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510(k) Data Aggregation
(289 days)
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:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Purity | Generates and delivers USP grade 93% ± 3% oxygen. Monitored and controlled by an integral oxygen analyzer. |
| Flow Rate | Ranges from 66 to 500 liters per minute at a pressure of 50 - 100 psig under standard conditions (depending on unit size). |
| Electrical Safety | Met all required performance criteria per IEC 60601-1-1 ("Safety requirements for medical electrical systems"). |
| Mechanical Operation | Met all required performance criteria. |
| Hardware and Software Controls | Met all required performance criteria. |
| Environmental Conditions | Met all required performance criteria. |
| Overall Functionality | Functioned as intended, meeting acceptance criteria. |
| Equivalence | Substantially equivalent to predicate devices, raising no new questions of safety and effectiveness. |
| Standards Conformance | Conforms to USP 30-NF 25. |
| Electromagnetic Compatibility | Passed required tests per IEC 60601-1-2. |
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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(71 days)
The Deployable Oxygen Concentration System (DOCS) is designed to reliably and continuously provide supplemental oxygen to patients who may have difficulty extracting oxygen from the air that they breathe. It is intended for supplemental use in Department of Defense medical facilities or institutions, in nursing locations, health care facilities, in sub-acute care, and/or in acute care environments, whether in peacetime conditions or in deployed military scenarios.
DOCS has the capability to supply pressurized oxygen to fill gas cylinders that can be transported to remote locations away from the DOCS system or to fill cylinders for a patient's ambulatory use.
The device has no contraindications.
DOCS is intended to provide supplementary oxygen. The device is to be used by trained medical personnel for military use only.
The Deployable Oxygen Concentration System (DOCS) draws in normal air and produces concentrated oxygen. Air in nature is a mixture of roughly 78% nitrogen, 21% oxygen, and 1% other trace gasses. The DOCS separates the nitrogen from the air, producing an output of concentration oxygen at 93 percent, by volume, of O2, the remainder consisting mostly of argon and nitrogen.
DOCS employs an integral oxygen analyzer to provide control of oxygen purity.
The DOCS device is an electromechanical device consisting primarily of an oxygen concentrator module, and one or more oxygen collection cylinders. The oxygen concentrator operates on the principle of using a pressure differential to strip oxygen and nitrogen from filtered air. The resulting oxygen output is 240 liters per minute at pressure of 100 psi nominal and high pressure cylinder filling capability.
The provided document is a 510(k) summary for a medical device called the Deployable Oxygen Concentration System (DOCS). This document outlines the device's technical specifications, intended use, and its equivalence to predicate devices, but it does not contain the detailed information necessary to answer all parts of your request which are typically found in clinical studies for AI/ML-based devices.
The DOCS is an oxygen concentrator, a conventional medical device, not an AI/ML-based device. Therefore, many of your questions, such as "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," "standalone performance," "training set size," and "ground truth for the training set" are not applicable to the information provided.
However, I can extract the acceptance criteria and the summary of performance testing that proves the device meets those criteria.
Acceptance Criteria and Device Performance for Deployable Oxygen Concentration System (DOCS)
The Deployable Oxygen Concentration System (DOCS) is a conventional oxygen concentrator and not an AI/ML-based device. Therefore, the detailed information requested regarding sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, and MRMC studies are not applicable and not present in this 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (Basis) | Reported Device Performance |
|---|---|---|
| Oxygen Purity | Meets requirements of USP 24-NF 19 Oxygen 93% standard; Integral oxygen analyzer for purity control. (Voluntary standards and US Army specifications) | "concentrated oxygen at 93 percent from air... output of concentration oxygen at 95 percent, by volume, of O2" (Implies meeting at least 93%, with a reported performance of 95%) |
| Flow Rate | Established in voluntary standards and US Army specifications. | "concentrator operates at assess of actives per minute at pressure of 100 psi nominal and high pressure cylinder filling capability." |
| Electrical Safety | Established in voluntary standards and US Army specifications. | "device met all required performance criteria and functioned as intended" |
| Mechanical | Established in voluntary standards and US Army specifications. | "device met all required performance criteria and functioned as intended" |
| Controls | Established in voluntary standards and US Army specifications. | "device met all required performance criteria and functioned as intended" |
| Device Performance | Established in voluntary standards and US Army specifications. | "device met all required performance criteria and functioned as intended" |
Study Proving Device Meets Acceptance Criteria:
A "Verification and validation testing activities" study was conducted.
Summary of the Study:
- Study Description: Verification and validation testing activities were conducted to establish the performance and reliability characteristics of the DOCS.
- Proof of Meeting Criteria: "In all instances the device met all required performance criteria and functioned as intended, meeting the acceptance criteria."
- Conclusion: "The combined testing and analysis of results conclude that the device meets its specifications, is safe and effective for its intended use, and is substantially equivalent to the currently marketed devices."
Parts of your request that are NOT APPLICABLE or NOT AVAILABLE in this document (as it concerns a conventional, not AI/ML, device):
- Sample size used for the test set and the data provenance: Not applicable/provided. This is a conventional medical device, not an AI/ML system requiring a defined test set for algorithmic evaluation. Performance testing would typically involve a small number of units tested under various conditions to verify engineering specifications.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth from experts is not relevant for verifying the performance of an oxygen concentrator.
- Adjudication method for the test set: Not applicable.
- 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-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" here is based on physicochemical measurements and engineering specifications, primarily the concentration of oxygen produced, flow rate, and adherence to electrical/mechanical safety standards.
- The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
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