(86 days)
The Insight Plus 9000 Phased Array Torso and Pelvis Coil is a receive only phased array RF coil, used for obtaining diagnostic images of the torso and pelvic regions, including the abdomen, chest, and hips, in Magnetic Resonance Imaging Systems. The Insight Plus 9000 Phased Array Torso and Pelvis Coil is designed for use with the Philips Infinion 1.5T MRI system manufactured by Philips Medical Systems, Inc. The indications for use are the same as for standard MR Imaging.
The Insight Plus 9000 Phased Array Torso and Pelvis Coil is designed to provide Magnetic Resonance Images of the torso and pelvic regions, including the abdomen, chest, and hips. The Insight Plus 9000 Phased Array Torso and Pelvis Coil is designed for use with the Philips Intera 1.5T MRI scanner manufactured by Philips Medical Systems, Inc.
The 1.5T 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 Insight Plus 9000 Phased Array Torso and Pelvis Coil is an eight element receive only phased array coil. The coil elements and associated circuitry are enclosed in a semi-flexible housing, which is fire rated and has a high impact and tensile strength.
The provided text is a 510(k) summary for the "Insight Plus 9000 Phased Array Torso and Pelvis Coil," a Magnetic Resonance Imaging Accessory. This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a performance study with detailed acceptance criteria and reported device performance metrics in the way that would typically be seen for a new algorithmic device or a device requiring a specific clinical outcome.
Therefore, the requested information, particularly regarding specific numerical acceptance criteria, reported device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not present in this document.
The document states that the device's acceptable performance is established through comparison to legally marketed predicate devices, meaning its capabilities are similar to existing devices that have already met safety and effectiveness standards.
Here's an analysis of the provided information in relation to your request:
1. Table of acceptance criteria and reported device performance
Not present in the document. The document establishes substantial equivalence by comparing the features and intended use of the new coil to predicate devices. It does not define specific performance metrics (e.g., signal-to-noise ratio, image quality scores) with corresponding acceptance criteria and then report the device's achievement of those criteria. Instead, it states the new device is "similar" for various features.
| Acceptance Criteria (Not Explicitly Stated as Numerical Criteria) | Reported Device Performance (as described in comparison to predicate) |
|---|---|
| Intended Use (Imaging of torso/pelvic regions, abdomen, chest, hips) | Similar to the Insight Plus 9000 Phased Array Torso and Pelvis Coil (K001209) and Flow 7000 Peripheral Vascular Coil (K010730) |
| Indications for Use (Identical to routine MRI imaging) | Similar to the Insight Plus 9000 Phased Array Torso and Pelvis Coil (K001209) and Flow 7000 Peripheral Vascular Coil (K010730) |
| Coil Enclosure Material (Flame Retardant Polyurethane, Vinyl Coated EVA Foam, Chlorinated Polyethylene Foam, Flame Retardant Polycarbonate) | Similar to the Mark 5000 Quadrature Shoulder coil (K013854) and Insight Plus 9000 Phased Array Torso and Pelvis Coil (K010730) |
| Coil Design (Receive-only phased array coil) | Similar to the Insight Plus 9000 Phased Array Torso and Pelvis Coil (K001209) and Flow 7000 Peripheral Vascular Coil (K010730) |
| Decoupling (Switching diode decoupling) | Similar to the Insight Plus 9000 Phased Array Torso and Pelvis Coil (K001209) and Flow 7000 Peripheral Vascular Coil (K010730) |
| Prevention of RF Burns (Does not transmit RF power, decoupling isolates coil elements, non-conductive housing) | Similar to the Insight Plus 9000 Phased Array Torso and Pelvis Coil (K001209) and Flow 7000 Peripheral Vascular Coil (K010730) |
| Radio Frequency Absorption (Receive only, does not transmit RF power) | Similar to the Insight Plus 9000 Phased Array Torso and Pelvis Coil (K001209) and Flow 7000 Peripheral Vascular Coil (K010730) |
| Formation of Resonant Loop (Decoupling isolates coil elements, cable length/stiffness prevents looping) | Similar to the Insight Plus 9000 Phased Array Torso and Pelvis Coil (K001209) and Flow 7000 Peripheral Vascular Coil (K010730) |
2. Sample size used for the test set and the data provenance
Not applicable/Not present. This document does not describe a performance study with a test set of data in the context of an AI/ML device. The device is an MRI accessory (a coil), and its safety and effectiveness are established by demonstrating that its technical characteristics are substantially equivalent to existing, legally marketed devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not present. As this is not a study requiring diagnostic accuracy assessment of images by experts, there is no mention of ground truth establishment by experts for a test set.
4. Adjudication method for the test set
Not applicable/Not present.
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/Not present. This is not an AI/ML device, and no MRMC study is described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable/Not present. This is not an algorithmic device.
7. The type of ground truth used
Not applicable/Not present.
8. The sample size for the training set
Not applicable/Not present. This is not an AI/ML device, and no training set is mentioned.
9. How the ground truth for the training set was established
Not applicable/Not present.
In summary: The provided 510(k) summary (K023650) for the "Insight Plus 9000 Phased Array Torso and Pelvis Coil" demonstrates substantial equivalence to predicate devices based on its intended use, indications for use, materials, design, and safety features. It does not detail a performance study with specific numerical acceptance criteria, reported performance metrics, or data sets (test or training) in the manner expected for software or AI/ML devices. Therefore, most of the requested information is not available in this document.
§ 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.