(244 days)
The Rapid Aid Infant Transport Mattress Warmer with Disc provides warmth during transport of an infant within the hospital or between hospitals. It is recommended for full-term infants.
The Rapid Aid Infant Transport Mattress Warmer with Disc (Infant Transport Mattress) is a rectangular pad that is intended to provide warmth during transport of an infant within a hospital or between hospitals. The single-use disposable device consists of an outer pouch with a liquid solution activated by bending an activator disc; an exothermic reaction warms the Infant Transport Mattress to no higher than 104°F (range 101°F to 104°F) for a dwell time of ≥10 minutes.
This document describes the premarket notification (510(k)) for the Rapid Aid Infant Transport Mattress Warmer with Disc. It's important to note that this device is a medical warming device, not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical acceptance criteria and study designs associated with AI/SaMD (like those involving human readers, ground truth establishment by experts, MRMC studies, or training sets) are not applicable to this physical device.
Based on the provided document, here's an analysis of the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are primarily focused on the physical and performance characteristics of the warming mattress, demonstrating its substantial equivalence to a predicate device.
| Acceptance Criteria (Characteristic being tested) | Reported Device Performance (Rapid Aid Infant Transport Mattress Warmer with Disc) |
|---|---|
| Temperature Target Range | Achieved temperature range of 101°F to 104°F |
| Dwell Time at Temperature | ≥10 minutes |
| Seal Strength (Pressure Test) | Remained intact when subjected to 500 PSI for 30 seconds (Passed) |
| Seal Width | Measured; Passed |
| Seal Integrity (Visual) | Measured; Passed |
| Weight | Measured; Passed |
| Outer Packaging Thickness | Measured; Passed |
| Shipping Testing | Passed |
| Biocompatibility | Performed Cytotoxicity, Irritation, and Sensitization tests per ISO 10993-1; Passed all applicable requirements |
| Shelf Life (Accelerated Temperature at 40°C) | Passed pressure test and temperature test after 30 weeks (corresponds to 24 months of real-time shelf life) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of units tested) for each performance test. It states "all tests were a pass," implying multiple units were tested to demonstrate consistency and meet specifications.
The data provenance is from performance testing conducted by Rapid Aid Corp. The studies are inherently prospective as they are tests performed on manufactured devices to demonstrate compliance with specifications. The location of the testing is not explicitly stated but would likely be internal to the manufacturer or a contracted lab. Given the manufacturer is based in Canada (Mississauga, ON, Canada), the tests would have been performed there or an affiliated laboratory.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of medical device. "Ground truth" in the context of AI/SaMD for diagnostic tasks involves expert consensus on medical images or patient records. For a physical warming device, the "ground truth" is measured physical properties like temperature, pressure resistance, and material compatibility, established through validated testing methodologies by engineers and laboratory technicians, not medical experts for diagnostic purposes.
4. Adjudication method for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers provide subjective assessments (e.g., categorizing medical images). For physical performance tests, the results are objective measurements against defined specifications. There is no subjective human interpretation requiring adjudication.
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
This question is not applicable as this is not an AI/SaMD device. MRMC studies are used to evaluate the impact of AI assistance on human reader performance in diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as this is not an AI/SaMD device. Standalone performance refers to the accuracy of an automated AI algorithm without human intervention in diagnostic or analytical tasks.
7. The type of ground truth used
The "ground truth" for this device's performance is established by objective engineering and laboratory measurements against predefined physical and chemical specifications. This includes:
- Direct temperature readings.
- Timers for dwell time.
- Pressure gauges for seal strength.
- Weight scales for weight.
- Microscopes/visual inspection for seal integrity and material assessment.
- Standardized biocompatibility tests (e.g., ISO 10993-1).
- Accelerated aging tests.
8. The sample size for the training set
This question is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This question is not applicable as there is no training set for a physical device.
§ 890.5710 Hot or cold disposable pack.
(a)
Identification. A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.(b)
Classification. Class I (general controls). Except when intended for use on infants, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.