(74 days)
Magnetic resonance imaging (MRI) of the knee, ankle, foot, and associated structures.
Model 473PH-64 Quadrature Lower Extremity Coil. Compatible with Philips Gyroscan ACS-NT 1.5T MRI System.
The provided 510(k) summary for the K99724 "Model 473PH-64 Quadrature Lower Extremity Coil" is focused on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria for algorithm performance.
Here's an analysis based on the information provided:
Acceptance Criteria and Study Details
This submission does not describe a study involving an algorithm or artificial intelligence. Instead, it details a comparison of a new medical device (an MRI coil) against an existing MRI system without that specific coil. The "acceptance criteria" are therefore framed in terms of maintaining the safety and imaging performance parameters of the predicate MRI system.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Safety/Performance Parameter) | Reported Device Performance (with Model 473PH-64 Coil) |
|---|---|
| Safety Parameters | |
| Maximum Static Magnetic Field | No change |
| Rate of Magnetic Field Strength Change | No change |
| RF Power Deposition | No change |
| Acoustic Noise Levels | No change |
| Imaging Performance Parameters | |
| Specification Volume | No change |
| Signal-to-Noise Ratio | No change |
| Image Uniformity | No change |
| Geometric Distortion | No change |
| Slice Thickness and Gap | No change |
| High Contrast Spatial Resolution | No change |
Note: The acceptance criterion for each of these parameters is implicitly "No change" or "equivalent to the predicate device performance." The reported device performance indicates that the new coil does not affect these parameters.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a medical device (MRI coil) submission, not an AI/algorithm submission. There is no "test set" of patient data in the typical sense for an AI study. The evaluation is based on the technical specifications and expected performance of the MRI system with the new coil.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth for patient data is not established in this type of submission. The safety and performance parameters are typically assessed through engineering tests, phantom studies, and adherence to established standards for the MRI system.
4. Adjudication Method for the Test Set
Not applicable. There is no test set of patient data being adjudicated by experts.
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 submission is not for an AI device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This submission is for an MRI coil, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable in the context of diagnostic performance evaluation of an AI. For the device itself, the "ground truth" for its performance is its physical and operational characteristics measured against engineering specifications and the established safe operating parameters of the compatible MRI system.
8. The sample size for the training set
Not applicable. This is not an AI/algorithm submission.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/algorithm submission.
Summary of the document's purpose:
This 510(k) submission demonstrates that a new MRI coil (Model 473PH-64 Quadrature Lower Extremity Coil) is substantially equivalent to an existing MRI system (Philips Gyroscan ACS-NT 1.5T MRI System) without the new coil. The core argument is that the addition of this coil does not negatively impact the established safety and imaging performance parameters of the predicate MRI system. It's a hardware submission, not a software/AI submission, hence the lack of data-driven performance metrics typically associated with AI.
§ 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.