(84 days)
The Pediatric 16 is intended for use with the Siemens 1.5T/3T MRI systems to produce diagnostic images of the head and neck of neonates and infants that can be interpreted by a trained physician.
This filing describes local RF coils intended to be used with the MAGNETOM Aera and Skyra MR systems. The Pediatric 16 is a sixteen-channel receive-only array coil designed for magnetic resonance imaging (MRI) using the Siemens MAGNETOM Aera (1,5T) and Skyra (3T) MR systems. The Pediatric 16 is intended to be used for imaging of the head and neck of neonates and infants.
The provided document describes a medical device, the Pediatric 16, which is a magnetic resonance imaging (MRI) coil. It details the device's technical characteristics, its intended use, and non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety | AAMI/ANSI ES60601-1 conformance | Conforms to AAMI/ANSI ES60601-1 |
| Medical Electrical Equipment | IEC 60601-2-33 conformance | Conforms to IEC 60601-2-33 |
| Surface Heating | Maximum temperature ≤ 41°C (plugged and unplugged) | Never exceeded 41°C in either configuration |
| Image Quality (SNR & Uniformity) | NEMA MS 9-2008 conformance | Conforms to NEMA MS 9-2008 |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not mention a "test set" in the context of patient data. The testing described is for the device's physical and electrical performance, not its diagnostic accuracy using a dataset of patient images. Therefore, information on sample size or data provenance for a test set of patient data is not applicable/available in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable/available as the testing described is not related to establishing diagnostic ground truth from patient images.
4. Adjudication Method for the Test Set
This information is not applicable/available as the testing described is not related to establishing diagnostic ground truth from patient images.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was NOT done based on the provided document. The submission focuses on non-clinical performance testing of the coil itself, not the diagnostic performance of human readers with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study of an algorithm was NOT done. This device is an MRI coil, a hardware component, not an AI algorithm.
7. Type of Ground Truth Used
The "ground truth" for the performance criteria in this document refers to:
- Standard safety limits (e.g., maximum temperature).
- Standard performance specifications (e.g., NEMA standards for SNR and uniformity).
- Compliance with recognized industry standards (AAMI/ANSI ES60601-1, IEC 60601-2-33).
There is no mention of ground truth related to clinical diagnoses, pathology, or outcomes data in this document.
8. Sample Size for the Training Set
This information is not applicable/available. The device is an MRI coil, and its non-clinical performance testing does not involve a "training set" of data for an algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/available as there is no training set for an algorithm.
§ 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.