(135 days)
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:
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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The sample size for the training set:
- Not applicable/Not provided. There is no "training set" in the context of this physical device.
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How the ground truth for the training set was established:
- Not applicable/Not provided. There is no "training set."
§ 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).