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The RID-Decube II Alternating Pressure Mattress System is intended for medical purposes to be used to prevent and treat decubitus ulcers.

The RID-decube II is an alternating pressure air flotation mattress intended for medical purposes with multiple air cells that can be filled and emptied in an alternating pattern by associated control units to provide regular, frequent and automatic changes in the distribution of body pressure.

The provided text is a 510(k) summary for the RID-Decube II, an alternating pressure air flotation mattress. This type of document is for premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

Based on the information provided, the document does not contain acceptance criteria for device performance or any study details that would prove the device meets such criteria.

Here's why and what information is available:

• Purpose of a 510(k) Summary: A 510(k) is primarily to demonstrate that a new device is "substantially equivalent" to a predicate device already on the market. This often means showing similar design, materials, intended use, and performance characteristics, but typically doesn't involve presenting detailed clinical study results with acceptance criteria in the summary document unless specific performance claims are being made that exceed the predicate's established use.
• Missing Information: The provided text is essentially a cover letter and a brief description of the device and its intended use. It does not include:
  • Specific performance metrics (e.g., pressure redistribution efficacy, durability, patient comfort levels)
  • Acceptance criteria for any performance metrics
  • Details of any study (clinical or non-clinical) conducted to evaluate the device's performance
  • Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
  • Any information regarding MRMC studies or standalone algorithm performance, as this device is a physical medical mattress, not an AI/software device.

Table of Acceptance Criteria and Reported Device Performance:

(No acceptance criteria or device performance data is provided in the document.)

Other Information based on the provided text:

1. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not provided.
2. 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): Not applicable, as no study or ground truth establishment details are provided.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no study or adjudication details are provided.
4. 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. The RID-Decube II is an alternating pressure air flotation mattress, not an AI/software device.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The RID-Decube II is an alternating pressure air flotation mattress, not an AI/software device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no study or ground truth establishment details are provided.
7. The sample size for the training set: Not applicable, as no training set (relevant for AI/ML) or study details are provided.
8. How the ground truth for the training set was established: Not applicable, as no training set or ground truth establishment details are provided.

Summary from the provided documents:

The RID-Decube II is an alternating pressure air flotation mattress intended for medical purposes to prevent and treat decubitus ulcers. It was found substantially equivalent to the Air Flow 5000 Manufactured by Atlantis Medical. The 510(k) process focuses on demonstrating equivalence to an already approved device rather than presenting detailed performance studies with acceptance criteria in the summary itself.

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