(30 days)
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:
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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.
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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): 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."
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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, as no clinical studies or test sets with ground truth were conducted or described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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. This device is an infant radiant warmer, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
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The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device undergoing a training phase.
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How the ground truth for the training set was established: Not applicable.
What the document does provide regarding "studies" and "criteria":
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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.
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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.
§ 880.5130 Infant radiant warmer.
(a)
Identification. The infant radiant warmer is a device consisting of an infrared heating element intended to be placed over an infant to maintain the infant's body temperature by means of radiant heat. The device may also contain a temperature monitoring sensor, a heat output control mechanism, and an alarm system (infant temperature, manual mode if present, and failure alarms) to alert operators of a temperature condition over or under the set temperature, manual mode time limits, and device component failure, respectively. The device may be placed over a pediatric hospital bed or it may be built into the bed as a complete unit.(b)
Classification. Class II (Special Controls):(1) The Association for the Advancement of Medical Instrumentation (AAMI) Voluntary Standard for the Infant Radiant Warmer;
(2) A prescription statement in accordance with § 801.109 of this chapter (restricted to use by or upon the order of qualified practitioners as determined by the States); and
(3) Labeling for use only in health care facilities and only by persons with specific training and experience in the use of the device.