(89 days)
The OmniBed is a combination of an infant incubator ("incubator") and an infant radiant warmer ("warmer"). Incubators and warmers provide heat in a controlled manner to neonates who arc unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperature controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate's transition from the uterus to the external environment.
The Ohmeda Medical OmniBed is an infant bed which provides thermal support for infants who are unable to provide for their own heat requirements. This bed has two modes of operation, enclosed bed operation and open bed operation.
In the enclosed bed mode of operation, the bed functions as an incubator, maintaining the infant's temperature by circulating heated air within the enclosed bed compartment. The operator may select either the air or skin temperature control method. Depending on the control method selected, heat is regulated based on either the air temperature or the infant's skin temperature compared to the operator selected control temperature. Physical access to the patient is obtained through the side portholes or by opening one of the side doors. In the enclosed bed mode, humidity and oxygen may also be increased.
In the open bed mode, this bed operates like a convention open radiantly heated infant from an infrared heat source is focused on to 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.
This bed can be changed from either mode to the other by the activation of a foot or hand operated switch. The hood canopy will automatically open or close creating either an open or enclosed bed respectively. It should be noted that the device can be operated as conventional incubator or as a conventional infant radiant warmer, but both modes of operation cannot be active at the same time.
The provided text describes the Ohmeda Medical OmniBed, a combination infant incubator and radiant warmer, and its 510(k) submission to the FDA. However, the document does not contain specific acceptance criteria, performance data in a quantitative format, or details of a study designed to prove the device meets such criteria.
The submission focuses on establishing substantial equivalence to predicate devices and describes the device's technological characteristics and indications for use. It explicitly states:
"Since care of newborns in incubators and warmers is a well established clinical practice, Ohmeda submits that clinical or animal testing to demonstrate safety and effectiveness is not necessary. The product was subject to extensive bench testing, the software was validated, and, to the best of Ohmeda Medical's knowledge, the requirements of 21 CFR 820, Subpart C -- Design Controls -- were satisfied."
Therefore, I cannot populate the table or answer most of your specific questions as the information is not present in the provided text.
Here's what I can extract and state based on the document:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in quantitative terms.
- Reported Device Performance: Not provided in quantitative terms. The document only generally states that "The product was subject to extensive bench testing, the software was validated."
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The document states "clinical or animal testing to demonstrate safety and effectiveness is not necessary," implying no formal clinical test set was used for this 510(k) submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no external "test set" with ground truth was used for a clinical study.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no external "test set" with ground truth was used for a clinical study.
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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. The device is a medical apparatus (incubator/warmer), not an AI-assisted diagnostic tool for "human readers."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a medical apparatus (incubator/warmer), not an AI algorithm. Its performance is inherent in its electromechanical function.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of a clinical performance study. The "ground truth" for this device's function would be its ability to maintain a set temperature within specified tolerances, alarms functioning correctly, etc., which would be verified during bench testing.
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The sample size for the training set: Not applicable. The device is a physical medical apparatus, not a machine learning model that requires a training set of data.
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How the ground truth for the training set was established: Not applicable.
Summary of available information regarding performance:
- Type of Testing: "extensive bench testing" and software validation.
- Rationale for absence of clinical/animal testing: "care of newborns in incubators and warmers is a well established clinical practice, Ohmeda submits that clinical or animal testing to demonstrate safety and effectiveness is not necessary."
- Compliance: "requirements of 21 CFR 820, Subpart C -- Design Controls -- were satisfied."
Essentially, the basis for clearance here is substantial equivalence to existing, legally marketed devices (Ohmeda Ohio Care Plus Incubator, Ohmeda Ohio Infant Warmer System, Ohmeda Ohio Intensive Care Incubator) combined with internal bench testing and software validation, rather than a prospective clinical study with defined acceptance criteria and performance metrics.
§ 880.5400 Neonatal incubator.
(a)
Identification. A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.(b)
Classification. Class II (performance standards).