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The Imaging system of positron emission and X-ray computed tomography is a PET/CT system for producing attenuation corrected PET images. It is intended to be used by qualified health care professionals for imaging the distribution and localization of any positron-emitting radiopharmaceutical in a patient, for the assessment of metabolic (molecular) and physiologic function in patients, with a wide range of sizes and extent of disease, of all ages.

Imaging system of positron emission and X-ray computed tomography is intended to image the whole body, head, heart, brain, lung, breast, bone, the gastrointestinal and lymphatic systems, and other organs. The images produced by the system may be used by physicians to aid in radiotherapy treatment planning, therapy guidance and monitoring, and in interventional radiology procedures. The images may also be used for precise functional and anatomical mapping (localization, registration, and fusion).

When used with radiopharmaceuticals approved by the regulatory authority in the country of use, the raw and image data is an aid in; detection, localization, diagnosis, staging, restaging, monitoring, and/or follow up, of abnormalities, lesions, tumors, inflammation, infection, organ function, disorders, and/or disease, such as, but not limited to, those in oncology, cardiology, and neurology. Examples of which are:

Cardiology:

• Cardiovascular disease
• Myocardial perfusion
• Myocardial viability
• Cardiac inflammation
• Coronary artery disease

Neurology:

• Epilepsy
• Dementia, such as Alzheimer's disease, Lewy body dementia, Parkinson's disease with dementia. and frontotemporal dementia.
• Movement disorders, such as Parkinson's and Huntington's disease
• Tumors
• Inflammation
• Cerebrovascular disease such as acute stroke, chronic and acute ischemia
• Traumatic Brain Injury (TBI)

Oncology/Cancer:

• Non-Small Cell Lung Cancer
• Small Cell Lung Cancer
• Breast Cancer
• Prostate Cancer
• Hodgkin disease
• Non-Hodakin Ivmphoma
• Colorectal Cancer
• Melanoma

Imaging system of positron emission and X-ray computed tomography is also intended for standalone, diagnostic CT imaging in accordance with the stand-alone CT system's cleared indications for use.

The Imaging system of positron emission and X-ray computed tomography (model: DigitMI 930) is a PET/CT diagnostic imaging system combining a Positron Emission Tomography (PET) System and a Computed Tomography (CT) System.

The Imaging system of positron emission and X-ray computed tomography (model: DigitMI 930) consists of a scanning system, power distribution unit, table system, data processing system, and console system. The PET part consists of a 72 ring LYSO detector, while the CT part has 64 physical rows of detectors.

The provided FDA 510(k) summary for the Imaging system of positron emission and X-ray computed tomography (DigitMI 930) does not contain information about specific acceptance criteria related to a clinical study or device performance against clinical metrics. Instead, it focuses on non-clinical performance specifications and regulatory standards for showing substantial equivalence to a predicate device.

Here's an analysis of the information provided, addressing your questions to the extent possible:

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

The document provides a "Performance Comparison" table that lists various physical and imaging specifications for the proposed device and compares them to the predicate device (Discovery MI, K161574). These are not clinical acceptance criteria in the sense of accuracy, sensitivity, or specificity for a diagnostic task, but rather technical performance metrics of the PET/CT system itself. The "Remark" column for these items is consistently "Analyse 1," indicating that any differences were further evaluated.

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

The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no test set of patient data, no sample size, and no data provenance information.

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)

Since there was no clinical study, there are no experts establishing ground truth for a test set.

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

Not applicable, as no clinical test set was used.

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

Not applicable. This is a PET/CT imaging system, not an AI-powered diagnostic aid for human readers. No MRMC study was conducted.

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

This refers to an imaging system, not an algorithm, so "standalone" performance in the context of AI algorithms is not applicable here. The performance described is the standalone performance of the PET/CT hardware and software in generating images based on physical measurements and reconstruction.

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

For the technical performance specifications (e.g., Sensitivity, FWHM), the "ground truth" is established through standardized phantom measurements according to NEMA NU 2-2018 (Performance Measurements of Positron Emission Tomographs) and other international standards like IEC. This is a physical or engineering ground truth, not a clinical one.

8. The sample size for the training set

Not applicable. This document describes a medical imaging device (hardware and reconstruction software), not a machine learning or AI model that requires a training set of patient data.

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

Not applicable, as no training set was used in the context of an AI/ML model.

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