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The Deployable Oxygen Concentration System (DOCS) Family of devices generates and delivers USP grade 93% ± 3% oxygen. The oxygen supplied by these units is for supplemental not considered to be life supporting or life sustaining.

DOCS Family devices may be used to fill high pressure oxygen cylinders for use in locations remote to the DOCS unit or for ambulatory patient use.

These devices are to be used only by trained personnel in disaster relief, crisis response or humanitarian relief situations where bottled or bulk oxygen is not readily available, as hospital backup systems, in local emergencies where disaster has rendered the primary oxygen supply unusable, or by trained military personnel in peacetime or wartime support of Armed Forces.

The Deployable Oxygen Concentration System (DOCS) is a family of electromechanical devices that use a molecular sieve to adsorb nitrogen, water and carbon dioxide from filtered air, producing an output of high purity oxygen (93 ± 3 %) via the Vacuum Swing Adsorption process. The remainder of the gas product consists mostly of argon and nitrogen.

Depending on the unit size, the resulting high purity oxygen can be delivered at flow rates ranging from 66 to 500 liters per minute at a pressure of 50 - 100 psig under standard conditions.

Selected models may be configured with one or two integral high pressure compressors or an accessory high pressure compressor may be added to some models. These high pressure units are capable of filling oxygen cylinders to 2,250 or 3,000 psig.

The provided text describes the acceptance criteria and a summary of performance testing for the Deployable Oxygen Concentration System (DOCS) family.

1. Table of Acceptance Criteria and Reported Device Performance

While the document doesn't provide a precise numerical table of acceptance criteria for each specific characteristic, it broadly states the following:

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Testing was conducted to establish the performance and reliability characteristics of the DOCS family."

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

This information is not provided in the document. The testing appears to be focused on technical performance and adherence to standards rather than expert-derived ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned. The testing described is focused on the device's technical performance and compliance with relevant standards.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The testing described is inherently a standalone performance evaluation of the device itself (the Deployable Oxygen Concentration System). There is no "algorithm" in the sense of AI being evaluated, but rather the electromechanical system. The "Summary of Performance Testing" refers to the device's ability to meet specified criteria and function as intended without human intervention in its core oxygen generation process.

7. Type of Ground Truth Used

The "ground truth" for the performance testing appears to be based on:

• Established Technical Specifications: Purity (USP grade 93% ± 3% oxygen), Flow Rate (66 to 500 L/min), and Pressure (50-100 psig).
• Recognized Standards: USP 30-NF 25, IEC 60601-1-1 (Electrical Safety), and IEC 60601-1-2 (Electromagnetic Compatibility).
• Intended Use Parameters: Functionality under specified environmental conditions and mechanical operation.

8. Sample Size for the Training Set

This product is an electromechanical device, not an AI algorithm, so there is no concept of a training set in the context of machine learning.

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

As this is not an AI algorithm, this question is not applicable.

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The Expeditionary Deployable Oxygen Concentration System (EDOCS-120B) is intended to generate and deliver USP grade 93% +/- 3% oxygen for supplemental oxygen use. This device is to be used only by trained personnel in disaster relief situations where bottled oxygen is not readily available.

The Mobile Oxygen Storage Tank (MOST) is intended to store and dispense USP grade 93% (+7%/-3%) oxygen at 50psig nominal pressure for supplemental oxygen use. This device is to be used only by trained personnel in disaster relief situations where bottled oxygen is not readily available.

The Expeditionary Deployable Oxygen Concentration System (EDOCS) is a family of devices that draw in normal air and produce oxygen. The EDOCS separates nitrogen from the air, producing an output of concentrated oxygen at 93 percent by the molecular sieve process. The final product contains not less than 90 percent and not more than 96 percent oxygen, by volume. The remainder of the product consists mostly of argon and nitrogen. EDOCS employs an integral oxygen analyzer to provide control of oxygen purity. The EDOCS device is an electromechanical device consisting primarily of a molecular sieve type oxygen concentrator, a compressor module(s), and one or more oxygen collection cylinders. The oxygen concentrator operates by adsorbing water and nitrogen from filtered air. Depending on the unit size, the resulting gas has increased oxygen at flow rates from 30 to 500 liters per minute at a pressure of 50 - 100 psi nominal and is capable of high pressure cylinder filling.

The Mobile Oxygen Storage Tank (MOST) is a oxygen storage and distribution system consisting of lightweight, high-pressure, composite wound, brass lined cylinders and a distribution manifold secured within a rugged waterproof case. The MOST contains 10,000 liters of oxygen when filled to 2,250 psig (13,400 liters at 3,000 psig). The MOST has a maximum flow capability of 225 LPM, which is equivalent to 75 LPM per Oxygen Output fitting (3 fittings per MOST). These three oxygen output flows would typically be subdivided further by the customer's equipment.

Here's a breakdown of the acceptance criteria and study information for the Expeditionary Deployable Oxygen Concentration System (EDOCS) and Mobile Oxygen Storage Tank (MOST), based on the provided text:

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 specify the exact sample size for the test sets. It only mentions "Verification and validation testing activities were conducted."
• Data Provenance: The data provenance is not specified. It does not indicate the country of origin or whether the studies were retrospective or prospective.

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

• The document does not mention the use of experts or any process for establishing a "ground truth" in the context of human interpretation or diagnostic accuracy. The testing appears to be focused on device performance against engineering and regulatory standards rather than subjective human assessment.

4. Adjudication Method for the Test Set:

• Not applicable as the testing described is not related to subjective assessments requiring adjudication (e.g., image interpretation). The evaluation is based on objective measurements against predefined technical specifications.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study typically involves human readers evaluating cases with and without AI assistance to assess changes in diagnostic performance. The devices in question (oxygen concentrator and storage tank) are physical medical devices, not diagnostic AI algorithms.

6. Standalone (Algorithm Only) Performance Study:

• Yes, in essence. The performance testing described for both EDOCS and MOST relates to the standalone performance of the devices themselves, without direct human-in-the-loop intervention for the performance evaluation. The devices generate or store oxygen, and their output and characteristics are measured directly against predefined criteria.

7. Type of Ground Truth Used:

• The "ground truth" for the performance testing of these devices is based on objective technical specifications and accepted industry/regulatory standards. These include:
  • USP grade 93% +/- 3% oxygen (United States Pharmacopeia) for purity.
  • US Army specifications (USAMMA) and USAF specifications (AFMESA) for various performance aspects.
  • Voluntary standards.
  • IEC 60601-1-2 for Electrical Safety (Electromagnetic Compatibility).
  • ISO 14971 for Risk Analysis.
  • DOT-CFFC, NASA, and MIL-STD-810F for mechanical and safety aspects.

8. Sample Size for the Training Set:

• Not applicable. These are physical medical devices, not AI algorithms that require a "training set" in the machine learning sense. The devices' operational parameters are set during manufacturing and design, not learned from data.

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

• Not applicable for the reasons stated above.

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