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The Giraffe Incubator Carestation is an Infant 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 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 a 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.

Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology.

In the closed bed mode of operation, the bed functions as an incubator, maintaining the infant's temperature by circulating heated air within the enclosed bed compartment. Warm air is circulated through the closed patient 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.

In the open bed mode, 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, Servo O2, Uninterruptible Power Supply (UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storage drawers.

This document is a 510(k) premarket notification for the "Giraffe Incubator Carestation CS1" (K213553). The submission seeks to demonstrate substantial equivalence to a legally marketed predicate device, the "Giraffe Omnibed Carestation CS1" (K152814), specifically concerning modifications to porthole and wall latches.

Device Description:
The device, Giraffe OmniBed Carestation CS1, is a combination of an infant incubator and an infant radiant warmer. It provides a temperature-controlled environment for neonates. The modified device primarily features changes to the porthole latch design (from "press to open" to "turn to open") and the wall latches (addition of a secondary "catch" mechanism on the north side). The overall dimensions have also slightly increased in width from 66 cm to 68 cm.

Acceptance Criteria and Reported Device Performance:

The provided document defines acceptance criteria through compliance with voluntary standards and system performance metrics, and the reported device performance is that it meets these 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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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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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 Ohmeda Medical 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 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.

The provided text is a 510(k) summary for the Ohmeda Medical Giraffe Incubator, which is an infant incubator designed to provide thermal support for neonates. The document describes the device, its intended use, and the studies performed to demonstrate its safety and effectiveness.

Here’s a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on the safety and performance of the Giraffe Incubator, particularly with the addition of the Uninterruptible Power Supply (UPS) option. The acceptance criteria and performance are outlined for the UPS battery life.

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

• Sample Size: The document does not specify a numerical "sample size" in terms of a number of units tested for a specific performance metric. Instead, it states that the product was subjected to "extensive bench testing."
• Data Provenance: The testing was conducted in-house by GE Healthcare (Ohmeda Medical), a US-based company. The data is from retrospective bench testing. The document states, "The product was subject to extensive bench testing, the software was validated and, to the best of Ohmeda Medical's knowledge, the requirements of 21 CFR 820, Subpart C-Design Controls were satisfied."

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

• Number of Experts: Not applicable. The "ground truth" for the performance specifications, specifically for the UPS battery life, was established through direct measurement during bench testing against predefined product specifications and consensus standards, not through expert consensus or clinical judgment.
• Qualifications of Experts: Not applicable for establishing ground truth as described above.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Performance was measured directly against engineering specifications and consensus standards rather than requiring adjudication of subjective assessments.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This device is an infant incubator, a life-support system where direct performance metrics (like temperature control, oxygen delivery, battery life) are assessed, not diagnostic interpretations by human readers. Therefore, the concept of "human readers improve with AI vs without AI" is not relevant to this device's evaluation.

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

• Standalone Study: Yes, in a sense, the primary evaluation was a standalone performance assessment of the device (including its optional Servo Control Oxygen Delivery System and UPS) based on its engineering design and mechanical/electrical functionality. The incubator's ability to maintain temperature and oxygen levels (algorithm-driven controls in the case of servo systems) and the UPS's battery life were evaluated directly and independently of human operational input for the performance metrics specified. The document states, "Performance of the Giraffe Incubator with the addition of UPS has been established by bench testing against product specifications and recognized consensus standards."

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this device's performance was based on product specifications and recognized consensus standards. This is an engineering and regulatory approach, where the device must meet quantifiable, pre-defined operational parameters. For example, battery life was measured to meet specific duration targets under various operational conditions.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. The device is a physical medical device (infant incubator) with electro-mechanical systems. It does not employ machine learning or artificial intelligence in a way that requires a "training set" of data for an algorithm to learn from. Its control systems are based on established engineering principles and pre-programmed parameters, not a data-driven training process.

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

• Ground Truth for Training Set: Not applicable, as there was no training set in the context of machine learning. The "ground truth" for the device's design and control algorithms would be established through engineering design specifications, scientific principles, and regulatory requirements for medical device functionality and safety.

Ask a specific question about this device

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 for 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 Ohmeda Medical 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 anable to provided 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. the ur temperature of the patient is obtained through the side portholes or by opening one of the side doors.

The optional Giraffe Servo Controlled Oxygen System is a fully integrated option available on the Giraffe I Incubator. The Servo Controlled Oxygen 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 specific volue and compares it with the value corresponding to the concentration set by the operator. The school output and compartment compartment are opened and closed as necessary to maintain the varves that suppy only goll w set value. Fluctuations in fuel cell performance due to temperature and humidity are compensated for by the microprocessor.

The provided document is a 510(k) summary for the Ohmeda Medical Giraffe® Incubator. It states that "clinical or animal testing to demonstrate safety and effectiveness is not necessary" because "care of newborns in incubators, with or without supplemental oxygen, is a well established clinical practice."

Therefore, the document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically associated with AI/ML device evaluations (e.g., performance metrics, ground truth, expert adjudication).

Instead, the submission relies on:

• Substantial equivalence to previously cleared predicate devices (Ohmeda Medical Giraffe Incubator (original), Drager Incubator 8000 IC, and Isolette Infant Incubator Model C2HS).
• Bench testing: "The product was subject to extensive bench testing." No specific details about the nature of this testing, acceptance criteria, or results are provided.
• Software validation: "the software was validated." No details about the validation methodology, criteria, or results are provided.
• Compliance with design controls: "the requirements of 21 CFR 820, Subpart C -- Design Controls - were satisfied." This refers to general quality system regulations, not specific performance criteria.

Given the nature of the device (an incubator) and the submission type (510(k) for a non-AI/ML device from 2002), the requested information categories (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth for test/training sets, training set size, ground truth establishment for training set) are not applicable or not provided in this regulatory document.

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