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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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The InfaTherm™ Disposable Infant Warming Mattress is an instant warm pack intended to provide warmth during transport of an infant within the hospital or between hospitals. It is recommended for full-term infants. It is a single use, nontoxic, non-sterile, disposable device.

The InfaTherm™ Disposable Infant Warming Mattress is a single use, disposable pouch that is filled with a super saturated solution of food grade sodium acetate and water and a catalyst disk. When the catalyst disk inside the packet is flexed by the user, the catalyst disk reacts with the nontoxic solution and initiates a chemical exothermic crystallization of the sodium acetate, generating heat. When activated at 75°F, the Infant warming mattress will reach between 100-102°F and then gradually decrease in temperature over time. The InfaTherm™ Disposable Infant Warming Mattress is rectangular in shape. Immediately following activation of the mattress, the user places the infant on the mattress.

This document describes the InfaTherm™ Disposable Infant Warming Mattress and its substantial equivalence to a predicate device, as submitted for FDA 510(k) clearance.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a numerical or pass/fail threshold manner for performance. Instead, it compares the subject device's characteristics and performance to those of a predicate device to demonstrate substantial equivalence. The implication is that if the subject device's performance is similar to or equivalent to the predicate device, it meets the "acceptance criteria" for safety and effectiveness.

2. Sample Size for Test Set and Data Provenance

The document does not specify a separate "test set" in the context of clinical trials or AI model evaluation. The performance evaluation is based on bench testing of the physical device.

• Sample Size: Not explicitly stated for each test (e.g., how many mattresses were tested for temperature profile).
• Data Provenance: Bench testing would be prospective, conducted by the manufacturer, International Biomedical. The country of origin for the testing itself is not specified but is presumably the USA, where the company is located.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The InfaTherm™ device is a physical medical device (warming mattress), not a diagnostic or AI algorithm requiring expert ground truth for its performance evaluation in the context of this 510(k) submission. Its performance criteria are physical properties and safety measures.

4. Adjudication Method

Not applicable for a physical device performance evaluation based on bench testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is not an AI algorithm or diagnostic tool that would typically undergo an MRMC study comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical warming mattress, not an algorithm.

7. Type of Ground Truth Used

For the physical characteristics and performance (temperature, seal strength, stability), the ground truth is established by:

• Physical Measurements/Instrument Readings: Temperature, pressure, material properties.
• Engineering Standards and Specifications: Adherence to defined parameters for functionality and safety.
• Regulatory Standards: Compliance with FDA guidance and international standards (e.g., ISO-10993 for biocompatibility).

8. Sample Size for Training Set

Not applicable. There is no training set as this is a physical device, not an AI/machine learning model.

9. How Ground Truth for Training Set was Established

Not applicable as there is no training set.

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1. MediHEAT Infant Heel Warmer is primarily used in hospitals, Doctor's offices, and other healthcare facilities.
2. Normally, Medical Practitioners squeeze the heels of Infants to increase blood circulation in the area before drawing blood for analyses.
3. The Infant Heel Warmer is used to warm the heel of an Infant to increase blood circulation to the area to facilitate blood sampling.

The MediHeat Infant Heel Warmer is a self-contained unit comprised of a flexible Nylon/Polyethylene bag containing the ingredients: a) Food grade sodium acetate, b) Water and c) Activator disk. When the disk is clicked, it activates the sodium acetate solution causing it to pass from the liquid phase to a solid phase (crystallization), making it exothermic. d) An adhesive tape to hold the warmer in place. It heats up to a maximum temperature of up to 105°F and gradually diminishes.

Here is the detailed breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance Study

The MediHEAT Infant Heel Warmer is a simple device designed to warm an infant's heel to facilitate blood drawing. The acceptance criteria and supporting study primarily focus on its temperature characteristics and equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Conclusion from Studies: The performance of MediHEAT Infant Heel Warmer is similar and substantially equivalent to that of other commercially available Infant Heel Warmers.

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

• Sample Size: Not explicitly stated, but the study compared the MediHEAT Infant Heel Warmer against "Predicate devices, bought in open market." This implies testing was done on at least one unit of each predicate device and at least one unit of the MediHEAT device.
• Data Provenance: The testing was conducted "in our lab" (referring to MediHeat, Inc.'s lab) which suggests internal testing. The country of origin for the data is therefore likely the USA (Dalton, GA). The study appears to be prospective as it involved testing new devices for their performance characteristics.

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

• None. For this type of device (a heat pack), the "ground truth" is objective physical measurements (temperature, duration) rather than expert interpretation. Experts are not mentioned as being involved in establishing the ground truth for this device's performance study.

4. Adjudication Method for the Test Set

• None. Adjudication methods like 2+1 or 3+1 are typically used for studies involving subjective human interpretation of data (e.g., medical images). This study involves direct physical measurements of temperature over time, which do not require interpretive adjudication.

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

• No. An MRMC study is not applicable here. This device warms a physical object (an infant's heel) and its performance is measured by objective temperature readings, not by human reader interpretation of complex data.

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

• Yes, effectively. The "study" described is a standalone performance test of the device itself. There is no algorithm or human-in-the-loop component for the function of a heel warmer; it's a direct physical-chemical reaction. The performance characteristics (temperature, duration) were measured directly from the device.

7. The Type of Ground Truth Used

• Objective Physical Measurements: The ground truth was established through direct measurement of temperature and duration of heat from the devices.

8. The Sample Size for the Training Set

• Not Applicable. This device is a physical product, not an AI or machine learning algorithm. Therefore, there is no "training set" in the computational sense. The device's performance is inherent to its design and chemical composition, not learned from data.

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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