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The Fisher & Paykel Healthcare IW930 Servo-Control CosyCot Infant Warmer and IW950 Manual-Control CosyCot Infant Warmer are infant radiant warmers (as per 80 FMT, CFR §880.5130) containing an infrared heating element mounted above a builtin pediatric bed assembly, in order to maintain an infant's body temperature by means of controlled radiant heat.

The IW930 and IW950 are designed to provide warmth to babies in the first few weeks of life, when an infant's self-thermoregulation capacity may be reduced, or if external thermal support is required or desirable. This may include new-born babies in delivery room applications, including premature / low birth-weight infants, and support of critically ill babies in neonatal intensive care units (NICU's) or special care baby units (SCBU's). Situations which necessitate unobstructed access to an infant, including during resuscitation or surgical procedures, may indicate the need for a radiant heat source instead of equivalent support devices such as infant incubators.

The Fisher & Paykel Healthcare IW930 Servo-Control and IW950 Manual-Control CosyCot Infant Warmers consist of a heater assembly, controller unit, support column, built-in bed assembly, and base section.

The heater assembly includes a single rod infrared heating element housed inside a parabolic reflector. An observation lamp is mounted at the back of the heater unit. The thermoplastic enclosure is of similar cross-sectional shape to the reflector and is approx. 125mm high × 197mm wide × 625mm deep. It can be rotated to either side of the warmer, clear of the infant bed. A metal grill on the underside of the heater assembly prevents contact with the element.

The heater assembly is mounted on top of the support column, which extends down to the base of the unit, and consists of a single aluminum extrusion section with thermoplastic front panel sections attached. Instruction / warning labeling is located on the back at the top of the support column. Identification labeling is located on the front panel at the base of the support column, with the power inlet and auxiliary power outlet sockets. The dimensions of the support column are approx. 1448mm high × 193mm wide × 90mm deep (104mm deep at controller section top).

The controller unit is built into the top of the support column. The transformer and Power PCB are mounted to the aluminum extrusion back section. The Control PCB is mounted on the inside of the thermoplastic front panel. This panel contains the control buttons, displays, main power switch and temperature sensor socket.

Controls consist of buttons to select operating modes, timer functions and lamp operation. A control knob selects temperature or power level. LED displays include indicators for operating mode, alarms, timer, lamp and heater power, and 3-digit displays for temperature and timer readings.

The bassinet assembly is supported by a four-bar link system attached to the support column extrusion. It consists of a stretched fabric surface over an aluminum extrusion frame. Removable barriers on each side may be folded down for access to an infant, and latch into clips in the bassinet frame. The bassinet may be tilted continuously through +10° to -10° to achieve Trendelenburg and Fowler positions. A spring-loaded cable brake system is used to change the tilt position. An x-ray tray module can be mounted underneath the bassinet for placement of an x-ray cassette. The bassinet assembly is approx. 650mm square x 86mm high, with side barrier panels 127mm above the bassinet surface.

The base assembly consists of a steel main chassis with thermoplastic leg sections. The leg assemblies pivot at their connection points at each end of the main chassis to allow for height adjustment. The height may be mechanically fixed at one of three positions, or an optional electrical height adjustment system allows bassinet heights between 93 and 108 cm. It is activated by foot-controlled buttons on the right front leg of the unit. An electrical actuator system moving rods connected to the leg assemblies changes their angle with respect to the chassis and hence alters the warmer height. Four casters provide for positioning of the unit, two are lockable to prevent inadvertent movement. The main chassis of the base assembly is approx. 87mm high × 207mm wide × 582mm deep. The base has a rectangular 'footprint' area 770mm wide and a depth variable from 120mm to 110mm depending on height adjustment position.

A variety of accessory mounting and storage options are available. Infant resuscitator and oxygen flowmeter modules may be mounted in column front panels. A gas supply module may be mounted to the back of the support column. The column extrusion features a channel mounting system in either side to support mounting blocks for further accessories, which may be fixed at the required height. These include short and long mounting poles, side shelves, venturi suction unit mounting blocks and accessory hooks. Storage trays and bins may be mounted under the bassinet area also using this mounting system. Labeling is provided on the support column stating the maximum accessory loads which may be used depending on the height of the load, in order to ensure stability of the unit is maintained.

In Baby mode, the IW930 provides stable control of the baby's skin temperature by automatically adjusting the heater power to compensate for varying metabolic and environmental conditions. In Manual mode, both the IW930 and IW950 provide useradjustable heater power. In Prewarm mode, the IW930 and IW950 maintain power at a constant level of 25% ready for use.

A double thermistor sensor probe measures the baby's skin temperature, and audible and visual alarms alert the user to high or low temperature situations, equipment fault, power failure and periodic reminders to reassess the baby's clinical condition, depending on the control mode being used. Various independent safety features are included to control maximum output and avoid thermal injury to the infant.

Here's a breakdown of the acceptance criteria and the study information for the Fisher & Paykel IW930 and IW950 CosyCot Infant Warmers, based on the provided 510(k) summary:

The provided document is a 510(k) summary for a medical device and describes performance testing rather than a comparative study. Therefore, some of the requested information (like multi-reader multi-case studies, effect sizes, specific training set details, and expert adjudication for test sets) would not typically be found in this type of submission. This document focuses on demonstrating that the device meets safety and performance standards.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Test Set): Not explicitly stated in terms of patient numbers or specific measurement counts. The document refers to "Performance testing" and "Clinical verification studies" as being carried out, implying a test set was used, but the size is not quantified.
• Data Provenance: The studies were likely conducted internally by Fisher & Paykel Healthcare, based in Auckland, New Zealand, given the company's origin and the submission of the 510(k) from there. It's almost certainly retrospective for the 510(k) submission, meaning the testing was completed before the submission date.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The "clinical verification studies" would have involved medical professionals, but the role of "experts" in establishing a ground truth for a test set (as might be relevant for AI or diagnostic devices) is not detailed. For a medical device like an infant warmer, ground truth might refer to actual measured temperatures against a gold standard thermometer, which doesn't directly involve human expert consensus in the same way.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers are interpreting images or data, and their disagreements need to be resolved to establish a ground truth. For performance testing of a physical medical device like an infant warmer, direct measurements and adherence to engineering standards are the primary assessment methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of results, often comparing human performance with and without AI assistance. This document describes the performance testing of a physical infant warmer, not a diagnostic or AI-assisted interpretation device. Therefore, there is no mention of "effect size of how much human readers improve with AI vs without AI assistance."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in essence. The performance testing described (functional verification, temperature control, irradiance distribution, clinical verifications) assesses the device's inherent capabilities and adherence to standards when operated as intended. While humans operate the device, the "performance" described refers to the device's output (e.g., stable temperature, accurate measurement) in achieving its therapeutic goal. The device itself (the IW930 with its servo-control) is an automated system whose "algorithm" (control logic) operates primarily standalone to maintain temperature.

7. The Type of Ground Truth Used

The ground truth used for performance assessment would primarily be based on:

• Direct Physical Measurements/Engineering Standards: Comparison of measured temperatures, irradiance levels, and control accuracy against established specifications and the international standard IEC 601-2-21.
• Clinical Outcomes/Observations: In the "clinical verification studies," the "ability of the warmers to warm up babies to a stable desired set temperature level accurately in a short period of time, and the ability to control the set temperature very accurately for a stable situation" would be observed against clinical goals for infant thermoregulation. This could involve comparing device readings to a gold standard thermometer for body temperature.

8. The Sample Size for the Training Set

This information is not provided and is largely not applicable in the context of this device and document. Infant warmers are not typically "trained" in the sense that AI algorithms are with large datasets. The device's control system is designed and calibrated based on engineering principles and regulatory standards, not through machine learning training.

9. How the Ground Truth for the Training Set Was Established

This information is not provided and is not applicable for the reasons stated above (the device is not "trained" with a ground truth dataset in the AI sense). The device's calibration and control parameters would be established through engineering design, testing, and adherence to performance specifications.

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