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The Versalet 7700 Care Center is a mobile, caster mounted, neonatal device, which is used to assist in maintaining an infant's skin temperature and thermal environment. The device accomplishes this using radiant or convective heat. Accessories and options to the device permit environmental control and monitoring and may include optional features such as humidification and in-bed scale. 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.

The Versalet™ 7700 Care Center is a warming device that combines the heating technologies of both incubators and radiant warmers into one product. The Versalet™ 7700 Care Center provides thermal isolation through a convective air system with canopies and side panels forming an enclosure that isolates the air surrounding the infant from the room air, much the same as a traditional infant incubator. The Versalet™ 7700 Care Center offers access to the infant in the incubator mode by allowing the caregiver to open port holes or side panels. If more access is needed, the device can then be transitioned into a radiant warmer device by opening the canopies and raising the over head arm. This allows full access to the infant. The over head arm contains two infrared heaters that provide radiant heat only when the canopies are opened and the over head arm is fully raised. Thus the Versalet™ 7700 Care Center offers the caregiver excellent access while providing good thermal stability. While the device is in the transition mode from incubator to warmer there is a continued supply of convective heat to minimize the heat loss during this period.

The provided text for K053399 states that "The Versalet 7700 Care Center technology is well established in clinical practice, therefore, pre-clinical and clinical testing are not required to establish the performance of the device."

This means that a detailed study proving the device meets specific acceptance criteria, as usually understood in terms of new device performance evaluation, was not performed, nor was it deemed necessary for this 510(k) submission.

Therefore, many of the requested elements about acceptance criteria and study details cannot be directly extracted from this document, as they were not part of the submission's requirements for this particular device.

Here's an attempt to answer based on the provided information, indicating when information is explicitly stated as not applicable or not provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for test set: Not applicable/Not provided. Clinical testing was not required.
• Data provenance: Not applicable/Not provided. Pre-clinical and clinical data were not required.

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

• Not applicable/Not provided, as formal pre-clinical or clinical testing requiring expert ground truth establishment was not performed.

4. Adjudication method for the test set

• Not applicable/Not provided, as formal pre-clinical or clinical testing requiring adjudication was not performed.

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 an infant warming device, not an AI-assisted diagnostic tool. No MRMC study was mentioned or performed.

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

• Not applicable. This device is an infant warming device, not an algorithm. No standalone algorithm performance study was mentioned or performed.

7. The type of ground truth used

• Not applicable/Not provided, as formal pre-clinical or clinical testing requiring ground truth was not performed. The basis for safety and effectiveness primarily relies on substantial equivalence to predicate devices and established technology.

8. The sample size for the training set

• Not applicable/Not provided, as this is not an AI/machine learning device that would typically involve a training set.

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

• Not applicable/Not provided, as this is not an AI/machine learning device.

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The Versalet 7700 Care Center is a mobile, caster mounted, neonatal device, which is used to assist in maintaining an infant's skin temperature and thermal environment. The device accomplishes this using radiant and convective heat. Accessories and options to the device permit environmental control and monitoring including humidification. It is intended for inpatient use in maternity nurseries, and neonatal care environments of hospitals or other healthcare facilities.

The Versalet™ 7700 Care Center is a warming device that combines the heating technologies of both incubators and radiant warmers into one product. The Versalet™ 7700 Care Center provides thermal isolation primarily through a convective air system with canopies and side panels to form an enclosure that isolates the air surrounding the infant from the room air. The Versalet™ 7700 Care Center offers access to the infant by allowing the caregiver to open port holes, side panels, canopies, and, if more access is needed, raising up of the over head arm. The over head arm is the upper half of the infant enclosure containing the canopies. The over head arm can be is raised to obtain full access to the infant. The over head arm contains two Calrod (Magnesium oxide encased in Incoloy sheath) heaters that provide heat when the canopies are opened or the over head arm is raised.

In addition to providing thermal support, the Versalet™ 7700 Care Center is capable of controlling options and accessories to aid the caregiver in rendering care to the infant. A humidification accessory is designed to operate with the Versalet™ 7700 Care Center.

This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The provided text is a 510(k) summary for the Versalet™ 7700 Care Center, an infant incubator. It describes the device, its intended use, and its substantial equivalence to predicate devices. It also includes the FDA's clearance letter.

However, it does not contain any information regarding:

• Specific acceptance criteria (e.g., performance metrics, thresholds).
• Details of a study conducted to demonstrate the device meets any such criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts.
• Adjudication methods.
• Multi-reader multi-case (MRMC) studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for a training set was established.

The "Performance Standards: None applicable" section likely refers to the absence of specific FDA-mandated performance standards for this type of device at the time, not to the absence of internal performance testing by the manufacturer. However, the details of any such internal testing are not provided in this public summary.

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