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The 'ANCORIS' PET Scanner is designed to acquire data, process and display images by appropriated trained medical professionals via measuring the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic and physiologic functions within the human body.

The proposed device 'ANCORIS' is a PET system providing volume measurements of metabolic and physiologic processes. It is the same as the legally market device, name 'ECAT ACCEL PET scanner', K002584, from CTI PET Systems (now Siemens Medical), combined with the legally market device, name 'ECAT Scintron PET', K130269 from MiE GmbH. It is designed to close the economical gap between the demand and availability of stand-alone PET scanner. 'ANCORIS' PET Scanner is designed to perform acquisitions, image The reconstruction, processing, viewing and analysis of data. It uses the same technology and has the same performance as well as indications for use as the leqally market devices. The system includes the gantry with transmission scan capability, the currently market integrated workstation 'ECAT Scintron PET' (K130269) and the new designed PHS. The system is available as a three detector-ring system with a 16.2cm field of view same as used in currently marketed device ECAT ACCEL PET Scanner (K002584).

The provided text describes the ANCORIS PET Scanner and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria or a study that proves the device meets those criteria in the context of clinical performance or diagnostic accuracy.

The document focuses on:

• Regulatory clearance: Obtaining 510(k) clearance based on substantial equivalence.
• Device description: How ANCORIS combines elements of existing, cleared PET scanners.
• Key differences from predicates: Primarily a patient handling system (PHS) for higher patient weights and an integrated trigger unit and graphical user interface.
• Performance verification and validation: Stating that performance was successfully checked and meets specifications, and that safety tests (IEC 60601-1) were conducted.
• Transmission technology: Confirmation that the Ge68 rod source transmission technology is similar to that of a predicate device.

Therefore, I cannot provide the requested information for the following items based on the given text:

1. A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria for diagnostic accuracy/clinical performance are mentioned.
2. Sample size used for the test set and the data provenance: No clinical test set or data is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a clinical test set is mentioned.
4. Adjudication method for the test set: Not applicable as no clinical test set 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: No MRMC study or AI assistance is mentioned. The device is a PET scanner, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as the device is a PET scanner, not a standalone algorithm.
7. The type of ground truth used: Not applicable as no diagnostic ground truth for a clinical study is described.
8. The sample size for the training set: Not applicable as no training set for an AI algorithm is described.
9. How the ground truth for the training set was established: Not applicable as no training set for an AI algorithm is described.

The document instead highlights engineering verification and validation which confirm the device functions as intended and meets safety standards, rather than clinical performance criteria. The "Conclusion" states that the manufacturing, design, and development processes conform to valid standards and that the system is substantially equivalent, implying that its performance is expected to be comparable to the predicate devices it is based upon.

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