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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 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 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.

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 has a color touchscreen user interface (UI) and includes a Hands-Free Alarm Silence (HFAS) feature. The incubator includes a mattress for patient comfort.

The Giraffe Incubator Carestation incorporates an optional weighing scale, Servo O2, Uninterruptible Power Supply (UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storage drawers.

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The mOm Essential Incubator is indicated for thermoregulation for both premature and full-term infants up to a maximum of 6 kg (13 lbs).

The mOm Essential Incubator is not intended for home use.

The mOm Essential Incubator, ME1, is a neonatal incubator used for thermoregulation for both premature and full-term infants up to a maximum of 6 kg (13 lbs). Power is sourced either from an external AC supply or an internal rechargeable battery.

The mOm Essential Incubator (ME1) is intended to provide a heated environment with a stable temperature for infants who require assistance with thermoregulation but do not require a humidity-controlled environment. The ME1 should only be used within healthcare settings providing neonatal and infant care, by properly trained personnel, as directed by an appropriately qualified attending physician familiar with current known risks and benefits of infant incubator use.

The mOm Essential Incubator provides a filtered air system creating a thermally controlled environment based on air temperature control. It provides incubation as well as a degree of isolation for infants who may be near others or being cared for in clinical areas. The incubator is designed to allow adequate visibility and access to the infant to deliver care.

The Infant Compartment is designed to be disassembled and packed into a compact unit for storage and transportation and must be assembled before use. It has been designed as a cost-effective alternative to traditional incubators.

The mOm Essential Incubator is made up of several key components and sub-assemblies, which are assembled by the user prior to use:

• The incubator base unit, which includes the device's electronics, fan, heating system, display and controls.
• A rigid front panel which contains a door and two portholes.
• A flexible panel that makes up the top and rear of the infant compartment – this includes an inflatable section and is supplied with a manual inflation bulb.
• A rigid top and back U-shaped panel which provide the structure for the top and rear of the infant compartment.
• Two side panels which form the ends of the infant compartment.

An infant mattress is supplied, which is inserted into the infant compartment. A skin temperature probe is also supplied. An optional cart (trolley) is available.

The provided 510(k) clearance letter pertains to the mOm Essential Incubator (ME1), a Class II medical device. It focuses on the device's technical specifications and comparison to a predicate device (Isolette® 8000 plus), as well as a range of non-clinical bench testing to demonstrate safety and effectiveness.

*Crucially, this document does not describe a study involving a test set, expert ground truth establishment, a multi-reader multi-case (MRMC) study, or a standalone algorithm performance study.

The "study" referenced in the provided text is a collection of non-clinical performance data and bench testing to demonstrate the device meets various safety and performance standards for neonatal incubators. It explicitly states: "Bench testing of the mOm Essential Incubator met all relevant requirements for neonatal incubators. Testing was performed in accordance with applicable standards, to characterize and evaluate the device, including performance testing, functional/operational testing, verification and validation, biocompatibility, human factors, risk analysis and verification of risk control measures. Testing included accessories and optional components."

Therefore, I cannot populate the requested sections related to traditional "studies" with human readers, expert ground truth, or AI performance metrics, as this device is a physical medical device (an incubator) not a software-driven diagnostic or AI-powered system that would require such studies.

However, I can extract the acceptance criteria and the results of the non-clinical testing for critical device features based on the provided document.

Acceptance Criteria and Reported Device Performance (Based on Non-Clinical Bench Testing)

The acceptance criteria for the mOm Essential Incubator (ME1) are largely aligned with international standards for medical electrical equipment and infant incubators (e.g., IEC 60601 series) and are demonstrated through direct comparison to the predicate device and specific non-clinical tests.

Regarding the Absence of Certain Study Types:

This 510(k) submission is for a physical device (neonatal incubator) whose primary function is thermoregulation, and its safety and effectiveness are established through engineering design, material selection, adherence to electrical and performance standards, and rigorous bench testing. It is not an AI/ML-driven diagnostic or treatment device, nor does it involve image analysis, therefore:

• Sample size used for the test set and data provenance: Not applicable in the context of clinical "test sets" as described for AI/diagnostic devices. The "test set" here refers to the actual physical device prototypes subjected to various non-clinical bench tests in a lab environment.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" for an incubator is established by physical measurement against calibrated standards (e.g., temperature probes for thermal regulation, sound meters for noise).
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Performance is measured against engineering specifications and international standards.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, because this device does not involve human "readers" interpreting data or cases. It's an incubator.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, there is no discrete AI algorithm whose performance is being evaluated in isolation. The "algorithm" here refers to the software controlling the physical properties of the incubator, which is verified through functional testing of the device itself.
• The type of ground truth used: For performance metrics like temperature, noise, CO2 levels, etc., the "ground truth" is derived from measurements taken with calibrated instruments against established physical and engineering standards (e.g., IEC standards for incubators). For biocompatibility, it's based on laboratory testing of materials as per ISO standards.
• The sample size for the training set: Not applicable. This is not an AI/ML model that undergoes "training."
• How the ground truth for the training set was established: Not applicable for the same reason.

In summary, the provided document details the regulatory clearance of a physical medical device (an incubator) based on a comprehensive set of non-clinical bench tests and engineering evaluations, rather than clinical efficacy studies involving patient data or AI performance metrics.

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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 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 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 has a color touchscreen user interface (UI) and includes a Hands-Free Alarm Silence (HFAS) feature. The incubator includes a mattress for patient comfort. The Giraffe Incubator Carestation incorporates an optional weighing scale, Servo O2, Uninterruptible Power Supply (UPS) & Shuttle, Mounting Accessories Rail and Shelves and Storage drawers.

The provided document describes the Giraffe Incubator Carestation CS1, a medical device. The submission focuses on modifications to the porthole and wall latches of an existing predicate device (K152809). The document does not describe the device's main performance in terms of medical outcomes but rather the safety and functionality of the latch modifications.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria for the overall medical device performance (e.g., temperature control accuracy, humidity control). Instead, it focuses on demonstrating that the modified latch mechanisms continue to meet existing safety and performance standards, and that their functionality is equivalent or improved compared to the predicate without introducing new risks.

However, the document lists system performance specifications that are identical to the predicate device, implying these are the baseline acceptance criteria for the overall incubator function. For the latch modifications, the acceptance criteria are demonstrated through successful completion of various tests.

Acceptance Criteria (Implied from "Identical" or "Meets all performance and standards requirements") and Reported Performance for the General Device:

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

The document describes non-clinical testing which includes various functional and reliability bench tests for the modified latches, as well as summative usability testing.

• Test Set Sample Size: The document does not specify a numerical sample size for the bench tests (e.g., number of latches tested, number of cycles for reliability). It lists the types of tests performed. For the "Summative Usability Testing," the sample size of participants is not provided.
• Data Provenance: The testing appears to be prospective and conducted by GE Healthcare (the submitter) in their own labs, as part of their quality system. The country of origin of the data is not explicitly stated but can be inferred to be internally generated by the manufacturer.

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

• Number of Experts: Not specified for the bench tests. For the "Summative Usability Testing," the number of participants is not provided, and whether these participants are considered "experts" (e.g., clinicians) or typical end-users is not detailed.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of expert opinions (e.g., for image interpretation). The testing involves physical and functional evaluation against established standards and internal quality criteria. For usability, the findings are reported, implying evaluation against predefined usability metrics and safety 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

• Not applicable. This submission is for an infant incubator with modified latches, not an AI-powered diagnostic or interpretive device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

• Not applicable. This device does not have an "algorithm only" component that would require standalone performance evaluation typical of AI/ML software.

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

For the latch modifications, the "ground truth" is defined by:

• Compliance with Voluntary Standards: IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-19.
• Engineering Specifications: Internal design requirements for load, torque, cycles, and physical dimensions that ensure safety and functionality.
• Risk Analysis: Identification and mitigation of potential risks associated with the changes.
• Usability Objectives: Ensuring the modified latches do not introduce new use errors or significantly alter the user experience negatively.

8. The sample size for the training set

• Not applicable. This device submission does not involve a "training set" in the context of machine learning or AI.

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

• Not applicable. As there is no training set mentioned or relevant for this device, there is no ground truth established for one.

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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.

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of non-clinical performance and reliability bench tests and a summative usability study.

1. Compliance with Voluntary Standards:

   • The device was designed and tested for compliance with:
     • AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And 1. A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
     • AAMI / ANSI / IEC 60601-1-2 Edition 4.0 2014-02 Medical Electrical Equipment --Part 1-2: General Requirements For Basic Safety And Essential Performance --Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests
     • IEC 60601-2-19 Edition 2.1 2016-04. CONSOLIDATED VERSION Medical Electrical Equipment - Part 2-19: Particular Requirements For The Basic Safety And Essential Performance Of Infant Incubators
     • IEC 60601-2-21 Edition 2.1 2016-04, CONSOLIDATED VERSION Medical Electrical Equipment - Part 2-21: Particular Requirements For The Basic Safety And Essential Performance Of Infant Radiant Warmers [Including: Amendment 1 (2016)]
   • Manufactured under Quality System Regulations of 21CFR 820 and ISO 13485, with quality assurance measures including:
     • Risk Analysis
     • Requirements Reviews
     • Design Reviews
     • Performance Testing (Verification)
     • Safety/Reliability Testing (Verification)
     • Summative Usability Testing (Validation)

2. Verification and Validation Testing (Non-Clinical Testing):

   • Evaluations: Safety and effectiveness of the modified wall and porthole latches were evaluated using controlled performance and reliability testing under worst-case conditions.
   • Test Methods:
     • Performance Tests: Rough Handling Testing (Ascending Step Shock, Descending Step Shock, Door Frame Shock as per IEC 60601-1 Cl 15.3.5a, 15.3.5b, 15.3.5c and IEC 60601-2-19), Check for Rough surfaces, sharp corners and edges (IEC 60601-1 Clause 9.3), Humidifier Operating Time, Air Velocity, Opening and Closing of E/W Doors and South Wall, Opening of Doors and Portholes, E/W Doors latch mechanism and N/S Walls as Barriers (IEC 60601-2-19 Clause 201.9.8.3.101), Porthole latch mechanism as Barriers (IEC 60601-2-19 Clause 201.9.8.3.101), Removing of E/W Doors and infant compartment design, E/W Doors remains secure even if the North Wall and South Wall receptacle is not latched, Maximum sidewall upright angle.
     • Reliability Tests: Porthole Latch: Over Torque Test; Wall Latch and Porthole Latch: Vibration / Reliability Threshold Test; Porthole Latch: Push Load; Porthole Latch: Pull Load for Cleaning; Porthole Latch: Open Close Cycles of Knob Latch; Porthole Latch: Cleaning Pull Cycles of Knob Latch; Wall Latch: Handling Load Test; Wall Latch: Pull and Push Loads with chemical exposure; Wall Latch: Handling Load on Snap; Wall Latch: Pinch Action Open Close Cycles; Wall Latch: Push Close Cycles (Push to Close from Secondary Latch Position to Primary Latch Position).
   • Results: The proposed device "successfully completed all testing per our quality system," and the evaluations "substantiate the performance of the new latches in worst-case conditions."

3. Human Factors Analysis (Summative Usability Study):

   • Study Purpose: To evaluate the modified wall and porthole latches and their instructions for use.
   • Results: The study "successfully completed a summative usability study," and "There were no findings from the summative usability testing that led to changes in wall latches, porthole latches, or on-product labeling. The latch modifications did not introduce any new risks or use-related issues."

Detailed Information for the Study:

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

• Test Set Sample Size: Not explicitly stated for each individual bench or reliability test. The tests were performed on the "modified wall and porthole latches," implying testing on the physical components of the device. For the Summative Usability Study, the sample size of users is not provided in this document.
• Data Provenance: The studies are laboratory and human factors evaluations conducted by the manufacturer (GE Healthcare). The data is presumably retrospective in nature, as it's part of the design verification and validation process for a modified existing product. Country of origin for the data is not specified but would be where GE Healthcare conducts its product testing.

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

• This information is not provided in the document. For bench/reliability tests, "experts" typically refers to test engineers and quality control personnel, whose qualifications are inherent to their roles in device manufacturing and verification. For the human factors study, the qualifications of the "users" involved are not detailed.

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

• Not applicable in the context of engineering bench and reliability testing or human factors usability studies as described. These are objective tests against predefined specifications or assessments of user interaction, not expert consensus for diagnostic interpretation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This is not an AI-assisted diagnostic device, and no MRMC study was conducted. The device is a neonatal incubator/warmer; the changes are mechanical (latches) and do not involve "human readers" or "AI assistance."

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

• Not applicable. This device is not an algorithm, and its performance involves direct physical interaction and function.

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

• Ground truth for the engineering tests was based on objective performance specifications derived from international standards (IEC 60601 series) and internal quality system requirements. For example, "Temp Control accuracy: ± 1.0ºC" is an objective metric.
• For the Human Factors Analysis, the ground truth was the observed user interaction and direct feedback regarding the usability and safety of the modified latches. The absence of findings that required design changes indicates that the user experience met safety and usability requirements.

8. The sample size for the training set:

• Not applicable. This device does not use machine learning or AI models, so there is no "training set."

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

• Not applicable for the same reason as above.

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The device is an infant incubator and an infant warmer. The two functions can be converted through the canopy lifting system. The incubator provides an enclosed, temperature-controlled environment and the warmer provides infrared heat in an open environment. The warmer provides heat in a controlled manner to neonates who are unable to thermoregulate based on their own physiology. The incubator and warmer may also be used for short periods of time to facilitate a neonate's transition from the uterus to the external environment.

The YP-3000 has the functions of an infant incubator and an infant radiant warmer. The infant radiant warmer is optional, the two functions can be converted through the canopy lifting system. For the infant incubator, the temperature control system implements servo control on the temperature in the incubator (air temperature / skin temperature) and the device performs proportional heating control based on the setting of the temperature and the actual measured temperature. The internal air is adjusted through thermal convection to create an environment with proper temperature and humidity for infant incubation. It is intended to be used for constant temperature incubation of low birth weight infants, critically sick babies and neonates, as well as neonatal body temperature resuscitation, transfusion, oxygen therapy, emergency treatment, and hospitalization for neonates. The Infant radiant warmer transfers heat to the patient from the infrared radiation heating source through the parabolic reflecting hood transmitting heat to the patient on the mattress. proportional heating is controlled based on actual skin temperature. The device is equipped with a mattress, an electronic scale, and an oxygen control system. Other accessories include an observation lamp, tray, and an IV pole.

The provided text describes the 510(k) premarket notification for the YP-3000 Infant Incubator, demonstrating its substantial equivalence to a predicate device (OHMEDA MEDICAL OmniBed). This document focuses on proving equivalence through bench testing against recognized standards rather than detailing a clinical study with human readers or AI performance.

Therefore, many of the requested criteria for reporting an acceptance criteria and study proving performance (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable or not specified in this regulatory submission, as it is for a physical medical device (infant incubator/warmer) and not an AI/ML powered diagnostic device.

However, I can extract information related to the acceptance criteria for the device's technical specifications and how its performance was proven through non-clinical testing.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comprehensive comparison table between the subject device (YP-3000 Infant Incubator) and the predicate device (OmniBed), detailing various specifications and performance characteristics. The acceptance criteria essentially align with meeting the performance characteristics of the predicate device or demonstrating that any differences do not raise new questions of safety and effectiveness, often by showing compliance with relevant IEC and ISO standards.

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

• Sample Size: Not applicable. This is a physical medical device. Performance claimed is based on laboratory bench testing against recognized standards, not on a data set of patient cases.
• Data Provenance: Not applicable. The "data" here refers to the outcomes of physical device measurements and assessments in a laboratory setting. No geographical or retrospective/prospective data collection is relevant.

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

• Not applicable. Ground truth for a physical device's performance (e.g., temperature accuracy, noise levels) is established through standardized engineering and safety tests, not through expert human interpretation of medical data (like in AI diagnostics). The "experts" involve engineers and technicians conducting the tests.

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

• Not applicable. This is not a study involving human or AI interpretation 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:

• No MRMC study was done. This is a medical device for infant care, not an AI diagnostic tool that assists human readers.

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

• Not applicable. This is a physical device, not an algorithm. Bench testing demonstrates its standalone performance (i.e., the device itself performs according to specifications).

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

• Ground Truth: The "ground truth" for this device's performance is derived from measurements taken during rigorous bench testing against established international performance and safety standards (e.g., IEC 60601 series, ISO 10993 series). These standards define acceptable ranges for various parameters (temperature control, humidity, noise, alarms, electrical safety, biocompatibility, etc.). The device's measurements serve as its performance, and these are compared against the required thresholds and the predicate device's performance.

8. The sample size for the training set:

• Not applicable. This device does not use a training set as it is not an AI/ML system.

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

• Not applicable. As there is no training set for this physical device.

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Babyleo TN500 is intended for use with premature babies and neonates and can be used as both an incubator and a radiant warmer. When the product is switched between incubator and radiant warmer operation, patients continue to be kept warm during the transition. The device provides a thermally requlated environment for patients with a body weight of up to 5 kg (11 lbs) and a height of up to 55 cm (22 in). The device can be operated as either a closed care unit or an open care unit. As a closed care unit, Babyleo TN500 is an incubator. Neonates are kept warm in the patient compartment with humidifiable air, which can be enriched with oxygen (option). As an open care unit, Babyleo TN500 is a radiant warmer. Babyleo TN500 provides controlled ambient conditions for premature babies and neonates. The following parameters are regulated, according to the intended use: Temperature; Humidity; Oxygen (option).

The device Babyleo TN500 is a medical device used to maintain environmental conditions suitable for preterm babies and neonates. The important features are temperature and humidity. The operational principle is a combination of a neonatal incubator and an open warmer. Babyleo TN500 can be operated in closed care therapy as an incubator according to IEC60601-2-19 or in open care therapy as a warmer according to IEC60601-2-21. Additionally, an optional x-ray translucent heated mattress is intended to provide sensible heat to the preterm babies and neonates. The device consists of the following components: Incubator (=bassinet) with a convection heater and closed humidification system for the patient, trolley, radiant warmer, display, mattress, x-ray tray and height adjustment. Optional components are scale, heated mattress, drawer, oxygen regulation with cylinder holder and Auto Thermo package and Developmental Care package. The subject of this submission is the addition of the optional Touch time function, which can be activated in order to stabilize the thermal environment in the patient compartment when the hand ports are opened. It supports users during routine tasks (e.g. changing diapers, washing the baby, checking sensors). Additionally, the scale resolution is changed from 5q to 10g.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Babyleo TN500 (Neonatal Incubator and Radiant Warmer)
Reason for Submission: Addition of optional "Touch time" function and change in scale resolution.

Acceptance Criteria and Reported Device Performance

Since this 510(k) submission is for modifications to an already cleared device (K162821), the core performance specifications of the Babyleo TN500 remain unchanged and are considered the acceptance criteria based on the predicate device. The changes are specifically for the "Touch time" feature and the scale resolution.

The table below focuses on the elements changed or directly impacted by the submission. For other parameters, the document states "Identical" meaning the performance meets the existing criteria from the predicate device (K162821).

Study Information

The provided document describes a verification and validation (V&V) testing approach for the modifications, not a typical clinical study with patient data, ground truth establishment, or human reader involvement. This is common for modifications that do not significantly alter the intended use or fundamental technological characteristics of a device.

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

   • Test Set Size: Not explicitly stated as individual "samples" in terms of patient data. The testing was focused on the device's functionality and safety regarding the "Touch time" feature and scale resolution. This likely involved engineering bench testing or simulated use cases.
   • Data Provenance: Not specified. Given the nature of V&V testing for a medical device modification, it would be laboratory-based data generated during manufacturing and development, likely in Germany (Drägerwerk AG & Co. KGaA is in Luebeck, Germany) with adherence to international standards. It is prospective testing specific to the modifications.

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

   • Not applicable as this was not a study requiring expert-established ground truth in the clinical sense (e.g., diagnosis). The ground truth for device performance features like temperature regulation, alarm functionality, and scale accuracy is typically against engineering specifications and validated test equipment.

3. Adjudication method for the test set:

   • Not applicable. The V&V testing would involve comparing device performance against predetermined engineering specifications and international standards, rather than expert adjudication of clinical outcomes.

4. 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 not an AI-assisted device and therefore no MRMC study was conducted.

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

   • Not applicable. This device is not an algorithm-only device. The V&V testing evaluated the functional performance of the device and its new feature.

6. The type of ground truth used:

   • Engineering Specifications and International Standards: The performance of the device and its new features were evaluated against established engineering specifications for the device and compliance with recognized international standards (IEC 60601-1-2, 60601-2-19, and 60601-2-21). This is the "ground truth" for demonstrating safety and effectiveness of device functions.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

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

   • Not applicable for the same reason as above.

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The Isolette® 8000 plus is indicated for thermoregulation and controlling oxygen (optional), and humidity (optional) for both premature and full-term infants up to a maximum of 10 kg (22lbs).

The Isolette® 8000 plus is not intended for home use.

The Isolette® 8000 plus is a neonatal incubator that provides a controlled environment for both premature and full-term infants up to a maximum of 10 kg (22lbs). It controls temperature, oxygen and humidity (both are optional).

The predicate device as cleared in K172154 is offered with the hood and shell assembly of the incubator mounted on a variable high adjustable (VHA) trolley. All components and accessories for the device were cleared as part of the system.

The modification of the device is the replacement of the variable height adjustable (VHA) trolley with a fixed-height cabinet stand trolley. All other components and accessories of the device are identical to those cleared under K172154.

The modification does not change the intended use or alter the fundamental scientific technology of the currently approved predicate device.

This document is a 510(k) premarket notification for a modification to an existing medical device, the Isolette® 8000 Plus Neonatal Incubator. The modification involves replacing the variable height adjustable (VHA) trolley with a fixed-height cabinet stand trolley. No AI/ML components are involved in this device, therefore, many of the requested fields are not applicable.

Here's a summary based on the provided text:

1. Table of acceptance criteria and the reported device performance:

The document focuses on demonstrating that the modified device remains substantially equivalent to its predicate device (Isolette® 8000 plus, K172154) despite the change in the trolley. The acceptance criteria essentially align with the predicate device's established performance and safety standards. The performance of the modified device is reported as "Same" for nearly all specifications, with "Different – No impact on effect on safety and effectiveness" for the few physical attribute changes.

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

This document describes a modification to an existing device, not a study involving human or animal subjects that would typically have a "test set" in the context of clinical data. The "test set" here refers to the engineering verification and validation activities. The document summarizes these activities as having been "carried out under well established methods." There is no information regarding the sample size of devices tested for Instability, Electrical Safety, and EMC, nor is there information on data provenance beyond being "non-clinical testing."

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 is not applicable to an engineering verification of a medical device modification. The "ground truth" for the tests performed (Instability, Electrical Safety, EMC) is established by the relevant international standards (IEC60601-1, IEC60601-1-2) which define the pass/fail criteria. Expertise would be in the form of qualified engineers and technicians performing the tests and reviewing the results against these standards.

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

Not applicable. This is not a study involving human reader interpretation or consensus on data. The verification activities are against predefined technical standards.

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 neonatal incubator, not an AI-powered diagnostic tool, and its modification does not involve human readers or AI assistance.

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

Not applicable. This device is not an algorithm.

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

The "ground truth" for the non-clinical testing refers to the established standards for medical device safety and performance, specifically IEC60601-1 (general medical electrical equipment safety), IEC60601-1-2 (electromagnetic compatibility), and IEC60601-2-19 (basic safety and essential performance of infant incubators). These standards define the acceptable limits and performance characteristics.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

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The Isolette® 8000 plus incubator is indicated for thermoregulation and controlling oxygen (optional), and humidity (optional) for both premature and full-term infants up to a maximum of 10 kg (22lbs).

The Isolette® 8000 plus is not intended for home use.

The Isolette 8000 plus is a device used to maintain environmental conditions suitable for neonates. The Isolette 8000 plus incubator provides a controlled environment for both premature and full-term infants up to a maximum of 10 kg (22lbs). It controls temperature, oxygen (optional) and humidity (optional). It is a controller-based incubator featuring the ability to enable simultaneous control of temperature, and optional oxygen and humidity. The system operates on AC power. Data is provided on a liquid crystal display. It is operated in closed care therapy as an incubator according to IEC60601-2-19.

Components include hand ports or iris ports, access panel, serial port, trolley with height adjustment, castor wheels with brakes, power receptacle, a Trendelenburg bed-tilt mechanism (0° to 12°), softbed mattress, skin temperature probes, probe covers, oxygen inlet, sensor module, hose grommets, accessoryrail and cable wrap. Optional components include IV pole, drawers, water reservoir, collection bottler mount litter bag holder, basket for gloves, breathing hose holder kit, tray, high frequency ventilation (HFV) door with grommets, positioning aids, incubator cover, and monitor shelf.

The provided text describes the regulatory clearance of the Isolette® 8000 plus neonatal incubator and its comparison to a predicate device (Isolette® Infant Incubator, Model C2HS, K001242) for showing substantial equivalence. It does not contain information about an AI-powered device or a study involving human experts or a training set for machine learning. Therefore, many of the requested details are not applicable as this is a traditional medical device submission without AI.

However, based on the provided text, I can extract the acceptance criteria and a summary of the non-clinical studies performed to demonstrate that the device meets those criteria.

Acceptance Criteria and Device Performance for Isolette® 8000 plus (K172154)

This submission is for a traditional medical device (neonatal incubator) and does not involve AI. Therefore, numerous requested sections related to AI performance, human expert evaluation, and training sets are not applicable.

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

The acceptance criteria are generally implied by the stated specifications and compliance with recognized standards. The "Device Under Review" column effectively serves as the reported device performance compared to the predicate.

2. Sample sized 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. The studies were non-clinical bench testing, not clinical studies involving patient data.

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 is a non-AI medical device submission, and the ground truth was established through engineering specifications, regulatory standards compliance, and bench testing, not human expert interpretation of data.

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

Not applicable. This is a non-AI medical device submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a non-AI medical device submission.

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

Not applicable. This is a non-AI medical device submission. The device performs as a standalone incubator without human-in-the-loop performance in the context of an AI algorithm; however, human operators are inherently part of its use.

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

The "ground truth" for this device is based on engineering specifications, recognized international standards (e.g., IEC 60601-1, IEC 60601-2-19, IEC 60601-1-2, ISO-10993), and internal design control procedures. Performance benchmarks are set by these standards and the predicate device's capabilities.

8. The sample size for the training set

Not applicable. This is a non-AI medical device submission; there is no "training set" in the machine learning sense.

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

Not applicable.

Summary of Studies to Prove Acceptance Criteria are Met (Non-Clinical Testing):

The Isolette® 8000 plus underwent a series of non-clinical bench tests and evaluations to demonstrate its safety and effectiveness and substantial equivalence to the predicate device. These include:

• Performance Testing: Conducted in accordance with applicable standards and technical system requirements, as well as the device's Instructions for Use (IFU) Technical Data Section. This covers all the operational specifications listed in the table above (e.g., temperature control ranges, humidity accuracy, oxygen control, noise levels, warm-up times).
• Electrical Safety and Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1, IEC 60601-2-19 (safety and performance), and IEC 60601-1-2 (EMC).
• Software Verification and Validation Testing: Conducted following FDA guidance for medical device software. The software was considered a "major" level of concern.
• Biocompatibility Testing: Conducted in accordance with FDA guidance on ISO 10993 standards. Tests included:
  • Integral Test for volatile organic compounds
  • Photogenic bacteria test
  • Emission of particles
  • Material characterization (ISO 10993-18)
  • Toxicological Evaluation (ISO 10993-17)
  • Cytotoxicity
  • Irritation
  • Sensitization
• Human Factors: Usability evaluation conducted in accordance with FDA guidance on Human Factors and Usability Engineering.
• Reprocessing: Assessed following FDA guidance ("Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling").
• Cleaning/Disinfection: Macroscopic and microbiological validation performed with Oxycide by an accredited laboratory (DIN EN ISO/IEC 17025).
• Kangaroo Mode Performance Testing: Performed according to the technical requirements for this new feature.
• Autohumidity Performance Testing: Performed according to technical requirements for the optional humidification system.
• Thermomonitoring Performance Testing: Performed according to technical requirements.
• External Communication (Serial data output or Medibus X) Performance Testing: Performed according to technical requirements.
• Trendelenburg (Tilt Mechanism) Regression Testing: Performed for mechanical changes compared to the predicate device.

No animal or clinical studies were conducted for this submission. The conclusion drawn from these non-clinical studies was that the Isolette® 8000 plus meets performance requirements and standards and is substantially equivalent to the predicate device K001242.

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Babyleo TN500 is intended for use with premature babies and can be used as both an incubator and a radiant warmer. When the product is switched between incubator and radiant warmer operation, patients continue to be kept warm during the transition. The device provides a thermally regulated environment for patients with a body weight of up to 5 kg (11 lbs) and a height of up to 55 cm (22 in). The device can be operated as either a closed care unit or an open care unit. As a closed care unit, Babyleo TN500 is an incubator.Neonates are kept warm in the patient with humidifiable air, which can be enriched with oxygen (option). As an open care unit, Babyleo TN500 is a radiant warmer. Babyleo TN500 provides controlled ambient conditions for premature babies and neonates. The following parameters are regulated, according to the intended use: - Temperature - Humidity - Oxygen (option)

The device Babyleo TN500 is a medical device used to maintain environmental conditions suitable for preterm babies and neonates. The important features are temperature and humidity. The operational principle is a combination of a neonatal incubator and an open warmer.

Babyleo TN500 can be operated in closed care therapy as an incubator according to IEC60601-2-19 or in open care therapy as a warmer according to IEC60601-2-21. Additionally, an optional x-ray translucent heated mattress is intended to provide sensible heat to the preterm babies and neonates.

The device consists of the following components: Incubator (=bassinet) with a convection heater and closed humidification system for the patient, trolley, radiant warmer, display, mattress, x-ray and height adjustment. Optional components are scale, heated mattress, drawer, oxygen regulation with cylinder holder and Auto Thermo package and Developmental Care package.

This document is a 510(k) Premarket Notification for the Babyleo TN500, a neonatal incubator and radiant warmer. It aims to demonstrate substantial equivalence to legally marketed predicate devices. The information provided heavily focuses on design verification and validation testing, and therefore, does not contain the details on acceptance criteria and study proving performance in the context of an AI/ML medical device that would typically involve clinical studies, multi-reader multi-case studies, and explicit ground truth establishment with expert consensus.

Given the document talks about a physical medical device (neonatal incubator/radiant warmer) and not an AI/ML diagnostic or prognostic tool, the questions posed about "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or AUC, multi-reader multi-case studies, expert consensus for ground truth, effect size for human reader improvement with AI assistance, and training/test set sample sizes and provenance for AI/ML models are not applicable to this submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" for this conventional medical device primarily revolve around safety and performance standards, electrical safety, EMC, software verification, biocompatibility, human factors, and reprocessing validation.

Here's how to address the prompt based on the provided document:

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

The document lists compliance with various standards and provides specifications that serve as performance criteria.

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

• Test Set Sample Size: Not applicable. This is a conventional medical device; performance testing is often conducted on a representative number of units or components, but the "sample size" concept as used in AI/ML clinical studies for a test dataset does not directly apply. The testing mentioned (electrical safety, EMC, software verification, biocompatibility, human factors, reprocessing) would be performed on the device itself or its materials.
• Data Provenance: Not applicable in the sense of patient data. The provenance for the testing data would be from internal lab testing conducted by the manufacturer (Drägerwerk AG & Co. KGaA, Germany) or their designated testing facilities. It's not retrospective or prospective patient data.

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

• Not applicable. Ground truth in the context of an AI/ML clinical study (e.g., diagnosis of disease) is not relevant for this device. The "ground truth" for this device's performance is established by objective measurements against engineering specifications and recognized international standards. Experts involved would be engineers, quality assurance personnel, and regulatory specialists.

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

• Not applicable. Adjudication methods are typically for resolving discrepancies in expert labeling or diagnoses in AI/ML studies. For a physical device, performance is measured against established limits derived from standards or engineering requirements.

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, not done. This is a physical medical device, not an AI-assisted diagnostic tool. MRMC studies are not relevant for demonstrating the effectiveness of an incubator/warmer.

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

• Not applicable. There is no "algorithm only" performance for a neonatal incubator/radiant warmer as it is not an AI/ML-driven diagnostic or treatment algorithm. Its performance is measured by its ability to maintain specified environmental conditions.

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

• Objective Measurement against Standards and Specifications: The "ground truth" for this device is the adherence to internationally recognized safety and performance standards (e.g., IEC 60601 series, ISO 10993) and the manufacturer's own detailed engineering specifications. For example, the "truth" of the noise level is the scientifically measured sound pressure level, not an expert's subjective assessment.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of an AI/ML model for this device. Design and development of the device would involve engineering principles, materials science, and iterative testing, not machine learning model training.

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

• Not applicable. As there is no training set for an AI/ML model, this question is not relevant. The "ground truth" for the device's design and manufacturing is derived from scientific and engineering principles, regulatory requirements, and established medical device standards.

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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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