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The V-2200 Infant Incubator is a device to keep premature infants or neonatal infants in a warm environment which is covered by a hood and isolated from ambient air and of which internal air temperature and humidity, are controlled. It is intended for inpatient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities. Optional functions include pulse oximetry and oxygen delivery. This device is not intended for home use. This device is not intended as a transport incubator. This is a prescription device.

This product consists of a hood, a sensor module, a mattress platform, a middle deck section, a conditioning chamber, a humidity chamber, an operation control section, a power source, a relay box, an oxygen supply/filter box, a pulse oximeter, an oxygen controller and a weight monitor. It is equipped with an incubator air temperature control function to circulate the air containing the heat energy generated by the heater attached to the conditioning chamber inside the hood by means of a fan in order to maintain the incubator air temperature at a fixed level. The device is also equipped with a skin temperature control function to maintain the infant's skin temperature at a fixed level in response to the patients temperature as measured by the skin probe. There is a humidity control function to adjust the amount of vapor generated in the humidity chamber. The following additional features can be installed into the incubator: a pulse oximeter function to monitor Sp02 concentration and pulse rate non-invasively; an oxygen control function to draw oxygen and outside air and control the oxygen concentration delivered to the patient compartment to the desired level; and a weight monitor to facilitate taking the infants weight without moving them from the incubator. This device is designed to be used in treatment, procedures and observation of low-birth-weight and sick neonates, providing heat to the neonate when the body temperature is low and also to provide humidity if desired

The provided text describes a 510(k) premarket notification for the V-2200 Infant Incubator, focusing on the addition of an optional pulse oximeter. However, the document does not contain any information regarding acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria for the pulse oximetry function.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. The document is primarily a regulatory filing for substantial equivalence, detailing the device description, intended use, modifications, and classification, but it does not include performance study data.

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The V-2200 Infant Incubator is a device to keep premature infants or neonatal infants in a warm environment which is covered by a hood and isolated from ambient air and of which internal air temperature and humidity, are controlled. It is intended for inpatient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities.

This device is not intended for home use.

This device is not intended as a transport incubator.

This is a prescription device.

This product consists of a hood, a sensor module, a mattress platform, a middle deck section, a conditioning chamber, a humidity chamber, an operation control section, a power source, a relay box, an oxygen supply/filter box, an oxygen controller and a weight monitor. It is equipped with an incubator air temperature control function to circulate the air containing the heat energy generated by the heater attached to the conditioning chamber inside the hood by means of a fan in order to maintain the incubator air temperature at a fixed level. The device is also equipped with a skin temperature control function to maintain the infant's skin temperature at a fixed level in response to the patients temperature as measured by the skin probe. There is a humidity control function to adjust the amount of vapor generated in the humidity chamber. The following additional features can be installed into the incubator: an oxygen control function to draw oxygen and outside air and control the oxygen concentration delivered to the patient compartment to the desired level; and a weight monitor to facilitate taking the infants weight without moving them from the incubator. This device is designed to be used in treatment, procedures and observation of low-birth-weight and sick neonates, providing heat to the neonate when the body temperature is low and also to provide humidity if desired

The provided document does not contain the information requested for acceptance criteria and a study proving device performance.

The document is a 510(k) summary for the V-2200 Infant Incubator, focusing on its substantial equivalence to predicate devices due to a user interface display modification. It describes the device, its intended use, and the regulatory approval process.

Specifically, the document does not include:

• A table of acceptance criteria or reported device performance metrics.
• Details about a study conducted to demonstrate the device meets any specific performance criteria.
• Information on sample sizes, data provenance, expert qualifications, adjudication methods, or ground truth establishment for any such study.
• Any mention of AI, MRMC comparative effectiveness studies, or standalone algorithm performance.

The document is a regulatory submission for a medical device (infant incubator), and while it mentions "performance standards: none applicable," it does not include performance data or studies that would fall under the categories requested. The "description of modifications" section explicitly states the difference between the V2200 and the V2100G is solely the user interface display (an independent component, multicolor LCD). This suggests the core therapeutic functions (temperature and humidity control) were likely considered equivalent to the predicate without requiring new performance studies for those aspects.

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