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510(k) Data Aggregation
(86 days)
The Fisher & Paykel Healthcare IW980 Servo-Control Wall-Mount Infant Warmer and IW990 Manual-Control Wall-Mount Infant Warmer are infant radiant warmers (as per 80 FMT, CFR §880.5130) containing an infrared heating element intended to be mounted over an infant in a pediatric hospital bed, to maintain the infant's body temperature by means of controlled radiant heat.
The IW980 and IW990 are designed to provide warmth to bables 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 IW980 Servo-Control and IW990 Manual-Control Wall-Mount Infant Warmers consist of heater assembly and controller unit sections, with wall mounting hardware components.
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 controller unit. 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 main label is located on the controller unit rear panel, with a duplicate copy of label instructions provided. The power inlet socket is mounted in the underside, and dimensions of the controller are approx. 329mm high × 193mm wide × 104mm deep.
The controller section is supported by a dual 30mm channel bracket mounting system, attached via a mounting frame to a wall. The channel brackets enable the entire warmer unit to be lifted clear of the mounting hardware for purposes of cleaning, maintenance, or moving the unit to an alternate mounting position.
In Baby mode, the IW980 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 IW980 and IW990 provide useradjustable heater power. In Prewarm mode, the IW980 and IW990 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.
The provided document describes an infant warmer and its performance characteristics but does not contain the level of detail required to answer all parts of your request regarding acceptance criteria and a specific study proving device meets those criteria, particularly in the context of an AI/ML device. This document is for a traditional medical device (infant warmer) and was approved in 1997, predating the widespread use of the detailed AI/ML study reporting you are asking for.
However, I can extract the information that is present and indicate where information is missing based on your query structure.
Here's an attempt to answer based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document hints at acceptance criteria by referencing compliance with IEC 601-2-21 and detailing areas of performance testing.
| Acceptance Criteria (Implied / Referenced Standard) | Reported Device Performance (from text) |
|---|---|
| Compliance with IEC 601-2-21 standard for Infant Radiant Warmers | "The proposed devices meet specific aspects of performance required by the standard for Infant Radiant Warmers, IEC 601-2-21." |
| Temperatures achieved on the mattress surface for different materials | Testing demonstrated "absolute accuracy of temperatures achieved on an infant bed". Specific values or ranges not provided. |
| Temperature distribution and variance across the mattress surface | Testing demonstrated "uniform distribution" and "temperature distribution and variance across the mattress surface". Specific values not provided. |
| Accuracy of temperature control in the servo-controlled mode (IW980) | "The temperature controlling system and software used to regulate this allow for very accurate and stable control of an infant's skin temperature". Clinical studies demonstrate "the ability to control the set temperature very accurately for a stable situation." |
| Absolute accuracy of temperature measurement against an external comparison | Testing demonstrated "absolute accuracy of temperature measurement against an external comparison". Specific values not provided. |
| Maximum irradiance levels for overall IR and near IR spectrum regions | Testing demonstrated "qualitative nature of the irradiance distribution pattern on the mattress, including irradiance in specific regions of the infra-red spectrum" and addressed "maximum irradiance levels for overall IR and near IR". Specific levels not provided. |
| Functional verification | "Performance testing for the IW980 and IW990 has been carried out in the areas of functional verification." |
| Clinical verification (warming babies to stable set temperature, accuracy, and speed) | "Clinical verification studies demonstrate 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." Also "Clinical verification studies demonstrate the successful use of the warmers and their ability to provide accurate and stable warming of infants." |
| Safety features (e.g., maximum output, thermal injury avoidance, sensor detection) | "Various independent safety features are included to control maximum output and avoid thermal injury to the infant." "use of a dual-thermistor skin temperature sensor, the comparison of readings from which allows the equipment to detect any variation in the sensor performance, and ensure accurate temperature measurement." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified. The document mentions "Performance testing" and "Clinical verification studies" but does not provide details on the number of subjects or test cases.
- Data provenance: Not specified. The manufacturer is based in New Zealand, but the location of the clinical verification studies is not mentioned. It can be inferred as prospective based on "clinical verification studies demonstrate the ability of the warmers to warm up babies..." indicating active testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided as the device is an infant warmer, not an AI/ML diagnostic tool that requires expert-established ground truth in the typical sense. Expertise would have been involved in the design and interpretation of the clinical verification studies, but not in establishing ground truth for a test set as would be relevant for an AI model.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. This question is typically relevant for studies validating diagnostic AI/ML devices where reader disagreement needs resolution. For an infant warmer, performance is measured against physical parameters and clinical outcomes, not expert interpretation.
5. 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
- No. This is explicitly a traditional medical device, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI assistance effect size are not relevant or discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical infant warmer, not an algorithm. Its operation is inherently "standalone" in that it performs its warming function directly, but it's not an algorithm whose performance needs to be evaluated in isolation from hardware.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance would be established through objective physical measurements (temperature, irradiance) and clinical outcomes (infant's stable temperature, warming time). This is implicitly "outcomes data" in a clinical setting and objective measurement in laboratory settings.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no AI/ML training set.
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