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The Babyroo TN300 is an open care radiant warmer that provides a controlled source of heat and regulation of skin temperature for neonates and infants. The optional integrated resuscitation module provides emergency respiratory support administered by clinicians and includes the functionality of suction. Additionally, the device provides weighing (optional) and pulse oximetry (optional) of neonates and infants. The device is designed for use with a body weight up to 10 kg (22 lb).

The device is indicated for thermoregulation, skin temperature regulation, weighing (optional), pulse oximetry (optional), and resuscitation (optional) of neonates and infants.

The purpose of this premarket notification is to activate, for the US market, existing optional functionality which enables the display of SpO2 information by the subject Babyroo TN300 via its graphical user interface (GUI). The SpO2 display functionality is facilitated through connection with existing, cleared pulse oximetry accessories which generate the SpO2 information that is displayed on the subject Babyroo TN300 GUI.

As originally cleared under K230278:
The Babyroo TN300 is an open care infant radiant warmer that provides controlled source heat and skin temperature display for use with neonates and infants. The device can be configured for either labor and delivery or the newborn intensive care unit (NICU) and can be used for intra hospital transfer. Warming therapy is interrupted during intra hospital transfer and patient is not supplied with heat.

The Babyroo TN300 device is offered with a fixed height or adjustable height trolley configuration and provides two heat sources for infant warming: a radiant warmer and an optional heating plate with conductive gel mattress. The device's bed can be tilted up to 15° in Trendelenburg and reverse Trendelenburg directions and the design of the device is intended to facilitate uniform heat distribution over the entire mattress surface across the range of bed tilt angulation. An optional removable canopy is available for intra-hospital transfer.

Infant warming is facilitated via three (3) available thermorequlation modes:

• Manual mode
• Skin temperature mode
• Kangaroo mode

The Babyroo TN300 is available with an optional Resuscitation module. The optional Resuscitation module is pneumatically powered, can be connected to central gas supplies or gas cylinders, and provides emergency resuscitation and suction to the patient. The optional Resuscitation module includes adjustment for gas flow, peak inspiratory pressure, O2 concentration, and suction functionality and is available in three (3) variants:

• Resuscitation module with gas mixer and AutoBreath®.
• Resuscitation module with gas mixer.
• Resuscitation with O2 only.

The optional AutoBreath® function facilitates pneumatically driven, automatic respiratory rate and positive end-expiratory pressure control.

The Babyroo TN300 can be configured to include an optional integrated electronic scale, as well as, optional heated gel mattress, optional integrated single or dual storage drawers, optional gas cylinder holders, and optional x-ray tray.

The provided text describes a 510(k) premarket notification for a modification to the Babyroo TN300 infant warmer device. The modification involves activating existing optional software functionality to display SpO2 information generated by existing, cleared pulse oximetry accessories. The core device functions for warming, resuscitation, and weighing remain unchanged from the predicate device (K230278).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaway: The submission focuses on demonstrating substantial equivalence for the new functionality (SpO2 display and associated alarms) by relying on existing clearances of the core device and the OEM pulse oximetry accessories, in conjunction with specific non-clinical verification testing of the integrated system. No new clinical studies were performed.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a modification (enabling SpO2 display), the acceptance criteria primarily revolve around demonstrating that the new functionality performs as expected and does not introduce new safety or effectiveness concerns, especially concerning the integration with existing, cleared pulse oximetry technology. The performance is assessed by confirming conformity to relevant standards and effective data transfer.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No human clinical data are included in support of substantial equivalence." This means there isn't a "test set" in the traditional sense of patient data.

The testing relied on non-clinical performance testing:

• Sample Size: Not numerical. The testing involved the Babyroo TN300 device itself, presumably one or more units, integrated with the specific OEM Masimo SET® pulse oximetry accessories. The "sample" here refers to the actual device and integrated components under test in a laboratory/engineering setting.
• Data Provenance: The data comes from laboratory/engineering testing performed by the manufacturer (Draeger Medical Systems, Inc.). It is implicitly prospective in the sense that the testing was conducted specifically for this 510(k) submission to demonstrate the safety and effectiveness of the new functionality. No geographic origin for the test data is specified, but it would typically be conducted at the manufacturer's R&D facilities.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Since no human clinical data or expert evaluations of images/readings were used for the test set (as this is a device modification for display of existing, cleared parameters), there were:

• Number of Experts: N/A.
• Qualifications of Experts: N/A.

The acceptance criteria were demonstrated through objective non-clinical performance testing against recognized standards (e.g., ISO 80601-2-61) and internal verification activities. The "ground truth" for the SpO2 display functionality would be the accurate and reliable transmission and display of the SpO2 and pulse rate data generated by the cleared OEM pulse oximetry accessories themselves, as validated in the OEM integration testing.

4. Adjudication Method for the Test Set

• Adjudication Method: N/A. As no human interpretation of data (e.g., images, vital signs patterns) was involved in a "test set" requiring ground truth establishment through expert consensus or adjudication, this is not applicable. The performance was verified through direct measurements and compliance with technical standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• MRMC Study: No. The document explicitly states: "No human clinical data are included in support of substantial equivalence." This type of study is typically performed to evaluate diagnostic accuracy or human performance with AI assistance, neither of which is the primary focus of this specific device modification (which is display of a physiological parameter).
• Effect Size of Human Readers Improvement with AI vs Without AI Assistance: N/A, as no MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

• Standalone Study: Yes, in a practical sense, the "OEM Integration Validation" is a form of standalone testing. This is described as validating "the effective transfer of pulse oximetry signals generated by a clinical simulator through the cleared OEM Masimo SET® pulse oximetry technology board to the subject Babyroo TN300 device's display." This tests the algorithm's ability (within the Babyroo TN300's software) to receive, process, and display the SpO2 data accurately from the source. The "algorithm" here isn't a complex diagnostic AI but rather the software logic for data handling and display.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for validating the SpO2 display functionality was the known, simulated pulse oximetry signals generated by a "clinical simulator" and then interpreted by the already cleared OEM Masimo SET® pulse oximetry technology board. The test ensured that the Babyroo TN300 accurately displayed what the cleared OEM technology was reporting. Essentially, the ground truth was the output of the "cleared OEM Masimo SET® pulse oximetry technology," and the new device's display was compared directly to that expected output.

8. The Sample Size for the Training Set

• Training Set Sample Size: N/A. This device modification does not involve a machine learning or AI algorithm that requires a "training set" in the traditional sense. The software functionality being activated is to display existing, cleared data.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: N/A, as no training set was used.

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The Babyroo TN300 is an open care radiant warmer that provides a controlled source of heat and regulation of skin temperature for neonates and infants. The optional integrated resuscitation module provides emergency respiratory support administered by clinicians and includes the functionality of suction. Additionally, the device provides weighing (optional) of neonates and infants. The device is designed for use with a body weight up to 10 kg (22 lb).

The device is indicated for thermoregulation, skin temperature regulation, weighing (optional), and resuscitation (optional) of neonates and infants.

The Babyroo TN300 is an open care infant radiant warmer that provides controlled source heat and skin temperature display for use with neonates and infants. The device can be configured for either labor and delivery or the newborn intensive care unit (NICU) and can be used for intra hospital transfer. Warming therapy is interrupted during intra hospital transfer and patient is not supplied with heat.

The Babyroo TN300 device is offered with a fixed height or adjustable height trolley configuration and provides two heat sources for infant warming: a radiant warmer and an optional heating plate with conductive gel mattress. The device's bed can be tilted up to 15° in Trendelenburg and reverse Trendelenburg directions and the design of the device is intended to facilitate uniform heat distribution over the entire mattress surface across the range of bed tilt angulation. An optional removable canopy is available for intra-hospital transfer.

Infant warming is facilitated via three (3) available thermoregulation modes:

• Manual mode
• Skin temperature mode
• Kangaroo mode

The Babyroo TN300 is available with an optional Resuscitation module. The optional Resuscitation module is pneumatic powered, can be connected to central gas supplies or gas cylinders and provides emergency resuscitation and suction to the patient. The optional Resuscitation module includes adjustment for gas flow, peak inspiratory pressure, O2 concentration, and suction functionality and is available in three (3) variants:

• Resuscitation module with gas mixer and AutoBreath®.
• Resuscitation module with gas mixer.
• Resuscitation with O2 only.

The optional AutoBreath® function facilitates pneumatically-driven, automatic respiratory rate and positive end-expiratory pressure control.

The Babyroo TN300 can be configured to include an optional integrated electronic scale, as well as, optional heated gel mattress, optional integrated single or dual storage drawers, optional gas cylinder holders, and optional x-ray tray.

The Babyroo TN300 device has an expected service life of 10 years.

The provided text is a 510(k) summary for the Dräger Babyroo TN300 infant radiant warmer. It details the device's indications for use, its comparison to a predicate device, and the non-clinical performance testing conducted to demonstrate substantial equivalence.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with corresponding reported device performance values in a single, clear format as typically expected for specific performance metrics (e.g., a specific temperature range, with a specific accuracy requirement, and the measured accuracy).

Instead, the "7. Substantial Equivalence Comparison and Discussion" section (pages 6-7) serves as the de-facto presentation of performance characteristics and how they compare to the predicate device. For the characteristics where the proposed device differs, the "Comment" column often implies the acceptance criteria (i.e., that the performance meets safety and effectiveness requirements, even if different from the predicate).

Here's a partial reconstruction of a table based on the provided comparison, focusing on performance-related aspects and inferring acceptance criteria where possible:

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The Giraffe OmniBed Carestation is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the on user's demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.

Incubators provide an enclosed, temperature-controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate's transition from the uterus to the external environment.

This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).

The Giraffe Incubator Carestation is an enclosed infant bed, which provides thermal support for infants who are unable to provide for their own heat requirements. The device maintains the infant's temperature by circulating heated air within the closed bed compartment. The operator may select either the air or skin temperature control method. Depending on the control method selected, heat is regulated based on either the air temperature or the infant's skin temperature compared to the operator selected control temperature. Physical access to the patient is obtained through the side portholes or by opening one of the side doors. The Giraffe Incubator Carestation has a color touchscreen user interface (UI) and includes a Hands-Free Alarm Silence (HFAS) feature. The incubator includes a mattress for patient comfort. The Giraffe Incubator Carestation incorporates an optional weighing scale, Servo O2, Uninterruptible Power Supply (UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storage drawers.

The provided document describes the Giraffe Incubator Carestation CS1, a medical device. The submission focuses on modifications to the porthole and wall latches of an existing predicate device (K152809). The document does not describe the device's main performance in terms of medical outcomes but rather the safety and functionality of the latch modifications.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria for the overall medical device performance (e.g., temperature control accuracy, humidity control). Instead, it focuses on demonstrating that the modified latch mechanisms continue to meet existing safety and performance standards, and that their functionality is equivalent or improved compared to the predicate without introducing new risks.

However, the document lists system performance specifications that are identical to the predicate device, implying these are the baseline acceptance criteria for the overall incubator function. For the latch modifications, the acceptance criteria are demonstrated through successful completion of various tests.

Acceptance Criteria (Implied from "Identical" or "Meets all performance and standards requirements") and Reported Performance for the General Device:

2. Sample size used for the test set and the data provenance

The document describes non-clinical testing which includes various functional and reliability bench tests for the modified latches, as well as summative usability testing.

• Test Set Sample Size: The document does not specify a numerical sample size for the bench tests (e.g., number of latches tested, number of cycles for reliability). It lists the types of tests performed. For the "Summative Usability Testing," the sample size of participants is not provided.
• Data Provenance: The testing appears to be prospective and conducted by GE Healthcare (the submitter) in their own labs, as part of their quality system. The country of origin of the data is not explicitly stated but can be inferred to be internally generated by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not specified for the bench tests. For the "Summative Usability Testing," the number of participants is not provided, and whether these participants are considered "experts" (e.g., clinicians) or typical end-users is not detailed.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of expert opinions (e.g., for image interpretation). The testing involves physical and functional evaluation against established standards and internal quality criteria. For usability, the findings are reported, implying evaluation against predefined usability metrics and safety outcomes.

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 submission is for an infant incubator with modified latches, not an AI-powered diagnostic or interpretive device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

• Not applicable. This device does not have an "algorithm only" component that would require standalone performance evaluation typical of AI/ML software.

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

For the latch modifications, the "ground truth" is defined by:

• Compliance with Voluntary Standards: IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-19.
• Engineering Specifications: Internal design requirements for load, torque, cycles, and physical dimensions that ensure safety and functionality.
• Risk Analysis: Identification and mitigation of potential risks associated with the changes.
• Usability Objectives: Ensuring the modified latches do not introduce new use errors or significantly alter the user experience negatively.

8. The sample size for the training set

• Not applicable. This device submission does not involve a "training set" in the context of machine learning or AI.

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

• Not applicable. As there is no training set mentioned or relevant for this device, there is no ground truth established for one.

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Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermoregulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. An optional integrated SpO2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate (measured by a SpO2 sensor). An optional integrated resuscitation system may be used to provide the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant.

The Panda iRes Warmer and Giraffe Warmer are infant radiant warmers with a heating source intended to maintain the thermal balance of an infant patient by direct radiation of energy in the infrared region of the electromagnetic spectrum. This device also provides optional integrated SpO2 Monitoring and Resuscitation.

Radiant heat from an infrared heat source is focused onto the bed to warm the patient. The operator may select either the heater power or skin temperature control method. Depending on the control method selected, the heater is either regulated at the operator selected power level or the heater output is modulated to maintain the patient's temperature at the value selected by the operator.

The subject devices have two control modes, Manual Mode and Baby Mode. In the manual Mode, the warmer controls radiant heater output from a heater power percentage setting that you enter using the control panel. In baby mode, the warmer controls radiant heater output based on temperature readings from a probe attached to the baby's skin (skin temperature probe and the reflective probe patch) and a set temperature (set temp) you enter using the control panel.

This document describes the 510(k) summary for the Panda iRes Warmer and Giraffe Warmer, which are infant radiant warmers. The submission is for modifications to strengthen the bedside panels and latches.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria for each test in a numerical format that can be directly compared to reported device performance. Instead, it indicates that testing was "completed with passing results per the acceptance criteria defined in the test cases." The specific quantitative acceptance criteria are not provided in this summary.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify the sample sizes used for each test. The tests are described as "controlled engineering test fixtures" and "mathematical and statistical analyses," suggesting these were bench tests rather than tests on a specific patient or clinical dataset.

The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective; however, the testing appears to be non-clinical performance and reliability testing conducted internally by GE Healthcare as part of their quality system.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable. The testing described is non-clinical engineering and reliability testing of mechanical components. "Ground truth" in the context of clinical or diagnostic performance is not relevant here. The ground truth for these tests would be the established engineering specifications and regulatory standards (e.g., IEC 60601-1).

4. Adjudication Method for the Test Set

This information is not applicable as the tests are non-clinical engineering and reliability tests, not assessments that require human adjudication of a "ground truth" based on expert consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The document states, "The Panda iRes Warmer and Giraffe Warmer did not require clinical tests to support substantial equivalence." This submission is for modifications to a mechanical component (bedside panel and latches) of an existing device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This question is not applicable. The device is a physical medical device (infant radiant warmer) and not an AI algorithm. The testing focuses on the mechanical integrity and safety of the bedside panels and latches.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing appears to be based on:

• Engineering Specifications: Internal design requirements for the strength, durability, and functionality of the bedside panels and latches.
• Regulatory Standards: Compliance with relevant international standards such as AAMI / ANSI ES60601-1, AAMI / ANSI / IEC 60601-1-2, and IEC 60601-2-21, which define performance and safety criteria for medical electrical equipment and infant radiant warmers.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is a modification to a physical medical device and not an AI/ML algorithm development.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the reasons mentioned in point 8.

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The HYDRO-TEMP Neonatal Skin Surface Temperature Sensor is a non-sterile device intended for connection to an infant radiant warmer to monitor the neonatal patient's skin surface temperature.

The HYDRO-TEMP Neonatal Skin Surface Temperature Sensor consists of a probe used to monitor a neonate's skin surface temperature used as an accessory while the patient is on an infant radiant warmer. The probe is a wire set with a thermistor chip at the distal end that passively modifies the electrical current traveling through the device. A colored connector at the proximal end of the wire set interfaces with the warming bed or a cable that interfaces with the bed. The probe is packaged with an adhesive pad used to affix the sensor to the patient's skin surface. The device is non-sterile and individually packaged in a resealable plastic bag.

Based on the provided text, the device in question is the HYDRO-TEMP Neonatal Skin Surface Temperature Sensor.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set in terms of the number of individual devices or patients. It mentions that "All testing was performed on final, finished product manufactured with the proposed modification." However, it does not specify how many units constituted this "final, finished product."

Regarding data provenance, the document does not specify the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The studies performed are primarily technical performance tests.

4. Adjudication Method

This information is not applicable and not provided in the document, as the studies are technical performance tests rather than clinical evaluations requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study was not done. The device is a temperature sensor, and the studies performed are related to its technical performance and safety, not diagnostic interpretation by human readers.

6. Standalone Performance Study

Yes, standalone performance studies were done. The document states:

• "Accuracy testing was performed to IEC 60601-2-21 demonstrating the tolerance range of temperature readings with the proposed change."
• "Additionally, a time response test in accordance with ISO 80601-2-56 also was performed."
• "Evaluation and testing according to IEC 60601-1 and IEC 60601-1-2 also was performed to ensure the change to the thermistor encapsulation did not affect the electrical safety of the device."
• "The following biocompatibility tests were performed on the final, finished proposed device in accordance with ISO 10993 and FDA guidance: cytotoxicity, sensitization, and irritation."

These are all standalone tests evaluating the device's technical performance and safety characteristics.

7. Type of Ground Truth Used

The ground truth for the performance tests was based on established engineering standards and specifications:

• Accuracy: Reference to IEC 60601-2-21, implying comparison against a calibrated temperature standard.
• Time Response: Reference to ISO 80601-2-56, implying comparison against a defined response time standard.
• Biocompatibility: Reference to ISO 10993 and FDA guidance, ensuring compliance with established biological safety benchmarks.
• Electrical Safety: Reference to IEC 60601-1 and IEC 60601-1-2, ensuring compliance with established electrical safety standards.

8. Sample Size for the Training Set

This information is not applicable and not provided in the document. The device is a physical sensor, not an AI or machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided in the document. The device is a physical sensor, not an AI or machine learning algorithm that requires a training set and associated ground truth.

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The DeRoyal HYDRO-TEMP® Neonatal Skin Temperature Probe Covers are used to adhere the thermistor of the temperature probe to the patient and insulate the thermistor from ambient room temperature ensuring correct temperature readings.

The HYDRO-TEMP® Neonatal Skin Temperature Probe Cover is an accessory to be used with DeRoyal-branded NICU neonatal skin temperature probes used with an infant radiant warmer. They have not been evaluated for use with other manufacturer's products. It is an adhesive pad used to affix a temperature sensor to a neonate's skin to monitor the skin surface temperature. The cover also insulates the temperature sensor from ambient room temperature to ensure temperature readings are accurate.

There are two configurations of the probe cover. Both of these configurations contain a release liner, a patient-contacting hydrogel adhesive, and a metallized polyester backing. One configuration contains an additional foam material that is placed in between the hydrogel adhesive and metallic backing. The device is non-sterile and can be packaged on its own in a foil pouch or in a resealable plastic bag with a temperature probe.

The provided text describes the regulatory filing for the DeRoyal HYDRO-TEMP® Neonatal Skin Temperature Probe Cover (K191425) and its equivalence to a predicate device. The information is focused on mechanical and biocompatibility testing, rather than a clinical study evaluating the device's performance in terms of temperature reading accuracy.

Therefore, many of the requested categories related to clinical study design, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, and training set information, cannot be fully addressed from the provided document.

Here's a summary of the available information structured to answer your questions:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "The proposed device is similar to the predicate but with a modified hydrogel material to improve the adhesive strength, which is supported by performance testing." This implies the acceptance criterion for adhesive strength was to be at least equivalent to, if not better than, the predicate. The data shows it is better.

2. Sample size used for the test set and the data provenance

• Sample size: Not specified for any of the individual tests (peel force, pull test, insulation, accuracy, biocompatibility).
• Data provenance: The tests were conducted internally by DeRoyal Industries, Inc. (or contracted labs for biocompatibility) as part of their 510(k) submission. The data is retrospective for the purpose of demonstrating substantial equivalence to a legally marketed predicate device. Country of origin not explicitly stated, but DeRoyal is a U.S.-based company.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This was not a clinical study involving human judgment or "ground truth" established by experts in the context of diagnoses or interpretations. The tests were objective mechanical and biological safety assessments.

4. Adjudication method for the test set

Not applicable. This was not a study requiring adjudication of expert opinions.

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 device is a passive accessory (probe cover) and does not involve AI or human "readers" making interpretations.

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

Not applicable. This device is a physical medical accessory, not an algorithm.

7. The type of ground truth used

The "ground truth" for the performance tests would be the standardized testing methods themselves (e.g., ASTM D903-98 for peel strength, IEC 60601-2-21 for accuracy, ISO 10993 for biocompatibility) and the physical measurements obtained from those tests. There is no expert consensus, pathology, or outcomes data used as "ground truth" in the way it might be for a diagnostic device.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

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The NuBorne 500 Infant Warmer is an open care environment used for providing controlled infrared heat to neonates who are physiologically unable to maintain their body temperature or may require external heat to ease the transition from the mother's womb to the external environment.

The device is intended to be used in a Labor & Delivery environment for infants immediately after birth, or in a Neonatal Intensive Care Unit for providing premature infants long duration therapy, or in newborn care areas, for providing external heat to low-birth weight infants, and for cases where clinical indications require short/ long duration warming therapy.

The device allows access to the infants for various procedures, tilting of the infant and x-ray diagnostics. The device provides three modes of warming: Manual, Skin, and Standby mode for varying care requirements. Also, allows attaching optional accessories on the rail for therapy and monitoring of the infant.

The NuBorne Infant Warmer is an open care environment used for providing controlled infrared heat to neonates who are physiologically unable to maintain their body temperature or who need external heat to smoothen the transition from the mother's womb to the external environment.

The NuBorne Infant Warmer has three modes of temperature control available – manual temperature mode, skin temperature control mode and standby mode. The device includes a bed that tilts, has height adjustment, side panels, APGAR timer, x-ray tray and an optional inbed scale.

Here's a breakdown of the acceptance criteria and the study information for the NuBorne Infant Warmer, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific, predefined performance criteria through a traditional clinical study with human patients. As such, information regarding sample sizes, ground truth establishment for AI, human reader studies, and training sets (common in AI/software device submissions) is not applicable to this type of device and submission. This device is a hardware medical device, not an AI or software-as-a-medical-device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are derived from compliance to recognized medical device standards and functional performance compared to predicate devices. The "reported device performance" reflects how the NuBorne Infant Warmer meets these standards and compares to its predicates.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable. This is a hardware medical device, not an AI/software device that uses a "test set" of data in the sense of classification or diagnostic performance. Performance was evaluated through bench testing and compliance with standards.
• Data Provenance: Not applicable. The "data" here refers to direct measurements and observations during engineering and safety testing of the device itself, rather than patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable. The "ground truth" for a hardware device like an infant warmer is established through engineering specifications, regulatory standards, and physical measurements (e.g., temperature accuracy, noise levels, safety features). This does not typically involve expert radiologists or similar medical specialists establishing a "ground truth" for classification tasks.
• Qualifications of Experts: N/A for establishing "ground truth" in this context. However, engineering and regulatory experts would have overseen the testing and documentation.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This is a hardware device; thus, there is no "test set" that requires adjudication by human readers for diagnostic or classification concordance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No. This type of study is relevant for diagnostic imaging devices or AI-powered clinical decision support systems where human reader performance is being evaluated with and without AI assistance. The NuBorne Infant Warmer is a therapeutic/supportive care device.
• Effect Size: Not applicable.

6. Standalone Performance Study (Algorithm Only)

• Standalone Performance Study: No. This concept is for AI algorithms. The NuBorne Infant Warmer is a physical device with embedded software controlling its functions, but it's not an "algorithm only" device in the sense implying standalone diagnostic or predictive performance. Its performance is its standalone performance as a medical device.

7. Type of Ground Truth Used

• Type of Ground Truth: For this device, the "ground truth" is defined by:
  • Engineering Specifications: Designed parameters and tolerances for temperature, noise, physical dimensions, etc.
  • International and National Medical Device Standards (e.g., IEC 60601 series): These standards define acceptable safety, electrical, mechanical, and performance characteristics.
  • Internal Validation and Verification Protocols: Procedures to confirm the device operates according to its design and specifications.
  • Biocompatibility Standards (ISO-10993): Defining acceptable biological response of materials.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device does not use machine learning or AI that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this device type.

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Babyleo TN500 is intended for use with premature babies and can be used as both an incubator and a radiant warmer. When the product is switched between incubator and radiant warmer operation, patients continue to be kept warm during the transition. The device provides a thermally regulated environment for patients with a body weight of up to 5 kg (11 lbs) and a height of up to 55 cm (22 in). The device can be operated as either a closed care unit or an open care unit. As a closed care unit, Babyleo TN500 is an incubator.Neonates are kept warm in the patient with humidifiable air, which can be enriched with oxygen (option). As an open care unit, Babyleo TN500 is a radiant warmer. Babyleo TN500 provides controlled ambient conditions for premature babies and neonates. The following parameters are regulated, according to the intended use: - Temperature - Humidity - Oxygen (option)

The device Babyleo TN500 is a medical device used to maintain environmental conditions suitable for preterm babies and neonates. The important features are temperature and humidity. The operational principle is a combination of a neonatal incubator and an open warmer.

Babyleo TN500 can be operated in closed care therapy as an incubator according to IEC60601-2-19 or in open care therapy as a warmer according to IEC60601-2-21. Additionally, an optional x-ray translucent heated mattress is intended to provide sensible heat to the preterm babies and neonates.

The device consists of the following components: Incubator (=bassinet) with a convection heater and closed humidification system for the patient, trolley, radiant warmer, display, mattress, x-ray and height adjustment. Optional components are scale, heated mattress, drawer, oxygen regulation with cylinder holder and Auto Thermo package and Developmental Care package.

This document is a 510(k) Premarket Notification for the Babyleo TN500, a neonatal incubator and radiant warmer. It aims to demonstrate substantial equivalence to legally marketed predicate devices. The information provided heavily focuses on design verification and validation testing, and therefore, does not contain the details on acceptance criteria and study proving performance in the context of an AI/ML medical device that would typically involve clinical studies, multi-reader multi-case studies, and explicit ground truth establishment with expert consensus.

Given the document talks about a physical medical device (neonatal incubator/radiant warmer) and not an AI/ML diagnostic or prognostic tool, the questions posed about "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or AUC, multi-reader multi-case studies, expert consensus for ground truth, effect size for human reader improvement with AI assistance, and training/test set sample sizes and provenance for AI/ML models are not applicable to this submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" for this conventional medical device primarily revolve around safety and performance standards, electrical safety, EMC, software verification, biocompatibility, human factors, and reprocessing validation.

Here's how to address the prompt based on the provided document:

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

The document lists compliance with various standards and provides specifications that serve as performance criteria.

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Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. An optional integrated SpO2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor). An optional integrated resuscitation system may be used to provide the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant.

The Giraffe and Panda Warmers are devices with a radiant heating source intended to maintain the thermal balance of an infant patient by direct radiation of energy in the infrared region of the electromagnetic spectrum. The warmers operate similarly to warmers currently in use in hospitals. Radiant heat from an infrared heat source is focused onto the bed to warm the patient. The operator may select either the heater power or skin temperature control method. Depending on the control method selected, the heater is either regulated at the operator selected power level or the heater output is modulated to maintain the patient's temperature at the value selected by the operator. Infant radiant warmers are also used to provide thermal support during surgical procedures and during procedures such as extracorporeal membrane oxygenation, resuscitation, or other procedures requiring open access and thermal support. The units also feature optional integrated SpO2 and Resuscitation modules. The Resuscitation Module may feature either a traditional bag-and-mask technology or a T-piece technology. Both the SpO2 module and the Resuscitation Modules use existing technology. The Giraffe and Panda Warmers can be used with the Giraffe Shuttle and UPS, a mobile power source that allows for transport of the patient between care areas within the hospital building and provides power to the Warmers.

The provided GE Healthcare 510(k) Premarket Notification Submission (K123309) describes modifications to existing Giraffe and Panda Warmers, specifically introducing Freestanding and Wall Mount configurations. However, the document explicitly states that clinical studies were not required to support substantial equivalence for these modifications. Therefore, the submission does not contain information about acceptance criteria or a study proving the device meets them in the context of clinical performance or diagnostic efficacy.

The submission focuses on engineering verification and validation (non-clinical tests) to demonstrate that the modified warmers maintain the same safety and effectiveness as the predicate devices.

Here's a breakdown of the requested information based on the provided text, highlighting what is available and what is explicitly not available or applicable:

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

   No such table is provided in the document for clinical performance. The document describes several non-clinical quality assurance measures and testing but does not detail specific acceptance criteria or performance metrics in a table format for clinical use.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   Not applicable. The document states: "The subject of this premarket submission... did not require clinical studies to support substantial equivalence." Therefore, there was no clinical test set with a specific sample size or data provenance.

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. As no clinical studies were performed, there was no ground truth to establish for a clinical test set by experts.

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

   Not applicable. As no clinical studies were performed, there was no test set requiring adjudication.

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 device is an infant radiant warmer, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed.

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

   Not applicable in the context of diagnostic AI. The device features an "patient temperature control algorithm previously cleared per 510(k) K090697." The software changes involved scaling heater power and adopting this existing proportional heater control algorithm. The performance of this control algorithm was likely validated during the original 510(k) for the Giraffe and Panda Warmer (K090697) through engineering tests, but not as a "standalone diagnostic algorithm."

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

   Not applicable for clinical ground truth. For the engineering validation of the device (non-clinical tests), the ground truth largely relies on compliance with voluntary standards, design specifications, and safety requirements (e.g., surface touch temperatures at maximum altitude, maximum ambient operating temperature, bed surface height).

8. The sample size for the training set

   Not applicable. As no AI/machine learning model for clinical/diagnostic use is being described, there is no training set in that context. The "software changes" mentioned relate to control algorithms for heater power, which are typically derived from engineering principles and validated through testing, not "trained" on data in the AI sense.

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

   Not applicable, as there is no training set in the AI/machine learning context described in this document.

Summary of Non-Clinical Tests (from the document):

The device underwent the following non-clinical tests to demonstrate substantial equivalence:

• Risk Analysis
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Performance testing (Verification)
• Safety testing (Verification)
• Simulated use testing (Validation)

These tests evaluate the device's compliance with engineering specifications, safety standards, and functional performance, but they are not clinical studies designed to establish diagnostic accuracy or compare human reader performance. The main purpose of this 510(k) was to introduce new mechanical configurations and minor software adjustments to an already cleared device, without changing its fundamental technology or indications for use.

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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.

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.

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.

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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