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SmartPerfusion assists in the diagnosis of perfusion of tissues based on digital subtraction angiography (DSA) and can be used for any location in the body where DSA is used.

SmartPerfusion is a software product (Interventional Tool) that provides color coded representation of a digital subtraction angiography (DSA). It can visualize multiple functional parameters related to the time density function. It also provides a comparison between pre-, peri-, and post- procedural color coded images. SmartPerfusion is provided as an accessory to the Philips Interventional X-ray system.

The provided text does not contain detailed acceptance criteria or a specific study that demonstrates the device meets these criteria in the format requested. The document is a 510(k) summary for the Philips SmartPerfusion device. It states that non-clinical performance testing demonstrated compliance with FDA recognized consensus standards and guidance documents, and that verification and validation tests were performed. However, it does not provide:

• A table of specific acceptance criteria and detailed reported device performance.
• Information on sample sizes used for a test set, data provenance, or the number/qualifications of experts for ground truth establishment.
• Adjudication methods.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study, nor did it mention an effect size for human readers with and without AI assistance.
• A standalone algorithm performance study.
• The type of ground truth used (e.g., pathology, outcomes data).
• The sample size for the training set or how ground truth for the training set was established.

The document indicates that the device does not require a clinical study because substantial equivalence with the predicate device (2D Perfusion, K132147) was demonstrated through:

• Indications for use
• Technological characteristics
• Non-clinical performance testing, including safety and effectiveness.

It explicitly states: "SmartPerfusion does not require a clinical study as the substantial equivalence Summary of with the predicate device 2D Perfusion (K132147) is demonstrated with the following attributes: Indication for use; ● Technological characteristics; . . Non-clinical performance testing, including safety and effectiveness. Non-clinical performance data provides sufficient evidence that the subject device works as intended The verification and validation test results of the modified device SmartPerfusion described above support the safety and effectiveness of the product. It conforms to the intended use, the user needs and the claims and is therefore considered substantially equivalent to the predicate device 2D Perfusion (K132147)."

Therefore, based on the provided text, I cannot complete the requested tables and information fields for acceptance criteria and study details.

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