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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 (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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