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The CAPSULS™ (Containment and Protection System Utilizing Life Support) is a portable Patient Isolation Unit (PIU), which prevents particulate (biological and radiological) cross-contamination between the patient and the external environment; and with features that enable medical intervention to the patient via end-user supplied medical equipment. The CAPSULS is intended to be used for:

• . The transport and isolation of patients on aircraft, ambulances, ships, and any vehicle capable of safely transporting a patient on a standard litter,
• . The temporary isolation, with or without transport, of patients within hospitals or other medical facilities.

The CAPSULS (Containment And Protection System Utilizing Life Support) Patient Isolation Unit Model 2004 is a clear, tubular, flexible, patient isolation unit (PIU) for use during transport and evacuation. Each unit employs a clear envelope (either polyurethane [PUR] or polyvinylchloride [PVC]) to allow visual monitoring of the patient; the unit also has multiple glove arms and tubular access ports to facilitate medical intervention.

The PIUs have a reinforced base mat with integrated handholds and tethers to enable lifting and attachment to a standard litter, and are supported by external ribs and end stanchions. Chamber airflow to the patient is provided by a battery-powered airpurifying respirator, which HEPA-filters contaminated air. The unit is operated under negative pressure mode during transport of a contaminated patient, and is operated in positive pressure mode during transport of a patient through a contaminated environment.

The provided text describes a medical device, the CAPSULS™ Patient Isolation Unit, and its 510(k) summary for FDA clearance. However, the document does not contain the detailed acceptance criteria and study information typically associated with AI/ML device performance evaluations (e.g., sensitivity, specificity, AUC, sample sizes for training/test sets, ground truth establishment by experts, MRMC studies).

The CAPSULS™ is a physical medical device (patient isolation unit), not an AI/ML diagnostic or therapeutic software. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed in terms of its physical function and equivalence to a predicate device, rather than statistical performance metrics of an AI model.

Given the nature of the device, I will extract and present the information as it relates to the device's functional performance and regulatory clearance process from the provided text.

Here's the information based on the provided FDA 510(k) summary for the CAPSULS™ Patient Isolation Unit:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance values in the way one would for an AI/ML algorithm (e.g., specific sensitivity or specificity targets). Instead, the "acceptance criteria" can be inferred from the device's intended use and the "performance data" provided, focusing on its ability to isolate and prevent cross-contamination, which was verified through government testing.

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

• Sample Size for Test Set: The document indicates that "applicable system level testing was conducted on the CAPSULS Patient Isolation Unit." It does not specify a numerical sample size for the test set (e.g., number of individual units tested, or number of test scenarios). It refers to the testing conducted on the unit itself.
• Data Provenance: The primary performance testing was conducted by the US government at the West Desert Test Center (WDTC) of the US Army Dugway (Utah) Proving Ground. This would be considered prospective testing specifically for this device's validation.

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

This information is not applicable in the context of this device. The "ground truth" for the CAPSULS unit's performance (e.g., isolation efficacy, pressure maintenance) would be established by scientific and engineering measurements in a test environment, not by expert consensus on clinical data or images.

4. Adjudication Method for the Test Set

Not applicable. This concept (e.g., 2+1, 3+1) is relevant for clinical expert review of data, typically in AI/ML performance studies, not for the functional testing of a physical isolation unit.

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 is not an AI/ML device, and no MRMC study was mentioned or would be relevant for this type of product.

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

Not applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance was established through physical testing and measurements (e.g., direct measurement of isolation efficacy, differential pressure, leak testing) rather than pathology, expert consensus on clinical outcomes, or observational data. The HEPA filter component's performance (P-100 certification) received NIOSH certification, a specific regulatory standard.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set. The term "training set" is not relevant here.

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

Not applicable, as there is no training set for this type of device.

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