(29 days)
The 8ch Wrist Coil is intended to be used in conjunction with a SIGNA Prime Magnetic Resonance scanner to produce diagnostic images of the wrist anatomy that can be interpreted by a trained physician.
The 8ch Wrist Coil magnetic resonance (MR) coil is a receive only phased array coil with 8 channels for wrist imaging. This Wrist Coil is designed for use with the SIGNA Prime (K211980). The 8ch Wrist Coil is designed to be used vertically at the patient's side or horizontally overhead. The wrist array comes with two rigid base plates (for flat or curved tabletops) for fixation to reduce patient motion. The coil receives magnetic resonance signals generated in hydrogen nuclei (protons) in the wrist while blocking the high-frequency B1 field applied by the MRI scanner at specified timing. The 8ch Wrist Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation. Images are typically generated as axial, sagittal, coronal oblique slices and include coverage of the wrist anatomy.
The provided document is a 510(k) summary for the Philips 8ch Wrist Coil, a magnetic resonance (MR) coil. It describes the device, its intended use, and the testing conducted to demonstrate its safety and effectiveness.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics. Instead, it lists the types of performance testing conducted and generally states that the device "meets predefined performance criteria."
However, based on the non-clinical and clinical performance data summary, we can infer the areas of acceptance:
| Acceptance Criteria Category | Specific Acceptance Criteria/Test | Reported Device Performance |
|---|---|---|
| Image Quality | Signal to Noise Ratio (SNR) (based on NEMA MS-1, NEMA MS-9, IEC 62464-1) | Demonstrated satisfactory performance/meets criteria |
| Image Uniformity (based on NEMA MS-3) | Demonstrated satisfactory performance/meets criteria | |
| Safety - Thermal | Surface Heating (based on NEMA MS 14) | Demonstrated satisfactory performance/meets criteria |
| Safety - Electrical/EMC | Decoupling circuit performance | Demonstrated satisfactory performance/meets criteria |
| EMC Immunity, electrostatic discharge testing (IEC 60601-1-2) | Demonstrated satisfactory performance/meets criteria | |
| General electrical/mechanical safety (IEC 60601-2-33, AAMI/ANSI ES 60601-1) | Demonstrated satisfactory performance/meets criteria | |
| Safety - Biocompatibility | Biological safety evaluation (ISO 10993-1) | Compliance with biocompatibility standards |
| Reprocessing | Cleaning and disinfection validations (ISO 17664) | Validated reprocessing instructions |
| Clinical Efficacy | Diagnostic image quality suitable for interpretation by a trained physician | Clinical images reviewed by a radiologist were found adequate |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a numerical sample size for the clinical test set. It mentions "clinical images" were reviewed by a radiologist. It does not indicate the number of images or cases.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It simply refers to "clinical images reviewed by a radiologist provided in this submission."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: One expert was used.
- Qualifications of Expert: "US Board Certified radiologist." No specific information on years of experience is provided.
4. Adjudication Method for the Test Set
The document states that a "US Board Certified radiologist's review of clinical images" was conducted. This suggests that a single expert provided the assessment, implying no formal adjudication method (like 2+1 or 3+1 consensus) was used for establishing ground truth from multiple readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study focused on the performance of the device itself, rather than comparing human reader performance with and without AI assistance. The device is an MRI coil, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense, a "standalone" performance evaluation of the device itself was conducted through the non-clinical and clinical image review. This device is an MRI coil, which is a component of an imaging system, not an AI algorithm. The performance being evaluated is its ability to acquire diagnostic-quality images. The "standalone" aspect here refers to the intrinsic performance of the coil (e.g., SNR, uniformity, safety) and the quality of the images it produces, which are then interpreted by a human.
7. The Type of Ground Truth Used
The ground truth for the clinical performance assessment was primarily based on expert assessment/consensus (from a single US Board Certified radiologist) of the diagnostic quality of the images produced by the device. Pathology or outcomes data are not mentioned as being used for ground truth in this context.
8. The Sample Size for the Training Set
The document does not mention a training set because the device is a physical MRI coil, not an AI algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as the device is not an AI algorithm and therefore does not have a training set or associated ground truth for training purposes.
§ 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.