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Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate 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 (SpO2) and pulse rate (measured by an SP02 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.

For professional use only, by trained clinicians.

The Ohmeda Medical Giraffe and Panda Warmers are devices with a radiant 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. Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate 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 (SpO2) and pulse rate (measured by an SP02 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.

This 510(k) summary does not contain the kind of detailed information about acceptance criteria and a study proving a device meets them that your request outlines.

Instead, this document describes a submission for infant radiant warmers (Giraffe and Panda Warmers) and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study against specific acceptance criteria.

Here's why the requested information cannot be extracted and what the document does say:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on regulatory compliance and substantial equivalence to existing devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance from a performance study is described. The document states, "The subject of this premarket submission, Giraffe and Panda Warmers, did not require clinical studies to support substantial equivalence."

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 no clinical studies or test sets with ground truth were conducted or described.

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 device is an infant radiant warmer, not an AI-assisted diagnostic tool.

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.

8. The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device undergoing a training phase.

9. How the ground truth for the training set was established: Not applicable.

What the document does provide regarding "studies" and "criteria":

• Summary of Non-Clinical Tests:

  • The document states that the Giraffe and Panda Warmer and its applications "comply with voluntary standards as detailed in this premarket submission." However, it does not list those specific standards or acceptance criteria.
  • It lists general quality assurance measures applied to the development, which are:
    • Risk Analysis
    • Requirements Review
    • Integration testing (System verification)
    • Performance testing (Verification)
    • Safety testing (Verification)
  • No specific results or acceptance criteria for these tests are provided, only that they were applied.

• Summary of Clinical Tests:

  • "The subject of this premarket submission, Giraffe and Panda Warmers, did not require clinical studies to support substantial equivalence."

In conclusion, this document is a regulatory submission focused on demonstrating substantial equivalence of a medical device (infant radiant warmer) to existing predicate devices, rather than detailing a study that measures its performance against specific acceptance criteria for a novel algorithm or diagnostic tool.

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Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate 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 (SpO2) and pulse rate (measured by an 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.
For professional use only, by trained clinicians.

The Ohmeda Medical Giraffe and Panda Warmers are devices with a radiant 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.
The warmers operate similarly to warmers currently in use in hospitals. 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.
Infant radiant warmers are also used to provide thermal support during surgical procedures and during procedures such as extracorporeal membrane oxygenation, resuscitation, or other procedures requiring open access and thermal support.
Both units also feature optional intearated SpO2 and Resuscitation Modules. The Resuscitation Module may feature either a traditional bag-and-mask technology or a T-piece technology. Both the SpO2 module and the Resuscitation Modules use existing technology.
Infant radiant warmers may incorporate other features, such as tilting of the bed, elevating base, and data output to remote monitors or nurse call systems. Infant radiant warmers may also allow use with or attachment of an independent phototherapy device or other accessories.
The Giraffe and Panda UPS is a stand-by power supply that will serve the purpose of temporarily maintaining the operation of the parent devices, the Giraffe and Panda Warmers.

The provided text describes the acceptance criteria and a study demonstrating the device's performance, but it focuses on performance testing rather than an AI/ML-driven diagnostic device. Therefore, several requested fields, such as MRMC studies, details about expert ground truth, and training set information, are not applicable.

Here's the available information presented in the requested format:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated. The study relies on "bench testing" against product specifications and recognized consensus standards.
• Data Provenance: Not applicable, as no patient data was used. The testing was conducted in a laboratory setting ("bench testing").

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth was established by conformance to engineering specifications and recognized consensus standards for infant radiant warmers, not by expert interpretation of data.

4. Adjudication method for the test set:

• Not applicable. The study involved bench testing against predefined performance criteria and standards, not clinical adjudication of diagnostic findings.

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 medical device (infant warmer) without AI or diagnostic functionality, so an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.

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

• Not applicable. The device is not an algorithm, but a physical medical device. Performance was assessed through bench testing of its physical and electrical functions.

7. The type of ground truth used:

• Performance Specifications and Recognized Consensus Standards: The ground truth was based on the device meeting its predefined engineering performance specifications (e.g., battery life, recharge time) and conforming to established, recognized consensus standards for infant radiant warmers.

8. The sample size for the training set:

• Not applicable. This device does not involve machine learning and therefore has no "training set."

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

• Not applicable. This device does not involve machine learning and therefore has no "training set" or associated ground truth establishment process for training.

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