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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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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.

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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 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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