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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 OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to ther 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, temperatures 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 uternal environment. 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 OmniBed is an infant bed which provides thermal support for infants who are unable to provide for their own heat requirements. This bed has two modes of operation, enclosed bed operation and open bed operation.

In the enclosed bed mode of operation, 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 operator selected control temperature. Physical access to the patient is obtained through the side portholes or by opening one of the side doors. In the enclosed bed mode, humidity and oxygen may also be increased.

In the open bed mode, this bed operates like a convention open, radiantly heated infant bed. Radiant heat from an infrared heat source is focused on to the bed to warm the patient. The operator may select either the heater power or skin temperature control method. Depending on the control method selected, the heater is either regulated at the operator selected power level or the heater output is modulated to maintain the patient's temperature at the value selected by the operator.

The optional Giraffe Servo Controlled Oxygen System is a fully integrated option available on the Giraffe OmniBed. 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 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 provided document is a 510(k) summary for the Ohmeda Medical Giraffe® OmniBed™. It describes the device's function, indications for use, and a comparison to predicate devices. However, it explicitly states that no clinical or animal testing was deemed necessary to demonstrate safety and effectiveness for this device. Instead, the submission relies on "extensive bench testing" and software validation.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance (especially those related to clinical studies, human readers, ground truth establishment, and sample sizes for clinical test/training sets) cannot be extracted from this document, as such a study was not conducted or submitted.

Here's a breakdown based on the information available:

Acceptance Criteria and Device Performance for Ohmeda Medical Giraffe® OmniBed™

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, specific quantitative acceptance criteria or a direct comparison table for performance from a clinical study are not available. The document states: "Since care of newborns in incubators and infant radiant warmers, with or without supplemental oxygen is a well established clinical practice. Ohmeda submits that clinical or animal testing to demonstrate safety and effectiveness is not necessary."

The performance is implicitly understood to meet the functional requirements for an incubator and warmer, including:

• Providing thermal support for infants.
• Operating in enclosed (incubator) and open (warmer) modes.
• Maintaining infant temperature via air or skin temperature control.
• Adjusting humidity and oxygen in enclosed mode.
• Providing stable oxygen concentration (21-65%) with the optional Servo Controlled Oxygen System.

No quantitative performance metrics (e.g., accuracy of temperature control to within X degrees, stability of oxygen concentration to within Y%) are reported in this 510(k) summary.

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

Not applicable. No clinical or animal test set was used for a study demonstrating safety and effectiveness. The document refers to "extensive bench testing," which implies laboratory-based tests, but no sample sizes for these tests are provided.

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

Not applicable. No clinical test set requiring expert-established ground truth was reported.

4. Adjudication method for the test set

Not applicable. No clinical test set 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 a medical apparatus (incubator/warmer), not an AI-assisted diagnostic or interpretive tool that would involve human readers.

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

Not directly applicable in the sense of an "algorithm" for diagnosis or interpretation. The device itself is the "standalone" entity that performs its functions (heating, oxygen control). Its performance was assessed through "extensive bench testing" and "software validation," rather than a clinical trial.

7. The type of ground truth used

For the "extensive bench testing" and "software validation," the ground truth would have been established by engineering specifications, calibration standards, and validated measurement equipment. For example, for temperature control, the "ground truth" would be the actual temperature measured by precise instruments, compared against the device's set and reported temperatures. For oxygen concentration, it would involve calibrated gas analyzers.

8. The sample size for the training set

Not applicable. This device is hardware with software control, not a machine learning model that requires a training set in the conventional sense. Software validation would involve testing against various inputs and scenarios to ensure correct operation according to specifications.

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

Not applicable. As above, no training set for a machine learning model was used. The "ground truth" for software validation would be the expected output and behavior based on the software design specifications and functional requirements.

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The OmniBed is a combination of an infant incubator ("incubator") and an infant radiant warmer ("warmer"). Incubators and warmers provide heat in a controlled manner to neonates who arc 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.

The Ohmeda Medical OmniBed is an infant bed which provides thermal support for infants who are unable to provide for their own heat requirements. This bed has two modes of operation, enclosed bed operation and open bed operation.

In the enclosed bed mode of operation, 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 operator selected control temperature. Physical access to the patient is obtained through the side portholes or by opening one of the side doors. In the enclosed bed mode, humidity and oxygen may also be increased.

In the open bed mode, this bed operates like a convention open radiantly heated infant from an infrared heat source is focused on to 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.

This bed can be changed from either mode to the other by the activation of a foot or hand operated switch. The hood canopy will automatically open or close creating either an open or enclosed bed respectively. It should be noted that the device can be operated as conventional incubator or as a conventional infant radiant warmer, but both modes of operation cannot be active at the same time.

The provided text describes the Ohmeda Medical OmniBed, a combination infant incubator and radiant warmer, and its 510(k) submission to the FDA. However, the document does not contain specific acceptance criteria, performance data in a quantitative format, or details of a study designed to prove the device meets such criteria.

The submission focuses on establishing substantial equivalence to predicate devices and describes the device's technological characteristics and indications for use. It explicitly states:

"Since care of newborns in incubators and warmers is a well established clinical practice, Ohmeda submits that clinical or animal testing to demonstrate safety and effectiveness is not necessary. 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."

Therefore, I cannot populate the table or answer most of your specific questions as the information is not present in the provided text.

Here's what I can extract and state based on the document:

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

   • Acceptance Criteria: Not explicitly stated in quantitative terms.
   • Reported Device Performance: Not provided in quantitative terms. The document only generally states that "The product was subject to extensive bench testing, the software was validated."

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. The document states "clinical or animal testing to demonstrate safety and effectiveness is not necessary," implying no formal clinical test set was used for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no external "test set" with ground truth was used for a clinical study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no external "test set" with ground truth was used for a clinical study.

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. The device is a medical apparatus (incubator/warmer), not an AI-assisted diagnostic tool for "human readers."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a medical apparatus (incubator/warmer), not an AI algorithm. Its performance is inherent in its electromechanical function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of a clinical performance study. The "ground truth" for this device's function would be its ability to maintain a set temperature within specified tolerances, alarms functioning correctly, etc., which would be verified during bench testing.

8. The sample size for the training set: Not applicable. The device is a physical medical apparatus, not a machine learning model that requires a training set of data.

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

Summary of available information regarding performance:

• Type of Testing: "extensive bench testing" and software validation.
• Rationale for absence of clinical/animal testing: "care of newborns in incubators and warmers is a well established clinical practice, Ohmeda submits that clinical or animal testing to demonstrate safety and effectiveness is not necessary."
• Compliance: "requirements of 21 CFR 820, Subpart C -- Design Controls -- were satisfied."

Essentially, the basis for clearance here is substantial equivalence to existing, legally marketed devices (Ohmeda Ohio Care Plus Incubator, Ohmeda Ohio Infant Warmer System, Ohmeda Ohio Intensive Care Incubator) combined with internal bench testing and software validation, rather than a prospective clinical study with defined acceptance criteria and performance metrics.

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