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The Carecube is a patient isolation unit (PIU) designed for the temporary isolation of patients within a hospital setting to prevent particulate (biological) cross-contamination between user and patient, while enclosing the contaminated patient from the external environment. Device should only be used in a hospital setting. This is for temporary housing of a patient prior to transfer to an appropriate hospital destination. Transfer to a more permanent hospital setting should occur as soon as possible. The Carecube is designed with features that enable low-moderate complexity medical interventions. This includes the following procedures: blood draw, medication administration, palpating abdomen, cardiac auscultation, and connection to IV line/monitoring cables.

The Carecube Negative Pressure Isolation Chamber is a modular, negative pressure, isolation patient care system with both reusable and disposable components that can rapidly augment capacity to care for airborne infectious diseases and other biological threats for common patient care protocols with features built into the unit to allow ease of execution. The device is intended to be used indoors, in a hospital setting, as a temporary isolation of patients with suspected or confirmed diagnosis of infectious disease to prevent Healthcare Practitioners (HCP) exposure to pathogenic biological airborne particulates and is designed with features that enable low-moderate complexity medical interventions.

This document describes the Carecube Negative Pressure Isolation Chamber, a patient isolation unit (PIU), and its assessment for substantial equivalence to a predicate device. This device is not an AI/ML powered device, so an analysis of acceptance criteria relative to an AI/ML device is not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not an AI/ML device, the acceptance criteria are based on various performance and safety tests rather than metrics like sensitivity, specificity, or AUC. The document lists the following performance tests and their results:

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

The clinical study conducted for the Carecube Negative Pressure Isolation Chamber was a prospective, single-center, non-blinded study.

• Sample Size: A minimum of ten (10) subjects were included.
• Data Provenance: The study used normal, healthy volunteers aged 21-47 years old, comprising a cross-section of males and females. This indicates prospective data collection from a single, unspecified center (presumably in the US given FDA submission).

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

Since this is not an AI/ML device, the concept of "ground truth" as established by experts (e.g., radiologists) for a test set is not directly applicable. The clinical study focused on patient safety and comfort, assessed through routine monitoring of vital signs, STAID evaluation (for anxiety), and environmental monitoring (temperature, humidity, CO2, O2). The determination of "Pass" likely relies on established medical norms for vital signs and comfort levels, and environmental safety standards, interpreted by the study's clinical team, rather than a panel of independent expert adjudicators for a "ground truth" diagnosis.

4. Adjudication Method

Not applicable for this type of device and study. The study assessed physiological parameters and environmental conditions, not diagnostic outcomes requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI-powered device, and the study was designed to assess safety and comfort, not diagnostic performance with or without AI assistance.

6. Standalone Performance Study

Not applicable. This device is not an algorithm; it is a physical patient isolation unit. The performance studies detailed are for the physical device's characteristics and its interaction with a human patient (comfort, safety).

7. Type of Ground Truth Used

As mentioned above, the "ground truth" in the clinical study related to:

• Physiological measurements: Vital signs (blood pressure, body temperature, pulse, oxygen saturation), which have objective measurements.
• Patient-reported outcomes: Level of anxiety using the STAID evaluation, which is a standardized psychological assessment.
• Environmental measurements: Temperature, relative humidity, carbon dioxide (CO2), and atmospheric oxygen (O2) within the Carecube, which are objective measurements.

These measurements were used to determine if the device provided a safe and comfortable environment, not to establish a diagnostic ground truth.

8. Sample Size for the Training Set

Not applicable. This device does not use an AI/ML algorithm, so there is no training set as understood in the context of AI.

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

Not applicable, as there is no training set for an AI/ML algorithm.

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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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The Gentex Patient Isolation Unit (PIU) is a temporary, single-use, portable structure that is designed to fully contain and transport a patient and prevent particulate crosscontamination between the patient, the external environment and the caregivers. The PIU is designed to enable medical care-giving to the patient via integrated medical bulkheads interfaced with end-user supplied medical products and equipment. The PIU is intended to be used as a means to temporarily isolate a contaminated patient , outside or within patient care facilities. The PIU can also be used to transport those patients within vehicles, including aircraft, via a NATO-type or similar litter/gumey.

The Gentex Patient Isolation Unit (PIU) is a temporary, single-use, portable structure that is designed to fully contain and transport a patient and prevent particulate crosscontamination between the patient, the external environment and the caregivers. The PIU is designed to enable medical care-giving to the patient via integrated medical bulkheads interfaced with end-user supplied medical products and equipment.

This document is a 510(k) clearance letter from the FDA for a Patient Isolation Unit, Model G019-1000. It does not contain information about acceptance criteria or a study proving the device meets them in the context of AI/ML performance. The letter simply states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information from the given text.

The numbered information you asked for (acceptance criteria, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types, training set size, and ground truth establishment for training set) is not present in this regulatory document.

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For Transporting and Isolating a TB patient or a suspected TB patient

Not Found

The provided text is a 510(k) summary for a medical device (Failsafe Isolation Systems Transport Model 07 and Portable Isolation Model 77). It is a letter from the FDA confirming substantial equivalence to a predicate device. This type of document does not contain details about specific acceptance criteria, study designs, sample sizes, or ground truth establishment for the device itself.

It focuses on regulatory approval based on equivalence to existing devices, not performance criteria from a clinical trial or algorithm validation study. Therefore, I cannot extract the requested information from the provided text.

To answer your questions, I would need a different type of document, such as a clinical study report, a device validation report, or a detailed technical submission describing the performance evaluation.

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