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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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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 CooperSurgical Infant Heel Warmer, which is available in both a liquid version (The Infant Heel Warmer, Model 24401) and a gel version (WarmGel® Infant Heel Warmer, Model 20418), is a non-sterile, single-use, disposable device comprised of a biaxially oriented nylon (BON)/polyethylene outer pouch filled with a supersaturated solution of food grade sodium acetate and water (liquid version), or food grade sodium acetate, water, and hydroxyethylcellulose, a common thickener (gel version). An adhesive tape is attached to the pouch, which can hold the warmer in place if desired. The pouch also contains a stainless steel disc that, when flexed, initiates an exothermic crystallization of the sodium acetate, generating heat. When activated at 75° + 1° F, the maximum peak temperature of the CooperSurgical Infant Heel Warmer is 107° F, which is reached in approximately 40 seconds and then gradually decreases over time.

The provided text describes the 510(k) premarket notification for the CooperSurgical Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418). This device is a hot or cold disposable pack and is classified as Class I. The submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving specific numerical acceptance criteria for a novel AI/software medical device.

Therefore, many of the requested categories related to AI/software device studies (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this traditional medical device submission.

Here's a breakdown of the available information regarding acceptance criteria and the study that proves the device meets them, adapted to the context of this manual heating device:

Acceptance Criteria and Device Performance

The core "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to legally marketed predicate devices, particularly regarding safety and effectiveness for its intended use. The primary performance aspect evaluated is its temperature profile and its effect on infant skin.

Study Details

The primary "study" described is a combination of non-clinical performance testing and an animal study.

1. Sample Size used for the test set and the data provenance:

   • Temperature Profile Testing: "For each sample, a calibrated thermocouple was attached to the center..." The exact number of samples tested for temperature profiling is not explicitly stated. It implies multiple samples were tested to establish the profile.
   • Animal Study: 6 pigs (3 light-skinned, 3 dark-skinned), aged 3 to 3.5 weeks.
   • Data Provenance: Not specified, but generally assumed to be internal laboratory testing by the manufacturer or contracted labs. The animal study involved "pigs."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable in the context of an AI/software device. For this device, "ground truth" for temperature was measured by calibrated thermocouples. For the animal study, grading of thermal insult and erythema was done against "established criteria," implying veterinary or pathology expertise, but the number and specific qualifications of graders are not provided.

3. Adjudication method for the test set:

   • Not Applicable. This is not a human-reader-based diagnostic device.

4. 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 not an AI/software diagnostic device that involves human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not Applicable. This is a physical heating device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Temperature Profile: Objective measurements from calibrated thermocouples.
   • Biocompatibility: Adherence to international standards (AAMI/ANSI/ISO 10993-5:2003, AAMI/ANSI/ISO 10993-10:2010), likely involving established lab tests for cytotoxicity and sensitization/irritation.
   • Animal Study (Skin Safety): Visual grading against "established criteria" for thermal insult and erythema, which would typically involve macroscopic and potentially microscopic (pathology) assessment by trained personnel/veterinarians, but the specific detail is not explicitly provided.

7. The sample size for the training set:

   • Not Applicable. This is not a device based on trained algorithms.

8. How the ground truth for the training set was established:

   • Not Applicable.

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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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For use by hospital, Ambulatory Surgery staff, Outpatient Clinics for warming of Infant's Heels prior to drawing blood for sampling or general analysis. This device is intended for Rx use only. This device is single use, non-sterile, and disposable.

Not Found

This document is a 510(k) clearance letter for a medical device called the "DeNovo Teddy Gel Infant Heel Warmer." It is not a study report and therefore does not contain information about acceptance criteria or a study proving device performance as requested in the prompt.

The document primarily states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It lists the device name, regulation number, regulatory class, and product code. It also includes an "Indications for Use Form" which specifies the intended use of the device.

Since the input document does not provide the requested information, I cannot fill out the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert qualifications.

Here's what I can extract from the provided text, noting that the core request for study data cannot be fulfilled:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not applicable. This document is a clearance letter, not a study report. It does not contain acceptance criteria or reported device performance metrics.

2. Sample size used for the test set and the data provenance:

• Not applicable. No study details are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No study details are provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. No study details are provided.

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 non-AI medical device (a heel warmer). No MRMC study or AI component is mentioned.

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

• Not applicable. This is a non-AI medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not applicable. No study details are provided.

8. The sample size for the training set:

• Not applicable. No study details are provided.

9. How the ground truth for the training set was established:

• Not applicable. No study details are provided.

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The Infant Heel Warmer by Intco is a single use, non-toxic, non-sterile, disposable device. It is an instant warm pack intended to be used on an infant's heel to aid in the drawing of blood for analysis. The device is to be limited to use in hospitals, doctors' offices, and other healthcare facilities that administer health care services to newborns and infants. Prescription Use Only. The Indication for use of the Infant Heel Warmer by Intco is the same to the Rapid Aid Infant Heel Warmer, a legally marketed predicate device.

• Classified by FDA's Physical Medicine Device Panel as Class I, 21 CFR 890.5710, Pack, Hot or Cold disposable, MPO, and meets all requirements of ISO 7176 and EN 1021.
• The Infant Heel Warmer by Intco is a self contained unit comprised of a flexible, poly/nylon outer pouch containing: I) A flexible, perforated, polyethylene/polyester inner pouch that holds the liquid solution. II) Liquid solution of food grade sodium acetate and water contained in I). III) 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 102 degree F. The adhesive tape strip is used to hold the warmer in place on the infant's heel.

The provided document describes the acceptance criteria and a study for the "Infant Heel Warmer by Intco." However, this is a Class I medical device (Hot or cold disposable pack) which typically relies on substantial equivalence to a predicate device rather than extensive clinical studies with complex acceptance criteria like those for higher-risk devices or AI-powered diagnostics.

Based on the provided text, the device's performance is measured against that of a predicate device, focusing on fundamental physical characteristics rather than diagnostic accuracy or human interpretation.

Here's the breakdown of the information requested, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a table format that would typically be seen for a diagnostic or AI device. Instead, the acceptance is based on "substantial equivalence" in performance to a predicate device.

Study Proving Device Meets Acceptance Criteria:

The study described is primarily a comparative performance study against a predicate device and various material and product integrity tests.

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

• Sample Size for Test Set: The document does not specify a numerical sample size for the "Infant Heel Warmer by Intco" units tested for performance or the predicate devices used for comparison. It refers to "batch production results" for peak temperature, suggesting multiple units from production batches were tested, but no specific number is given.
• Data Provenance: Not explicitly stated. The manufacturer is Shanghai Intco Medical Supply Co., Ltd., suggesting testing likely occurred in China or at an associated facility. The document does not describe the origin of subject data (e.g., patient data) as this is not a diagnostic device.

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

This information is not applicable and not provided in the document. The "ground truth" for this device is based on physical properties and performance (e.g., temperature, material strength) measured by instruments and verified by standard tests, not expert interpretation of medical images or patient data.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth from multiple human expert opinions in diagnostic studies, which is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable and not provided. This is not an AI-powered diagnostic device, and therefore, an MRMC study or assessment of AI assistance for human readers is irrelevant.

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

This information is not applicable and not provided. 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 established through:

• Physical measurements and laboratory testing: For temperature characteristics, material properties (e.g., thickness, tensile strength, seal integrity, burst strength), and chemical composition analysis.
• Conformance to standards: ASTM standards (D1203, D-882), ISO 7176, and EN 1021 are mentioned for material and product testing.
• Comparison to a predicate device: The performance (specifically temperature characteristics) was directly compared to the "Rapid Aid Infant Heel Warmer."

8. The Sample Size for the Training Set:

This information is not applicable and not provided. As this is a traditional medical device, there is no "training set" in the context of machine learning or AI. The product validation relies on engineering tests and comparison to a predicate device.

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

This information is not applicable and not provided for the same reasons as #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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The Respironics Heel Snuggler infant heel warmer is intended for use whenever circulation needs to be stimulated in the infant heel in order for blood sampling to occur.

The Heel Snuggler is a butterfly shaped packet that is filled with a non-toxic solution and a catalyst disk. Two straps with adhesive ends are attached to one side of the packet for securing the heel warmer to the infant's foot. Immediately following activation of the user rests the bottom of the infant's foot on the larger portion of the packet and holds the smaller 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 packet. The adhesive portion of the strap is affixed to the packet only, not the infant's skin. This forms a boot shape around the infant's foot. 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.

When the catalyst disk inside the packet is flexed by the catalyst reachs with the solution a ri initiates a chemical exothermic reaction, which produces warmth.

The Heel Snuggler Infant Heel Warmer is a Class I device, and the provided documentation is a 510(k) summary for its clearance. Medical devices in Class I, especially those cleared via a 510(k), are generally considered low risk and do not require the rigorous clinical efficacy studies that higher-risk devices or software as a medical device (SaMD) might.

From the provided text, there is no information about an AI/ML powered device, acceptance criteria or a study that proves a device meets acceptance criteria in the context of an AI/ML device. The document describes a traditional medical device (an infant heel warmer) and its 510(k) clearance process.

Therefore, I cannot provide the requested table and information about acceptance criteria and studies related to an AI/ML device. The document specifically states:

• "Design verification tests were performed on the Heel Snuggler as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria." This indicates that the device underwent engineering and design verification testing to ensure it met pre-defined product requirements and safety standards, which is typical for a non-AI/ML medical device.
• The comparison is made to a predicate device (DeRoyal Industries, Inc. Infant Heel Warmer (K954716)) to establish substantial equivalence, which is the standard pathway for 510(k) clearance for traditional medical devices.

The information you are requesting (AI/ML relevant details) is not present in this document because the device described is not an AI/ML product.

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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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The Recover® Infant Heel Warmer is intended to be used for warming the heel site of an infant prior to a heel stick procedure. The warmth enhances vasodilation and increases blood flow in an infant's heel to ensure adequate blood for sampling.

Non Toxic, Food Grade Sodium Acetate and water with a stainless steel catalytic disc sealed in a nylon /polyethylene laminate bag. Provides heat to 105°F.

This 510(k) summary describes a medical device, the Recover® Infant Heel Warmer, and compares it to a predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it provide details about clinical performance, ground truth, or expert involvement as requested in your prompt.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone (algorithm only) performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document provided focuses on the physical description, contents, temperature, and intended use of the device, along with its classification and predicate device. It's a pre-market notification (510(k)) summary from 1997, which might predate the regulatory requirements for the types of detailed performance studies you are asking about, especially those related to AI/algorithm performance.

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The Baxter Sodium Acetate Infant Heel Warmer™ is a single-use, non-sterile device. It is a heat therapy pack intended to be used on an infant's heel in order to increase peripheral blood flow and oxygenation prior to blood sampling.

The Baxter Sodium Acetate Infant Heel Warmer™ is comprised of a polyethylene/BON pouch enclosing the phase change chemical and the activator disk-like trigger. Upon pinching and flexing trigger also located within the pouch, aluminum oxide grit is released into the sodium acetate and water mixture thus initiating a chemical exothermic reaction. The hot pack immediately reaches a maximum temperature of 104 °F +/- 2.9 °F and gradually diminishes over time.

Here's an analysis based on the provided text, though it's important to note that the document describes a medical device (infant heel warmer) and not an AI/ML-driven diagnostic tool. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not directly applicable. I will interpret the acceptance criteria and "device performance" in the context of a physical medical device.

Acceptance Criteria and Study for Baxter Sodium Acetate Infant Heel Warmer™

The provided document, K961154, is a "SUMMARY OF SAFETY AND EFFECTIVENESS" for a medical device, not a study evaluating an AI algorithm. Therefore, the questions related to AI/ML performance, ground truth establishment, expert review, training sets, and MRMC studies are not directly relevant to this document. I will focus on the information that is applicable to a physical device's performance and safety assessment.

1. Table of Acceptance Criteria and Reported Device Performance

Device Name: Baxter Sodium Acetate Infant Heel Warmer™

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

The document does not specify exact sample sizes for each test. It refers to "All materials used" and "The outer pouch material," and "The active chemical mixture." This implies that the materials constituting the device were sampled and subjected to various tests.

• Sample Size: Not explicitly stated for each test (e.g., number of guinea pigs for sensitization, number of chemical batches tested).
• Data Provenance: The tests are described as being performed internally or by labs adhering to established standards (USP XXII, ISO 10993). The country of origin for the data generation is implied to be within the manufacturer's operational scope (Moberly, Missouri), but no specific external lab locations are given. The studies are by nature retrospective in relation to the submission date, as they were conducted to support the pre-market application.

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

This section is not applicable as the document describes a physical medical device, not an AI/ML system requiring expert-established ground truth. The "ground truth" for this device relates to objective physical and biological properties (e.g., actual temperature, material strength, biological response in animal models).

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used in expert consensus for diagnostic tasks, not for evaluating the physical and biological properties of a device. The tests performed are objective measurements or standardized animal/in vitro tests.

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

This section is not applicable. MRMC studies are designed to compare the diagnostic performance of human readers, often with and without AI assistance. This document describes a physical therapeutic device, not a diagnostic tool where human reader performance would be directly relevant.

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

This section is not applicable. There is no algorithm described in this document.

7. The Type of Ground Truth Used

For the purpose of this device, the "ground truth" was established by:

• Objective Physical Measurements: Calibrated instruments for temperature, tensile strength, and timing.
• Standardized Biological Assays:
  • In vitro cytotoxicity tests.
  • In vivo animal models (guinea pig maximization test for skin sensitization, primary skin irritation test).
• Chemical Composition and Purity Standards: USP XXII and ISO 10993 for material evaluation.

8. The Sample Size for the Training Set

This section is not applicable. The concept of a "training set" applies to machine learning algorithms where a model learns from data. This document describes the testing and validation of a physical device.

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

This section is not applicable as there is no training set for a machine learning algorithm.

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