(85 days)
The Stabilet- Infant Radiant Warmer maintains the infant's body temperature at a level determined by the caregiver through the use of an infrared radiant heating element and is designed to be used in those areas of the healthcare facility that provide neonatal and infant care.
The Hill-Rom Stabilet- is a device consisting of an infrared heating element positioned over an infant to maintain the infant's body temperature by means of radiant heat. Available features include a warming/lighting module which provides heat through two stainless steel heater tubes, manual or servo heat control with a temperature monitoring sensor and temperature alarms, procedural Apgar timer, bassinet with mattress and spring loaded fold down sides, trendelenburg/reverse trendelenburg, x-ray cassette tray, retractable Mayo tray, slide through storage drawer, resuscitation equipment, storage bin and casters with front locking brakes, optional scale and hilo feature.
This appears to be a 510(k) premarket notification for a medical device (Infant Radiant Warmer). The provided text describes the device and its modifications, but it does not contain any information about acceptance criteria or a study proving the device meets those criteria in the context of, for example, diagnostic or analytical performance.
The document is purely descriptive and compares the new device to a predicate device, focusing on safety and efficacy from an engineering and design perspective rather than a clinical performance study. The "study" mentioned is not a clinical study in the sense of evaluating diagnostic accuracy or reader improvement, but rather a description of design modifications and how they maintain or improve safety and function.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: No such criteria or performance metrics (like sensitivity, specificity, AUC) are provided.
- Sample size used for the test set and the data provenance: Not applicable, as there's no diagnostic test set.
- Number of experts used to establish the ground truth... and their qualifications: Not applicable.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document is a submission for a radiant warmer, which is a piece of equipment designed to maintain an infant's body temperature, not a diagnostic imaging or AI-driven device that would typically have the kind of performance metrics you're asking for.
The "study" in this context refers to the engineering design and testing, ensuring the device meets its functional requirements and safety standards, largely by comparison to an existing predicate device. For example, it mentions:
- "The new element eliminates tube breakage as a hazard..."
- "The electrical contacts have been changed... This provides a positive locking electrical connection..."
- "the irradiance pattern is more evenly distributed and the time required to warm the infant to the caregiver- selected skin temperature is reduced."
These are functional improvements and safety considerations, not performance metrics of an AI algorithm or diagnostic tool.
§ 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.