(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.
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).