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The PSK-20CT phased array transducer will add adult transcranial indications for use to the SSA-380A diagnostic ultrasound system.

Phased Array Transducer - - PSK-20CT

The provided text is related to a 510(k) summary for a medical device (a phased array transducer for diagnostic ultrasound) and describes its substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria, device performance metrics, or any studies involving AI, human readers, or ground truth establishment.

Therefore, I cannot populate most of the requested fields. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study as would be described for an AI/ML medical device.

Here's what I can extract or deduce based on the lack of information:

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

   • Acceptance Criteria: Not provided. The submission focuses on substantial equivalence to a previously cleared device.
   • Reported Device Performance: Not provided in terms of specific metrics like sensitivity, specificity, accuracy, etc. The document generally states that "cleared patient contact materials and acoustic output intensities are unchanged."

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 "test set" in the context of an AI/ML performance study is mentioned. The submission is for a hardware modification and relies on substantial equivalence.

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 for a test set is mentioned.

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

   • Not applicable. No test set or adjudication method is mentioned.

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. This is not an AI/ML device, and no MRMC study is mentioned.

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

   • No. This is not an algorithm-only device.

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

   • Not applicable. No ground truth is mentioned in the context of device performance.

8. The sample size for the training set

   • Not applicable. This is not an AI/ML device requiring a training set.

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

   • Not applicable.

In summary, the provided 510(k) summary (K970047) is for the regulatory clearance of a transducer for a diagnostic ultrasound system based on substantial equivalence, not on the performance evaluation of an AI/ML device. Therefore, the detailed information about acceptance criteria, sample sizes, ground truth establishment, and expert involvement, as typically required for AI/ML device evaluations, is not present in this document.

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