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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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