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.

Device Description

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.

AI/ML Overview

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.

Summary

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K970074

APR -3 1997

510(k) Summary

January 6, 1996

Applicant:

Hill-Rom, Inc. 1069 St. Route 46 East Batesville, IN 47006 Reg. No: 1824206

Contact Person:

James G. Carpenter Ph: (812)934-1671 Fx: (812)934-1675

Device trade/proprietary name:

" Stabilet-"

Device common/usual/classification name:

Infant Radiant Warmer

Classification:

General Hospital and Personal Use Device, 21 CFR 880.5130 , Infant Radiant Warmer, 80FMT, Class III

Predicate (Current) Device:

Hill-Rom " Stabilet-" Infant Radiant Warmer, K942948

Device Description

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tray, slide through storage drawer, resuscitation equipment, storage bin and casters with front locking brakes, optional scale and hilo feature.

Intended Use:

Federal law restricts this device to sale by or on the order of a licensed health care practitioner and its use is restricted to health care facilities.

Design and construction:

Both the new and predicate warmers utilize the same materials and methods of construction. The warmers are fabricated from steel, aluminum, and plastic. The submitted warmer's most highly stressed areas utilize only steel and aluminum. Plastics are used in less stressed areas. Steel and aluminum warmer components are welded or assembled with commercially available fasteners. Plastics used in less stressed areas are assembled with fasteners.

The subject warmer and predicate warmer in this submission are substantially equivalent. There is some variation in the available features of the warmers, but the variations do not significantly affect the safety or efficacy of the warmers.

This submission is a result of the introduction of several improvement modifications Hill-Rom has introduced to the existing product. The principal changes are:

Modification of the heater lamp housing

Image /page/1/Picture/9 description: The image shows a close-up of handwritten text on a white background. The text appears to be written in cursive, with the word "pig" clearly visible at the bottom left. The rest of the text is less clear, but it seems to be a single word written diagonally above "pig".

Bare quartz element changed to a stainless steel element. ●
The new element eliminates tube breakage as a hazard to the patient or caregiver. The electrical contacts have been changed from a spring compression socket arrangement to an insulated wire with a screw. This provides a positive locking electrical connection to the power supply.
One heating element to two.

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Heating element length increased from 12" to 16"
Change parabolic reflector from pebbled to smooth to optimize . irradiance pattern with new dual heating elements

Two 375W elements centered over the bassinet replace the single 760W element in the predicate warmer. In conjunction with the increased length and the changes to the parabolic reflector, the irradiance pattern is more evenly distributed and the time required to warm the infant to the caregiver- selected skin temperature is reduced.

Height adjustability for the 1500C and 2000D.

This is a customer preference feature and does not impact the safety of the device to the user or patient. The heater lamp housing to bassinet surface relationship is maintained.

Quartz Halogen task light replaces the florescent task light.

The light is balanced to 3200°K. This more closely approximates natural ambient light and eliminates the color bias imparted by florescent lighting.

Accessories

Resusitation and Suction modules are offered as options on all current and previous models and the 1250C and 1500C Stabiler. This does not represent an increased risk to the user or patient as these options are already standard features on the Predicate 2000C.

A scale option (Premarket Notification K926174) is also available on the P1500C and P2000D models.

Regulation Number and Section

§ 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.