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Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermoregulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. An optional integrated SpO2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate (measured by a SpO2 sensor). An optional integrated resuscitation system may be used to provide the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant.

The Panda iRes Warmer and Giraffe Warmer are infant radiant warmers with a heating source intended to maintain the thermal balance of an infant patient by direct radiation of energy in the infrared region of the electromagnetic spectrum. This device also provides optional integrated SpO2 Monitoring and Resuscitation.

Radiant heat from an infrared heat source is focused onto the bed to warm the patient. The operator may select either the heater power or skin temperature control method. Depending on the control method selected, the heater is either regulated at the operator selected power level or the heater output is modulated to maintain the patient's temperature at the value selected by the operator.

The subject devices have two control modes, Manual Mode and Baby Mode. In the manual Mode, the warmer controls radiant heater output from a heater power percentage setting that you enter using the control panel. In baby mode, the warmer controls radiant heater output based on temperature readings from a probe attached to the baby's skin (skin temperature probe and the reflective probe patch) and a set temperature (set temp) you enter using the control panel.

This document describes the 510(k) summary for the Panda iRes Warmer and Giraffe Warmer, which are infant radiant warmers. The submission is for modifications to strengthen the bedside panels and latches.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria for each test in a numerical format that can be directly compared to reported device performance. Instead, it indicates that testing was "completed with passing results per the acceptance criteria defined in the test cases." The specific quantitative acceptance criteria are not provided in this summary.

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

The document does not specify the sample sizes used for each test. The tests are described as "controlled engineering test fixtures" and "mathematical and statistical analyses," suggesting these were bench tests rather than tests on a specific patient or clinical dataset.

The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective; however, the testing appears to be non-clinical performance and reliability testing conducted internally by GE Healthcare as part of their quality system.

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

This information is not applicable. The testing described is non-clinical engineering and reliability testing of mechanical components. "Ground truth" in the context of clinical or diagnostic performance is not relevant here. The ground truth for these tests would be the established engineering specifications and regulatory standards (e.g., IEC 60601-1).

4. Adjudication Method for the Test Set

This information is not applicable as the tests are non-clinical engineering and reliability tests, not assessments that require human adjudication of a "ground truth" based on expert consensus.

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

No, an MRMC comparative effectiveness study was not done. The document states, "The Panda iRes Warmer and Giraffe Warmer did not require clinical tests to support substantial equivalence." This submission is for modifications to a mechanical component (bedside panel and latches) of an existing device.

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

This question is not applicable. The device is a physical medical device (infant radiant warmer) and not an AI algorithm. The testing focuses on the mechanical integrity and safety of the bedside panels and latches.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing appears to be based on:

• Engineering Specifications: Internal design requirements for the strength, durability, and functionality of the bedside panels and latches.
• Regulatory Standards: Compliance with relevant international standards such as AAMI / ANSI ES60601-1, AAMI / ANSI / IEC 60601-1-2, and IEC 60601-2-21, which define performance and safety criteria for medical electrical equipment and infant radiant warmers.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is a modification to a physical medical device and not an AI/ML algorithm development.

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

This information is not applicable for the reasons mentioned in point 8.

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