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The Infant Heel Warmer™ Heel Snuggler® are instant warm packs 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, nontoxic, non-sterile, disposable device. The Infant Heel Warmer™, Heel Snuggle® have two configurations, the Heel Snuggler®, which is designed to conform to the shape of the infant's heel, and the standard Infant Heel Warmer™. The devices are primarily used in hospitals, Doctor's offices, and other healthcare settings.

The Infant Heel Warmer™/Heel Snuggler® is a single use, disposable pouch that is filled with a super saturated solution of food grade sodium acetate and a catalyst disk. When the catalyst disk inside the packet is flexed by the user, the catalyst disk reacts with the non-toxic solution and initiates a chemical exothermic crystallization of the sodium acetate, generating heat. When activated at 75°F, both models will reach between 104-107°F and then gradually decrease in temperature over time.

The Heel Snuggler® is a butterfly shape with two straps and the Infant Heel Warmer™ is rectangular with one strap. Straps with adhesive ends are attached to the packet for securing the heel warmer to the infant's foot, if desired. Immediately following activation of the user rests the bottom of the infant's foot on one portion of the packet and holds the other portion of the packet to the ankle. The straps with adhesive tape on the end are then fitted across the infant's foot and ankle and secured to the opposite side of the adhesive portion of the strap is affixed to the packet only, not the infant's skin. The straps on the heel warmer are perforated, which enables the user to easily tear the straps and remove the heel warmer from the infant's foot after use.

The provided text details a 510(k) summary for the Infant Heel Warmer™/Heel Snuggler®, arguing for its substantial equivalence to a predicate device. This submission primarily focuses on bench testing and comparison of technical specifications, not on an AI/ML-driven medical device that would involve a study of the type described in the request.

Therefore, many of the requested elements are not applicable to this document. The document describes a physical medical device (a warming pack), not a software or AI-based diagnostic tool.

However, I can extract the acceptance criteria and the "study" (bench testing) that was performed to demonstrate the device meets those criteria, as well as addressing the applicable parts of your request.

Here's a breakdown based on the provided text, with notes on what is not applicable:

Device: Infant Heel Warmer™; Heel Snuggler®

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the successful completion of specified tests. The performance is reported as meeting these implied criteria.

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

• Sample Size: Not explicitly stated for bench tests (e.g., how many units were tested for temperature, burst, stability). It typically refers to a statistically significant number of units for product testing, but specific numbers are not provided in this summary.
• Data Provenance: The testing was performed internally by International Biomedical. The location of the testing is not specified beyond "International Biomedical 8206 Cross Park Drive Austin, TX 78754 U.S.A." This is prospective testing of manufactured devices for performance and safety.

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

N/A. This device is a physical warming pack, not an AI/ML-driven diagnostic tool that requires expert annotation for ground truth. Its performance is measured directly through physical tests (temperature, burst strength, stability).

4. Adjudication Method for the Test Set

N/A. Not applicable to physical device bench testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

N/A. This is a physical device, not an AI/ML-driven diagnostic system. No human reader study or AI assistance is involved.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

N/A. Not an algorithm-driven device. Bench testing was performed on the physical device in a "standalone" manner (i.e., the device itself was tested, not in conjunction with a human operator as part of a performance study, though it is used by a human).

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering and safety standards, and direct measurement of physical properties (e.g., temperature, burst strength, material properties) against predefined acceptance thresholds and comparison to a legally marketed predicate device's characteristics. There's no "expert consensus" on imaging or pathology results here.

8. The Sample Size for the Training Set

N/A. This is not an AI/ML device, so there is no training set.

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

N/A. This is not an AI/ML device, so no ground truth for a training set was established.

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