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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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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 flexible, perforated, polyethylene/polyester inner pouch that holds the liquid solution.
• b) Liquid solution of food grade sodium acetate and water contained in a).
• c) Minute crystals of sodium acetate.
  An adhesive tape is attached to the top of the unit. 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 exothermic reaction causes the unit to heat up to 105 degrees F. The adhesive tape strip is used to hold the warmer in place on the infant's heel.

This 510(k) summary does not contain sufficient detail to fully answer all aspects of the request, particularly regarding specific numerical acceptance criteria and a detailed study design for device performance. However, based on the provided text, here's an analysis of the acceptance criteria and the study conducted for the Rapid Aid Infant Heel Warmer:

The primary "acceptance criterion" for this device, as presented in the 510(k), is substantial equivalence to predicate devices, specifically concerning temperature characteristics and intended use. The study focuses on demonstrating that the Rapid Aid Infant Heel Warmer performs "very similarly" to and is "substantially equivalent" to predicate infant heel warmers.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state numerical acceptance criteria for temperature output beyond "within the range of the predicate devices" and "reaching a maximum temperature around 105 F."

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

The document does not explicitly state the sample size used for the performance testing against predicate devices. It refers to "batch production results" for peak temperature but does not specify how many units or batches were tested.

• Sample Size: Not specified.
• Data Provenance: Not explicitly stated, but assumed to be internal testing by Rapid Aid Ltd. There is no mention of country of origin for data or whether it was retrospective or prospective, although performance testing is generally prospective.

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

This type of device (a simple warming pack) does not typically require expert-established ground truth in the way diagnostic or prognostic AI devices do. The "truth" here is objective physical measurements of temperature and material properties. Therefore:

• Number of Experts: Not applicable/not specified for ground truth establishment.
• Qualifications of Experts: N/A. The "ground truth" is based on instrumental measurements and adherence to ASTM standards.

4. Adjudication Method for the Test Set

Not applicable. This device does not involve subjective interpretations requiring adjudication (e.g., medical image reading). Performance is evaluated through objective measurements and comparisons to predicate device characteristics.

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. This is a physical medical device (an infant heel warmer), not an AI diagnostic or prognostic tool. Therefore, MRMC studies and "human reader improvement with AI" are not relevant.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for this device's performance is based on:

• Objective Physical Measurements: Temperature (peak and duration), material properties (thickness, tensile strength, seal integrity, burst strength), and chemical composition analysis.
• Predicate Device Performance: The primary "ground truth" for comparison is the established performance characteristics and safety profile of the legally marketed predicate infant heel warmers.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a "training set." The device's function is based on a chemical reaction, not a learned algorithm.

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

Not applicable, as there is no training set for this type of device.

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