(56 days)
Infant radiant warmers provide infrared heat, in a controlled manner, to neonates who are unable to thermoregulate based on their own physiology or necessitate external heat to smoothen the transition from the uterus to the external environment. They fulfill the same purpose of neonatal incubators but they may be preferred over incubators when total access to the patient is needed or desirable (e.g., surgical procedures, cxtracorporcal membrane oxygenation, frequent resuscitation, etc.). Most infant radiant warmers can be used in two operating modes:
a) Manual: The clinician sets the appropriate heater output for maintaining the desired patient temperature. The heater output is initially selected based on the clinician's training and experience and then is adjusted based on the patients' needs and clinical status.
Servo: The clinician sets the desired patient temperature. A skin temperature probe senses the patient temperature and feeds this information to the infant radiant warmer. The controller then adjusts the heater output to maintain the patient temperature at the set value. These adjustments to the heater output are made in such a way to gradually change the patient's temperature while minimizing overshooting and patient stress.
Infant radiant warmers have alart clinicians when certain patient or equipment conditions occur, such as a malfunction, or an excessive departure of the patient's temperature from the set value.
Infant radiant warmers may incorporate other features, such as phototherapy, observation light, tilting of the bed, and data output to remote monitors or nurse call systems.
All functions of the modified IWS, with the exemption of the optional communications module, remain the same as in the predicate device. The current IWS includes an optional RS-232 communications module (Thermalink) that interfaces with the SpaceLabs Flexport monitors or other monitors that adhere to the ThermaLink protocol. The communications module of the modified IWS will also be able to interface with the Hewlett Packard VueLink monitor using the Hewlett Packard proprietary protocol. This change does not affect the operation (displays, alarms, user's controls, etc.) of the incubator. The hardware and software of the IWS controller have not been changed. A microcontroller has been added to the communications module printed circuit board to (a) identify the connected monitor and (b) output data to the monitor using the applicable protocol.
The provided text is a 510(k) summary for the Ohmeda - Ohio® Infant Warmer System, specifically for a modification to its communications module. It explicitly states that clinical or animal testing was not deemed necessary for this submission. Therefore, it does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria.
However, based on the information provided, we can infer some aspects and highlight what is missing:
Inferences and Missing Information:
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A table of acceptance criteria and the reported device performance:
- Inferred Acceptance Criteria: The primary acceptance criterion for the modification is that the communications module functions correctly with both SpaceLabs Flexport monitors (using ThermaLink protocol) and Hewlett Packard VueLink monitors (using Hewlett Packard proprietary protocol) without affecting the core operation (displays, alarms, user's controls) of the infant warmer.
- Reported Device Performance: The document states, "The modified design will be verified by bench testing." It does not provide specific performance metrics or results from this bench testing.
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Sample size used for the test set and the data provenance:
- No information on sample size (e.g., number of units tested, number of communication events tested).
- No information on data provenance (as it's bench testing, not clinical data).
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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 human-expert-based ground truth was established for this bench testing.
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Adjudication method for the test set:
- Not applicable; bench testing does not typically involve adjudication in this context.
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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. This device is an infant warmer, not an AI diagnostic tool. No MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- While the device has a microcontroller for communication, it's not an "algorithm-only" device in the diagnostic sense. The "bench testing" mentioned evaluates its standalone communication functionality.
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The type of ground truth used:
- The "ground truth" for the bench testing would be the expected output and behavior of the communications module when connected to the specified monitors, as per the established communication protocols. This is a technical specification ground truth.
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The sample size for the training set:
- Not applicable. This is a hardware/software modification to an existing medical device, not a machine learning model requiring a training set.
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How the ground truth for the training set was established:
- Not applicable for the same reason as above.
Summary Table of What Can Be Inferred/Extracted:
| Acceptance Criteria Aspect | Description from Document (or Inferred) |
|---|---|
| Acceptance Criteria (Inferred) | The modified communications module must successfully interface with Hewlett Packard VueLink monitors using the Hewlett Packard proprietary protocol, in addition to existing ThermaLink protocol support. The change should not affect the operation (displays, alarms, user's controls, etc.) of the infant warmer. The technological characteristics of the device, specifically temperature and humidity control, must remain unchanged. |
| Reported Device Performance | "The modified design will be verified by bench testing." (No specific results or metrics are provided in this summary.) |
| Study Type to Prove Acceptance | Bench Testing |
| Sample Size (Test Set) | Not specified. |
| Data Provenance (Test Set) | Bench testing (not clinical data). |
| Number of Experts for Ground Truth (Test Set) | Not applicable (technical specifications/protocol compliance). |
| Qualifications of Experts (Test Set) | Not applicable. |
| Adjudication Method (Test Set) | Not applicable. |
| MRMC Comparative Effectiveness Study | No. |
| Standalone Performance Study (Algorithm Only) | Bench testing of the communications module functionality; not an "algorithm only" in the diagnostic AI sense. |
| Type of Ground Truth Used | Technical specification compliance (adherence to communication protocols). |
| Sample Size (Training Set) | Not applicable. |
| How Ground Truth for Training Set Established (Training Set) | Not applicable. |
§ 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.