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Portable powered low air loss flotation therapy mattress.

This document, K963674, is a 510(k) summary for the LUMEXAIR portable powered low air loss flotation therapy mattress. It is a premarket notification to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device.

There is no information in this document regarding a clinical study to prove the device meets acceptance criteria.

The document primarily focuses on establishing "substantial equivalence" of the LUMEXAIR mattress to other legally marketed predicate devices, such as the Orthoderm HC System®, Akrotech 4000®, and Plexus 3000®. This means the submission argues that the new device is as safe and effective as these existing devices, often by demonstrating similar design, materials, and intended use.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment because these details are not present in the provided 510(k) summary. The 510(k) process for devices like this typically relies on performance data and comparisons to predicate devices, rather than robust clinical trials with specific acceptance criteria as you might see for novel, high-risk devices or pharmaceuticals.

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The device, brand name AkroTech 4000T Kinetic Turning Low Air Loss (LAL) System, is substantially equivalent to the AkroTech 4000 Dynamic Low Air Loss (LAL) (K923077) (K923977). Both Low Air Loss support systems consist of two operating components: 1. The electromechanical, computer controlled Air Control unit (ACU) 2. The Air Floatation Mattress. Both Systems promote pressure reduction by redistributing patient weight over a surface area / medium or by shifting patient we in a area / medium or by shifting patient weight of redistributing patient weight over a

The provided text is a 510(k) summary for the AkroTech 4000T Kinetic Turning Low Air Loss (LAL) System. This document focuses on demonstrating substantial equivalence to a previously cleared device (AkroTech 4000 Dynamic Low Air Loss (LAL) - K923077/K923977), rather than presenting a study with specific acceptance criteria and performance metrics in the way a clinical trial or algorithm validation study would.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, effect size of human readers with AI assistance, standalone performance, training set data) are not applicable to this type of regulatory submission.

However, I can extract information related to the device's features and safety standards, which serve as the implicit "acceptance criteria" for substantial equivalence.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance

Since this is a submission for substantial equivalence, the "acceptance criteria" are not predefined performance metrics in the traditional sense. Instead, the device needs to demonstrate that it is as safe and effective as the predicate device. The performance is reported in terms of feature comparison and adherence to safety standards.

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

• Not Applicable. This document describes a comparison to a predicate device based on features and specifications, not a clinical study or performance test involving a specific test set of data.

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

• Not Applicable. See point 2. The "ground truth" here is the established safety and effectiveness of the predicate device, against which the new device's features are compared by the engineers and regulatory reviewers.

4. Adjudication method for the test set

• Not Applicable. See point 2.

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 medical bed system, not an AI-assisted diagnostic tool.

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

• Not Applicable. This device is a medical bed system, not an algorithm.

7. The type of ground truth used

• The "ground truth" in this context is the established safety and effectiveness of the predicate device (AkroTech 4000 Dynamic Low Air Loss (LAL) - K923077/K923977) as determined by its previous FDA clearance. The new device demonstrates "substantial equivalence" by having similar intended use, technological characteristics, and safety/effectiveness profile, potentially with some differences that do not raise new questions of safety or effectiveness.

8. The sample size for the training set

• Not Applicable. This device is a medical bed system. There is no "training set" in the context of an algorithm. Development would involve engineering design, testing, and verification, not machine learning model training.

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

• Not Applicable. See point 8.

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