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The Resuscitaire® Radiant Warmer is intended for thermoregulation, skin temperature monitoring, APGAR timing and resuscitation of newly born infants up to 10kg. It is not intended for long term resuscitation or home use.

Device Description

The modified Resuscitaire Radiant Warmer is for newbom infants and consists of a bassinet, warmer and a controller module which provides heat control, monitoring of the skin temperature and an APGAR timer. It also includes optional manual and automated resuscitation with suction and oxygen delivery and a patient gas supply breathing circuit.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the "Resuscitaire Radiant Warmer." This type of document is for premarket notification of a device claiming substantial equivalence to a legally marketed predicate device, not typically for evaluating AI/algorithm performance. Therefore, much of the requested information, specifically regarding AI algorithm performance, ground truth, sample sizes for training/test sets, expert adjudication methods, and MRMC studies, is not applicable to this type of traditional medical device submission.

The "study" described in this document is a comparison of technological characteristics with predicate devices and non-clinical testing to demonstrate safety and effectiveness for a modified device.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present acceptance criteria in a quantitative table with corresponding device performance metrics in the typical format for AI/algorithm performance studies. Instead, it compares specifications and performance characteristics of the device under review (Resuscitaire Radiant Warmer with AutoBreath feature) against three predicate devices. The "reported device performance" is implied by demonstrating substantial equivalence across these characteristics.

Based on the "Comparison of Technological Characteristics with Predicate Devices" table, here's an attempt to structure relevant points into the requested format, focusing on the added AutoBreath™ Infant Resuscitator Feature (AB) as it represents the primary modification and subject of comparative analysis. It's important to note that the "acceptance criteria" here are essentially the characteristics of the predicate devices or established medical norms.

Acceptance Criteria (Based on Predicate Devices/Medical Norms)	Reported Device Performance (Resuscitaire Radiant Warmer with AutoBreath-AB)	Comments from Document
I:E Ratio: Within normal range for neonatal ventilation (e.g., 1:1 to 1:3). Predicate MVP-10: 1:8 to 3:1 (adjustable). Predicate Neopuff: Manually estimated.	Fixed internally at 1:2 nominal (1:1.6 to 1:2.2) (non-adjustable).	"The fixed I:E ratio of the AB falls within the normal range for neonatal ventilation as published in the Assisted Ventilation of the Neonate 4th Edition copyright 2003, (1:1 to 1:3). Additionally the 2010 AHA Guidelines for neonatal resuscitation recommend breath rates of 40 -60 BPM. All three devices can provide I:E ratios within the recommended range. The Neopuff is manually estimated and controlled by the user therefore both the I:E ratio and BPM will vary. The preset I:E ratio of the RW82 w/ AB eliminates human variation by guaranteeing a consistent I:E ratio."
Adjustable PEEP: Minimum 3-4 cmH2O for newborns, flow rate 5-8 LPM for low birth weight, 6-10 LPM for term infants. Predicate MVP-10: Variable up to 18 ± 3 cm H2O. Predicate Neopuff: 1-25 cm H2O/mbar across different LPMs.	@ 5 LPM minimum PEEP 14 cm H2O.	"Although not identical, the PEEP ranges are similar. Based on the application of use the differences are not significant. For newborns the recommendations are: minimum PEEP from 3 to 4 cmH2O, and flow rate 5 to 8 LPM for low birth weight infants and flow rate 6 to 10 LPM for term infants."
Adjustable Respiratory Rate Range: Predicate MVP-10: 0 to 120 BPM. Predicate Neopuff: User dependent.	18 to 60 BPM ± 10% of setting.	"Both the RW82 w/ AB and the MVP10 allow the user to set the respiratory rate. The advantage of a set respiratory rate is to eliminate the human variation associated with manually controlled rates (RW82 & Neopuff). The MVP10 has a larger respiratory rate range, is due to the patient population of the MVP10 which includes pediatrics. The RW82 w/ AB is only intended for the resuscitation of newborns in L&D environments."
Adjustable Airway Pressure Relief (PIP): Predicate MVP-10: 10 + 5 to 80 + 10 cm H2O. Predicate Neopuff: 2 to 80 cm H2O.	0 to 50 cmH2O + 5 cm H2O (0 to 4.9 kPa + 0.5 kPa).	"The MVP10 and the Neopuff have a larger range based on patient populations for ventilation, while RW82 w/ AB is only intended for the resuscitation of newborns in L&D environments."
Fixed Max Pressure (P Lim min): Predicate MVP-10: Variable up to 70 ± 10 cm H2O. Predicate Neopuff: Variable up to 80 cm H2O.	50 cm H2O + 10% (5.0 kPa + 10%).	"The differences between the fixed max pressures of the MVP-10, Neopuff & Auto-Breath are related to the environment in which resuscitation is provided... Like the Neopuff, the RW82 w/ AB also provides manually adjustable PEEP & PIP. It differs in that it provides a lower fixed max. pressure because the intended use is limited to the L&D."
Fixed Min Pressure (P Lim min): Predicate RW82: 0 cmH2O. Predicate MVP-10: 0 cmH2O. Predicate Neopuff: 0 cm H2O ± 2.	Same as predicate RW82 (0 cmH2O).	None specified beyond "Same as predicate RW82". This indicates it meets or is equivalent to the predicate.
Logic Circuit (Pneumatic Control): Predicate MVP-10: Approx 4 LPM at 50 BPM. Predicate Neopuff: None.	5 LPM (for pneumatic control for AutoBreath).	"Like the MVP-10 the RW82 w/ AB is a pneumatically controlled device. Both circuits control the time intervals between exhalation and inspiration and the pressure in the patient circuit."
Dead Space: Predicate MVP-10: 0.5 ml max. Predicate Neopuff: 6 ml.	3.4 ml.	"Dead space will vary based on the make up/mfg. of the patient breathing circuit."
Body Weight Range: Predicate MVP-10: Applications requiring TV up 660 ml. Predicate Neopuff: Up to 10 kg.	Same as Neopuff (up to 10 kg).	This indicates it meets or is equivalent to the predicate.
Patient Interface: Predicate MVP-10: Endotracheal Tube. Predicate Neopuff: Face Mask or Endotracheal Tube.	Face Mask.	None.

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: Not applicable. This device is a hardware product with added functionality, not an AI/algorithm. The "testing" referred to is engineering verification and validation, as well as comparison of specifications to predicate devices.
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not an AI/algorithm being evaluated for diagnostic or prognostic accuracy against a ground truth established by experts. The "ground truth" for this device's performance is its physical and functional specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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

Not applicable. This is not an AI-assisted device requiring an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The AutoBreath feature is an integrated pneumatic control system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of an AI/algorithm's "ground truth." For this device, the "ground truth" for its performance evaluation (non-clinical testing) refers to established engineering standards, guidance documents (e.g., ISO, AAMI/ANSI), and the performance characteristics of its predicate devices, as well as physiological recommendations for neonatal resuscitation (e.g., AHA Guidelines for neonatal resuscitation).

8. The sample size for the training set

Not applicable. There is no training set for this type of device.

9. How the ground truth for the training set was established

Not applicable.

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