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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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Bisto's BT-500 is a Infant Incubator and intended to keep Premature in a warm environment in the hood for Neonatal hypothermia, Observation and Examination in newborn nurseries.

BT-500 provides Heat and Air in a controlled manner to neonates or premature infants who are unable to themn-regulate on their own physiology.

BT-500 is not intended for transport.

BT-500 Infant Incubator consists of Hood, Control Box, LCD external monitor and main body with stand ( optional), This device incorporates two sensors to control Humidity, and Temperature inside the Hood and monitors the Air Conditions, and controls Circulation with proper temperature.

Also Heater is equipped inside of the hood to control the Skin Temperature of Infant at a fixed level as measured by the skin probe and showing, measuring and graphing the humidity, Air Temperature, Skin Temperature, Weight and SpO2

This Incubator is provided with function to control the infant's skin temperature.

The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria. The document is a 510(k) summary for the BT-500 Infant Incubator, primarily focused on demonstrating substantial equivalence to a predicate device.

While it mentions "various Performing, Safety test voluntary and accordance with the guidance for Industry and FDA Staff -Neonatal Transport Incubator Premarket notifications," and states "all test report attached," the specific details of these tests, their acceptance criteria, and the reported performance are not included in the provided text.

Therefore, I cannot populate the table or answer the specific questions about sample size, ground truth, expert qualifications, or comparative effectiveness studies based on the given information.

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The V-2200 Infant Incubator is a device to keep premature infants or neonatal infants in a warm environment which is covered by a hood and isolated from ambient air and of which internal air temperature and humidity, are controlled. It is intended for inpatient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities. Optional functions include pulse oximetry and oxygen delivery. This device is not intended for home use. This device is not intended as a transport incubator. This is a prescription device.

This product consists of a hood, a sensor module, a mattress platform, a middle deck section, a conditioning chamber, a humidity chamber, an operation control section, a power source, a relay box, an oxygen supply/filter box, a pulse oximeter, an oxygen controller and a weight monitor. It is equipped with an incubator air temperature control function to circulate the air containing the heat energy generated by the heater attached to the conditioning chamber inside the hood by means of a fan in order to maintain the incubator air temperature at a fixed level. The device is also equipped with a skin temperature control function to maintain the infant's skin temperature at a fixed level in response to the patients temperature as measured by the skin probe. There is a humidity control function to adjust the amount of vapor generated in the humidity chamber. The following additional features can be installed into the incubator: a pulse oximeter function to monitor Sp02 concentration and pulse rate non-invasively; an oxygen control function to draw oxygen and outside air and control the oxygen concentration delivered to the patient compartment to the desired level; and a weight monitor to facilitate taking the infants weight without moving them from the incubator. This device is designed to be used in treatment, procedures and observation of low-birth-weight and sick neonates, providing heat to the neonate when the body temperature is low and also to provide humidity if desired

The provided text describes a 510(k) premarket notification for the V-2200 Infant Incubator, focusing on the addition of an optional pulse oximeter. However, the document does not contain any information regarding acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria for the pulse oximetry function.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. The document is primarily a regulatory filing for substantial equivalence, detailing the device description, intended use, modifications, and classification, but it does not include performance study data.

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The V-2200 Infant Incubator is a device to keep premature infants or neonatal infants in a warm environment which is covered by a hood and isolated from ambient air and of which internal air temperature and humidity, are controlled. It is intended for inpatient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities.

This device is not intended for home use.

This device is not intended as a transport incubator.

This is a prescription device.

This product consists of a hood, a sensor module, a mattress platform, a middle deck section, a conditioning chamber, a humidity chamber, an operation control section, a power source, a relay box, an oxygen supply/filter box, an oxygen controller and a weight monitor. It is equipped with an incubator air temperature control function to circulate the air containing the heat energy generated by the heater attached to the conditioning chamber inside the hood by means of a fan in order to maintain the incubator air temperature at a fixed level. The device is also equipped with a skin temperature control function to maintain the infant's skin temperature at a fixed level in response to the patients temperature as measured by the skin probe. There is a humidity control function to adjust the amount of vapor generated in the humidity chamber. The following additional features can be installed into the incubator: an oxygen control function to draw oxygen and outside air and control the oxygen concentration delivered to the patient compartment to the desired level; and a weight monitor to facilitate taking the infants weight without moving them from the incubator. This device is designed to be used in treatment, procedures and observation of low-birth-weight and sick neonates, providing heat to the neonate when the body temperature is low and also to provide humidity if desired

The provided document does not contain the information requested for acceptance criteria and a study proving device performance.

The document is a 510(k) summary for the V-2200 Infant Incubator, focusing on its substantial equivalence to predicate devices due to a user interface display modification. It describes the device, its intended use, and the regulatory approval process.

Specifically, the document does not include:

• A table of acceptance criteria or reported device performance metrics.
• Details about a study conducted to demonstrate the device meets any specific performance criteria.
• Information on sample sizes, data provenance, expert qualifications, adjudication methods, or ground truth establishment for any such study.
• Any mention of AI, MRMC comparative effectiveness studies, or standalone algorithm performance.

The document is a regulatory submission for a medical device (infant incubator), and while it mentions "performance standards: none applicable," it does not include performance data or studies that would fall under the categories requested. The "description of modifications" section explicitly states the difference between the V2200 and the V2100G is solely the user interface display (an independent component, multicolor LCD). This suggests the core therapeutic functions (temperature and humidity control) were likely considered equivalent to the predicate without requiring new performance studies for those aspects.

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The CHS-i1000 Infant Incubator provides a controlled thermal environment for neonates who are unable to provide their own thermoregulation. They may be used for short periods of time to facilitate the neonate's transition from the uterus to the external environment. The CHS-i1000 Infant Incubators can be used in two operating modes, such as Air Control Mode and Skin Control Mode. The CHS-i1000 incubator is not for the transport of the patient.

The CHS-i1000 Infant Incubator has alarms to alert clinicians when certain patient or equipment conditions occur, such as a malfunction, or an excessive departure of the patient's temperature from the set value.

The CHS-i1000 Infant Incubator incorporates other features, such as humidification of the infant environment and tilting of the bed.

The CHS-i1000 incubator provides a controlled temperature and humidity for infants. It is designed to minimize the effect of external heat loss on infants.

The incubator is composed of 4 main elements namely, the hood, base, cabinet and controller. Together they measure W1000 x H1367 x D634mm. The foam based mattress that measures W690 x D370mm positions centrally within the confines of the hood. The mattress can also be raised at the head and foot end to a maximum incline of 12°. This is achieved by turning the handles that are located on each end of the base.

The hood is made of a clear acrylic to permit clear visibility of the baby yet provide isolation for the baby. The hood comprised of access ports gives access to the baby without compromising the thermal environment. Four of the access ports(two on the front and two on the rear) allow for regular access by the caregiver. The other two access ports are in the form of iris ports with are used primarily for ventilator tubes and monitoring cables to be channeled into the hood to the baby. Pulling the mattress towards the caregiver can enhance access even further.

The provided text does not contain detailed acceptance criteria or a specific study proving the device meets them. Instead, it describes a 510(k) submission for a neonatal incubator (CHS-i1000) seeking substantial equivalence to a predicate device (OHMEDA Medical Model 4000 CARE-PLUS).

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of explicit acceptance criteria with specific quantitative thresholds for the CHS-i1000's performance. Instead, it states that:

• "Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1 and EN/IEC 60601-2-19 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(1993), and Biocompatibility testing was conducted in accordance with standard ISO 10993-1."
• "All test results were satisfactory."

This indicates that the device's performance was evaluated against the requirements of these standards, and it successfully met those requirements. The specific performance metrics and their acceptance limits as defined by these standards are not detailed in this summary.

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

The document does not specify a "test set" in the context of clinical data or human subjects. The testing mentioned (safety, EMC, performance, biocompatibility) likely involved laboratory testing of the device itself rather than a clinical study with patients. Therefore, information about sample size, country of origin, or retrospective/prospective nature of a clinical test set is not applicable or provided.

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

This information is not applicable. The device is a neonatal incubator, and the testing described pertains to its engineering and safety specifications, not a diagnostic or prognostic capability requiring expert-established ground truth from clinical data.

4. Adjudication Method for the Test Set:

This information is not applicable for the reasons stated above.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging or AI-assisted diagnostic tools to assess the impact of technology on human reader performance. The CHS-i1000 is an incubator, not a diagnostic device.

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

The concept of "standalone performance" typically applies to AI algorithms. The CHS-i1000 is a physical medical device (an incubator), not an AI algorithm. Therefore, "standalone performance" in this context is not applicable. The performance testing was for the device itself.

7. The Type of Ground Truth Used:

For the "performance" testing mentioned, the "ground truth" would be the engineering specifications and safety requirements defined by the standards (EN/IEC 60601-1, EN/IEC 60601-2-19, EN/IEC 60601-1-2, ISO 10993-1). The device's measurements and functionalities are compared against these predetermined, objective standards to determine compliance. There is no expert consensus, pathology, or outcomes data used as ground truth in the context of this summary.

8. The Sample Size for the Training Set:

This information is not applicable. The CHS-i1000 is not described as an AI/ML device that requires a training set.

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

This information is not applicable for the reasons stated above.

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The Air Shields ISOLETTE® Infant Incubator is designed to care for the smaller premature baby as well as the healthier full term baby. It does this by providing a controlled environment, one in which the baby can be provided with the necessary care as well as being left undisturbed in the security of the incubator.

It is to this end that the product can be used in any department of the hospital that provides neonatal and infant care. One would typically expect the ISOLETTE® to be used in the NICU/SCBU (Neonatal Intensive Care Unit and/or the Special Baby Care Unit). The design lends itself to all levels of care in the NICU making it suitable for use in level I, II, III, and IV where applicable. Other departments would include the Step Down Nursery, Newborn Nursery and Pediatrics.

This device, when fitted with the battery backup feature, may be used to move the infant from one area of the hospital to another while maintaining the controlled environment.

This device is not intended for home use.

This is a prescription device.

The C2000e is an enhancement to the currently marketed C2000 Isolette Infant Incubator originally cleared under 510(k) K960980. The features, functions, and performance of the C2000 incubator remain the same. The C2000e enhancements are additions to the C2000 product features. These additions are a horizontal rail system for attachment of accessories and a battery back up for the unit to maintain the controlled environment in the event of a power failure or to move the infant within the hospital environment.

The provided text describes a 510(k) submission for the C2000e Isolette® Infant Incubator, an enhancement to an already marketed device. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through clinical studies in the same way a new, high-risk device might.

Therefore, the document does not contain the kind of information requested in the prompt (acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, training sets, etc.). The focus is on the modifications made and how they relate to the predicate device.

Here's why the requested information is absent and what the document does provide:

• No Acceptance Criteria or Reported Device Performance Table: The document doesn't define specific performance metrics or acceptance criteria for the C2000e beyond the general statement that "The features, functions, and performance of the C2000 incubator remain the same." The enhancements are merely additions (horizontal rail and battery backup).
• No Clinical Study Details: There is no mention of a formal clinical study to prove the device meets acceptance criteria. The 510(k) process for device enhancements often relies on engineering testing and comparison to the predicate, not clinical trials with human subjects to establish diagnostic performance.
• No Sample Sizes, Data Provenance, Expert Ground Truth, Adjudication, MRMC, or Standalone Performance: These are all concepts related to clinical performance studies, typically for diagnostic or predictive AI/ML devices. An infant incubator, particularly an enhanced version of an existing one, would not undergo such evaluation in a 510(k) submission.
• No Training Set Information: As there's no AI/ML component described, there's no training set.
• No Ground Truth Type: Similarly, ground truth is a concept for evaluating diagnostic accuracy, which is not applicable here.

What the document does provide in relation to regulatory approval:

• Predicate Device: K960980 C2000 Isolette® Infant Incubator. The C2000e is an enhancement, meaning its substantial equivalence hinges on the original C2000's proven safety and effectiveness.
• Modifications: Addition of a horizontal rail system and a battery backup.
• Intended Use Statement: Describes the incubator's purpose (controlled environment for infants) and where it can be used (NICU, SCBU, Step Down Nursery, Newborn Nursery, Pediatrics). It also clarifies that the battery backup allows for safe transport within the hospital.
• Regulatory Classification: Class II device, specifically a Neonatal Incubator (21 CFR 880.5400).
• Performance Standards: "None applicable" (referring to specific mandatory standards for the device's original submission, though general requirements like GMP still apply).

In summary: The nature of this 510(k) submission for an enhanced infant incubator does not require or include the detailed performance study information requested in your prompt. The regulatory approval is based on demonstrating that the new features do not raise new questions of safety or effectiveness and that the device as a whole is substantially equivalent to a legally marketed predicate.

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The V-2100G Advanced Infant Incubator is a hooded container that is intended to provide a controlled thermal environment and isolation from ambient air for premature and neonatal infants. The V-2100G is not intended for the transport of infants.

The V-2100G Infant Incubator provides standard functions to control the incubator temperature, either by manual (air) or servo (baby) control, and air humidity. The incubator also provides an external communication function that allows data to be exported to the user's PC for evaluation and storage. In addition, the incubator provides the following optional functions: oxygen controller, pulse oximeter, and weight monitor.

The temperature in the incubator can be controlled using one of two modes: manual control mode or servo control mode. In manual control mode, the incubator air temperature is controlled to maintain the desired infant temperature. The air temperature is initially set based on the user's training and experience and is then adjusted based on the infant's needs and clinical status. In the servo control mode, a skin temperature probe is attached to the infant and is monitored by the incubator controller. The heater output is controlled to maintain the infant's skin temperature at a set value. Changes to the heater output are made gradually, so as to minimize temperature overshoot and infant stress.

The provided text is a 510(k) Summary for a medical device called the "V-2100G Advanced Infant Incubator." This document is used for regulatory submission to the FDA and primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results typical for novel devices or AI/software-as-a-medical-device (SaMD) clearances.

Therefore, many of the requested categories related to clinical studies, AI performance, ground truth, and expert adjudication are not applicable or extractable from this specific document. The performance testing mentioned is for functional and design verification against recognized consensus standards for medical electrical equipment and infant incubators, not for evaluating accuracy or effectiveness in an AI context.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is described as "Performance testing for the V-2100G Infant Incubator has been conducted for functional and design verification." The summary states this testing "demonstrates that the V-2100G Infant Incubator is in compliance with the following recognized consensus standards."

Summary of Device Performance:

The device is reported to be in compliance with the listed IEC, EN, and ISO standards for medical electrical equipment safety, electromagnetic compatibility, and particular requirements for baby incubators. This indicates that the incubator meets the established safety and performance benchmarks defined by these standards for its designated function of providing a controlled thermal environment.

Further Requested Information (Not Applicable or Extractable):

2. Sample size used for the test set and the data provenance: Not applicable. This document describes performance testing against safety and design standards, not a clinical study with a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical "ground truth" or expert review is mentioned for this type of device and submission.
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 is not an AI-powered device nor is it a diagnostic device that involves "human readers."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device's performance would be the specifications and requirements of the engineering and safety standards it complies with.
8. The sample size for the training set: Not applicable. This device does not use AI or machine learning that requires a "training set."
9. How the ground truth for the training set was established: Not applicable.

Conclusion:

The 510(k) summary for the V-2100G Advanced Infant Incubator demonstrates substantial equivalence through comparisons with predicate devices and compliance with recognized consensus standards for functional and design verification. It does not contain information related to clinical trials, AI performance, or expert-adjudicated ground truth, as it is a traditional medical device, not an AI/SaMD product.

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