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Intended Use: The SENSE Body Coil does not change the intended use of the Philips 1.5T Infinion system. The 1.5T Infinion system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

Indications for Use: The SENSE Body Coil is indicated for use in the following anatomic regions and with the designated nuclei: Anatomic Regions: Abdominal, pelvic and thoracic regions. Nuclei Excited: Hydrogen.

The SENSE Body Coil is enclosed in a flexible, water-resistant fabric housing and is secured to the patient with Velcro straps. This receive-only coil is designed to give improved signal-to-noise, image resolution and image acquisition time over that of the standard body coil.

The provided text describes a 510(k) premarket notification for the "SENSE Body Coil." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing direct evidence of device performance against specific acceptance criteria through a comprehensive clinical study.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not present in this document. The submission relies on demonstrating that the SENSE Body Coil is fundamentally similar to a previously cleared device (Philips Phased Array Flexible Cardiac Coil (K984588)).

Here's a breakdown of what can and cannot be extracted from the document:

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

Note: The acceptance criteria are implied by the characteristics of the predicate device, K984588. The SENSE Body Coil's performance is reported by stating it is "Same" for most parameters, except for the antenna configuration and the specific anatomic regions for its Indications for Use, where a difference is noted and presumably deemed acceptable due to the nature of a body coil vs. a cardiac coil. The core functionality and safety are still considered equivalent.

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

• Not provided. This document does not describe a clinical study with a test set of patient data. The submission is based on substantial equivalence to a predicate device, focusing on technical specifications and intended use.

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/Not provided. No test set or ground truth establishment by experts is described in this 510(k) submission.

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

• Not applicable/Not provided. No test set or adjudication method 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 passive MRI coil, not an AI or image processing algorithm. Therefore, no MRMC study or AI assistance evaluation was performed.

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

• Not applicable. This device is a passive MRI coil, not an algorithm.

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

• Not applicable/Not provided. No ground truth type is mentioned as no clinical performance study for this device is detailed. The "ground truth" for this submission revolves around the technical specifications and safety profile being equivalent to a predicate device.

8. The sample size for the training set

• Not applicable/Not provided. As this is not an AI/ML device, there is no training set in the conventional sense.

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

• Not applicable/Not provided. There is no training set for this device.

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