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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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