(65 days)
The V-505 Atom Infa Warmer is a radiant warming, open type incubator intended to provide an optimum clinical environment for observation, examination, temperature regulation, and management of neonates. Optional functions include pulse oximetry and oxygen delivery.
This device is not intended for home use.
This is a prescription device.
The Atom Infa Warmer V-505 is designed to maintain an infants body temperature by means of infrared radiant heat emitted from a heater located above the mattress. Temperature control is achieved either by manual adjustment of the heater output or by servo control based on changes in the infants skin temperature. All models of the V-505 may also be purchased with the following optional functions: a pulse oximeter that measures the infant's SpO2 and pulse rate, an oxygen delivery system consisting of either an oxygen blender or an oxygen flowmeter, and a suction unit. Other device features (depending on the model) include a timer, illumination lamps, an RS232 connector for communication with an external computer, a rotating/tilting canopy, a tilting mattress platform, baby quards, and support column rails for attaching an optional tray set or IV pole.
The provided document is a 510(k) summary for the Atom Medical Inc. V-505 Infa Warmer, which is an infant radiant warmer. It describes the device, its intended use, modifications from a previous version, and states its substantial equivalence to predicate devices. This document does not contain information about specific acceptance criteria or a study proving the device meets them in the way typically expected for an AI/ML device (e.g., performance metrics like sensitivity, specificity, or AUC against a ground truth).
The information provided pertains to the regulatory clearance of a medical device (infant radiant warmer) and focuses on demonstrating substantial equivalence to a predicate device, as opposed to proving a specific performance level of an AI algorithm.
Therefore, I cannot populate the table or answer the questions as they relate to AI/ML device performance studies. The document does not contain any of the following:
- Specific acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy).
- A study detailing device performance against such criteria.
- Information about sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth, or details about training sets, because this is not an AI/ML device clearance.
The "Performance Standards: None applicable" section further confirms that there are no specific performance benchmarks detailed in this submission for this device type.
§ 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.