(45 days)
The Spirit III TotalSENSE Cardiac Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the cardiovascular system in Magnetic Resonance Imaging Systems. The Spirit III Total SENSE Cardiac Coil is designed for use with the Intera 3.0T MRI system manufactured by Philips Medical Systems, Inc. The indications for use are the same as for standard MR Imaging.
The Spirit III TotalSENSE Cardiac Coil is designed to provide Magnetic Resonance Images of the cardiovascular system. The Spirit III TotalSENSE Cardiac Coil is designed for use with the Philips 3.0T Intera MR scanner manufactured by Philips Medical Systems, Inc.
Anatomic Regions: cardiovascular system Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The 3.0T MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, 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.
The Spirit III TotalSENSE Cardiac Coil is a six element receive only phased array coil. The coil is composed of a flexible top piece and a rigid bottom piece. The flexible top piece allows for imaging of patients of different sizes. The open, patient friendly design minimizes claustrophobic effects and maximizes patient comfort. The coil elements and accessory electronics are enclosed in flexible and rigid plastic housings, which are fire rated. All rigid plastic housing parts have a high impact and tensile strength.
Here's an analysis of the provided text regarding the Spirit III TotalsENSE Cardiac Coil, structured to address your requested information.
1. Table of Acceptance Criteria and Reported Device Performance
The provided documentation is primarily a 510(k) submission summary for a Magnetic Resonance Imaging Accessory. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria and detailed quantitative results.
| Acceptance Criteria Category | Specific Acceptance Criteria (as implied or stated for device) | Reported Device Performance (Summary) |
|---|---|---|
| Intended Use | Imaging of the cardiovascular system. | Similar to predicate device (K024187). |
| Indications for Use | Identical to routine MRI imaging (soft tissue structure of head and whole body, etc.). | Similar to predicate device (K024187). |
| Coil Enclosure Material | Flame Retardant Polyurethane, Vinyl Coated EVA foam, Flame Retardant Polycarbonate. | Similar to predicate device (K024187). |
| Coil Design | Receive-only phased array coil. | Similar to predicate device (K024187). |
| Decoupling | Switching diode decoupling. | Similar to predicate device (K023650). |
| Prevention of RF Burns | Does not transmit RF power, decoupling isolates coil elements, enclosed in non-conductive housing. | Similar to predicate device (K024187). |
| Radio Frequency Absorption | Coil is receive-only, does not transmit RF power. | Similar to predicate device (K024187). |
| Formation of Resonant Loop | Decoupling isolates coil elements, cable length and stiffness prevent looping. | Similar to predicate device (K024187). |
Note: The acceptance criteria are largely implied by the comparison to predicate devices, where the "acceptance" is that the new device performs identically or similarly in these functional and safety aspects. This document does not provide quantitative performance metrics (e.g., signal-to-noise ratio, image resolution benchmarks) that would typically be associated with a detailed performance study. The safety aspects (RF burns, RF absorption) are critical for MR coils and are addressed by design features.
2. Sample Size Used for the Test Set and the Data Provenance
The provided text does not describe a specific clinical or technical test set with a defined sample size. The submission focuses on a comparison to predicate devices based on design features, intended use, and indications for use. There is no mention of a study involving real patient data or a specific "test set" that was evaluated. Therefore, no information on data provenance (country, retrospective/prospective) is available.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Since no specific test set or clinical study is described, there is no information provided regarding experts establishing ground truth. The assessment is primarily technical and regulatory, comparing the new device's specifications to existing, cleared devices.
4. Adjudication Method for the Test Set
As there is no described test set or clinical data evaluation, there is no adjudication method 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
The document describes an MRI accessory (a cardiac coil), not an AI-powered device. Therefore, no MRMC comparative effectiveness study was conducted or is relevant in this context. The study is not comparing human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This device is an MRI coil, a hardware component. It is not an algorithm or software that would have a standalone performance evaluated. Therefore, no standalone performance study was done in the context of an algorithm.
7. The Type of Ground Truth Used
Given that this is a 510(k) for an MRI coil, the "ground truth" for demonstrating safety and effectiveness relies on engineering specifications, design comparisons to predicate devices, and adherence to established safety principles for MRI equipment. It does not involve medical ground truth like pathology, expert consensus on disease diagnosis, or outcomes data from a clinical trial in the way an AI diagnostic device would. The ground truth here is predominantly technical conformance and substantial equivalence.
8. The Sample Size for the Training Set
The device is a hardware component (an MRI coil), not a software algorithm that requires a training set. Therefore, there is no training set sample size.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no training set for this device.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.