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The 'ECAT Scintron PET' integrated workstation is designed to acquire data, process and display images, by appropriated trained health care professionals, from ECAT EXACT and ECAT ACCEL PET scanners of CTI PET Systems via measuring the distribution of injected positron emitting radiopharmaceutical in humans for purpose of determining various metabolic and physiologic functions within the human body.

The 'ECAT SCINTRON PET' is designed to replace the integrated workstation (advanced computational system) of the legally market devices ECAT EXACT PET System and ECAT ACCEL PET scanner. The 'ECAT SCINTRON PET' integrated workstation is proposed to perform simultaneous 2D or 3D acquisitions, image reconstruction, processing and analysis of data received from ECAT Positron Emission Tomographs of CTI PET Systems. In addition it controls the motion of the patient handling system, the transmission sources and septa for 2D scans with the scanner. The 'ECAT SCINTRON PET' is used to acquire data from whole body positron emission tomography system and providing 3D volume measurements of metabolic and physiologic processes. The software is designed to run only on 'ECAT SCINTRON PET' integrated workstations. The software is only available as package and in combination with the computer hardware. Some software modules not needed for the basic usage are optional. The development processes of the software and hardware are based on the legally market device, name SCINTRON, K101013. The 'ECAT SCINTRON PET' uses industry standard and well tried hardware components and software techniques which ensures long term support.

The provided 510(k) summary for the ECAT Scintron PET device does not contain a study to demonstrate that the device meets specific acceptance criteria.

Instead, the submission relies on a substantial equivalence claim to predicate devices (ECAT EXACT PET System, K962797, and ECAT ACCEL PET Scanner, K002584). The core argument is that the ECAT Scintron PET is an updated workstation designed to replace the integrated workstation of these predicate devices, using updated electronics and software while maintaining the same fundamental functionality and compatibility with the existing PET scanners.

Here's an analysis based on the provided document, addressing your specific points:

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

No explicit acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy) are provided in this 510(k) summary. The submission focuses on the design and development processes being conformant to standards and the functional equivalence to predicate devices rather than quantifiable performance targets.

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

Not applicable. No clinical or performance test set data is presented in this summary. The "test results" mentioned refer to the internal testing of the system to ensure its functionality and conformity with standards, rather than a clinical performance study.

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)

Not applicable. No ground truth establishment by experts for a test set is described.

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

Not applicable. No test set adjudication is described.

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 device is a workstation for existing PET scanners and does not involve AI or a human-in-the-loop performance study.

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

Not applicable in the context of an algorithm's diagnostic performance. The device itself is a standalone workstation, but its "performance" is tied to its ability to acquire, process, and display images from the existing PET scanners, consistent with the predicate devices.

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

Not applicable. No ground truth for diagnostic performance is mentioned. The "ground truth" for this submission is implicitly the established functionality and performance of the predicate ECAT PET systems that the new workstation is designed to interface with and replace.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that would require a training set in the conventional sense for diagnostic performance.

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

Not applicable. As above, no training set for diagnostic performance is described.

Summary of the K130269 Submission's Approach:

The K130269 submission for the ECAT Scintron PET is primarily a substantially equivalent claim. The manufacturer (MiE GmbH) argues that their new workstation simply replaces the integrated workstation of existing, legally marketed PET systems (ECAT EXACT and ECAT ACCEL).

Their reasoning for substantial equivalence relies on:

• Identical Intended Use: To acquire, process, and display images from ECAT PET scanners for determining metabolic and physiologic functions.
• Similar Function, Operating Principle, and Fundamental Technologies: The new workstation performs the same tasks (data acquisition, image reconstruction, processing, analysis) and interfaces with the PET scanner using the same core components (coincidence board, gantry communication board).
• Technological Updates: The "major difference is the improvement of available electronics components as well as state-of-the-art software techniques for the acquisition, processing and viewing." This means newer industry-standard hardware (VMEbus PowerPC, Windows PC with multi-core processor) and software are used, but they aim to replicate the existing functionality.
• No Mechanical Modifications to the Scanner: The PET scanner itself remains unchanged.
• Conformity to Standards: The design and development processes comply with applicable medical device safety and performance standards.

In essence, the submission asserts that because the new workstation performs the same tasks as the original workstations in a commensurate manner with the existing PET scanners, and is built using validated processes and components, it is substantially equivalent and does not raise new questions of safety or effectiveness. They do not conduct a new clinical performance study because the device's function is to maintain the established performance of the overall PET system.

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