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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 other 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 OmniBed Carestation is an updated version of the cleared predicate Giraffe OmniBed. The Giraffe OmniBed Carestation is a combination device that can function as an incubator (with the canopy closed) or as an infant radiant warmer (with the canopy open) based on the user's selection.

Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. With the canopy closed, the bed functions as an incubator, maintaining the infant's temperature by circulating heated air within the enclosed 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 operated selected control temperature. Physical access to the patient is obtained through the side portholes or by opening one of the side doors.

With the canopy opened, this bed operates like a conventional open, radiantly heated infant bed. Radiant heat from an infrared heat source is focused onto the bed to warm the patient.

The Giraffe OmniBed Carestation incorporates an optional weighing scale, Uninterruptible Power Supply (UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storage drawers.

The proposed modification of the Giraffe OmniBed is referred to as the Giraffe OmniBed Carestation.

The Giraffe OmniBed Carestation updates the graphical monochrome display user interface (UI) on the predicate to a digital touchscreen UI, with the required software changes to support the new format and layout. The main system control software was not changed; however the software for the UI was updated because of the UI format change. The modified Giraffe OmniBed Carestation maintains the predicate Giraffe OmniBed functionality, performance, and clinical workflows. The changes also include a modified device visual indicator light and the capability for Hands Free Alarm Silencing (HFAS).

Other modifications being made for the Giraffe OmniBed Carestation include upgrading the power supply from 75W to 120W to support the increased power requirements of the touchscreen and associated electronics.

There is no change in the indications for use or intended use of the system. There are no changes to the patient contacting materials of the device, and they remain identical to the predicate. The changes made do not affect the function, performance, safety, or clinical use of the device.

This document is a marketing submission (510(k) summary) for a medical device, specifically a neonatal incubator/warmer, and not a study proving a device meets acceptance criteria. Therefore, the detailed information requested regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be extracted from this document, as it does not contain the specifics of a performance study with defined acceptance criteria and results.

The document states: "The subject of this premarket submission, Giraffe OmniBed Carestation, did not require clinical studies to support substantial equivalence." This means that the manufacturer is claiming substantial equivalence based on non-clinical tests (such as electrical safety, performance verification against standards, software testing) and the device's technological similarity to previously cleared predicate devices, rather than through a comparative clinical study.

Here's what can be inferred and what cannot, based on the provided text:

What Can Be Inferred/Extracted (to some extent):

• Device Name: Giraffe OmniBed Carestation CS1 (K152814)
• Device Type: Combination infant incubator and infant warmer.
• Indication for Use: To provide heat in a controlled manner to neonates unable to thermoregulate. Can operate as an incubator (closed canopy) or radiant warmer (open canopy). May incorporate a Servo Controlled Oxygen Delivery System for stable oxygen concentration (21-65%).
• Predicate Device(s): Giraffe OmniBed (K101788, K071175, K020543, K993407)
• Key Modification: Updates the graphical monochrome display user interface (UI) to a digital touchscreen UI, with associated software changes. Also, an upgraded power supply (75W to 120W) and updated visual indicator light and Hands Free Alarm Silencing (HFAS) capability.
• Determination of Substantial Equivalence: Based on non-clinical tests and technological similarity to predicates.
• Non-Clinical Tests Mentioned (examples of types of tests, not specific results or acceptance criteria):
  • Risk Analysis
  • Design Reviews
  • Unit level testing (Module verification)
  • Integration testing (System verification)
  • Software testing (Verification and Validation, IEC 62304:2006)
  • Performance testing (Verification of performance specifications, including IEC 60601-2-21:2009 for warmers, IEC 60601-2-19:2009 for incubators)
  • Safety and EMC testing (Verification ES 60601-1:2005+A1 2012, IEC60601-1-2:2007)
  • Usability testing (Validation IEC 62366: 2014)

What Cannot Be Extracted (because the document is not a study report):

1. A table of acceptance criteria and the reported device performance: This document lists types of tests performed (e.g., performance testing against standards), but it does not provide the specific numerical acceptance criteria (e.g., "temperature stability must be within +/- 0.5°C") nor the measured device performance against those criteria.
2. Sample sizes used for the test set and the data provenance: Not applicable as it's not a clinical study. The non-clinical tests would have involved specific test units, but the "sample size" of patients/data as in a clinical study is not relevant here.
3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable as no clinical ground truth was established for "testing" in the sense of patient data. Usability testing might involve experts, but details are not provided.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: No, the document explicitly states: "The subject of this premarket submission... did not require clinical studies to support substantial equivalence." An MRMC study would be a clinical study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is electro-mechanical, not AI-driven in the sense of an algorithm interpreting data to generate a finding.
7. The type of ground truth used: Not applicable. Ground truth for clinical studies would be, for example, pathology results for a lesion, or confirmed diagnosis; here, "ground truth" would be the engineering specifications and performance standards.
8. The sample size for the training set: Not applicable. This device is not an AI/ML device that requires a training set of data.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text is a regulatory submission demonstrating substantial equivalence of a medical device based on non-clinical testing and comparison to predicate devices, not a report of a study designed to prove the device meets specific clinical acceptance criteria.

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The Giraffe Incubator Carestation is an Infant Incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. They achieve this by providing an enclosed temperature controlled environment to the infant. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).

The Giraffe Incubator Carestation is an updated version of the cleared predicate Giraffe Incubator. 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 incorporates an optional weighing scale, Uninterruptible Power Supply (UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storage drawers.

The provided text describes a 510(k) premarket notification for the "Giraffe Incubator Carestation CS1", which is an updated version of a predicate device, the "Giraffe Incubator". The focus of the modifications is primarily on updating the user interface from a graphical monochrome display to a digital touchscreen.

Based on the provided document, the device in question does not involve AI or machine learning algorithms, and therefore, the acceptance criteria and study information related to those aspects are not applicable. The device is a neonatal incubator, and the modifications are related to its hardware and user interface.

Consequently, many of the requested points regarding AI/ML device performance and studies cannot be answered from this document.

Here's what can be extracted:

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

The document does not provide a specific table of acceptance criteria with detailed performance metrics in the way one would for an AI/ML diagnostic device with quantifiable sensitivity, specificity, etc. Instead, it refers to compliance with voluntary standards and quality assurance measures for the modified device to demonstrate substantial equivalence to the predicate device.

The "reported device performance" is essentially the device's adherence to these standards and the successful verification and validation activities.

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

This information is not provided in the document as it is not an AI/ML study. The testing described is verification and validation of hardware and software components, not a clinical trial on a 'test set' of patient data in the typical sense.

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)

This information is not provided and is not applicable for a device that is not an AI/ML diagnostic tool. Validation activities would involve engineers and testers.

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

This information is not provided and is 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is not an AI-assisted diagnostic tool.

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

This information is not applicable. The device is an incubator, not a standalone algorithm.

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

For the hardware and software modifications, the "ground truth" would be engineering specifications, established medical device safety and performance standards (like IEC 60601-2-19), and the functional requirements derived from the predicate device. These are verified through various testing methodologies described (module verification, system verification, etc.). It's not a clinical 'ground truth' in the diagnostic sense.

8. The sample size for the training set

This information is not applicable as there is no mention of a training set, the device is not an AI/ML product.

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

This information is not applicable as there is no mention of a training set, the device is not an AI/ML product.

In summary, the provided document describes a 510(k) submission for an updated medical device (a neonatal incubator) with hardware and user interface modifications, not an AI/ML-driven device. Therefore, most of the detailed questions related to AI/ML study design and performance metrics found in your request are not addressed by this document. The safety and effectiveness are established through compliance with existing standards and verification/validation testing against the predicate device.

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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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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 (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 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. Both 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 a UPS module, 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 document is a 510(k) Premarket Notification Submission for the GE Healthcare Giraffe and Panda Warmers, specifically concerning the addition of Nellcor pulse oximetry. The document states that no clinical studies were required to support substantial equivalence for this modification. Therefore, it does not contain the detailed information necessary to answer all aspects of your request regarding acceptance criteria and a study proving the device meets those criteria.

However, based on the non-clinical information provided, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions compliance with voluntary standards but does not provide a specific table of acceptance criteria with corresponding performance metrics for the Nellcor pulse oximetry addition. It states that the SpO2 performance is "substantially equivalent to the corresponding parameters in the Masimo SET technology," which implies the acceptance criteria would be those met by the predicate Masimo SET technology. Without information on the Masimo SET technology's specific performance criteria, a table cannot be constructed.

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

Not applicable, as no clinical human testing was conducted for the Nellcor SpO2 addition to establish performance in a test set. Non-clinical testing was performed, but details on sample sizes for specific non-clinical tests (e.g., number of units tested) are not provided in this summary.

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

Not applicable, as no clinical human testing requiring expert-established ground truth was reported.

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

Not applicable, as no clinical human testing requiring adjudication was reported.

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 warmer with integrated pulse oximetry, not an AI-assisted diagnostic imaging device that would typically undergo MRMC studies with human readers.

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

The document implies "standalone" technical performance was assessed during non-clinical testing (e.g., "Testing on unit level (Module verification)", "Integration testing (System verification)", "Performance testing (Verification)"), but specific details on performance metrics for the Nellcor module in isolation are not provided. The key claim is "substantially equivalent to the corresponding parameters in the Masimo SET technology."

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

For the non-clinical testing, the "ground truth" would likely refer to engineering specifications and established performance standards for pulse oximetry. For example, in performance testing, calibration references or simulated physiological signals would serve as ground truth for accuracy measurements. These details are not explicitly described.

8. The sample size for the training set:

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

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

Not applicable, as no training set for an AI algorithm was used.

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

The document states that the following quality assurance measures were applied to the development of the system:

• 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 non-clinical tests, along with compliance with voluntary standards (mentioned in Sections 9, 11, and 17, though not included in the provided excerpt), were deemed sufficient to demonstrate substantial equivalence to the predicate device (K101804). The core argument is that the Nellcor pulse oximetry technology is "fundamentally equivalent to Masimo Pulse Oximetry" and its integration technique is "extremely similar" to the previously cleared Masimo SpO2 option.

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The OmniBed 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 other 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%).

Legally Marketed Device
Giraffe OmniBed is a combination device that can function as an incubator (in the closed mode) or as an infant radiant warmer (in the open mode), based on the user's selection. The device cannot function in both modes at the same time.

Giraffe OmniBed can be used with the Giraffe Uninterruptible Power Supply (UPS) accessory. The UPS is an accessory that mounts to the Giraffe OmniBed as well as the Giraffe Incubator and the Giraffe and Panda Warmers. Giraffe UPS provides uninterruptible power to the bed for quick trips. It also allows thermally supported, cordless mobility during periods of power uncertainty. Whether moving between bed places, or between care areas, the UPS for Giraffe and Panda offers uninterrupted power to the bed and display for continuous monitoring of the baby's situation, and bed controls.

When used with the UPS, the Giraffe OmniBed are is not intended for use as transport incubator or to be taken outside of the hospital building.

Description of Device Modification
The proposed modification of the Giraffe OmniBed is the addition of the Giraffe Shuttle accessory.

The Giraffe OmniBed can be used with the Giraffe Shuttle, a mobile power source that allows for transport of the patient between care areas within the hospital building and provides power to the OmniBed. These areas include, but are not limited to Labor and Delivery, NICU, Radiology, and Operating Room.

This eliminates the need to transfer the infant to and from a transport incubator for transport within the hospital building, reducing the potential for clinical problems associated with patient touch, handling and movement. This reduces the potential for clinical problems associated with intra-hospital transport that result from interrupted patient thermal regulation. .

Similarly to the UPS accessory, the Shuttle facilitates the mobility of the Giraffe OmniBed within the hospital building. Giraffe OmniBed when used with the UPS or with the Shuttle is not a transport incubator and is not intended to be used outside of the hospital building.

The Shuttle has two primary active functions: Locking to a bed and providing transportable power to the bed and accessories.

Attaching the Shuttle to a bed is accomplished by guiding the Shuttle between the legs of the bed and stepping on the Lock pedal. This effectively locks the Shuttle and bed together as one unit.

To detach the Shuttle from the bed, the locking arms are rotated back to their unlocked position by stepping on the Unlock pedal. Once unlocked, the Shuttle can be moved away from the bed.

The internal power source of the Shuttle consists of two 12 volt 42 amp hour lead acid batteries. The batteries are high capacity, sealed, no-maintenance batteries and are connected in series to provide a nominal 24 volts supply to the power generation module.

The provided text describes a 510(k) premarket notification for a modification to the Giraffe OmniBed, specifically the addition of the Giraffe Shuttle accessory. This is a medical device submission, and as such, it does not involve the typical "acceptance criteria" and "study" format usually associated with AI or diagnostic algorithm performance. Instead, it focuses on demonstrating "substantial equivalence" to an already legally marketed device.

Therefore, many of the requested categories for AI/diagnostic studies (like sample size for test/training sets, expert adjudication, MRMC studies, standalone performance, etc.) are not applicable to this type of submission.

However, I can extract the information relevant to the device and the nature of its evaluation as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

In the context of this 510(k) submission, "acceptance criteria" are related to compliance with voluntary standards and successful execution of quality assurance measures, rather than a specific numerical performance metric for a diagnostic algorithm. The "reported device performance" is framed as the device, with the modification, being "as safe, as effective, and performance is substantially equivalent" to the predicate device.

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

• Not Applicable. This submission is for a hardware modification to a medical device, not a diagnostic algorithm that processes data. The "testing" mentioned is for engineering verification and validation of the device and its accessory, not a clinical study with a "test set" of patient data in the typical sense.

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 document does not describe a study involving expert validation or ground truth establishment for a diagnostic output.

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

• Not Applicable. See point 3.

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 a hardware modification for an infant care device, not an AI-assisted diagnostic tool.

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

• Not Applicable. No algorithms or standalone diagnostic performance are discussed.

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

• Not Applicable. Not a diagnostic study. The "ground truth" for this type of submission would relate to engineering specifications, safety standards, and functional performance metrics of the device itself (e.g., power delivery, locking mechanism function, thermal regulation, etc.), which are verified through the "Quality Assurance Measures" listed in point 1.

8. The sample size for the training set

• Not Applicable. No training set for an algorithm is involved.

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

• Not Applicable. No training set for an algorithm is involved. This K101788 submission focuses on demonstrating that the modified device, the Giraffe OmniBed with the Giraffe Shuttle accessory, is substantially equivalent in terms of safety and effectiveness to the predicate Giraffe OmniBed. The evaluation is based on engineering testing, compliance with standards, and risk analysis related to the device's physical and electrical functions, rather than clinical trial data or algorithm performance.

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The Giraffe Incubator is an Infant Incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. They achieve this by providing an enclosed temperature controlled environment to the infant. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).

The Giraffe Incubator is an 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 enclosed 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 optional Giraffe Servo Control Oxygen Delivery System is a fully integrated option available on the Giraffe Incubator. The Giraffe Servo Control Oxygen Delivery System is capable of oxygenating the entire infant compartment at oxygen concentrations of 21%-65% by volume. The device uses fuel cell type sensors that generate specific voltages depending on the oxygen concentrations they contact. The microprocessor stores the sensor output and compares it with the value corresponding to the concentration set by the operator. The valves that supply oxygen to the infant compartment are opened and closed as necessary to maintain the oxygen concentration at the set value. Fluctuations in fuel cell performance due to temperature and humidity are compensated for by the microprocessor.

The Giraffe and Panda Uninterruptible Power Supply (UPS) provides a short term source of electrical power to the Giraffe Incubator, thus aiding its intra hospital mobility. The Giraffe UPS does not change the indications for use, control mechanisms, operating principles, performance specifications, or other features of the Giraffe Incubator. The UPS serves as an extension to the Giraffe Incubator by providing uninterrupted electric power to the device. The UPS comprises a medical grade battery and a shelf.

When used with the UPS, the Giraffe Incubator is not intended for use as transport incubator or to be taken outside of the hospital building.

The proposed modification of the Giraffe Incubator is the addition of the Giraffe Shuttle accessory.

The Giraffe Incubator can be used with the Giraffe Shuttle, a mobile power source that allows for transport of the patient between care areas within the hospital building and provides power to the Incubator. These areas include, but are not limited to Labor and Delivery, NICU, Radiology, and Operating Room.

This eliminates the need to transfer the infant to and from a transport incubator for transport within the hospital building, reducing the potential for clinical problems associated with patient touch, handling and movement. This reduces the potential for clinical problems associated with intra-hospital transport that result from interrupted patient thermal regulation. .

Similarly to the UPS accessory, the Shuttle facilitates the mobility of the Giraffe Incubator within the hospital building. Giraffe Incubator when used with the UPS or with the Shuttle is not a transport incubator and is not intended to be used outside of the hospital building.

The Shuttle has two primary active functions: Locking to a bed and providing transportable power to the bed and accessories.

Attaching the Shuttle to a bed is accomplished by guiding the Shuttle between the legs of the bed and stepping on the Lock pedal. This effectively locks the Shuttle and bed together as one unit.

To detach the Shuttle from the bed, the locking arms are rotated back to their unlocked position by stepping on the Unlock pedal. Once unlocked, the Shuttle can be moved away from the bed.

The internal power source of the Shuttle consists of two 12 volt 42 amp hour lead acid batteries. The batteries are high capacity, sealed, no-maintenance batteries and are connected in series to provide a nominal 24 volts supply to the power generation module.

The Shuttle contains two sensor systems:

• One system detects an interference condition.
• The other system determines the attaching status of the device.

The Shuttle features an LED Display Board, which contains the battery runtime indicator and the battery health indicator.

This document is a 510(k) Premarket Notification Submission for a medical device called the "Giraffe Incubator" with the addition of a "Giraffe Shuttle" accessory. It's not a study that proves a device meets acceptance criteria, but rather a regulatory submission demonstrating substantial equivalence to a predicate device for marketing purposes.

Therefore, the information requested regarding acceptance criteria and a study proving performance is largely not applicable in the context of this document. This submission primarily focuses on design changes and compliance with voluntary standards to justify substantial equivalence.

However, I can extract what is provided:

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

The document does not provide a table of acceptance criteria for specific performance metrics of the device as if it were a new, novel product being tested against defined performance goals. Instead, the submission describes the device's functions and states its compliance with voluntary standards.

The "reported device performance" is essentially that the modified device (Giraffe Incubator with Giraffe Shuttle) is considered as safe, effective, and substantially equivalent in performance to the legally marketed Giraffe Incubator.

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

• Sample Size for Test Set: Not applicable. No specific "test set" in the context of typical clinical or performance studies is described. The document refers to "Testing on unit level," "Integration testing," "Performance testing," and "Safety testing" but does not quantify the sample sizes of devices or patients used in these tests.
• Data Provenance: Not applicable. No clinical study data is presented.

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 submission is about a device modification and its regulatory equivalence, not a study requiring expert-established ground truth.

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 device is an incubator and accessory; it does not involve AI or human readers in the context of diagnostic interpretation.

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

Not applicable. This is not an algorithm-based device.

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

Not applicable.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

Not applicable.

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

The submission highlights several quality assurance measures and non-clinical tests applied to the development of the system to support substantial equivalence. These include:

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

Clinical Tests:

The document explicitly states: "The subject of this premarket submission, Giraffe Incubator used with Shuttle, did not require clinical studies to support substantial equivalence."

Conclusion:

GE Healthcare considers the modified Giraffe Incubator, used with the Giraffe Shuttle accessory, to be as safe, as effective, and performance is substantially equivalent to the legally marketed Giraffe Incubator.

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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. Both 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.

The proposed modification of the Giraffe and Panda Warmers is the addition of the Giraffe Shuttle accessory. The Giraffe and Panda Warmers can be used with the Giraffe Shuttle, 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 Shuttle has two primary active functions: Locking to a bed and providing transportable power to the bed and accessories. The internal power source of the Shuttle consists of two 12 volt 42 amp hour lead acid batteries. The Shuttle contains two sensor systems: One system detects an interference condition. The other system determines the attaching status of the device. The Shuttle features an LED Display Board, which contains the battery runtime indicator and the battery health indicator.

This document describes a Special 510(k) Premarket Notification Submission for the addition of the Giraffe Shuttle accessory to the existing Giraffe and Panda Warmers. The submission argues that the modified device is substantially equivalent to the legally marketed predicate devices and does not require clinical studies.

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific, quantifiable acceptance criteria or performance metrics for the Giraffe Shuttle. Instead, it relies on a general statement of compliance with voluntary standards and a series of quality assurance measures.

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

The document explicitly states: "Clinical Tests: The subject of this premarket submission, Giraffe and Panda Warmers, used with Shuttle, did not require clinical studies to support substantial equivalence."

Therefore, there is no test set in the traditional sense of a clinical study, and thus no sample size for a test set, nor data provenance (country of origin, retrospective/prospective). The evaluation was based on non-clinical testing and comparison to predicate devices, not patient data.

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

As no clinical studies were performed, there was no "ground truth" established by external experts for a test set in the context of device performance on patients. The ground truth for the non-clinical testing referenced would have been established by internal GE Healthcare engineers and quality assurance personnel, following their defined testing protocols and design specifications. Their qualifications are not specified but would typically include relevant engineering and technical expertise.

4. Adjudication Method for the Test Set

Since no clinical test set was used, there was no adjudication method for a test set of clinical 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

No MRMC comparative effectiveness study was done. This device is an infant warmer accessory (mobile power source), not an image analysis or diagnostic AI device that would involve human readers or AI assistance in interpretation.

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

This question is not applicable as the device is a medical accessory (mobile power source for an infant warmer) and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

For the non-clinical tests conducted (e.g., performance, safety, usability, biocompatibility), the "ground truth" would be established by:

• Design Specifications: The device was tested against its own design requirements and specifications.
• Voluntary Standards: Compliance with relevant industry and safety standards (as mentioned in "Section 9, 11 and 17" of the submission, though not detailed in the provided text).
• Engineering Measurement and QA: Direct measurement and verification by engineers and quality assurance teams during the development and testing phases.

8. The Sample Size for the Training Set

This question is not applicable as the device does not employ machine learning or AI, and therefore does not have a "training set."

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

This question is not applicable for the same reason as above.

Ask a specific question about this device

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 SP02 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.

For professional use only, by trained clinicians.

The Ohmeda Medical 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. 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 SP02 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.

This 510(k) summary does not contain the kind of detailed information about acceptance criteria and a study proving a device meets them that your request outlines.

Instead, this document describes a submission for infant radiant warmers (Giraffe and Panda Warmers) and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study against specific acceptance criteria.

Here's why the requested information cannot be extracted and what the document does say:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on regulatory compliance and substantial equivalence to existing devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance from a performance study is described. The document states, "The subject of this premarket submission, Giraffe and Panda Warmers, did not require clinical studies to support substantial equivalence."

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 or test sets with ground truth were conducted or described.

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 device is an infant radiant warmer, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.

8. The sample size for the training set: Not applicable, as this is not an AI/algorithm-based device undergoing a training phase.

9. How the ground truth for the training set was established: Not applicable.

What the document does provide regarding "studies" and "criteria":

• Summary of Non-Clinical Tests:

  • The document states that the Giraffe and Panda Warmer and its applications "comply with voluntary standards as detailed in this premarket submission." However, it does not list those specific standards or acceptance criteria.
  • It lists general quality assurance measures applied to the development, which are:
    • Risk Analysis
    • Requirements Review
    • Integration testing (System verification)
    • Performance testing (Verification)
    • Safety testing (Verification)
  • No specific results or acceptance criteria for these tests are provided, only that they were applied.

• Summary of Clinical Tests:

  • "The subject of this premarket submission, Giraffe and Panda Warmers, did not require clinical studies to support substantial equivalence."

In conclusion, this document is a regulatory submission focused on demonstrating substantial equivalence of a medical device (infant radiant warmer) to existing predicate devices, rather than detailing a study that measures its performance against specific acceptance criteria for a novel algorithm or diagnostic tool.

Ask a specific question about this device

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.
For professional use only, by trained clinicians.

The Ohmeda Medical 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.
Both units also feature optional intearated 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.
Infant radiant warmers may incorporate other features, such as tilting of the bed, elevating base, and data output to remote monitors or nurse call systems. Infant radiant warmers may also allow use with or attachment of an independent phototherapy device or other accessories.
The Giraffe and Panda UPS is a stand-by power supply that will serve the purpose of temporarily maintaining the operation of the parent devices, the Giraffe and Panda Warmers.

The provided text describes the acceptance criteria and a study demonstrating the device's performance, but it focuses on performance testing rather than an AI/ML-driven diagnostic device. Therefore, several requested fields, such as MRMC studies, details about expert ground truth, and training set information, are not applicable.

Here's the available information presented in the requested format:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated. The study relies on "bench testing" against product specifications and recognized consensus standards.
• Data Provenance: Not applicable, as no patient data was used. The testing was conducted in a laboratory setting ("bench testing").

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

• Not applicable. Ground truth was established by conformance to engineering specifications and recognized consensus standards for infant radiant warmers, not by expert interpretation of data.

4. Adjudication method for the test set:

• Not applicable. The study involved bench testing against predefined performance criteria and standards, not clinical adjudication of diagnostic findings.

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:

• No. This is a medical device (infant warmer) without AI or diagnostic functionality, so an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.

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

• Not applicable. The device is not an algorithm, but a physical medical device. Performance was assessed through bench testing of its physical and electrical functions.

7. The type of ground truth used:

• Performance Specifications and Recognized Consensus Standards: The ground truth was based on the device meeting its predefined engineering performance specifications (e.g., battery life, recharge time) and conforming to established, recognized consensus standards for infant radiant warmers.

8. The sample size for the training set:

• Not applicable. This device does not involve machine learning and therefore has no "training set."

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

• Not applicable. This device does not involve machine learning and therefore has no "training set" or associated ground truth establishment process for training.

Ask a specific question about this device

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 SP02 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 ait/oxygen mixtures and/or manual ventilation to the infant.

For professional use only, by trained clinicians.

The Ohmeda Medical 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.

Both 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.

Infant radiant warmers may incorporate other features, such as tilting of the bed. elevating base, and data output to remote monitors or nurse call systems. Infant radiant warmers may also allow use with or attachment of an independent phototherapy device or other accessories.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Giraffe and Panda Warmer:

The provided document, K070377, is a 510(k) Premarket Notification for the Giraffe and Panda Warmer. It focuses on demonstrating substantial equivalence to predicate devices and conformance to recognized consensus standards through bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "animal or clinical testing to support safety and effectiveness is not necessary." Therefore, there is no test set of clinical data (human or animal) to analyze for sample size or provenance. The evaluation was entirely based on bench testing.

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

Not applicable. As stated above, no clinical test set was used, and therefore no experts were required to establish ground truth for such a set. The ground truth for bench testing refers to the calibrated reference instruments and defined test conditions.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

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

No. The document does not describe any MRMC comparative effectiveness study. The evaluation focused on the device's standalone performance against engineering and safety standards, not its impact on human reader performance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, in spirit, but not in the context of an algorithm. The evaluation focuses solely on the device itself and its components' performance as a medical device, independent of human interaction beyond normal operation. While there isn't an "algorithm" in the typical sense (e.g., for image analysis), the "standalone performance" was assessed in terms of the warmer's ability to meet its technical specifications and regulatory standards through bench testing.

7. Type of Ground Truth Used

The ground truth for this device's evaluation was based on:

• Engineering specifications and design requirements: How the device was designed to function.
• Recognized consensus standards for infant radiant warmers: These standards (e.g., ISO, ASTM, IEC) define specific performance criteria, safety requirements, and test methods that the device must meet.
• Calibration standards: For instruments used in bench testing to measure temperature, power output, SpO2 accuracy (if applicable), etc.

Essentially, the ground truth was derived from established technical and regulatory benchmarks for medical devices of this type.

8. Sample Size for the Training Set

Not applicable. This device is a hardware medical device; it does not involve machine learning or AI models that require a "training set" of data in the conventional sense. The "training" for such a device is its design and manufacturing process, guided by engineering principles and regulatory standards.

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

Not applicable. As there is no training set as understood in AI/ML, there's no ground truth established for one. The design and development process for the device relies on fundamental engineering principles, material science, and established medical device design controls, all validated against recognized standards and internal specifications to ensure it performs as intended.

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