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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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