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The Picker International Eclipse/Polaris systems are indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and 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.

Device Description

The Picker iPass Bolus Tracking option improves image quality by coordinating the arrival of the contrast agent with the collection of the data for the center of k-space. The option also includes an auto-voice feature to assist the technician in communicating with the patient.

AI/ML Overview

The provided text describes the iPass Bolus Tracking MRI System. However, it does not include specific acceptance criteria or an analytical study proving the device meets those criteria in the way typically expected for a medical device performance study (e.g., sensitivity, specificity, accuracy metrics compared to a ground truth).

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Picker Eclipse/Polaris system K964626). The "study" presented is a comparison table highlighting the similarities and differences in technological characteristics and intended use.

Therefore, many of the requested fields cannot be filled as they pertain to a different type of performance study.

Here's the breakdown based on the provided text:

Acceptance Criteria and Device Performance

The "acceptance criteria" here are implicitly centered around demonstrating substantial equivalence to the predicate device. The performance is reported in terms of functional parity or improvement.

Acceptance Criterion (Implicit)	Reported Device Performance (iPass Bolus Tracking)
Functional Equivalence: Sequence Capabilities/Requirements	Same as predicate (2D RF-FAST sequence, Volume contrast enhanced angio sequence).
Functional Equivalence: Simulate Scan Feature	Same simulate-scan feature is used, now also to improve image quality of contrast enhanced angiography scans (predicate used it for single-shot EPI sequences). This implies improved functionality.
Functional Equivalence/Improvement: ROI Analysis	Software automatically calculates average pixel intensity of the ROI and reports when a 30% increase in this value occurs (predicate required manual analysis). This is an automation improvement.
Functional Equivalence/Improvement: Bolus Arrival Time	Software automatically calculates arrival time based on ROI analysis, with manual override possible (predicate required user to manually determine arrival time). This is an automation improvement.
Functional Equivalence/Improvement: Intercom Capabilities	AutoVoice feature instructs the patient and/or technician during scan (predicate relied on technician communicating via intercom). This is an automation improvement.
Equivalence: Intended Use and Indications for Use	Same as predicate: "indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and 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."

Study Details

Sample size used for the test set and the data provenance: Not applicable. The document describes a comparison against a predicate device's specifications and functionality, not a clinical study with a test set of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established by experts for a test set in the context of a performance study. The "ground truth" for the comparison is the established functionality and specifications of the predicate device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI algorithm for diagnostic assistance to human readers. It is an MRI system option to improve image quality and workflow.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device's improvements (automated ROI analysis, bolus arrival time calculation, AutoVoice) represent automated functionalities. In that sense, its "standalone" performance is described by its ability to perform these tasks (e.g., automatically calculate a 30% increase in pixel intensity, automatically calculate arrival time). There are no specific quantitative metrics (like sensitivity/specificity) for these automated functions provided in this document, other than stating they occur automatically.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this submission is implicitly the established and approved specifications, performance, and indications for use of the predicate device (Picker Eclipse/Polaris system K964626).
The sample size for the training set: Not applicable. This document does not describe a training set as would be relevant for a machine learning or AI-based device. It describes an MRI system option that coordinates contrast agent arrival and includes an auto-voice feature.
How the ground truth for the training set was established: Not applicable.

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