This device is a digital X-ray detector, not an AI-assisted diagnostic tool. The comparison is between the new detector and a predicate detector, not about AI assistance for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

• Was standalone performance done? Not applicable. The device is a hardware component (X-ray detector). Its "performance" is measured by physical metrics (DQE, MTF, Resolution) and its ability to produce diagnostically equivalent images for human interpretation, not by an autonomous algorithm making diagnoses.

7. The Type of Ground Truth Used:

• Type of Ground Truth: The document states that the "clinical image evaluation proved the clinical effectiveness of the subject device" and that the study confirmed "equivalent diagnostic capability." This strongly suggests that the ground truth was established by expert consensus (i.e., expert readers determining the diagnostic quality and clinical equivalence of images produced by the test device compared to the predicate). It does not mention pathology, outcomes data, or other definitive ground truths.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This document is for a hardware device (X-ray detector), not a machine learning algorithm that requires a "training set." The tests described are for objective performance metrics and clinical image evaluation for equivalence.

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

• How Ground Truth for Training Set was Established: Not applicable, as this is not an AI/ML device requiring a training set.

In summary, the document details a comparison of a new X-ray detector to a predicate device, focusing on technical specifications and demonstrating "equivalent diagnostic capability" through a clinical image evaluation. While it confirms the device meets acceptance criteria (primarily by demonstrating equivalence to a previously cleared device), many specific details about the clinical study's methodology, particularly regarding reader numbers, qualifications, and exact sample sizes, are not provided in this specific excerpt.

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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 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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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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The Applied Medical EVS is a single-use sheath intended for percutaneous access to the perioheral vascular system. The EVS is designed to assist in the placement and removal of therapeutic instrumentation.

The device consists of three major components: a sheath with deployable mesh funnel, an obturator with deployable mesh umbrella and a hemostasis valve with luer port.

The provided text is a 510(k) summary for the "Applied Medical Expanding Vascular Sheath" (EVS) and does not contain information related to software or AI-driven diagnostic devices. Therefore, it does not include the details typically found in studies evaluating acceptance criteria for such devices, such as:

• Acceptance Criteria Table and Reported Device Performance: No quantitative performance metrics like sensitivity, specificity, or AUC are present.
• Sample Size and Data Provenance for Test Set: Information regarding a test set sample size, country of origin, or whether data was retrospective or prospective is absent.
• Number of Experts and Qualifications for Ground Truth: There is no mention of experts establishing ground truth for a test set.
• Adjudication Method: No adjudication method is described.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: There is no MRMC study or effect size mentioned, as this device is a physical medical instrument, not an AI diagnostic tool.
• Standalone Performance: The concept of "standalone performance" for a physical sheath device as applied to AI algorithms is not applicable here.
• Type of Ground Truth: The ground truth concept as used for AI evaluation (e.g., pathology, outcomes data) is not relevant to this type of device.
• Sample Size for Training Set: There is no training set for a physical device.
• How Ground Truth for Training Set was Established: Not applicable.

Based on the provided text, the "acceptance criteria" and "study" are focused on mechanical, safety, and biocompatibility tests to demonstrate substantial equivalence to a predicate device.

Here's an interpretation of what could be considered "acceptance criteria" and the "study" for this type of device, drawn directly from the text:

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

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 does not specify sample sizes for the mechanical, safety, and biocompatibility tests. It also does not mention data provenance (country, retrospective/prospective), as these tests are typically performed in a laboratory setting on manufactured units.

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. Ground truth as typically defined for AI/diagnostic devices does not apply to the mechanical and biological testing of a physical medical device like an introducer sheath. The "ground truth" for such tests would be established by validated test methods and standards.

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

Not applicable. This is not a diagnostic device requiring expert adjudication.

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, an MRMC study was not done. This is a physical medical device, not an AI diagnostic algorithm.

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

Not applicable. This pertains to software devices, not a physical introducer sheath.

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

The "ground truth" for the EVS's evaluation would be based on:

• Mechanical performance standards: e.g., tensile strength, burst pressure, deployment force, as per relevant ISO or ASTM standards.
• Biocompatibility standards: e.g., cytotoxicity, irritation, sensitization, as per ISO 10993 series.
• Functional performance: successful deployment, hemostasis, ease of insertion, as measured against design specifications and predicate device performance.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI algorithm.

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

Not applicable. This is a physical device, not an AI algorithm.

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