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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.

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The NextGen Transport Incubator is intended for use by personnel care to facilitate the movements of neonates by air or ambulance. The transport incubator provides heat in a controlled manner to neonates through an enclosed temperature controlled environment. The transport incubator is also intended to carry equipment designed for airway management and monitoring of the neonatal infant's status. The device provides two modes of heat: Manual (operator) controlled or Skin (servo) controlled. All transport incubators may be optionally configured with pulse oximetry, a suction device, and an integrated heated mattress. In addition, the NextGen Incubator may be configured with optional blue LED phototherapy to treat indirect hyperbilirubinemia.

The NxtGen Infant Transport Incubator is designed to provide a thermally stable environment for the infant during transport. The incubator is designed to maintain temperatures within desired limits as prescribed by the caregiver.

The NxtGen Infant Transport Incubator has two modes of temperature control available – manual temperature mode and skin temperature control mode (or servo mode). The device includes several optional features including: integrated ambient oxygen monitor, integrated pulse oximeter, integrated phototherapy lighting, integrated electronic suction device, and an integrated heated mattress.

The document describes the K220742 NxtGen Infant Transport Incubator and its comparison to a predicate device, the International Biomedical Voyager Infant Transport Incubator (K103524). The information provided focuses on the device's technological characteristics, intended use, and compliance with various international standards in lieu of a clinical study.

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily discusses substantial equivalence to a predicate device and compliance with established standards. It does not present specific quantitative acceptance criteria and corresponding reported device performance metrics in a single table, as might be seen for diagnostic algorithms. Instead, the "acceptance criteria" are implied by adherence to recognized medical device standards and the device's performance aligning with or improving upon the predicate device's specifications.

Here's a summary of key performance characteristics and how they compare, which can be interpreted as demonstrating the device meets implicit acceptance criteria for functionality and safety based on its predicate and relevant standards:

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

This document is a 510(k) summary for a medical device (an infant transport incubator), not an AI/ML software as a medical device (SaMD). Therefore, the typical concepts of "test set sample size" and "data provenance" for algorithm performance evaluation do not directly apply in the same way.

The "testing" mentioned in the document primarily refers to bench testing, software verification and validation, biocompatibility testing, human factors evaluation, and reprocessing evaluation to confirm compliance with recognized performance standards (e.g., IEC 60601 series, ISO 10079-1, IEC 80601-2-35/50/55/61).

• Sample Size: The document does not specify a "sample size" of patient cases or data in the context of diagnostic/predictive performance. Instead, testing involves the physical device and its components under various simulated conditions as prescribed by the relevant engineering and safety standards.
• Data Provenance: Not applicable in the context of patient data for algorithm training/testing. The testing involves engineering and performance characteristics of the hardware and software systems.

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

This information is not applicable for this type of device submission. There is no mention of "ground truth" established by human experts in the context of diagnostic or predictive performance, as this is a hardware device with integrated functionalities, not an AI diagnostic tool. Expert involvement would be in establishing test protocols, assessing human factors usability, and evaluating compliance with standards by qualified engineers and technical personnel.

4. Adjudication method for the test set:

Not applicable. There is no test set in the context of diagnostic performance requiring adjudication of results based on expert consensus.

5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study:

Not applicable. This is not an AI/ML software requiring comparison of human reader performance with and without AI assistance.

6. Standalone (algorithm only without human-in-the-loop performance) study:

Not applicable. This device is an infant transport incubator; it is not a standalone algorithm. The device's functionalities (e.g., temperature control, pulse oximetry, phototherapy, suction) operate autonomously or with human interaction. Testing of these components (e.g., accuracy of temperature sensors, irradiance of phototherapy, suction pressure) would be considered "standalone" in their specific functional performance but not as a diagnostic algorithm.

7. Type of ground truth used:

Not applicable in the context of diagnostic or predictive ground truth. For the NxtGen Infant Transport Incubator, "ground truth" would relate to metrological standards for accuracy (e.g., precise temperature/pressure measurements, calibrated light intensity), and adherence to safety and performance specifications outlined in the referenced standards (e.g., IEC 60601-2-20 for transport incubators, ISO 10079-1 for suction equipment). These are established through validated test equipment and procedures.

8. Sample size for the training set:

Not applicable. This device does not use an AI/ML algorithm that requires a "training set" of data for learning.

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

Not applicable, as there is no training set for an AI/ML algorithm.

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The AeroNOx 2.0 is intended to provide a constant controlled concentration of nitric oxide in breathing gas by delivering a constant controlled flow of nitric oxide into the inspiratory limb of a mechanical ventilator that operates using a continuous constant flow of fresh gas into the inspiratory limb of the ventilator. The AeroNOx 2.0 is also intended to be used with a flow inflating manual ventilator (an AeroNOx 2.0 accessory), by introducing controlled flows of nitric oxide into the fresh gas flow to the manual ventilator. It is also intended to monitor nitric oxide, nitrogen dioxide, and oxygen concentrations in the breathing gas. The AeroNOx 2.0 is intended to be used within a hospital or during air or ground transport outside the hospital.

The AeroNOx 2.0 nitric oxide delivery system is specifically designed for the transmission and control of gaseous nitric oxide (NO) in parts per million (ppm) concentrations. It is divided into two main components: the delivery component and an analysis component. These two components are mounted into a single enclosure. The delivery component is designed to deliver a constant flow of nitric oxide gas into the main gas stream of a constant flow ventilator or a modified flow inflating manual resuscitator (see "AeroNOx Bagger" and "INOstat Bagger" below). The nitric oxide gas is titrated into the ventilator's gas delivery tubing at a point at least 30cm upstream of the gas analysis port to ensure adequate gas mixing prior to patient delivery. The analysis component of the AeroNOx 2.0 is designed to measure nitric oxide, nitrogen dioxide and oxygen from the ventilator tubing or flow inflating manual resuscitator on the inspiratory side, prior to patient administration. The analysis system consists of one nitric oxide electrochemical cell, one nitrogen dioxide electrochemical cell, one galvanic oxygen sensor, and a pump to draw the gas sample from the ventilator's bulk gas flow for analysis within the block that mounts sensors.

The provided text is a 510(k) summary for the AeroNOx 2.0 Nitric Oxide Titration & Monitoring System. It describes a device modification submission, specifically adding compatibility with more ventilators. This is not a submission for a new AI/ML-driven medical device, and as such, the typical acceptance criteria and study designs associated with AI/ML performance (like MRMC studies, ground truth establishment with experts, data provenance for AI training/test sets) are not applicable to this document.

The "acceptance criteria" here refer to the device meeting performance requirements with the newly compatible ventilators, ensuring substantial equivalence to the predicate device.

Here's how to address the request based on the provided document:

1. A table of acceptance criteria and the reported device performance:

The document broadly states that the device "met all the performance requirements as outlined above" but does not detail specific quantitative acceptance criteria (e.g., accuracy, precision ranges for gas concentrations) or the numerical results of those tests. This type of information would typically be in a more detailed test report, not usually fully replicated in a 510(k) summary.

Acceptance Criteria (Implied from the document):

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

• Sample Size: Not explicitly stated. The document only mentions "Ventilator Compatibility Testing." It does not specify how many different ventilators were tested, nor the duration or number of trials for each.
• Data Provenance: This is a physical device test, not a data-driven AI test. Therefore, data provenance in the context of "country of origin of the data, retrospective or prospective" is not directly applicable. The testing was prospective, as it was conducted to support this specific 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This question is not applicable. This is a hardware/system performance test, not a clinical study involving human expert interpretation of medical images or data. "Ground truth" for this device would refer to known gas concentrations in the test setup, measured by calibrated reference instruments. Experts are not involved in establishing this type of ground truth.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where human readers provide interpretations (e.g., radiologists interpreting images) and consensus is needed to establish ground truth. This is a bench test of a medical device's functional performance.

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:

This question is not applicable. MRMC studies are specific to evaluating the impact of AI/ML algorithms on human reader performance, typically in diagnostic imaging. This submission concerns a physical medical device (nitric oxide delivery and monitoring system), not an AI algorithm assisting human readers.

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

This question is not applicable. The AeroNOx 2.0 is a physical device, not a standalone algorithm. While it contains internal algorithms for controlling gas delivery and monitoring, the "standalone performance" concept usually refers to an AI algorithm's diagnostic or predictive accuracy when operating independently of human clinicians. The document describes bench testing of the system's overall functionality.

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

For this device, the "ground truth" would be established by reference instruments or known gas mixtures used during the bench testing. For example, if testing NO concentration accuracy, the "ground truth" would be the precisely known concentration of NO in the test gas, measured by a highly accurate, calibrated lab-grade gas analyzer. It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

This question is not applicable, and potentially misleading. The term "training set" refers to data used to train AI/ML models. This device is a traditional electromechanical medical device, not an AI/ML product. It does not have a "training set" in the machine learning sense. Any calibration data used by the sensors or control systems would be part of the device's inherent design and calibration process, not a "training set."

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

This question is not applicable for the same reasons as #8.

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The Puffin Lite Infant Resuscitator is intended to provide the basic equipment required for pulmonary resuscitation of neonatal infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the neonatal infant.

The resuscitation system provides the basic equipment required for pulmonary resuscitation of neonatal infants. The Puffin Lite Infant Resuscitator is a gas powered emergency resuscitation system. It is intended to be used inside the hospital by trained medical professionals to provide precise FIO2 delivery, and manual ventilation as established by resuscitation guidelines to neonatal infants weighing less than 10 kg (22 lb). The resuscitation system includes two medical gas flowmeters, an integrated oxygen blender, airway pressure manometer, peak inspiratory pressure (PIP) control, positive end expiratory pressure (PEEP) control, a gas supply pressure alarm and T-piece resuscitator.

The Puffin Lite Infant Resuscitation System underwent bench testing to demonstrate conformance to performance specifications.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes used for each individual bench test. The testing was described as "bench testing," which typically involves laboratory-controlled environments and simulated conditions rather than real patient data. The data provenance is from this bench testing, not from human subjects or real-world clinical data. Therefore, there is no information on country of origin or whether the data was retrospective or prospective.

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

This information is not applicable. The study involved bench testing of a medical device, where acceptance criteria were based on engineering and performance specifications (e.g., pressure, flow, FIO2 accuracy) rather than expert interpretation of medical images or data. Ground truth was established by measuring the physical performance parameters of the device against predefined technical requirements.

4. Adjudication method for the test set:

Not applicable. As the study was bench testing against predefined technical specifications, there was no need for an adjudication method by human experts for the "ground truth." The "passing" or "failing" of a test was determined by whether the device's measured performance fell within the specified limits.

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 510(k) submission for a physical medical device (infant resuscitator) and not an AI or imaging diagnostic device. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted.

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

Not applicable. This device is not an algorithm or an AI system. It is a physical medical device (infant resuscitator) that is intended for use by trained medical professionals.

7. The type of ground truth used:

The ground truth used for this study was the engineering and performance specifications outlined in the acceptance criteria. The device's performance was measured against these objective, predefined technical requirements. There was no reliance on expert consensus, pathology, or outcomes data in the context of this bench testing.

8. The sample size for the training set:

Not applicable. This device is not an AI or machine learning system that requires a "training set" of data.

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

Not applicable, as there was no training set for this device.

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The NuBorne 500 Infant Warmer is an open care environment used for providing controlled infrared heat to neonates who are physiologically unable to maintain their body temperature or may require external heat to ease the transition from the mother's womb to the external environment.

The device is intended to be used in a Labor & Delivery environment for infants immediately after birth, or in a Neonatal Intensive Care Unit for providing premature infants long duration therapy, or in newborn care areas, for providing external heat to low-birth weight infants, and for cases where clinical indications require short/ long duration warming therapy.

The device allows access to the infants for various procedures, tilting of the infant and x-ray diagnostics. The device provides three modes of warming: Manual, Skin, and Standby mode for varying care requirements. Also, allows attaching optional accessories on the rail for therapy and monitoring of the infant.

The NuBorne Infant Warmer is an open care environment used for providing controlled infrared heat to neonates who are physiologically unable to maintain their body temperature or who need external heat to smoothen the transition from the mother's womb to the external environment.

The NuBorne Infant Warmer has three modes of temperature control available – manual temperature mode, skin temperature control mode and standby mode. The device includes a bed that tilts, has height adjustment, side panels, APGAR timer, x-ray tray and an optional inbed scale.

Here's a breakdown of the acceptance criteria and the study information for the NuBorne Infant Warmer, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific, predefined performance criteria through a traditional clinical study with human patients. As such, information regarding sample sizes, ground truth establishment for AI, human reader studies, and training sets (common in AI/software device submissions) is not applicable to this type of device and submission. This device is a hardware medical device, not an AI or software-as-a-medical-device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are derived from compliance to recognized medical device standards and functional performance compared to predicate devices. The "reported device performance" reflects how the NuBorne Infant Warmer meets these standards and compares to its predicates.

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

• Sample Size for Test Set: Not applicable. This is a hardware medical device, not an AI/software device that uses a "test set" of data in the sense of classification or diagnostic performance. Performance was evaluated through bench testing and compliance with standards.
• Data Provenance: Not applicable. The "data" here refers to direct measurements and observations during engineering and safety testing of the device itself, rather than patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable. The "ground truth" for a hardware device like an infant warmer is established through engineering specifications, regulatory standards, and physical measurements (e.g., temperature accuracy, noise levels, safety features). This does not typically involve expert radiologists or similar medical specialists establishing a "ground truth" for classification tasks.
• Qualifications of Experts: N/A for establishing "ground truth" in this context. However, engineering and regulatory experts would have overseen the testing and documentation.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This is a hardware device; thus, there is no "test set" that requires adjudication by human readers for diagnostic or classification concordance.

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

• MRMC Study: No. This type of study is relevant for diagnostic imaging devices or AI-powered clinical decision support systems where human reader performance is being evaluated with and without AI assistance. The NuBorne Infant Warmer is a therapeutic/supportive care device.
• Effect Size: Not applicable.

6. Standalone Performance Study (Algorithm Only)

• Standalone Performance Study: No. This concept is for AI algorithms. The NuBorne Infant Warmer is a physical device with embedded software controlling its functions, but it's not an "algorithm only" device in the sense implying standalone diagnostic or predictive performance. Its performance is its standalone performance as a medical device.

7. Type of Ground Truth Used

• Type of Ground Truth: For this device, the "ground truth" is defined by:
  • Engineering Specifications: Designed parameters and tolerances for temperature, noise, physical dimensions, etc.
  • International and National Medical Device Standards (e.g., IEC 60601 series): These standards define acceptable safety, electrical, mechanical, and performance characteristics.
  • Internal Validation and Verification Protocols: Procedures to confirm the device operates according to its design and specifications.
  • Biocompatibility Standards (ISO-10993): Defining acceptable biological response of materials.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device does not use machine learning or AI that requires a "training set" of data.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this device type.

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The Airborne Phototherapy Light System is intended to be used in one of two modes: observation light mode or phototherapy light mode. The observation light mode utilizes white light and is intended to be used as auxiliary lighting that supplements the ambient lighting. The phototherapy light mode utilizes blue light and is intended to be used in the treatment of neonatal hyperbilirubinemia.

The Airborne Observation and Phototherapy Light is an LED phototherapy (and observation) light. The LED light has both white and blue LED lights that are designed to serve as an observation light or a phototherapy light for the treatment of neonatal hyperbilirubinemia, commonly known as neonatal jaundice. The phototherapy light can be used for infants in incubators by mounting it on the hood

The provided text describes a 510(k) premarket notification for a medical device called the "Airborne Phototherapy Light". This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and studies in the manner typically seen for novel AI/ML-driven devices or those undergoing rigorous clinical efficacy trials.

Therefore, the information required to answer your specific questions about acceptance criteria, test set details, expert ground truth, MRMC studies, standalone performance, training set details, and specific effect sizes is not present in the provided document.

This document is a marketing clearance notification for a phototherapy light for neonatal hyperbilirubinemia. The "performance testing" mentioned refers to compliance with electrical and medical device safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-50), which are general safety and performance requirements for a device of this type, not specific outcome-based acceptance criteria or a study proving its efficacy for treatment in a clinical sense.

The core argument for clearance is substantial equivalence based on:

• Similar indications for use (treatment of neonatal hyperbilirubinemia).
• Similar environment for use (hospital/institution).
• Similar patient population (neonatal).
• Similar technology (blue light-emitting diodes - LEDs).
• Compliance with relevant safety standards.

The discussion about irradiance levels (5 µW/cm²/nm resulting in a 15% decrease of serum bilirubin) refers to published guidelines from the American Academy of Pediatrics, not to a performance study conducted on the Airborne Phototherapy Light itself. The device's irradiance is stated to be within the therapeutic range suggested by these guidelines, even if slightly less than the predicates.

In summary, this document does not contain the information needed to fill out your request because it's a regulatory submission for a device demonstrating substantial equivalence to existing, well-understood technology, not a novel device requiring extensive performance studies as you've outlined.

To answer your request, if this were a document about a software with AI/ML components for diagnosis or treatment, it would typically include a dedicated section on clinical performance testing, often with a detailed statistical analysis plan, acceptance criteria, and specific study results. This document does not describe such a study.

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The LifeBorne Infant Resuscitator is intended to provide the basic equipment required for pulmonary resuscitation of neonatal infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the neonatal infant.

The resuscitation system provides the basic equipment required for pulmonary resuscitation of neonatal infants. The LifeBorne Infant Resuscitator is a gas powered emergency resuscitation system. It is intended to be used inside the hospital by trained medical professionals to provide precise FIO2 delivery, manual ventilation, and emergency airway clearance as established by resuscitation guidelines to neonates and infants weighing less than 10 kg (22 lb).

Here's a breakdown of the acceptance criteria and study information for the LifeBorne Infant Resuscitator, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

• Sample Size: Not explicitly stated as a separate "test set" sample size. The document refers to "bench testing" as the method for performance evaluation. The tests themselves are functional evaluations of the device's components and overall system.
• Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory or simulated environment. The country of origin of the data is not specified, but the submission is from International Biomedical, located in Austin, TX, U.S.A. It is retrospective in the sense that the testing was completed before the 510(k) submission.

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

• Not applicable. This device's performance was evaluated through bench testing against predefined technical specifications, not by expert interpretation of data. Therefore, no experts were used to establish ground truth in this context.

4. Adjudication method for the test set:

• Not applicable. As described above, the evaluation was based on meeting objective technical requirements through bench testing, not on human interpretation requiring adjudication.

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:

• No. This is a medical device (resuscitator) that does not involve "human readers" interpreting medical cases or utilizing AI. Its effectiveness is determined by its mechanical and functional performance.

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

• Yes, in a way. The device itself operates "standalone" in performing its functions (e.g., delivering precise FIO2, controlling PIP/PEEP). The "bench testing" represents the performance of the algorithm/device without human intervention during the test itself (though humans operate the test setup). There is no "algorithm" in the sense of AI or image analysis involved.

7. The type of ground truth used:

• The ground truth for the device's performance was based on predefined technical specifications and engineering standards. Each test had a specific, measurable requirement (e.g., FIO2 within 5%, dead space less than 7 mL) which served as the objective ground truth against which the device's performance was measured.

8. The sample size for the training set:

• Not applicable. This device is a mechanical/electronic system, not one that uses machine learning or AI that would require a "training set" of 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 transport incubator is a neonatal transport incubator. The incubator circulates warmed air at an operator selected, controlled temperature into a transparent chamber containing an infant. The structural integrity and weight of the incubator makes it suitable for ground and air transport. Auxiliary equipment for airway management and vital signs monitoring are not standard equipment. The system is to be operated by trained medical technical personnel.

The A750i Transport Incubator with PulseOx (hereafter referred to as the transport incubator) maintains a thermally regulated environment to prevent infant heat loss when transporting neonatal infants to hospitals prepared for neonatal infant care. The transport incubator maintains a thermally regulated environment with either externally supplied power or internal power supplied by a rechargeable battery. The transport incubator is also designed to offer integrated pulse oximetry and oxygen monitoring capability on the display panel. The transport incubator is also designed to carry equipment designed for life support and monitoring of the neonatal infant's status. The equipment includes but is not restricted to: hand and mechanical operated ventilator's; ventilator monitors; infusion pumps; patient monitors indicating blood pressure, respiration, electrocardiogram, oxygen saturation, pulse, etc.; suction pumps; oxygen analyzers; air and oxygen cylinders; air compressors; etc. The integrated pulse oximeter feature is designed to use either Nellcor or Masimo technology. The Nellcor PulseOx model utilizes a daughter board and patient cabling provided by Nellcor. The Masimo PulseOx model utilizes a daughter board and patient cabling provided by Masimo.

The provided text describes a Special 510(k) for a device modification: A750i Transport Incubator with PulseOx. This document focuses on demonstrating substantial equivalence to a predicate device and adherence to recognized consensus standards for safety and performance, rather than presenting a study specifically designed to establish "acceptance criteria" and subsequent "device performance" in the way one might for an AI/CADe device.

Therefore, many of the requested fields related to AI/CADe study design (like sample size for test sets, data provenance, expert ground truthing, MRMC studies, standalone performance, training sets) are not applicable to this type of submission. This document highlights compliance with engineering and safety standards for a modified medical device.

However, I can extract the relevant information from the provided text as best as possible, interpreting "acceptance criteria" as compliance with recognized standards.

Here's the breakdown of the information that is available or can be inferred from the provided text:

1. A table of acceptance criteria and the reported device performance

For a device modification like this, acceptance criteria primarily refer to compliance with established medical device safety and performance standards. The "reported device performance" is the statement that the testing indicates compliance.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: This information is not provided in the document. The performance testing mentioned is for "functional and design verification and validation," which typically involves engineering tests on the device itself, rather than a clinical "test set" in the context of an AI/CADe device.
• Data Provenance: Not applicable in the sense of clinical data. The testing is likely internal to the manufacturer (International Biomedical, based in Austin, TX, U.S.A.). It's functional testing of a physical device.

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

• Not Applicable. This type of information is relevant for studies involving human interpretation or diagnostic accuracy, which is not the primary focus of this device modification submission. The "ground truth" for this device would be its conformance to engineering specifications and safety standards.

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

• Not Applicable. See point 3.

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

• No. This is a device modification for a transport incubator with integrated pulse oximetry, not an AI/CADe device.
• Effect Size: Not applicable.

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

• No. This is not an algorithm-only device. The pulse oximetry is an integrated feature, and its performance would be assessed against the ISO 9919 standard.

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

• The "ground truth" here is the established specifications and requirements of the recognized consensus standards (IEC and ISO standards listed above). The device's performance is measured against these technical and safety requirements.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device that would require a "training set."

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

• Not Applicable. See point 8.

In summary, this 510(k) submission demonstrates that a modified medical device (an incubator with integrated pulse oximetry) meets its design and safety objectives by complying with relevant international standards. It is not an AI/CADe device submission, and as such, many of the typical questions for such studies do not apply.

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The transport incubator is a neonatal transport incubator. The incubator circulates warmed air at an operator selected, controlled temperature into a transparent chamber containing an infant. The structural integrity and weight of the incubator makes it suitable for ground and air transport. Auxiliary equipment for airway management and vital signs monitoring are not standard equipment. The system is to be operated by trained medical technical personnel.

The 185A+ Transport Incubator with PulseOx (hereafter referred to as the transport incubator) maintains a thermally regulated environment to prevent infant heat loss when transporting neonatal infants to hospitals prepared for neonatal infant care. The transport incubator maintains a thermally regulated environment with either externally supplied power or internal power supplied by a rechargeable battery. The transport incubator is also designed to offer integrated pulse oximetry and oxygen monitoring capability on the display panel. The transport incubator is also designed to carry equipment designed for life support and monitoring of the neonatal infant's status. The equipment includes but is not restricted to: hand and mechanical operated ventilator's; ventilator monitors; infusion pumps; patient monitors indicating blood pressure, respiration. electrocardiogram, oxygen saturation, pulse, etc.; suction pumps; oxygen analyzers; air and oxygen cylinders; air compressors; etc.

The integrated pulse oximeter feature is designed to use either Nellcor or Masimo technology. The Nellcor PulseOx model utilizes a daughter board and patient cabling provided by Nellcor. The Masimo PulseOx model utilizes a daughter board and patient cabling provided by Masimo.

This document describes a Special 510(k) for a device modification, specifically the addition of PulseOx functionality to an existing transport incubator. The provided text, however, focuses on regulatory compliance and functional description rather than detailed performance studies with acceptance criteria, sample sizes, and ground truth establishment for a device leveraging AI/ML.

Therefore, many of the requested sections about acceptance criteria and study details cannot be fully populated as the document does not contain this type of information. It primarily indicates that performance testing for functional and design verification and validation was conducted in compliance with recognized consensus standards for medical electrical equipment and pulse oximetry.

Here's an attempt to extract and describe what information is available based on the request:

1. A table of acceptance criteria and the reported device performance

The document does not provide specific acceptance criteria or reported device performance metrics in a tabular format for the integrated PulseOx functionality. It states that "The testing indicates the incubator is in compliance with the following recognized consensus standards," implying that meeting the requirements of these standards serves as the acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission focuses on regulatory compliance through standard adherence rather than a clinical performance study with defined test sets and data provenance for the PulseOx enhancement.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as the document does not describe the establishment of a ground truth for a test set in the context of a clinical study or AI/ML evaluation. The evaluation is based on adherence to recognized engineering and safety standards.

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

This information is not provided. An adjudication method is typically relevant for studies involving human interpretation or subjective assessment, which is not described here for the PulseOx integration.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned and is not applicable here. The device is a hardware modification (adding PulseOx) to an incubator, not an AI/ML-driven diagnostic tool intended to assist human readers.

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

This information is not provided and is not directly applicable. The PulseOx is an integrated measurement device, not an algorithm in the sense of AI/ML. Its performance would be evaluated as a standalone sensor system, which is implicitly covered by adherence to ISO 9919.

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

The concept of "ground truth" as typically applied to image analysis, pathology, or outcomes data is not directly relevant or described in the context of this device modification. The "ground truth" for the PulseOx functionality would be established by reference to a gold standard measurement technique for oxygen saturation (e.g., arterial blood gas analysis in a clinical setting, or calibrated test equipment in a lab setting) as part of the validation for ISO 9919. However, the document does not detail how this was performed.

8. The sample size for the training set

This information is not provided. There is no mention of a "training set" as this device does not utilize machine learning or AI that would require such a set.

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

This information is not provided and is not applicable, as there is no mention of a training set for machine learning.

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