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The Model ORCA-2016CN is a portable and ambulatory Patient Isolation Unit (PIU) designed to prevent chemical and particulate (biological and radiological) cross-contamination between an enclosed contaminated patient and the external environment during evacuation and transport activities.

The Operational Rescue Containment Apparatus (ORCATM) Patient Isolation Unit, Model ORCA-2016CN, is a tubular, flexible, Patient Isolation Unit (PIU) for use during transport and evacuation of chemical and particulate (biological and radiological) contaminated patients who have been medically stabilized. Each unit employs clear windows to allow visual monitoring of the patient. The unit incorporates multiple glove arms for minimal medical intervention. The PIU's have a reinforced base mat with integrated carry straps and tethers to enable lifting and attachment to a Stokes litter for hoisting operations or a North Atlantic Treaty Organization (NATO) litter for alternative transportation. Chamber airflow through the isolator and across the patient is provided by the blower from a Powered Air-Purifying Respirator (PAPR). Internal contaminated air in the PIU is vented out the exhaust ports which are fitted with two Chemical, Biological, Radiological, Nuclear (CBRN) filter cartridges, thus protecting the external environment from a contaminated patient.

The provided text describes the ISOVAC Products, LLC ORCA™ - Operational Rescue Containment Apparatus (K163223), a patient isolation unit. However, the document does not contain information relevant to all parts of the request. Specifically, it does not detail a study involving an algorithm or artificial intelligence, a common scenario for multi-reader multi-case (MRMC) comparative effectiveness studies. Therefore, some sections of your request cannot be fully addressed from the provided text.

Here's an analysis of the acceptance criteria and performance data available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for each performance test in a formal table format with numerical targets. Instead, it describes tests performed and their successful outcomes, implying that successful completion of these tests serves as the acceptance criteria.

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

• Operational Testing: The document mentions "multiple times" for hoisting. It doesn't specify a numerical sample size for the tests on the PIU during helicopter operations.
  • Data Provenance: Conducted by the U.S. Coast Guard, suggesting a domestic (USA) origin. The nature of the test (actual helicopter operations) implies prospective testing for the specific device, though it's evaluating a physical product's performance rather than data analysis.
• Chemical Agent Permeation, Liquid Penetration / Pathogen Passage, Human Use Comfort, Weight Lift Testing: These were performed by a "third-party testing party under contract with the USGC." No specific numerical sample sizes are given for the number of units tested or the number of samples for materials.
  • Data Provenance: The location of the third-party testing party is not specified, but the USGC contract suggests it's likely within the US. These tests are prospective.
• Human Use Comfort: "a test participant (TP)" was used, indicating a sample size of 1 for the comfort study.
  • Data Provenance: Not explicitly stated, but likely domestic (USA) given the context. Prospective.

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

This information is not applicable as the document describes performance testing of a physical medical device (Patient Isolation Unit), not an AI or algorithm-based device that would require expert consensus for establishing ground truth data. The "ground truth" for these tests is based on objective measurements (e.g., lack of permeation, stable vitals, weight holding capacity) and successful operational use as determined by the USCG.

4. Adjudication Method for the Test Set

This is not applicable for the type of device and testing described. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of medical data by multiple experts to establish a "true" label, which is not the nature of the tests conducted for this physical device. The USCG "deemed...sufficient testing" for the operational tests, indicating their internal expert judgment as an adjudicator, but not in the sense of a medical image or diagnostic interpretation.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers interpret medical cases with and without AI assistance. The ORCA™ is a physical containment apparatus.

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

No, a standalone (algorithm only) performance study was not done. The ORCA™ is a physical medical device and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests described is primarily based on:

• Objective performance measurements: For chemical permeation, liquid penetration, vital signs, and weight capacity. These are quantifiable outcomes.
• Operational success/validation: For hoisting and transport, determined by the U.S. Coast Guard's assessment of suitability for use in their aircraft.

8. The Sample Size for the Training Set

Not Applicable. The ORCA™ is a physical medical device, not an AI or algorithm that requires a training set.

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

Not Applicable. As mentioned above, there is no AI or algorithm with a training set for this device.

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