Search Results

The Cyl-Fil Oxygen System is intended to provide supplemental oxygen by prescription only. Cyl-Fil is a two component system. The first component consists of a high pressure regulator that delivers USP oxygen from a supply cylinder having two pressure settings. The second component is a light-weight portable, high pressure cylinder that is refilled by use of the Cyl-Fil pressure regulator.

The intended patient population is to supply, by prescription only, supplemental oxygen to patients requiring additional oxygen.

The Responsive Respiratory Cyl-Fil Oxygen System is a two component system. The first component is a high pressure regulator that delivers USP Grade oxygen at two pressure settings. The second component is a lightweight, portable high pressure cylinder with an oxygen specific post valve (similar to CGA-870 with an additional pin/hole location unique to the Cyl-Fil system) that incorporates a residual pressure retention device to insure that the USP oxygen is always retained in the cylinder. The portable cylinder is prepared and filled with USP oxygen according to industry and FDA requirements.

A supply cylinder supplies USP oxygen to the inlet connection (standard CGA-540) of the Cyl-Fil regulator. The Cyl-Fil regulator pressure setting delivers USP oxygen to the Cyl-Fil portable cylinder at a pressure and rate that does not exceed the safety rating of the cylinder, according to the cylinder manufacturer's specifications. The second Cyl-Fil regulator pressure setting delivers USP oxygen to an auxiliary outlet connection (CGA-1240) for continuous oxygen therapy support in the home.

The provided text describes a 510(k) premarket notification for the "Cyl-Fil Oxygen System," a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of technological characteristics. It does not typically involve detailed clinical studies with human subjects, complex statistical analysis of performance metrics like sensitivity/specificity, or multi-reader, multi-case studies, as would be expected for a device relying on AI or requiring efficacy testing.

Therefore, many of the requested categories for a study proving acceptance criteria are not applicable to this document. The "acceptance criteria" here are essentially that the device performs its intended function safely and effectively, and is substantially equivalent to existing predicate devices, as demonstrated by the non-clinical tests listed.

Here's a breakdown 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 for Test Set: Not applicable in the context of this 510(k) submission. No human subject "test set" data (e.g., patient cases) is mentioned. The testing refers to non-clinical, component-level engineering tests.
• Data Provenance: The data comes from non-clinical engineering tests performed on the device components (regulator, valve, cylinder) to ensure they meet specified standards and safety requirements. The specific testing facilities or retrospective/prospective nature of the engineering tests are not detailed beyond listing the types of tests and standards.

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

• Not Applicable: This type of information is pertinent to studies involving expert review of medical images or other diagnoses to establish a "ground truth" for evaluating an algorithm or human performance. This 510(k) concerns a physical medical device (oxygen system) and its non-clinical performance, not diagnostic accuracy requiring expert ground truth.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods (like 2+1, 3+1) are used in clinical studies or algorithm evaluations where multiple experts provide opinions that need to be reconciled to establish a ground truth. This is not reported for the non-clinical engineering tests performed on the Cyl-Fil Oxygen System.

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

• No: A MRMC study was not done. This type of study assesses how human readers' performance (e.g., diagnostic accuracy) changes with and without AI assistance across multiple cases. It is not relevant for a physical oxygen delivery system.

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

• No: This is not an AI/algorithm-based device. Therefore, a standalone algorithm performance study is not applicable. The listed "Performance Testing" are standalone tests of the device's physical components.

7. Type of Ground Truth Used

• Engineering Standards and Specifications: The "ground truth" for the non-clinical tests is adherence to established engineering standards (ISO, ASTM, CGA, DOT) and the manufacturer's own safety and performance specifications for the components (e.g., pressure ratings, material compatibility with 100% oxygen, cycle life). The objective is to demonstrate that the device meets these pre-defined technical criteria.

8. Sample Size for the Training Set

• Not Applicable: There is no "training set" in the context of an AI algorithm for this device. If interpreted as samples used for development/testing of the physical device components, the text does not specify quantities beyond referring to "all brass constructed regulators and brass post valves" and "components are designed for use in 100% pure oxygen applications and tested accordingly." This implies standard manufacturing and quality control sample sizes for component testing.

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

• Not Applicable: As there is no AI training set, this question is not relevant. The performance metrics for the device components are based on physical laws, material science, and established engineering standards.

Ask a specific question about this device