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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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The transport incubator is intended for use by personnel trained in neonatal care to facilitate the movements of neonates by air or ambulance. The transport incubator circulates warmed air at an operator selected and controlled temperature when transporting neonatal infants to hospitals prepared for neonatal infant care. The transport incubator is also intended to carry equipment designed for airway management and monitoring of the neonatal infant's status.

The Voyager Infant 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 document is a 510(k) summary for a device modification, specifically the "Voyager Transport Incubator with PulseOx." It focuses on demonstrating substantial equivalence to a predicate device and functional aspects, rather than presenting a performance study with acceptance criteria and results in the typical format of an AI/algorithm-based device study.

Therefore, the document does not contain the information required to populate a table of acceptance criteria and reported device performance, nor does it describe a study involving sample sizes, ground truth establishment, expert adjudication, or MRMC/standalone effectiveness for an AI/algorithm.

The "Performance Testing" section states that "Performance testing of the Voyager Infant Transport Incubator with PulseOx has been conducted for functional and design verification and validation," and that "The testing indicates the incubator is in compliance with the following recognized consensus standards." This implies the device was tested against specific requirements outlined in these standards (e.g., IEC 60601-1, ISO 9919), but the document does not enumerate those criteria or the detailed results of that testing.

Here's a breakdown of the requested information and why it cannot be extracted from the provided text:

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

   • Cannot be provided. The document lists consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-20, ISO 9919, ISO 21647) that the device complies with. However, it does not detail specific acceptance criteria or quantitative performance metrics for the device's functionality (e.g., temperature regulation accuracy, pulse oximetry accuracy) as one would expect from an AI/algorithm study. It simply states compliance with these general safety and performance standards.

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

   • Not applicable/Not provided. This device is a physical medical incubator with integrated pulse oximetry, not an AI or algorithm-based diagnostic tool that relies on a "test set" of patient data. The "performance testing" would likely involve laboratory testing of the physical hardware under various conditions, not data analysis on a patient cohort.

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):

   • Not applicable/Not provided. Ground truth with expert consensus is typically relevant for interpretative devices (like AI for imaging or diagnostics). For this device, "ground truth" would relate to the physical accuracy of its sensors (e.g., a calibrated thermometer for temperature, a calibrated SpO2 simulator for pulse oximetry), not expert interpretation of clinical data.

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

   • Not applicable/Not provided. No adjudication method is mentioned, as it's not relevant for this type of device's performance testing.

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/Not provided. This is not an AI-assisted diagnostic or interpretive device. An MRMC study would not be relevant.

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

   • Not applicable/Not provided. This is a physical device, not an algorithm.

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

   • Not explicitly stated/Not applicable in the typical sense. As mentioned for point 3, ground truth for this device would likely be derived from calibrated measurement instruments, not clinical expert consensus or pathology.

8. The sample size for the training set:

   • Not applicable/Not provided. There is no "training set" in the context of this physical device.

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

   • Not applicable/Not provided. There is no "training set."

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The transport incubator is intended for use by personnel trained in neonatal care to facilitate the movements of neonates by air or ambulance.

The Aviator Transport Incubator with PulseOx (hereafter referred to as the transport incubator) maintains a thermally regulated environment to ar uc 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 interes of a rece 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; axygen analyzers; air and oxygen cylinders; air compressors; etc. The integrate pulse oximeter feature is designed to use either Nellcor or Masimo technology. The Nellcor PulseOx model utilizes a daughter board or of Wiest cabling provided by Nellcor. The Masimo PulseOx model utilizes a daughter board and patient cabling provided by Masimo.

This document describes the Aviator Transport Incubator with PulseOx, a medical device, and its conformance to established performance standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a sample size for a "test set" in the context of clinical or observational data. The testing mentioned is related to engineering and safety standards compliance. Therefore, no information on data provenance (country of origin, retrospective/prospective) is available because the document describes device safety and performance testing against industry standards, not a clinical study involving patient data.

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

This information is not applicable and not provided in the document. The "ground truth" for the device's performance in this context is defined by the technical specifications and requirements outlined in the listed international consensus standards (IEC, ISO). Device performance is measured against these technical specifications, not against expert human consensus on clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods are typically used in studies involving expert review of clinical cases. The testing described here is focused on engineering validation and verification against predefined technical standards.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in this submission. The document focuses on the technical safety and performance of the device itself, not on how human readers or operators interact with or are augmented by the device's specific new feature (PulseOx).

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a physical medical instrument (transport incubator) with integrated features, not a standalone AI algorithm. The performance testing described is for the device's functional and design verification and validation. Therefore, the concept of a "standalone algorithm" performance is not applicable. The PulseOx feature is integrated into the device and its performance would be assessed as part of the overall system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by conformance to recognized international consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-20, ISO 9919, ISO 21647). These standards specify safety, essential performance, and electromagnetic compatibility requirements for medical electrical equipment, particularly transport incubators and pulse oximeters/respiratory gas monitors.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is a hardware product with integrated sensors (PulseOx). It is not described as utilizing a machine learning algorithm that requires a "training set" of data in the conventional sense.

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

This information is not applicable and not provided for the reasons outlined in point 8. The device's functionality is based on established engineering principles and sensor technology, not on a machine learning model trained on a specific dataset.

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The AeroNOx 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 is also intended to be used with a flow inflating manual ventilator (an AeroNOx 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 is intended to be used within a hospital or during air or ground transport outside the hospital.

The AeroNOx 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 titration delivery system and the NO/NO2/O2 . analyzer. These two components are mounted into a single enclosure. The construction materials are compatible with NO and will not contaminate the gas stream. A stainless steel, two stage regulator with CGA 626 gas fittings is coupled to a calibrated, high accuracy NO mass flow meter and precision metering valve. The NO is titrated continuously via tubing nearest to the ventilator outlet circuit where it is diluted by the ventilator gas flow. Initial NO flow required to approximate a desired NO concentration is estimated by calculation and verified by the monitoring component of the system. We have also included a look-up table for specific ventilator settings, AeroNOx NO flow setting and expected NO2 production based on 100% Oxygen source, in the operating manual. The AeroNOx analyzer continuously draws a sample from the ventilator circuit on the distal point of the inspiratory circuit nearest the patient wye connection. The sensors then measure NO and NO2 concentration in parts per million and Oxygen in %. The sensors operate by electrochemical means. NO, O2 and NO2 molecules diffuse across a membrane and react in the electrolyte solution augmenting an electrical current between the anode and cathode. The augmented current is proportional to the NO, O2 and NO2 concentration. The AeroNOx analyzer has been designed so that the user can set alarm limits to ensure that deviations in NO and NO2 can be monitored. These alarms are visual and audible. An oxygen analyzer is also incorporated into the system to act as a secondary monitor to display the fractional inspired oxygen concentration.

The provided document is a Special 510(k) submission for a device modification to the AeroNOx Nitric Oxide Titration & Monitoring System. Based on the document, no studies related to device performance or clinical claims were conducted or are presented.

The modification described is solely an update to the User Manual to include three additional ventilators in the list of validated ventilators that can be connected to the AeroNOx system. The submission explicitly states: "No device modifications have been made from the predicate device. The only modification made is to the list of ventilators that may connect to the AeroNOx in the Operator's Manual (page 22)."

Therefore, there is no information available in this document to populate the requested table or answer questions regarding acceptance criteria, device performance, sample size, ground truth, expert involvement, or study methodologies. The substantial equivalence argument is based on the device's continued use of the same intended use, operating principle, design, electronic circuitry, and materials as the predicate device.

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The transport incubator is intended to be used to transport neonatal infants including transport in ambulances or aircraft and to be used by personnel trained in neonatal care.

Not Found

I am sorry, but the provided text only contains regulatory information about a medical device (Aviator Transport Incubator) and does not include details about acceptance criteria, device performance studies, or AI/algorithm-related information. Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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