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The ImagenUniversaJTM system is a software. application that allows the user to visualize raw PET and/or PET/CT data, to correct for transmission and emission, and to correct PET 3D data for photon scatter and prompt gamma photons. The resulting corrected tomograms can be exported to cardiac interpretive software for interpretation. The use of this system is limited to qualified, licensed healthcare providers (radiologists or nuclear med icine physicians) trained in the use of nuclear medicine imaging devices.

ImagenUniversal™ is a Windows application which allows physicians and healthcare professionals to correct myocardial perfusion PET images for transmission and emission misregistration, prompt gamma events, photon scatter and image noise. The system processes perfusion and gated PET reconstructed emission and transmission data to create corrected 3D tomographic data. The user can select correction parameters, filter settings, range of reconstruction, and registration setting. The use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices.

The provided text describes the ImagenUniversal™ system, a software application designed to correct myocardial perfusion PET images. While the document is a 510(k) summary, it does not contain the detailed study information or acceptance criteria typically found in a clinical study report.

The document states:

• "Testing and comparison of technological characteristics and intended uses found that all components of the ImagenUniversal™ system are equivalent to the predicates." This implies that the device was evaluated against existing, legally marketed predicate devices (Siemens Biograph 64 and 40 (K060631), Siemens Biograph mCT (K151486), and ImagenPRO (K050366)) to demonstrate substantial equivalence, a common pathway for 510(k) clearances. However, the specifics of this "testing and comparison" are not provided.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert qualifications, and ground truth establishment are not explicitly present in the provided text.

Based on the information available, a summary can be constructed, but with significant gaps.

Summary of Acceptance Criteria and Study Information (Based on Provided Text)

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or provide detailed performance metrics for the ImagenUniversal™ system. The primary claim is substantial equivalence to predicate devices.

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The text mentions the system processes "raw PET and/or PET/CT data," implying clinical data, but no further details are given.

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

• Number of Experts: Not specified.
• Qualifications: Not specified. The device's intended users are "qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices." It is plausible that such experts would be involved in any evaluation, but this is not stated.

4. Adjudication Method for the Test Set:

• Not specified.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

• Not explicitly stated. The submission focuses on substantial equivalence to predicates, not a comparative effectiveness study demonstrating performance improvement with or without AI assistance. The device is described as a software application for correction, not necessarily an AI-assisted diagnostic tool in the sense of directly interpreting images.

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

• Not explicitly stated in terms of a formal standalone performance study. The device's function is to "correct" raw data into tomograms that "can be exported to cardiac interpretive software for interpretation." This implies an upstream processing role rather than a direct interpretive role, so a standalone diagnostic performance evaluation in the traditional sense might not be directly applicable or detailed here. However, the "testing and comparison of technological characteristics" would inherently involve evaluating the algorithm's performance in generating corrected images.

7. The Type of Ground Truth Used:

• Not specified. Given the nature of the device (correcting for transmission/emission misregistration, scatter, prompt gamma), ground truth would likely relate to the accuracy of these corrections compared to an ideal or gold standard measure, or the resultant image quality and diagnostic utility as assessed by experts. However, these specifics are not provided.

8. The Sample Size for the Training Set:

• Not specified. The document does not mention a training set, which may or may not be relevant depending on the specific algorithms employed for corrections (e.g., if machine learning models are used).

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

• Not applicable / Not specified. As no training set is mentioned, the method for establishing its ground truth is also not provided.

In conclusion, the provided FDA 510(k) summary focuses on establishing substantial equivalence to predicate devices based on "testing and comparison of technological characteristics and intended uses." It does not provide the detailed study design, acceptance criteria, sample sizes, or ground truth methodologies that would typically be found in a comprehensive clinical study report to explicitly "prove" device performance against specific, quantifiable acceptance criteria.

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