(38 days)
Magnetic resonance imaging (MRI) of the shoulder.
Model 415PH-64/42: Phased Array Shoulder Coil With Model 855PH: Synergy MultiConnect. Compatible with a Philips 1.5T/1.0T MRI System. Magnetic Resonance Imaging Coil.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Model 415PH-64/42: Phased Array Shoulder Coil:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices rather than establishing novel performance criteria for a new type of device. Therefore, the "acceptance criteria" are implicitly that the new device performs at least as well as, or identically to, the predicate device in terms of safety and imaging parameters. The "reported device performance" is essentially a statement of no change from the predicate.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| 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 |
| Biocompatibility | No change |
| Imaging Performance Parameters: | |
| Specification Volume | No change |
| Signal-to-Noise Ratio (SNR) | No change |
| Image Uniformity | No change |
| Geometric Distortion | No change |
| Slice Thickness and Gap | No change |
| High Contrast Spatial Resolution | No change |
| Overall Safety and Effectiveness (Instructions for use, precautions, etc.) | Instructions for use included (indications, precautions, cautions, contraindications, warnings, QA testing) assure safe and effective use. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not detail a specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective). This type of submission for a coil often relies on engineering testing and comparison to predicate device specifications rather than clinical trials with patient data. The "no change" statements imply that the technical characteristics of the coil were tested and found to be consistent with or within the acceptable range of the existing Philips MRI system and its predicate coils.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. As this is a submission for a medical device accessory (MRI coil) and not an AI-powered diagnostic algorithm, the concept of "ground truth" established by experts in a clinical context for a "test set" as typically understood for AI algorithms, is largely inapplicable here. The "ground truth" for the technical specifications of the coil would be established by engineering standards and measurements.
4. Adjudication Method for the Test Set
This information is not provided and is not typically relevant for a 510(k) submission of an MRI coil, which focuses on technical performance and safety rather than diagnostic accuracy requiring expert consensus.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an MRI coil, not an AI-powered diagnostic tool, therefore, the concept of "human readers improve with AI" is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm-only performance study was not done. This device is hardware (an MRI coil), not a software algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on engineering measurements and technical specifications compared against established standards for MRI system safety and imaging quality. This would involve measurements of static magnetic fields, RF power deposition, signal-to-noise ratios, image uniformity, geometric distortion, etc., rather than clinical ground truth derived from pathology or expert consensus on diagnostic images.
8. The Sample Size for the Training Set
This information is not applicable as this is a hardware device (MRI coil) and not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8.
§ 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.