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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 Polaris 2004 Capnograph is intended for the continuous, non-invasive measurement and monitoring or respiration rate and carbon dioxide concentration of the expired and inspired breath of neonatal, pediatric and adult patients wherever these measurements are required by attending medical personnel.

The Oridion Polaris Capnograph (the device being modified-K950388) is a device that measures end tidal CO2 (EtCO2). As a derivative of the EtCO2 measurement the devices measure and display the breath rate (BR). The capnograph module of both devices function as a carbon dioxide gas analyzer that measures in mmHg, Vol %, or kPa the concentration of CO2 in a gas mixture to aid in determining the patient's ventilatory status.

This 510(k) summary does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria, as it primarily focuses on demonstrating substantial equivalence to a predicate device. However, it does reference compliance with a standard.

Here's an attempt to extract and infer information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the document. The document primarily discusses device modifications and equivalence to a predicate, not performance testing on a specific "test set" of patient data.

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

This information is not provided in the document. As no specific "test set" or clinical study with patient data results are detailed, there is no mention of experts establishing ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

There is no mention of an MRMC study. This device is a capnograph, a medical instrument that measures physiological parameters. It does not appear to involve image interpretation or AI for diagnostic assistance to human readers.

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

This information is not explicitly stated as a "standalone" study in the context of an algorithm. However, the device itself, the Polaris 2004 Capnograph, operates independently to measure and display CO2 and respiration rate. The document implies that its performance (e.g., accuracy of CO2 measurement) was validated against the EN864 standard. This standard would dictate the methods for testing the device's inherent measurement capabilities.

7. The Type of Ground Truth Used

The primary "ground truth" referenced for performance is the EN864 standard for capnographs. This standard likely specifies objective criteria and methods for evaluating the accuracy and performance of carbon dioxide analyzers, which would involve calibrated gas mixtures or other validated reference methods.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This device is a hardware medical instrument for physiological measurement, not an AI/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/not provided for the same reasons as point 8.

Summary of what the document implies about validation:

The primary "study" proving the device meets acceptance criteria is the demonstration that the modified Polaris 2004 Capnograph conforms to the EN864 standard for capnographs. The 510(k) process for this device relies heavily on the concept of substantial equivalence to a previously cleared predicate device (Polaris Capnograph K950388). The document emphasizes that the modifications introduced (e.g., MiniMediCO2 module, aluminum manifold, removal of water trap with Filterline K980324) do not alter the fundamental safety, efficacy, or intended use, and leverage components or concepts already cleared by the FDA in other devices (e.g., MiniMediCO2 module in Microcap K981114, Filterline in K980324). Therefore, the "proof" is largely based on demonstrating that these changes maintain the performance characteristics of the predicate device and meet an internationally recognized standard.

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NIBP

The LIFEPAK®12 NIBP monitor non-invasively measures blood pressure of the adult and pediatric patients by professionally trained health care providers. It is not designed for continuous, unsupervised monitoring.

EtCO2

The use of the LIFEPAK®12 EtCo2 monitor is indicated whenever professionally trained health care providers determine that a patient requires the continuous, non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate.

The LIFEPAK®12 defibrillator / monitor series is a complete acute cardiac response system - battery or auxiliary powered defibrillator (manual and AED), monitor, pacemaker, 3 lead ECG, interpretive 12 lead ECG and pulse oximeter. Data can be transmitted by landline or cell phone to computer, fax, printer, or ECG storage system.
The users will be Advanced Life Support and Basic Life Support providers in a variety of hospital and pre-hospital settings. Emergency Medical Services users will include Paramedics and Emergency Medical Technicians trained and authorized to respond to medical emergencies. This device will be used in the pre-hospital setting and in the hospital, in critical areas (emergency departments, critical care, operating rooms, etc.) and on general duty floors (e.g. medical/surgical). It will also be used for patient transport (air and ground ambulance, in hospital transport, etc.)

Here's an analysis of the provided text regarding the acceptance criteria and study data for the NIBP and CO2 Options for the Physio-Control LIFEPAK®12 Defibrillator / Monitor System:

Based on the provided 510(k) summary, specific, quantitative acceptance criteria and the detailed study that proves the device meets those criteria are not explicitly described in the provided text. The document focuses primarily on establishing substantial equivalence to predicate devices and adherence to industry standards, rather than presenting a standalone performance study with detailed acceptance criteria and results.

However, we can infer some information from the text:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, explicit quantitative acceptance criteria are not provided. The document states that the device is subject to "extensive safety and performance testing" and that "Final testing for the system includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications."

The closest we get to "acceptance criteria" are the standards to which the device complies, implying that meeting the requirements of these standards constitutes acceptable performance.

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

• Sample Size for Test Set: Not specified. The document mentions "performance tests" and "safety testing" but does not provide any details about the number of subjects or cases used in these tests.
• Data Provenance: Not specified. There is no information provided about the country of origin of any testing data, nor if the data was retrospective or prospective.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. There is no mention of any expert consensus or adjudication process for establishing ground truth during testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• MRMC Study: No. The provided text does not mention any multi-reader multi-case comparative effectiveness study or any evaluation of human reader improvement with or without AI assistance. This document describes a modification to a medical device (defibrillator/monitor) with NIBP and CO2 options, which are sensors/measurement tools, not AI-driven diagnostic interpretation tools.

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

• Standalone Performance Study: The document focuses on the device's performance in meeting standards and functional specifications. While "performance tests" are mentioned for the system, it's not described as an "algorithm only" study in the context of typical AI/software device standalone performance. The NIBP and CO2 functions are direct measurements, not an algorithm providing a diagnosis or interpretation that would typically have a "standalone" or "human-in-the-loop" comparison.

7. The Type of Ground Truth Used

• Type of Ground Truth: This is not explicitly stated as pathology, outcomes data, or expert consensus in the traditional sense. For NIBP and CO2 measurement, the "ground truth" would typically refer to accepted, gold-standard reference measurement methods. The document states compliance with standards like ANSI/AAMI SP-10-1992 and EN 864, which themselves define reference methods and accuracy requirements for such measurements. Therefore, the ground truth would be implicitly derived from these established reference measurement techniques as per the specified standards.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not specified. This document describes a hardware device with integrated measurement capabilities (NIBP and CO2). There is no mention of an AI algorithm that would require a "training set" in the context of machine learning.

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

• Ground Truth for Training Set: Not applicable/Not specified. As there's no mention of a machine learning component requiring a training set, this information is not relevant to the provided text.

In summary: The 510(k) summary provided focuses on establishing substantial equivalence to predicate devices and adherence to recognized performance and safety standards. It does not contain the detailed, quantitative efficacy study results, sample sizes, expert qualifications, or ground truth methodologies that would typically be found in submissions for novel diagnostic algorithms or AI-driven systems. The "studies" referred to are generally compliance tests against established engineering and medical device standards.

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