(90 days)
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.
§ 880.5410 Neonatal transport incubator.
(a)
Identification. A neonatal transport incubator is a device consisting of a portable rigid boxlike enclosure with insulated walls in which an infant may be kept in a controlled environment while being transported for medical care. The device may include straps to secure the infant, a battery-operated heater, an AC-powered battery charger, a fan to circulate the warmed air, a container for water to add humidity, and provision for a portable oxygen bottle.(b)
Classification. Class II (performance standards).