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MI View&GO is a medical diagnostic application for viewing, manipulation, quantification, analysis and comparison of medical images with one or more time-points. MI View&GO supports functional data, such as positron emission tomography (PET) or nuclear medicine (NM), as well as anatomical datasets, such as computed tomography (CT) or magnetic resonance (MR).

MI View&GO is intended to be utilized by appropriately trained health care professionals to aid in the management of diseases associated with oncology, cardiology, neurology, and organ function. The images and results produced by MI View&GO can also be used by the physician to aid in radiotherapy treatment planning.

MI View&GO is a software-only medical device which will be delivered in conjunction with Siemens SPECT/CT and PET/CT scanners. MI View&GO software provides additional specific capabilities for handling of PET and SPECT as well as CT and MR data directly at the acquisition console.

The MI View&GO software integrates molecular imaging more efficiently in the clinical environment by providing an interface for its users to review, post-process and read medical images immediately after acquisition. The purpose of the MI View&GO is to allow the technologist and reading physician to:

• Review acquired and reconstructed images at the scanner console
• Determine that the acquired data is of sufficient quality for reading, so the patient can be released.
• Prepare images for reading
• Perform a basic read

The provided text is a 510(k) summary for the device MI View&GO VA30. It states that "The device under application, MI View&GO, did not conduct any additional performance testing" for determining substantial equivalence to the predicate device. Therefore, a study proving the device meets acceptance criteria as described in the prompt was not conducted and thus, the requested information (table of acceptance criteria, sample sizes, expert qualifications, etc.) is not available in the provided text.

The substantial equivalence determination was based on:

1. Software Verification and Validation: This involved demonstrating continued conformance with special controls for medical devices containing software. The testing supported that all software specifications met predetermined acceptance criteria and substantiated all requirements and functional specifications, including those related to device hazards.
2. Risk Analysis: A risk analysis was completed, and risk control was implemented to mitigate identified hazards.
3. Comparison to Predicate Device: The device was deemed substantially equivalent to the predicate device (MI View&GO VA20, K201202) because there are no differences in the Indications for Use, Intended Use, or Fundamental Technological Characteristics. The new features implemented (e.g., O Brain AC-PC, PERCIST, VOI Isocontour) did not raise any new issues of safety and effectiveness.

In summary, the document indicates that the device's performance was not evaluated through a specific comparative study against acceptance criteria of the kind typically seen for novel diagnostic algorithms. Instead, its substantial equivalence was primarily established through software verification and validation, risk analysis, and a direct comparison of its technological characteristics and intended use to a previously cleared predicate device.

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MI View&GO is a medical diagnostic application for viewing, manipulation, quantification, analysis and comparison of medical images with one or more time-points. MI View&GO supports functional data, such as position emission tomography (PET) or nuclear medicine (NM), as well as anatomical datasets, such as computed tomography (CT) or magnetic resonance (MR).

MI View&GO is intended to be utilized by appropriately trained health care professionals to aid in the management of diseases associated with oncology, neurology, and organ function. The images and results produced by MI View&GO can also be used by the physician to aid in radiotherapy treatment planning.

MI View&GO is a software-only medical device which will be delivered in conjunction with Siemens SPECT/CT and PET/CT scanners. MI View&GO software provides additional specific capabilities for handling of PET and SPECT as well as CT and MR data directly at the acquisition console.

The MI View&GO software integrates molecular imaging more efficiently in the clinical environment by providing an interface for its users to review, post-process and read medical images immediately after acquisition. The purpose of the MI View&GO is to allow the technologist and reading physician to:

• Review acquired and reconstructed images at the scanner console
• Determine that the acquired data is of sufficient quality for reading, so the patient can be released.
• Prepare images for reading
• Perform a basic read

This FDA 510(k) summary for Siemens' MI View&GO VA20A software describes modifications to an existing medical image management and processing system. The summary does not include a detailed study proving the device meets specific acceptance criteria in the format requested.

The document states that "Verification and Validation activities have been successfully performed on the software package, including assurance that functions work as designed, performance requirements and specifications have been met, and that all hazard mitigations have been fully implemented. All testing has met the predetermined acceptance values." However, it does not provide a table of acceptance criteria and reported device performance, nor does it specify the methodologies, sample sizes, or ground truth establishment for such testing.

Therefore, I cannot provide the requested information from the provided text. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed performance study with quantitative acceptance criteria.

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MI View&GO is a medical diagnostic application for viewing, manipulation, quantification, analysis and comparison of medical images with one or more time-points. MI View&GO supports functional data, such as positron emission tomography (PET) or nuclear medicine (NM), as well as anatomical datasets, such as computed tomography (CT) or magnetic resonance (MR).

MI View&GO is intended to be utilized by appropriately trained health care professionals to aid in the management of diseases associated with oncology, cardiology, neurology, and organ function. The images and results produced by MI View&GO can also be used by the physician to aid in radiotherapy treatment planning.

MI View&GO is a software-only medical device which will be delivered with the new generation of Siemens SPECT/CT and PET/CT scanners.

MI View&GO is a medical diagnostic application for viewing, manipulation, quantification, analysis and comparison of medical images with one or more time-points. MI View&GO supports functional data, such as positron emission tomography (PET) or nuclear medicine (NM), as well as anatomical datasets, such as computed tomography (CT) or magnetic resonance (MR)

MI View&GO is intended to be utilized by appropriately trained health care professionals to aid in the management of diseases associated with oncology, cardiology, neurology, and organ function.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the MI View&GO VA10A device:

Important Note: The provided document is a 510(k) summary for the MI View&GO VA10A device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed de novo clinical study with specific acceptance criteria for novel performance claims. As such, many of the typical clinical study elements like "effect size," "sample size for test set," "number of experts," etc., are not explicitly described in the same way they would be for a new device with novel performance claims requiring rigorous clinical validation. The testing described is primarily for verification and validation of the software’s functions, performance requirements, and hazard mitigations against predetermined acceptance values, in line with established industry standards for medical device software.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the submission (510(k) for a software update with substantial equivalence), the acceptance criteria are not in the form of clinical performance metrics like sensitivity/specificity for a diagnostic task. Instead, they relate to software engineering and regulatory compliance.

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

• Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of image data for diagnostic performance evaluation. The "test set" here refers to the software testing environment. The document states "Verification and Validation activities have been successfully performed on the software package." This implies internal testing with various inputs.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified. Since this is primarily a software update and substantial equivalence claim, the focus is on functional verification rather than a de novo clinical study with specific patient data sets to prove diagnostic accuracy.

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

• Number of Experts: Not specified. For this type of submission, "ground truth" refers more to established software requirements and specifications rather than a diagnostic standard established by human experts on a clinical dataset.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable or described. Adjudication is typically used in clinical studies when multiple human readers evaluate data, and their disagreements need to be resolved to establish a ground truth. Here, "ground truth" pertains to software functionality meeting its design specifications.

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: No, an MRMC comparative effectiveness study was not performed or described. The MI View&GO VA10A is described as an image processing software for viewing, manipulation, quantification, analysis, and comparison, not specifically an AI-driven diagnostic aid that would improve human reader performance in terms of diagnostic accuracy. Its features are largely related to workflow, display, and basic image processing.

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

• Standalone Performance: Not applicable in the sense of a diagnostic algorithm's standalone performance (e.g., sensitivity/specificity for a disease). MI View&GO is a "medical diagnostic application" intended to be "utilized by appropriately trained health care professionals to aid in the management of diseases." It's a tool for professionals, not an autonomous diagnostic algorithm. Its performance is linked to the functionality described (viewing, manipulation, etc.), which were verified to meet specifications, not generate diagnostic outputs independently.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this submission are the predetermined acceptance values and functional specifications as defined by the software's design and requirements. It also includes compliance with recognized industry standards (ISO 14971, IEC 62304, etc.) and regulatory requirements (21 CFR 820, cybersecurity guidance). This is a software engineering "ground truth" rather than a clinical diagnostic ground truth like pathology or outcome data.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. MI View&GO VA10A is not described as an AI/Machine Learning device that undergoes a "training phase" on a dataset. It is image processing software.

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

• Ground Truth for Training Set: Not applicable. As it's not an AI/ML device requiring a training set, the establishment of ground truth for such a set is not relevant.

Summary of the Study:

The "study" or rather, the evidence presented in this 510(k) submission, is a demonstration of Verification and Validation (V&V) activities. This included ensuring that:

1. The software's functions worked as designed.
2. Performance requirements and specifications were met.
3. All hazard mitigations were fully implemented according to risk analyses (ISO 14971).
4. All testing met predetermined acceptance values.
5. The device adheres to recognized industry standards (e.g., IEC 62304, ISO 13485) and Quality System Regulations (21 CFR 820).
6. Cybersecurity controls are in place.

The overall approach is a comparison to predicate devices (syngo.via MI Workflows, syngo.CT View&GO, syngo.CT Extended Functionality) to demonstrate substantial equivalence in terms of intended use, indications for use, and technological characteristics, especially for the new or modified features. The study proves that the device meets its acceptance criteria by stating that "All testing has met the predetermined acceptance values" and that V&V activities confirmed functional and performance requirements were met as per software development and regulatory standards.

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