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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 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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