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The dS Head 32ch 3.0T MR Coil is intended to be used in conjunction with a Philips 3.0T Magnetic Resonance Scanner to produce diagnostic images of the head on adult and pediatric patients that can be interpreted by a trained physician.

The subject dS Head 32ch 3.0T Coil is a receive-only, phased-array radiofrequency (RF) coil designed for high-resolution head examinations on adult and pediatric patients. The coil is intended for use with Philips magnetic resonance (MR) scanners with a 3.0 tesla magnetic field strength.

The provided text describes the 510(k) summary for the Philips dS Head 32ch 3.0T MR Coil. This document focuses on the safety and performance criteria for the device itself (a medical imaging coil), not on the performance of an AI algorithm interpreting images produced by the device.

Therefore, the information typically requested for AI/algorithm performance (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) is not applicable or not provided in this document as it's not a submission for an AI/ML powered device.

However, I can extract the relevant information regarding the device's acceptance criteria and the study proving it meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The study proving the device meets the acceptance criteria is detailed under "Summary of Non-Clinical and Clinical Performance Data":

The subject dS Head 32ch 3.0T Coil met all safety and performance criteria outlined in the FDA guidance "Magnetic Resonance (MR) Receive-only Coil – Performance Criteria for Safety and Performance Based Pathway" issued December 11, 2020.

The specific tests performed include:

• Image Signal to Noise and Image Uniformity characterization (NEMA MS 1, 3, 9 and IEC 62464-1)
• Surface heating (ANSI/AAMI ES 60601-1 and NEMA MS 14)
• Acquired Image quality assessment by a U.S. Board Certified radiologist
• Confirmation of the presence of decoupling mechanisms
• EMC – Immunity, electrostatic discharge (IEC 60601-1-2)
• General electrical/mechanical safety (IEC 60601-2-33 and AAMI/ANSI ES 60601-1)
• Biocompatibility evaluation (ISO 10993 series)

Regarding the specific questions about an AI study (which are not directly applicable to this device submission as it's not an AI device):

2. Sample size used for the test set and the data provenance: Not applicable. This submission is for an MR coil and focuses on its physical and imaging performance, not an AI algorithm's diagnostic performance on a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for an AI algorithm test set. For the device's image quality assessment, it states "Acquired Image quality was assessed by a U.S. Board Certified radiologist." It does not specify the number beyond "a" radiologist.

4. Adjudication method for the test set: Not applicable for an AI algorithm test set.

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 not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.

7. The type of ground truth used: For the device's performance, physical measurements and adherence to engineering standards (NEMA, IEC, ANSI/AAMI, ISO) served as ground truth for technical performance aspects. For diagnostic utility, the "U.S. Board Certified radiologist" assessment of image quality serves as the ground truth (expert opinion) that the images produced are suitable for diagnostic use.

8. The sample size for the training set: Not applicable. This device does not use an AI algorithm that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

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