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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.

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.

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Rapid Aid Infant Heel Warmer is primarily used in hospitals, doctor's offices, and other healthcare facilities. It is an instant warm pack intended to be used on an infant's heel to increase blood circulation to the area to aid in the drawing of blood for analysis. It is a single use, non-toxic, non-sterile, disposable warmer.

The Rapid Aid Infant Heel Warmer is a self contained unit comprised of a flexible, poly/nylon outer pouch containing:

• a) A metal disc that can be flexed during activation,
• b) Liquid solution of food grade sodium acetate and water,
• c) Minute crystals of sodium acetate.
  An adhesive tape is attached to the top of the unit is activated by squeezing firmly on the inner fluid pouch, this will cause the inner perforated pouch to activate. Rapid crystallization occurs when the liquid contents are exposed to the minute crystals of sodium acetate contained within the poly/nylon outer pouch. This exothermnic reaction causes the unit to heat up to 104ºF. The adhesive tape strip is used to hold the warmer in place if desired.

Here's an analysis of the provided text regarding the Rapid Aid Instant Disposable Infant Heel Warmer, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The main performance characteristic tested for this device is its temperature profile.

Note: The exact numerical "specified range" for maximum temperature and dwell time is not explicitly stated as a formal acceptance criterion but is implied by the comparison to the predicate device and the statement "both within the specified range for this device."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. The document mentions "The Infant Heel Warmer with Disc was tested against the predicate device," implying a test set, but does not provide the number of units tested.
• Data Provenance: Not explicitly stated, but it's a bench test conducted by the manufacturer, Rapid Aid Corp. (Canada). This would be prospective data generated for the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable to this type of device and study. The testing described is bench testing of physical properties (temperature, dwell time, material properties), not diagnostic accuracy requiring expert interpretation.

4. Adjudication Method for the Test Set

This information is not applicable as the study involves objective physical measurements, not subjective evaluations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not conducted. This device is a physical warmer, not an AI or diagnostic tool that would involve human readers interpreting cases.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This is a physical medical device, not an algorithm, so "standalone performance" in the context of AI does not apply. The performance evaluation was essentially a standalone bench test of the device's physical properties.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation appears to be the established performance characteristics of the legally marketed predicate device (Rapid Aid Instant Disposable Infant Heel Warmer, K040856) and the "specified range for this device" (though this range is not explicitly defined in the document). In essence, the new device's performance was compared to that of a previously cleared, substantially equivalent device.

For material properties, the ground truth is based on ASTM standards (for poly/nylon pouch material) and toxicological acceptability (for sodium acetate).

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not an AI model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated in point 8.

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