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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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Indications for use are for pre-term, term newborns and small infants requiring a diagnostic MRI exam and need to be moved from their warm and controlled intensive care units to the MRI scanner. Indications for use are to maintain a warm and controlled environment during inter-departmental transport and during the MRI procedure.

The SREE MRI Transport Incubator provides a warm and controlled environment during inter-departmental transport and during the diagnostic exam on a scanner with either 1.5T or 3T magnet field strengths. The SREE MRI Transport Incubator accommodates pre- and term newborns and infants up to 1 month of age and 4.5Kg whole body weight or 55cm whole body length (21.7").

The SREE MRI Transport Incubator system consists of a MRI incubator. MRI trolley and backup power supply.

The SREE MRI Transport Incubator is designed to accommodate infants up to 1 month of age. The patient is positioned head first onto the curved incubator patient table over a soft patient mattress is held in place with pads and straps. The SREE MRI Transport Incubator when transferred from the trolley to the MRI patient table allows diagnostic exams without removing the infant from its controlled incubator environment.

The MRI incubator is transported on a dedicated, MR-Conditional non-magnetic trolley with a custom top designed to accommodate the unique incubator base reproducibly. In addition to the incubator, the trolley is designed to accommodate non-magnetic (air, oxygen) tanks, storage bins, a transfer table and incubator electronics. In an extended position, the transfer table allows incubator movement between the trolley and MRI patient table gantry.

A backup power supply box used during transport is equipped with a dedicated uninterrupted power supply (UPS) and battery. This backup power supply box on wheels can be attached to or detached from the SREE MRI Transport Incubator system by sliding it between the trolley guide rails.

The provided documentation describes the SREE MRI Transport Incubator, a medical device. Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided in the document are primarily in the form of compliance with recognized standards and comparative equivalence to predicate devices, rather than specific quantitative performance targets with tolerance limits for all parameters. However, I can extract the explicit performance metrics mentioned.

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

The document does not specify a numerical sample size for the test set used in performance testing. It mentions "phantom and human testing" for MRI compatibility but does not provide details on the number of phantoms or human subjects.

The data provenance is from bench testing and, for MRI compatibility, involves "phantom and human testing." The country of origin for the data is not explicitly stated, but the company is US-based (Cleveland, Ohio). The testing described is prospective in nature, as it was performed to demonstrate device compliance and performance for the premarket submission.

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

This information is not provided in the document. The testing described appears to be primarily technical and engineering-focused, relying on standardized test methods (ASTM, IEC, ISO) and internal SREE QA protocols, rather than expert-established ground truth in a clinical context.

4. Adjudication Method for the Test Set

This information is not provided or applicable as the testing described doesn't involve subjective assessments requiring expert adjudication. The compliance is determined against objective standards and technical protocols.

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. The device is a transport incubator, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of human readers improving with AI vs. without AI assistance does not apply.

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

No, a standalone (algorithm only) performance study was not done in the context of an AI algorithm. The device is a physical medical device (an incubator) with integrated software for control, not an AI diagnostic algorithm. Software validation was performed according to FDA guidance, which focuses on the reliability and safety of the software controlling the device, not its diagnostic accuracy in a standalone AI capacity.

7. The Type of Ground Truth Used

The ground truth for the performance testing is based on:

• Standardized Test Methods: Adherence to established international and national standards (IEC, ISO, ASTM). These standards define objective criteria and measurement methods.
• Engineering Specifications: Internal SREE QA protocols for incubator temperature stability and MRI QA, indicating comparison to predefined engineering targets.
• Comparative Equivalence: The foundation of the 510(k) submission is demonstrating substantial equivalence to legally marketed predicate devices (LMT Nomag IC 1.5, 3.0). This implies that the device's performance is "ground-truthed" by its ability to perform comparably to devices already deemed safe and effective.

8. The Sample Size for the Training Set

This information is not applicable. The SREE MRI Transport Incubator is a hardware device with controlling software, not an AI-driven system that requires a "training set" in the machine learning sense. The software validation refers to functional testing and adherence to software development lifecycle processes, not machine learning model training.

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

This information is not applicable as there is no "training set" in the context of this device.

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The Globe-Trotter GT5400 neonatal transport system is intended for the transport of newborns weighing up to 10 kg (22 lb) between healthcare facilities. It provides means to control air temperature, deliver oxygen, resuscitate, provide passive humidification, and ventilate with active humidification (optional).

The Globe-Trotter GT5400 neonatal transport system is intended for use by trained health care professionals and is not intended for home use.

The GT5400 is a combination of individual currently marketed medical devices without modification of their individual principles of operation. The GT5400 system is comprised of three main parts with standard and optional components.

• o Transport Incubator
• . Modular Frame
• 0 Life Support Console (LCS).

Variants - The GT5400 has two variants, Air Vehicle configuration (AV) and Ground Vehicle (GV) configuration.

The provided document is a 510(k) Premarket Notification for the Globe-Trotter® GT5400 neonatal transport system. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel efficacy or performance against specific, quantifiable clinical acceptance criteria that might be seen in, for example, an AI/ML device submission.

As such, the document does not contain the specific information requested in your prompt regarding acceptance criteria and a study that proves the device meets those criteria in the context of AI/ML or diagnostic performance. Instead, it discusses the device's technical specifications and compliance with safety and performance standards.

Here's what can be extracted based on the provided text, and where the requested information is not present:

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

The document provides a comparative table of technological characteristics between the Globe-Trotter GT5400 and its predicate devices (TI500 Globe-trotter Neonatal Transport System and Airborne Life Support Transport Incubator Aviator). This table details specifications like dimensions, weight, operating conditions, electrical requirements, and sub-system features.

The "Comments" column often highlights how the GT5400's specifications align with or relate to the predicate devices. For example:

• Operating temperature: "Same as TI500 GT"
• Infant Weight: "The patient weight is linked to the Incubator. Although not previously published, the predicate TI500 GT and the GT5400 are the same."
• Pressure Gauges: "Testing showed the digital gauge to be functionally equivalent to the analog gauge"

However, these are not "acceptance criteria" in the sense of predefined performance thresholds for a diagnostic or AI/ML device (e.g., sensitivity, specificity, accuracy metrics). They are technical specifications and equivalency statements.

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. This is a medical device, and the testing described is primarily non-clinical engineering and performance testing against standards, not clinical data collection on a distinct "test set" of patient data.

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, as this is not a diagnostic device relying on expert-established ground truth from medical images or patient records.

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

Not applicable.

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 not an AI-assisted diagnostic device.

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

Not applicable.

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

Not applicable. The "ground truth" for this device would be its adherence to established engineering specifications, safety standards (e.g., electrical, environmental, mechanical), and functional performance described in its design. The testing described (performance testing, functional/operation testing, verification and validation) confirms these engineering attributes.

8. The sample size for the training set

Not applicable.

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

Not applicable.

Summary of what the document does provide regarding the device meeting criteria:

The document states:

• "The GT5400 was tested in accordance with applicable standards, guidance and internal design control procedures including performance testing, functional/operation testing, verification and validation, biocompatibility assessment, risk analysis and verification of risk control measures..." (Page 12)
• "...and was determined to be as safe and effective for its intended use as the predicates." (Page 12)
• "The results of the non-clinical testing, and comparison to the predicate devices show that the modified GT5400 meets the performance requirements of the standards and guidance mentioned above and is substantially equivalent to the predicate devices." (Page 13)

The document lists several international standards and guidance documents that the device was tested against and found to meet, including:

• IEC 60601-1:2005 (General Requirements for Basic Safety and Essential Performance)
• IEC 60601-1-2:2007 (Electromagnetic compatibility)
• IEC 60602-1-6:2010 (Usability)
• IEC 62366:2007 (Application of Usability engineering)
• ISO 14971:2007 (Risk Management)
• EN 1789, EN 13718-1:2008, EN13976-1 (Rescue Systems, Air Ambulances, Transportation of Incubators)
• RTCA DO 160 Environmental Conditions and Test Procedures for Airborne Equipment Section 7 (Operational Shocks and Crash Safety)
• FAR 23/CAR 523 and FAR 29/CAR 529 (Federal Aviation Regulations and Canadian Air Regulations).

Essentially, the "acceptance criteria" here are compliance with these recognized safety and performance standards for neonatal transport incubators, and the "study" proving it involves a comprehensive suite of non-clinical engineering and performance tests, along with a comparison to predicate devices' technological characteristics to demonstrate substantial equivalence.

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The Atom Transcapsule V-707 is a closed-type transport incubator for neonatal and premature infants intended to transport low birth weight infants and neonates.

The Atom Transcapsule V-707 is a closed-type transport incubator for neonatal and premature infants intended to transport low birth weight infants and neonates. It is intended to be used in hospitals, delivery suites, NICU, and transport. The Transcapsule V-707 controls temperature based on air temperature within the incubator. The front panel shows set temperature and the actual temperature. The heat source is electrically powered and can be set between 23.0 to 38.0℃ in 0.1℃ increments. The measured temperature within the incubator has a range of 20.0-42.0℃ in 0.1℃ increments with an accuracy of +/-1.0°C. It can also show skin temperature of the infant between 30.0 and 42.0°C in 0.1°C increments with an accuracy of +/-0.3℃. The Transcapsule V-707 can be mounted in a variety of mechanical configurations, the HL Stand for transport and Cabinet Stand for internal hospital use are typical examples, see Section 11 for further details. The HL Stand for transport and the Cabinet Stand for internal hospital use (and oxygen gas cylinder) are not included in this submission. The Transcapsule V-707 consists of a hood, a main body, a control panel and an external power pack which provides DC power to the incubator. The external power pack also contains batteries to allow for operation when external power is lost. The battery is automatically kept charged when there is an external source of power provided to the device. Battery status (charging and capacity) is indicated on the power pack. The device provides audible and visual alarms for: High temperature, set point, power failure, fan, system failure, silence, skin temperature probe, low voltage (when the voltage from the battery or the external DC power source falls to approx. 10.5V). The device complies with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-20.

Here's an analysis of the provided text regarding the Atom Transcapsule V-707, focusing on acceptance criteria and the study proving it meets these criteria:

Device: Atom Transcapsule V-707 (Neonatal Transport Incubator)

The provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria for a novel device. Therefore, much of the requested information (like sample sizes for test sets, expert qualifications, MRMC studies, standalone performance with specific thresholds, and ground truth for training data) is not present. The "acceptance criteria" discussed are primarily related to meeting recognized performance standards and comparing features to a predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the 510(k) Summary, the "acceptance criteria" are implied by the standards the device complies with and its performance characteristics as compared to the predicate. The "reported device performance" is a statement of compliance or the specified operating range/accuracy.

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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 intended use of this (single patient use) safety strap set is to act as a positioning aid and to prevent accidental falls of the pre-term (

The STATStrap™ Neonatal Incubator Safety Strap is a soft closed cell foam material covered with a laminate of soft fabric that allows Hook (Velcro® style) fabric to attach to it along the straps entire length. The end of each strap incorporates a hook fabric wing tab or a wire spring hook, so as to attach each strap to the infant incubator tray. These 13 inch straps are positioned in four positions altation our carp to the menthess tray so as to fit the patient's size. Once the straps are in place and securely fastened to the mattress tray, the straps cross over the neonate ( infant's ) body in a "X" pattern and attach to each other so as to provide positioning aid, prevent gross body movement or falls of the patient. A hook "tie strap" is included on both models to secure the two main straps together into a single unit. These straps are single patient use disposable items. Labeling states the disposable nature of the strap, precautions and the use instructions.

The provided text describes a 510(k) premarket notification for the STATStrap™ Neonatal Incubator Safety Strap. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical studies to prove safety and effectiveness.

Therefore, many of the typical acceptance criteria and study components usually associated with a novel device's performance evaluation (like specific accuracy metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone performance studies) are not applicable in this context. The focus here is on comparing the new device's characteristics and intended use to an existing, approved device.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy for the device itself. Instead, the "acceptance criteria" are implied by the demonstration that the STATStrap™ shares the same fundamental design, materials, chemical composition, intended purpose, and attachment mechanism as the identified predicate devices, with only minor differences such as single-patient use labeling. The reported "performance" is that it functions in the same manner as existing safety straps.

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

• Not applicable. No test set in the traditional sense of a performance study was conducted. The equivalence was based on a comparison of device characteristics to predicate devices.
• The "study" is a comparison to legally marketed predicate devices, not a clinical trial with a test set of patients.

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

• Not applicable. There was no test set requiring ground truth established by experts.

4. Adjudication Method for the Test Set:

• Not applicable. No test set or expert adjudication was performed.

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

• No. This type of study is not typically required for a 510(k) substantial equivalence submission for a physical accessory device like this.

6. If a Standalone (algorithm only without human-in-the-loop performance) was Done:

• Not applicable. This device is a passive physical accessory, not an algorithm or software. Its function inherently involves human interaction (placement by a user).

7. The Type of Ground Truth Used:

• Not applicable. No ground truth in the sense of clinical outcomes or pathology was established for the STATStrap™ as part of this submission. The "truth" considered by the FDA in a 510(k) is whether the new device is "substantially equivalent" to an existing, approved predicate device in terms of safety and effectiveness.

8. The Sample Size for the Training Set:

• Not applicable. No training set for an algorithm was used.

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

• Not applicable. No training set or ground truth for a training set was established.

Summary of the "Study" and Its Findings:

The "study" or evidence provided is a comparison to predicate devices (K031096/K850496A by International Bio Medical / Airborne Life Support, and K001019/K941106 by Hill-ROM Airshield / Draeger Medical Inc.).

• Conclusion from Testing: The submission explicitly states "Clinical Data: Not applicable" and "Summary / Conclusion from Testing: Not applicable." This indicates that no new clinical or performance testing was conducted or submitted with this 510(k).
• Proof of Meeting Acceptance Criteria: The device met the "acceptance criteria" by demonstrating that its characteristics (design, materials, intended use, function) are substantially equivalent to those of the legally marketed predicate devices. The minor differences (single-patient use labeling, specific attachment mechanisms for different incubator types, and being labeled with the company name) were deemed not to raise new questions of safety or effectiveness. The FDA's letter states they "have determined the device is substantially equivalent... to legally marketed predicate devices."

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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.

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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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