(233 days)
Indications for use are for pre-term, term newborns and small infants requiring a diagnostic MRI exam and need to be moved from their warm and controlled intensive care units to the MRI scanner. Indications for use are to maintain a warm and controlled environment during inter-departmental transport and during the MRI procedure.
The SREE MRI Transport Incubator provides a warm and controlled environment during inter-departmental transport and during the diagnostic exam on a scanner with either 1.5T or 3T magnet field strengths. The SREE MRI Transport Incubator accommodates pre- and term newborns and infants up to 1 month of age and 4.5Kg whole body weight or 55cm whole body length (21.7").
The SREE MRI Transport Incubator system consists of a MRI incubator. MRI trolley and backup power supply.
The SREE MRI Transport Incubator is designed to accommodate infants up to 1 month of age. The patient is positioned head first onto the curved incubator patient table over a soft patient mattress is held in place with pads and straps. The SREE MRI Transport Incubator when transferred from the trolley to the MRI patient table allows diagnostic exams without removing the infant from its controlled incubator environment.
The MRI incubator is transported on a dedicated, MR-Conditional non-magnetic trolley with a custom top designed to accommodate the unique incubator base reproducibly. In addition to the incubator, the trolley is designed to accommodate non-magnetic (air, oxygen) tanks, storage bins, a transfer table and incubator electronics. In an extended position, the transfer table allows incubator movement between the trolley and MRI patient table gantry.
A backup power supply box used during transport is equipped with a dedicated uninterrupted power supply (UPS) and battery. This backup power supply box on wheels can be attached to or detached from the SREE MRI Transport Incubator system by sliding it between the trolley guide rails.
The provided documentation describes the SREE MRI Transport Incubator, a medical device. Here's an analysis based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria provided in the document are primarily in the form of compliance with recognized standards and comparative equivalence to predicate devices, rather than specific quantitative performance targets with tolerance limits for all parameters. However, I can extract the explicit performance metrics mentioned.
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1 (Safety - Medical Equipment) | Comply |
| Compliance with IEC 60601-1-2 (Essential Performance - EMC) | Comply |
| Compliance with IEC 60601-2-20 (Essential Performance - Transport Incubator) | Comply |
| Compliance with IEC 60601-1 Sec 14 (Software) | Comply |
| Compliance with ISO 10993 (Biocompatibility) | Comply |
| Compliance with AAMI TIR-12 (Disinfection Validation) | Comply |
| Compliance with AAMI TIR-12 (Cleaning Validation) | Comply |
| B0 Displacement per ASTM F2052-15 (MRI Testing) | Comply |
| B0 Induced Torque per ASTM F2213-06 (MRI Testing) | Comply |
| RF Induced Heating per ASTM F2182-11a (MRI Testing) | Comply |
| MRI Phantom QA (SREE QA Protocol) | Comply (within a few percent deviation) |
| MRI Incubator Temperature Stability Tests (SREE Installation Testing Protocol) | Comply |
| Incubator Warm-up time | 45 minutes |
| Incubator holding temperature stability | Set ±1.0°C |
| Compatibility with 1.5T MRI field strength | Achieved |
| Compatibility with 3.0T MRI field strength | Achieved |
| MRI image quality with incubator presence (phantom & human testing) | Preserved (no appreciable deviation) |
| Incubator performance during MRI exam | Unaffected |
| Influence on other MRI scanner functions | Not influenced |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a numerical sample size for the test set used in performance testing. It mentions "phantom and human testing" for MRI compatibility but does not provide details on the number of phantoms or human subjects.
The data provenance is from bench testing and, for MRI compatibility, involves "phantom and human testing." The country of origin for the data is not explicitly stated, but the company is US-based (Cleveland, Ohio). The testing described is prospective in nature, as it was performed to demonstrate device compliance and performance for the premarket submission.
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. The testing described appears to be primarily technical and engineering-focused, relying on standardized test methods (ASTM, IEC, ISO) and internal SREE QA protocols, rather than expert-established ground truth in a clinical context.
4. Adjudication Method for the Test Set
This information is not provided or applicable as the testing described doesn't involve subjective assessments requiring expert adjudication. The compliance is determined against objective standards and technical protocols.
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 done. The device is a transport incubator, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of human readers improving with AI vs. without AI assistance does not apply.
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 in the context of an AI algorithm. The device is a physical medical device (an incubator) with integrated software for control, not an AI diagnostic algorithm. Software validation was performed according to FDA guidance, which focuses on the reliability and safety of the software controlling the device, not its diagnostic accuracy in a standalone AI capacity.
7. The Type of Ground Truth Used
The ground truth for the performance testing is based on:
- Standardized Test Methods: Adherence to established international and national standards (IEC, ISO, ASTM). These standards define objective criteria and measurement methods.
- Engineering Specifications: Internal SREE QA protocols for incubator temperature stability and MRI QA, indicating comparison to predefined engineering targets.
- Comparative Equivalence: The foundation of the 510(k) submission is demonstrating substantial equivalence to legally marketed predicate devices (LMT Nomag IC 1.5, 3.0). This implies that the device's performance is "ground-truthed" by its ability to perform comparably to devices already deemed safe and effective.
8. The Sample Size for the Training Set
This information is not applicable. The SREE MRI Transport Incubator is a hardware device with controlling software, not an AI-driven system that requires a "training set" in the machine learning sense. The software validation refers to functional testing and adherence to software development lifecycle processes, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" in the context of this device.
§ 880.5410 Neonatal transport incubator.
(a)
Identification. A neonatal transport incubator is a device consisting of a portable rigid boxlike enclosure with insulated walls in which an infant may be kept in a controlled environment while being transported for medical care. The device may include straps to secure the infant, a battery-operated heater, an AC-powered battery charger, a fan to circulate the warmed air, a container for water to add humidity, and provision for a portable oxygen bottle.(b)
Classification. Class II (performance standards).