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The Soteria Bed Barrier is a cover for compatible bed decks and mattresses to provide a protective physical barrier between the equipment and the patient. The device is intended to prevent soiling of bed decks and mattresses, helping to reduce contamination during use.

The Soteria Bed Barriers are classified as level 3 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.

The Soteria Bed Barrier is a mattress cover that fits securely over a healthcare mattress and bed deck and attaches to the bed frame. The device is available in multiple configurations to fit specific mattresses and beds, attaching with hooks or clips on each side and the head and foot section of the mattress fit inside a pocket allowing fitted sheets to work over the mattress. Color coding of the label used by the laundry and edge ribbon correspond to compatible beds and mattresses, each barrier model has a different ribbon color. The Soteria Bed Barrier helps to reduce contamination of the underlying surfaces by preventing the penetration of fluids. The Soteria Bed Barrier is a nonsterile reusable device that is laundered in accordance with the validated procedure to remove microbes and spores between each patient use. The Soteria Bed Barrier is removed from the mattress/bed deck for laundering upon soiling or between patient uses. After laundering and inspection, the product is then folded and wrapped with appropriate labels to be used again.

The provided document is a 510(k) Premarket Notification for the Soteria Bed Barrier, a Class I medical device. The document details the device's characteristics, indications for use, and a comparison to a predicate device. The core of this submission is to demonstrate "substantial equivalence" to a legally marketed predicate, not to prove improved human performance or algorithm-only performance. Therefore, many of the typical acceptance criteria for AI/ML-based diagnostic devices, such as MRMC studies, expert consensus ground truth, or training set details, are not applicable here.

This document focuses on the physical and material performance of a barrier product, not on a diagnostic or assistive AI system.

Here's an analysis based on the provided text, addressing the points where information is available and noting where it's not applicable given the device type:

Device: Soteria Bed Barrier
Device Type: Mattress Cover for Medical Purposes (Class I)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not explicitly state the numerical sample size (e.g., number of fabric samples or cleaning cycles) for each test. Instead, it refers to "all test specimens" or "each test replicate," implying that multiple samples were used as per standard testing protocols for these types of materials.
• Data Provenance: Not applicable in the context of patient data. The "test set" here refers to physical samples of the Soteria Bed Barrier material. The testing appears to be laboratory-based performance testing conducted by the manufacturer. No country of origin for "data" (in the sense of patient data) is relevant here. The studies were prospective in the sense that the manufacturer conducted these specific tests on their device samples to demonstrate compliance with standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• Not Applicable. This is a physical device, not a diagnostic or AI algorithm requiring expert interpretation of medical images or data. The "ground truth" is established by adherence to recognized engineering and material testing standards (e.g., AATCC, ASTM, 16 CFR).

4. Adjudication Method for the Test Set

• Not Applicable. As this is material and performance testing against objective, standardized criteria, no human adjudication (e.g., 2+1, 3+1) is relevant. The results are quantitative measurements against predefined thresholds.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• Was it done? No. This type of study (MRMC) is relevant for diagnostic devices, particularly those involving human readers of medical images, often with AI assistance. The Soteria Bed Barrier is a physical barrier, so an MRMC study is not applicable.
• Effect Size: Not applicable.

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

• Was it done? No. This concept applies to AI algorithms. The device is a physical product. Its "performance" is inherently "standalone" in that it performs its function (barrier protection, cleanability) without human intervention in the function itself, but this is distinct from an AI algorithm's standalone performance.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established by objective, quantitative measurements against recognized industry standards and regulatory requirements. For example:
  • Water resistance (AATCC 42, AATCC 127) measured in grams of weight gain or cm of water pressure.
  • Strength (ASTM D5034, D5587, D751) measured in pounds-force (lbf).
  • Flammability (16 CFR Part 1610) measured in burn time.
  • Cleaning validation measured in µg/cm² of residual protein/hemoglobin.
  • Laundering validation measured in % reduction of specific microbial strains.
• This is not "expert consensus," "pathology," or "outcomes data" in the medical sense, but rather compliance with engineering and material science metrics.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/Machine Learning device that requires a "training set." The device itself is manufactured; it does not "learn."

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. (See point 8).

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