(107 days)
The Embrace Neonatal MRI System is indicated for use as a magnetic resonance imaging device for producing axial, sagittal, coronal and oblique images that displays the internal structure of neonatal head with circumference of up to 38 cm and weight between 1Kg and 4.5 Kg. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
The Embrace Neonatal MRI System is a 1Tesla Permanent MRI system producing MR images of Neonatal head. During MRI scan, body parts to be imaged are held within a uniform static magnetic field, and are subject to sequences of RF pulses and gradient magnetic fields. The signal from the precession of the magnetization created by these fields is sampled and processed to produce image data.
The provided document is a 510(k) Premarket Notification for the Embrace Neonatal MRI System. It details the device's indications for use, comparison to a predicate device, and the non-clinical testing performed. However, it explicitly states that no clinical studies were conducted to establish substantial equivalence for this device. Therefore, it does not contain the acceptance criteria or study details regarding device performance from a clinical perspective.
Here's the information that can be extracted or inferred:
1. A table of acceptance criteria and the reported device performance:
Based on the document, direct clinical acceptance criteria and reported device performance from a clinical study are not available. The document focuses on non-clinical testing and comparison to a predicate device for substantial equivalence.
| Acceptance Criteria (Non-Clinical) | Reported Device Performance (Non-Clinical) |
|---|---|
| Compliance with ES/IEC 60601-1 | Demonstrated (implied by submission and clearance) |
| Compliance with IEC 60601-1-2 | Demonstrated (implied by submission and clearance) |
| Compliance with IEC 60601-2-33 | Demonstrated (implied by submission and clearance) |
| Compliance with IEC 60601-2-20 | Demonstrated (implied by submission and clearance) |
| Compliance with IEC 60601-1-6 | Demonstrated (implied by submission and clearance) |
| Compliance with IEC 62304 | Demonstrated (implied by submission and clearance) |
| Compliance with NEMA MS-1, MS-2, MS-3, MS-5, MS-12 | Demonstrated (implied by submission and clearance) |
| Demonstrated performance via System and Software V&V | Demonstrated (implied by submission and clearance) |
| Demonstrated diagnostic quality images from phantom studies | Demonstrated (stated in "Summary of Clinical Tests" section) |
2. Sample size used for the test set and the data provenance:
- Test set for clinical performance: Not applicable, as no clinical studies were performed.
- Test set for non-clinical performance (phantom images, V&V): Not specified in the document. The provenance of this data is from Aspect Imaging Ltd., likely internally generated during device development.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical studies with expert-established ground truth were performed. The document mentions "When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis," but this refers to the intended use of the device, not a performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical studies with adjudication were performed.
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. The device is an MRI system, not an AI diagnostic tool designed to assist human readers. Moreover, no clinical studies were performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is an MRI system, not a standalone algorithm. Its performance is evaluated on its ability to produce diagnostic quality images, which are then interpreted by a human physician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable for a clinical study. For the non-clinical phantom images, the "ground truth" would be the known properties and geometry of the phantoms themselves, used to assess image quality, resolution, and artifact levels.
8. The sample size for the training set:
Not applicable. This is an MRI system, not an AI model that requires a specific training set in the conventional sense. The "training" of the system would involve engineering and calibration using test data and phantoms.
9. How the ground truth for the training set was established:
Not applicable. As described in point 8, this is an MRI system, not an AI model with a training set. If considering the calibration and engineering process, the "ground truth" would be established through physical measurements, known phantom compositions, and established MRI physics principles.
In summary, the provided FDA 510(k) letter and summary explicitly state that no clinical studies were conducted to support substantial equivalence for the Embrace Neonatal MRI System. The device was cleared based on non-clinical testing, including phantom images, to demonstrate its ability to provide diagnostic quality images, and comparison to a legally marketed predicate device (Wrist 3 MRI System). The rationale given for not performing clinical studies was the "vulnerable patient population" (neonates) and that the "benefits of sample clinical images did not outweigh the risks associated with acquisition of those images."
§ 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.