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The FLAATZ 600 Series (FLAATZ 600/601) is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).

The FLAATZ 600 Series (FLAATZ 600/601) is a radiographic image acquisition device. It is a fully integrated image capture and routing system under human operator control. This system may be usable by a technician in a typical radiology environment. The FLAATZ 600 Series (FLAATZ 600/601) system includes a Detector Panel, Case, Grid, Power Box, Switch Box, Interconnecting Cables, and API. The Detector Panel is a direct conversion device in the form of a rectangular plate in which the input x-ray photons are absorbed in an a-Se layer. The Power Box functions as a buffer between the Detector Panel and Operating PC while also supplying power to the Detector Panel. The Switch Box transfers signals between the Power Box and X-ray Generator and also indicates the status of the panel using LED lights. Finally, the API contains functions for image data capture and correction of defects on the image data.

The FLAATZ 600 Series (FLAATZ 600/601) is a digital X-ray detector with some changes compared to its predicate device, the FLAATZ 560. The primary modification is the change in data communication methods to Ethernet & Wireless. There are no changes to the product performance specifications or intended use.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria for clinical performance or a direct comparison table against such criteria. Instead, it focuses on demonstrating substantial equivalence to the predicate device, FLAATZ 560, primarily by showing equivalent image quality and technical performance.

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

• Sample Size: The clinical study tested for "eight body parts (Chest, Shoulder, L-Spine L, L-Spine_AP, Hand, Forearm, Foot and Knee)". The exact number of images or patient cases for each body part is not specified in the provided text.
• Data Provenance: The text does not specify the country of origin of the data or whether it was retrospective or prospective.

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

This information is not provided in the given text.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

A MRMC comparative effectiveness study, in the sense of evaluating human reader performance with and without AI assistance, was not performed, nor is it applicable here. This device is an X-ray detector, not an AI-powered diagnostic aid for radiologists. The clinical study aimed to demonstrate diagnostic equivalency of the new detector to a predicate detector.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, a form of standalone performance evaluation was done through non-clinical testing of technical parameters.

• Non-Clinical Testing: DQE and MTF were evaluated according to IEC 62220-1:2003 Standard. These are objective measures of image quality for the device itself.
• Clinical Testing: The clinical study to investigate diagnostic equivalency (comparing images from the new device to the predicate device) can be considered a standalone assessment of the device's image output, without human-in-the-loop diagnostic assistance being part of its intended use.

7. The Type of Ground Truth Used

For the clinical study, the "ground truth" was established by comparing the images produced by the FLAATZ 600 Series to those of the predicate device (FLAATZ 560) to assess "diagnostic equivalency." This implies a comparison of perceived diagnostic quality by potentially expert readers, but the explicit nature of this "ground truth" (e.g., expert consensus on specific findings, pathology, or outcomes) is not detailed. It is more focused on the quality of the image for diagnosis rather than the correctness of a specific diagnosis derived from the image.

For the non-clinical testing (DQE, MTF), the ground truth is established by the specifications and methodologies outlined in the IEC 62220-1:2003 Standard for X-ray detector performance.

8. The Sample Size for the Training Set

This information is not applicable as this is not an AI/Machine Learning device that requires a training set. It's a hardware device (X-ray detector).

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

This information is not applicable for the same reason as point 8.

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The FLAATZ 760 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).

The FLAATZ 760 is a radiographic image acquisition device. It is a fully integrated image capture and routing system under human operator control. This system may be usable by a technician in a typical radiology environment.

The FLAATZ 760 system includes a Detector Panel, Control Box, Switch Box, Interconnecting Cables, and API. The Detector Panel is a direct conversion device in the form of a rectangular plate in which the input x-ray photons are absorbed in an a-Se layer. The Control Box functions as a buffer between the Detector Panel and Operating PC while also supplying power to the Detector Panel. The Switch Box transfers signals between the Control Box and X-ray Generator and also indicates the status of the panel using LED lights. Finally, the API contains functions for image data capture and correction of defects on the image data.

The provided text describes the 510(k) submission for the FLAATZ 760, a radiographic image acquisition device. The study presented is a non-clinical and clinical comparison to a predicate device, FLAATZ 750, to establish substantial equivalence.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the FLAATZ 760 are primarily based on demonstrating substantial equivalence to the predicate device, FLAATZ 750, across various performance metrics. The reported device performance is directly compared to the predicate.

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

• Test Set Sample Size: The text mentions a "clinical study" where "Various parts of FLAATZ 760 images were shown to 5 experts." It doesn't specify the exact number of images in the test set.
• Data Provenance: The country of origin for the data is not explicitly stated. However, the submitting company is DRTECH Corporation in South Korea. The study appears to be prospective in the sense that the FLAATZ 760 images were specifically generated for this evaluation.

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

• Number of Experts: 5 experts.
• Qualifications of Experts: The text states "5 experts" but does not specify their qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

The text states that in the clinical study, "Various parts of FLAATZ 760 images were shown to 5 experts and clinical study: concludes FLAATZ 760 diagnostic images of equivalent quality as FLAATZ 750." This implies a form of expert consensus or qualitative assessment, but the specific adjudication method (e.g., 2+1, 3+1, majority vote, independent review with a final decision by a super-reader) is not detailed. It simply states they "conclude equivalent quality."

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

No. The provided text does not describe an MRMC comparative effectiveness study in the typical sense of measuring human reader improvement with or without AI assistance. The study described is a comparison of image quality, with experts evaluating the diagnostic images of the FLAATZ 760 against the FLAATZ 750. This is a device performance comparison, not an evaluation of human reader performance with AI assistance. The FLAATZ 760 is an image acquisition device, not an AI-powered diagnostic tool.

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

Yes, partially, in the form of non-clinical technical performance tests. The "Performance test (MTF, DQE, Line Resolution)" were conducted for the FLAATZ 760. These are objective measures of the device's image formation capabilities and do not involve human interpretation in the loop to determine the metric itself. The clinical study, while involving human experts, focuses on the diagnostic quality of images produced by the device, not an algorithm's standalone diagnostic performance.

7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the clinical study, the ground truth was established by expert consensus or qualitative assessment of "diagnostic images of equivalent quality." This is based on the subjective assessment of the 5 experts. For non-clinical tests (MTF, DQE, Resolution), the "ground truth" is derived from established measurement methodologies for those physical properties.

8. Sample Size for the Training Set

The document does not mention a training set, as the FLAATZ 760 is a radiographic image acquisition device, not an AI algorithm that requires training. The validation is against a predicate device and technical specifications.

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

As there is no training set for this type of device, this question is not applicable.

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The FLAATZ 560 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammography applications).

The FLAATZ 560 is a radiographic image acquisition device. It is a fully integrated image capture and routing system under human operator control. TThis system may be usable by a technician in a typical radiology environment. The FLAATZ 560 system includes a Detector Panel, Case, Grid, Control Box, Switch Box, Interconnecting Cables, and API. The Detector Panel is a direct conversion device in the form of a rectangular plate in which the input x-ray photons are absorbed in an a-Se layer. The Control Box functions as a buffer between the Detector Panel and Operating PC while also supplying power to the Detector Panel. The Switch Box transfers signals between the Control Box and X-ray Generator and also indicates the status of the panel using LED lights. Finally, the API contains functions for image data capture and correction of defects on the image data.

Here's a summary of the acceptance criteria and the study that proves the FLAATZ 560 device meets those criteria, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the FLAATZ 560 are based on demonstrating substantial equivalence to its predicate device, the KRYSTALRAD 560 (FLAATZ 560) SYSTEM. The performance metrics are compared directly to the predicate device.

Study Details

The provided document describes both non-clinical and clinical studies to demonstrate the substantial equivalence of the FLAATZ 560 to its predicate device.

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

   • Test Set Sample Size: Not explicitly stated for either non-clinical or clinical tests. For the clinical study, it mentions "Various parts of FLAATZ 560 images were shown to 5 experts," implying multiple images, but the exact number isn't quantified.
   • Data Provenance: Not explicitly stated, but the submitter is DRTECH Corporation from Gyeonggi-do, Korea, which suggests the studies were conducted by or for them, likely using data generated in Korea or a similar setting. The studies are prospective in the sense that they are specifically conducted to evaluate the FLAATZ 560 for regulatory submission.

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

   • Number of Experts: 5 experts were used for the clinical study.
   • Qualifications of Experts: Not specified. It only states "5 experts."

3. Adjudication method for the test set:

   • Not explicitly described. It states that "clinical study concludes FLAATZ 560 diagnostic images of equivalent quality as KRYSTALRAD 560 (FLAATZ 560)" based on images shown to 5 experts. This implies a consensus or comparative evaluation by the experts, but the specific adjudication rules (e.g., majority vote, independent review with arbitration) are 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. This is not an AI-powered device. It is a radiographic image acquisition device intended to replace film/screen systems. The clinical study was a comparative effectiveness study between two imaging devices (FLAATZ 560 vs. KRYSTALRAD 560), not a study evaluating human reader improvement with AI assistance.

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

   • No. As explained above, this is an image acquisition device, not an AI algorithm. The performance tests (DQE, MTF, Resolution, Ghosting) are intrinsic technical performance measures of the device itself and can be considered "standalone" in the sense that they measure the device's physical output quality.

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

   • For the non-clinical tests (DQE, MTF, Resolution, Ghosting), the "ground truth" is established by direct measurement of physical properties of the imaging system against established industry or regulatory standards for image quality.
   • For the clinical test, the "ground truth" for equivalence was based on expert consensus regarding the diagnostic quality of images produced by the FLAATZ 560 compared to the predicate device.

7. The sample size for the training set:

   • This is not an AI/machine learning device, so there is no concept of a "training set" in the traditional sense. The device's performance is driven by its physical design and manufacturing, not by algorithms trained on data.

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

   • Not applicable, as there is no training set for this type of device.

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The FLAATZ 750E is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. (excluding fluoroscopic, angiographic, and mammographic applications).

The FLAATZ 750E is a radlographic image ecquisition device. It is a fully integrated image capture and routing system under human operator control. This system may be usable by a technician in a typical radiology environment.

The FLAATZ 750E system includes a Detector Panel, Control Box, Switch Box, interconnecting Cables, and API. The Detector Panel is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an a-Se layer. The Control Box functions as a buffer between the Detector Panel and Operating PC while also supplying power to the Delector Panel. The Switch Box transfers signals between the Control Box and X-ray Generator and also indicates the status of the panel using LED lights. Finally, the API contains functions for Image data capture and correction of defects on the image data.

The provided text is a 510(k) summary for the FLAATZ 750E device. It details the device's description, intended use, and substantial equivalence to a predicate device, but it does not contain any information about acceptance criteria or a specific study proving the device meets those criteria, especially not in the context of AI/ML performance.

The document states: "The FLAATZ 750E has been evaluated as per FDA's "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" and has shown good performance, substantially equivalent to the predicate device." This indicates that the evaluation was likely focused on demonstrating performance comparable to an existing device for general radiography, rather than establishing specific acceptance criteria for AI/ML performance or conducting a comparative effectiveness study with human readers.

Therefore, I cannot provide the requested information. The text does not include:

1. A table of acceptance criteria and reported device performance related to AI/ML.
2. Sample sizes or data provenance for a test set for AI/ML evaluation.
3. Number or qualifications of experts for ground truth establishment for AI/ML.
4. Adjudication method for an AI/ML test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
6. Results of a standalone AI algorithm performance study.
7. The type of ground truth used for AI/ML (as no AI/ML performance study is mentioned).
8. Sample size for a training set for AI/ML.
9. How ground truth for a training set for AI/ML was established.

This document is a standard 510(k) Pre-Market Notification for a radiographic image acquisition device, which essentially describes a digital X-ray detector system. It is not about an AI/ML-driven diagnostic device.

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The FLAATZ 500 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures (excluding fluoroscopic, anglographic, and mammography applications).

The FLAATZ 500 is a radiographic Image acquisition device. It is a fully integrated image capture and routing system under human operator control. This system may be usable by a technician in a typical radiology environment.

The FLAATZ 500 system Includes a Detector Panel, Control Box, Switch Box, Interconnecting Cables, and API. The Detector Panel is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an a-Se layer. The Control Box functions as a buffer between the Detector Panel and Operating PC while also supplying power to the Detector Panel. The Switch Box transfers signals between the Control Box and X-ray Generator and also indicates the status of the panel using LED lights. Finally, the API contains for image data capture and correction of defects on the image data.

Here's a breakdown of the acceptance criteria and study information for the FLAATZ 500, based on the provided text:

Acceptance Criteria and Device Performance:

The provided 510(k) summary for the FLAATZ 500 states that the device has been evaluated as per FDA's "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devises" and has shown good performance, substantially equivalent to the predicate device.

However, specific numerical acceptance criteria (e.g., minimum MTF, DQE values, contrast resolution) and corresponding reported device performance metrics are not explicitly provided in the text. The summary relies on the general statement of "good performance" and "substantially equivalent" to the predicate without detailing the quantitative measures.

Study Information:

Since specific performance metrics are not listed, many of the requested details about the study (sample size, ground truth, experts, etc.) are not available in the provided 510(k) summary. The document focuses on declaring substantial equivalence to a predicate device based on general performance.

Here's what can be inferred or is explicitly stated:

Summary and Caveats:

The 510(k) summary for the FLAATZ 500, K091747, is typical for an image acquisition device seeking substantial equivalence to a predicate. It emphasizes meeting FDA guidance for such devices and demonstrating "good performance" that is "substantially equivalent" to an already cleared device (FLAATZ 750, K080064). It does not contain the detailed clinical study information often associated with AI/CADe devices, which require extensive reader studies and ground truth establishment against clinical outcomes or expert consensus. The evaluation is focused on the technical performance of the imaging hardware itself.

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The FLAATZ 750 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).

The FLAATZ 750 is a radiographic image acquisition device. It is a fully integrated image capture and rouling system under human operator control. This system may be useble by a technician in a typical radiology environment. The FLAATZ 750 system includes a Detector Panel, Control Box, Switch Box, Interconnecting Cables, and API. The Detector Panel is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an a-Se layer. The Control Box functions as a buffen believe a the Detector Panel and Operating PC while also supplying power to the Detector Panell The Switch Box transfers signals between the Control Box and X-ray Generator and also indicates the status of the panel using LED lights. Finally, the API contains functions for image data capture and correction of defects on the image data.

The provided text describes a 510(k) submission for a new device, the FLAATZ 750, which is a radiographic image acquisition device. However, the document is a regulatory submission summary and an FDA letter, not a detailed study report. Therefore, it does not contain the specific information requested about acceptance criteria, detailed study design, sample sizes, expert qualifications, or ground truth establishment.

Here's a breakdown of what can be extracted and what is missing:

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

• Acceptance Criteria: Not explicitly stated in a quantifiable manner in this document. The document says, "The FLAATZ 750 has been evaluated as per FDA's "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" and has shown good performance, substantially equivalent to the predicate device." This implies the acceptance criteria were met by demonstrating substantial equivalence, but the specific metrics are not detailed here.
• Reported Device Performance: The document only states that the device "has shown good performance, substantially equivalent to the predicate device" (Saturn 9000, K063710). No specific performance metrics (e.g., DQE, MTF, SNR, contrast detectability) are provided in this summary.

Missing Information (2-9):

The provided 510(k) summary and FDA letter do not contain the following information:

• Sample sizes used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned. The focus is on demonstrating "substantial equivalence" of the device (FLAATZ 750) to a predicate device, not on human reader performance with or without AI assistance. This is a hardware device, not an AI diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a digital radiography detector, not an algorithm.
• The type of ground truth used: Not applicable in the context of diagnostic accuracy studies for AI. For a hardware device, "ground truth" often refers to quantitative imaging performance metrics compared against industry standards or predicate device specifications.
• The sample size for the training set: Not applicable. This is a hardware device, not a machine learning model.
• How the ground truth for the training set was established: Not applicable. This is a hardware device, not a machine learning model.

Summary of available information:

• Device Name: FLAATZ 750
• Intended Use: Generating radiographic images of human anatomy, replacing film/screen systems in general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).
• Predicate Device: Saturn 9000 (New Medical Co., LTD., 510(k) No.: K063710)
• Study described: A functional and safety testing to demonstrate substantial equivalence to the predicate device, following FDA guidance for solid-state X-ray imaging devices, and meeting EMC requirements.
• Conclusion: The FLAATZ 750 is substantially equivalent to the Predicate Device in design and performance.
• Date Prepared: December 5, 2007 (FDA response AUG 23 2013, correcting a previous letter from Jan 23, 2008).

To obtain the detailed information requested (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, etc.), one would need to review the full 510(k) submission, specifically the sections pertaining to "Performance Data" or "Clinical Data" which are not included in this summary.

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