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The WBR Xpress.PET including the Attenuation & Scattering Corrections is indicated for the acquisition, formatting and storage of scintigraphy output data. It is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs

The WBR Xpress.PET is image processing system, which is interfaced to PET/CT. Fast acquired, data are reconstructed by the device, which utilizes parallel and non - prrallal beams and produce high resolution images. The images can be transferred to any other PACS device, which is DICOM compatible. The device includes Attenuation and Scatterng Corrections (ACSC).

The provided text is a 510(k) summary for the WBR Xpress.PET device, which is an image processing system for PET/CT. It details the device's classification, predicate devices, description, and intended use, along with a statement on safety and effectiveness. The FDA's letter granting substantial equivalence is also included. However, the document does not contain specific acceptance criteria, a detailed study description with performance metrics, sample sizes for test or training sets, information about experts, adjudication methods, or MRMC study results.

Therefore, I cannot fulfill most of the requested points as the information is not present in the provided text.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in the provided document.
• Data Provenance (e.g., country of origin, retrospective or prospective): Not specified in the provided document. The submitter's address is Haifa, Israel.

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 in the provided document.
• Qualifications of Experts: Not specified in the provided document.

4. Adjudication method for the test set

• Adjudication Method: Not specified in the provided document.

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: Not specified or implied in the provided document. The focus is on the device's technical equivalence in image reconstruction and correction, not on human reader performance improvement with AI assistance.

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

• Standalone Performance: The document states "Bench and clinical data demonstrate that reconstructed and ACSC corrected images are equivalent in comparison to images that are reconstructed and ACSC corrected by predicate CT/PET device." This implies an evaluation of the device's output, which is a standalone assessment of its image processing capabilities, but no further details on the study's design are provided.

7. The type of ground truth used

• Type of Ground Truth: Not explicitly stated. The comparison is made against "images that are reconstructed and ACSC corrected by predicate CT/PET device," suggesting the predicate device's output serves as a reference for "equivalence."

8. The sample size for the training set

• Sample Size for Training Set: Not specified in the provided document.

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

• Ground Truth for Training Set: Not specified in the provided document. The document refers generally to "Bench and clinical data," but does not elaborate on how ground truth was established for any internal development or training purposes.

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The WBR Xpress3.Cardiac and WBR Xpress.Cardiac including the Attenuation & Scattering Corrections are indicated for the acquisition, formatting and storage of scintigraphy camera output data. They are capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the imaged organs

The Xpress.cardiac & Xpress3.cardiac are image processing systems, which are interfaced to gamma cameras. Gamma camera cardiac, fast acquired, data are reconstructed by the devices, which utilize parallel and non - parallel beams and produce high resolution images. The images can be transferred to any other PACS device, which is DICOM or Interfile compatible. The devices have been modified by including Attenuation and Scattering Corrections (ACSC).

Here's an analysis of the provided text regarding the acceptance criteria and the study conducted for the K091073 submission:

Acceptance Criteria and Study Details for Xpress.cardiac & Xpress3.cardiac

Based on the provided 510(k) summary, the device is a modified version of previously cleared devices, with the addition of Attenuation and Scattering Corrections (ACSC). The core of the acceptance criteria and the study is demonstrating equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Important Note: The provided text does not specify quantitative acceptance thresholds (e.g., "sensitivity must be >90%"). Instead, the fundamental acceptance criterion is a qualitative assessment of "equivalence" to a specific predicate device (Xeleris).

Detailed Study Information:

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

• Test Set Sample Size: Not explicitly stated. The document mentions "bench and clinical data" but does not quantify the number of cases or images used in the clinical study.
• Data Provenance: Not explicitly stated. The document does not specify the country of origin or whether the data was retrospective or prospective.

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

• Not explicitly stated. The document does not provide details about experts or how ground truth was established for the clinical data.

4. Adjudication Method for the Test Set:

• Not explicitly stated. The document does not mention any adjudication method (e.g., 2+1, 3+1).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

• Not explicitly stated that an MRMC comparative effectiveness study was done. The summary mentions "clinical data" demonstrating equivalence, but it does not describe a study design where human readers evaluated both AI-assisted and non-AI-assisted cases to measure improvement. The focus appears to be on the device's output being equivalent to the predicate, rather than human performance with and without the device.
• Effect Size: Not applicable, as an MRMC study with this objective is not described.

6. If a Standalone (algorithm only without human-in-the-loop performance) study was done:

• Yes, implicitly. The statement "Bench and clinical data demonstrate that reconstructed and ACSC corrected images are equivalent in comparison to images that are reconstructed and ACSC corrected by predicate Xeleris device" implies a standalone assessment of the algorithmic output. The comparison is between the device's output and the predicate's output, suggesting the algorithm's performance without direct human intervention as the primary point of comparison.

7. The type of Ground Truth used:

• Implicitly, the predicate device output. The ground truth for this equivalence study appears to be the images reconstructed and ACSC corrected by the predicate Xeleris device. The goal was for the new device's output to match or be equivalent to this established standard. There is no mention of pathology, long-term outcomes, or detailed expert consensus as the ground truth.

8. The Sample Size for the Training Set:

• Not explicitly stated. The document focuses on validation/testing data ("bench and clinical data") but does not provide information about the training data used to develop the algorithms for Attenuation & Scattering Corrections.

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

• Not explicitly stated. As the training set size is not mentioned, neither is the method for establishing its ground truth.

Summary of Limitations in Provided Detail:

The provided 510(k) summary is a high-level overview and lacks granular detail typically found in a full study report (e.g., number of subjects, specific metrics used for equivalence, reader qualifications, detailed study protocol). Its primary assertion is that the modified device's output (images) is equivalent to a legally marketed predicate, which is a common strategy for 510(k) clearances. The "acceptance criteria" here are qualitative in nature, focusing on the concept of "equivalence" rather than quantitative performance benchmarks against a gold standard.

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The Xpress3.Cardiac is indicated for the acquisition, formatting and storage of scintigraphy camera output data. It is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three dimensional renderings, ind in various forms of animated sequences, showing kinetic attributes of the image organs.

The Xpress3.cardiac is an image processing system, which is interfaced to gamma cameras. Gamma camera cardiac, fast acquired, data are reconstructed by the Xpress3.cardiac. The Xpress3.cardiac utilizes parallel and non - parallel beams and produce high resolution images. The images can be transferred to any other PACS device, which is DICOM or Interfile compatible.

The provided text does not contain specific acceptance criteria, study details, or performance metrics for the Xpress3.cardiac device. It primarily presents a 510(k) summary and the FDA's clearance letter, which focus on regulatory aspects like substantial equivalence to a predicate device and intended use, rather than a detailed technical evaluation or clinical study results.

Therefore, I cannot populate the table or answer most of the questions based on the provided input.

Here's what I can extract and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: Not mentioned.
• Data provenance: Not mentioned (e.g., country of origin, retrospective or prospective).

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

• Not mentioned.

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

• Not mentioned.

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

• A MRMC study is not mentioned. The device is described as an image processing system, which, in 2008, might have been evaluated differently than modern AI-powered diagnostic tools. There is no mention of "human readers improve with AI vs without AI assistance."

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

• The document implies a standalone evaluation in terms of image quality ("equivalent or of better resolution"), but a formal "standalone" study in the context of clinical decision-making performance (e.g., sensitivity, specificity) is not described.

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

• Not mentioned. The statement "Bench and clinical data demonstrate that reconstructed images are equivalent or of better resolution" suggests a comparison metric, but the ground truth for this comparison is not specified.

8. The sample size for the training set

• Not mentioned.

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

• Not mentioned.

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The WBR Half Dose is indicated for the acquisition, formatting and storage of scintigraphy camera output data. It is capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the image organs.

The WBR Half dose is a modification of labeling of the legally marketed device. The device is an image processing system, which is interfaced to gamma cameras, processes the cameras' acquired data utilizing parallel and non - parallel beams and produce high resolution images. The images can be transfered to any other PACS device, which is DICOM or Interfile compatible. The modified labeling claims that, as far as the acquired information density is maintained. the same image quality is achieved either by fast acquisition or by reduced dose acquisition modes.

The provided text is a 510(k) summary for the WBR Half Dose device, which is an image processing system for gamma cameras. It primarily focuses on the regulatory aspects, device description, and substantial equivalence to a predicate device.

Crucially, the document does NOT contain a detailed study report with specific acceptance criteria, device performance metrics, sample sizes, expert qualifications, or ground truth establishment relevant to the device's image processing claims.

The safety and effectiveness section vaguely states: "Bench and clinical data demonstrate that reconstructed images are equivalent or of better resolution comparing to images that are reconstructed by filter back projection. No adverse affects have been detected." This is a general statement and not a detailed study.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated based on the text, with clear indications of missing information:

Acceptance Criteria and Device Performance

The document does not explicitly define acceptance criteria in a quantitative manner. The closest statement regarding performance is a qualitative claim of equivalence or improvement:

Detailed Study Information (Much of this information is missing from the provided text)

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

   • Sample size: Not specified in the document. The text only mentions "Bench and clinical data."
   • Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

2. 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.

3. Adjudication method for the test set:

   • Not specified.

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:

   • The document does not mention an MRMC study. The device is primarily an "image processing system" that claims "high resolution images" and "equivalent or of better resolution." It's not described as an AI-assisted diagnostic tool for human readers, but rather a system for generating images. Therefore, the concept of "human readers improve with AI vs without AI assistance" as typically understood in MRMC studies for diagnostic AI, does not directly apply to this device's description.

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

   • The claims around "equivalent or of better resolution" could imply a standalone evaluation of image quality, but the specifics of how this was measured (e.g., against a reference standard or objective metrics) and whether human interpretation was completely excluded from the evaluation are not provided. The device itself is an algorithm only in the sense that it processes data to produce images without direct human intervention in the processing step.

6. The type of ground truth used:

   • Not specified. Given the claim is about "resolution," the ground truth would likely relate to objective image quality metrics or potentially human perception of image quality. Pathology or outcomes data are typically used for diagnostic accuracy claims, which are not the primary focus here.

7. The sample size for the training set:

   • Not applicable/Not specified. The document describes a "Special 510(k) Submission" for a "modification of labeling of the legally marketed device." It's an "image processing system," and while such systems involve algorithms, the text does not indicate that it uses machine learning/AI models that require a separate "training set" in the modern sense. It implies traditional image reconstruction algorithms.

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

   • Not applicable/Not specified, as a "training set" in the context of modern machine learning is not explicitly mentioned or implied. If it refers to data used for algorithm development/tuning, the method for establishing ground truth for such data is not provided.

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The WBR Xact.cardiac & Xpress.cardiac is indicated for the acquisition, formatting and storage of scintigraphy camera output data. They are capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the image organs.

The Xact.cardiac & Xpress.cardiac are image processing systems, which are interfaced to gamma cameras. Gamma camera cardiac data is reconstructed by the Xact.cardiac. . Gamma camera cardiac, fast acquired, data is reconstructed by the Xpress.cardiac. The Xact.cardiac & Xpress.cardiac utilize parallel and non parallel beams and produce high resolution images. The images can be transferred to any other PACS device, which is DICOM or Interfile compatible.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Xact.cardiac & Xpress.cardiac device:

Based on the provided 510(k) summary and FDA clearance letter, specific acceptance criteria and detailed study data (like sample sizes for test and training sets, exact ground truth establishment, or MRMC studies) are not explicitly provided. The document is a regulatory submission summary rather than a detailed scientific publication of a study.

The submission focuses on declaring substantial equivalence to a predicate device, and the "Safety & Effectiveness" section primarily states that the device was designed, verified, and validated according to 21 CFR 820.30 regulations. It generally claims that "Bench and clinical data demonstrate that reconstructed images are equivalent or of better resolution comparing to images that are reconstructed by filter back-projection. No adverse affects have been detected."

Given the limitations of the provided text, I will address each point based on what can be inferred or is directly stated, and explicitly state when information is not available in the document.

Acceptance Criteria and Device Performance

Study Details:

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

   • Sample Size: Not explicitly stated. The document mentions "bench and clinical data" but does not quantify the sample size of the clinical data used for validation.
   • Data Provenance: Not explicitly stated. Given UltraSPECT Ltd. is based in Haifa, Israel, it's possible some data originated there, but this is not confirmed. It's also not stated if the data was retrospective or prospective.

2. 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 explicitly stated. The document does not provide details on ground truth establishment or the involvement of experts in the validation process.

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

   • Not explicitly stated. There is no information provided about any adjudication methods used for the test set.

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

   • Not explicitly stated. The document does not mention a multi-reader, multi-case study nor does it discuss human reader improvement with or without AI assistance. The device is an image processing system for reconstruction, not explicitly an AI-assisted diagnostic tool in the sense of a standalone AI system for interpretation.

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

   • Implied: The device is an "image processing system" that "reconstructs" images. The claim is about the quality of the reconstructed images being equivalent or better. This suggests the primary "study" (clinical data) would assess the output images themselves, likely in a standalone manner comparing them to images generated by the predicate or traditional methods. However, a formal "standalone performance" study with specific metrics (e.g., sensitivity, specificity for a diagnostic task) is not detailed. The focus is on image quality.

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

   • Not explicitly stated. Given the claim is about "resolution," the "ground truth" for image quality assessment would likely involve objective measures of resolution (e.g., phantom studies, edge sharpness, contrast-to-noise ratio) and/or subjective assessments by experts comparing images, rather than a diagnostic ground truth like pathology for identifying disease. The document states "reconstructed images are equivalent or of better resolution comparing to images that are reconstructed by filter back-projection," suggesting a comparison of image characteristics.

7. The sample size for the training set

   • Not explicitly stated. The document does not provide details about a training set. As an image reconstruction algorithm, it might involve algorithm development and tuning without a distinct "training set" in the machine learning sense, or if it did, the size is not disclosed.

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

   • Not explicitly stated. Since information on a training set itself is absent, the method for establishing its ground truth is also not mentioned.

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The WBR - thr, wBR - wb are indicated for the acquisition, formatting and storage of scintigraphy camera output data. They are capable of processing and displaying the acquired information in traditional formats, as well as in pseudo three dimensional renderings, and in various forms of animated sequences, showing kinetic attributes of the image organs.

The WBR -- fHR and the WBR -- fWB are image processing systems, which are interfaced to gamma cameras. Camera- fast acquired data is reconstructed by the WBR - FHR or processed by the WBR - fWB, which utilize parallel and non parallel beams and produce high resolution images. The images can be transferred to any other PAC'S device, which is DICOM or Interfile compatible.

The provided text is a 510(k) Summary and FDA clearance letter for the WBR-fHR and WBR-fWB devices. It asserts that the devices are substantially equivalent to a predicate device (K031874 WBR-WB) and mentions "Bench and clinical data demonstrate that reconstructed images are equivalent or of better resolution comparing to the images that are back projection reconstructed." However, it does not provide detailed acceptance criteria or a comprehensive study plan with the specific information requested in your prompt.

Therefore, much of the requested information cannot be extracted directly from this document.

Here's an attempt to answer based only on the provided text, with clear indications of what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not specified. The document only mentions "Bench and clinical data."
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Adjudication Method: Not specified.

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: Not explicitly mentioned as an MRMC study. The document mentions "clinical data" but does not detail a comparative effectiveness study involving human readers with and without AI assistance, nor does it quantify an effect size for human reader improvement. The device is described as an image processing system, not an AI assistance tool for human readers in this context.

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

• Standalone Performance: The study description is too brief to confirm if a standalone algorithm-only performance assessment was done. It states "reconstructed images are equivalent or of better resolution," suggesting an evaluation of image quality produced by the algorithm itself.

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

• Type of Ground Truth: Not specified. The comparison is made against "images that are back projection reconstructed," implying a comparison of image quality or resolution, but not against a definitive ground truth of patient pathology or outcomes.

8. The sample size for the training set

• Sample Size (Training Set): Not specified.

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

• Ground Truth Establishment (Training Set): Not specified. It is unclear if a "training set" in the modern AI sense was used, as this document is from 2004 and the device is described as an "image processing system" rather than a machine learning algorithm.

Summary of Limitations:

This 510(k) summary provides a high-level overview of the device and its intended use, focusing on demonstrating substantial equivalence to a predicate device. It indicates that "Bench and clinical data" were reviewed but does not elaborate on the specific methodology, sample sizes, expert involvement, or statistical outcomes that would typically be found in a detailed study report for AI/ML-driven devices following current regulatory guidance. The information provided is insufficient to answer most of your detailed questions regarding acceptance criteria and study particulars.

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