Search Results

The CDI 400 Extracorporeal Blod Gas Monitoring System is intended for use during cardiopulmonary bypass procedures when continuous monitoring of blood gases is desired.

The 3M CDI H/S QUIK-CELLS with Heparin Treatment are sterile, single-use medical devices. They are available in 1/4", 1/8", and 1/2" diameter sizes. Additionally, the 3M CDI QUIK-CELLS with Heparin Treatment have a covalently bound heparin coating.

The provided document is a 510(k) summary for the 3M CDI QUIK-CELLS with Heparin Treatment, which are components of the CDI 400 Extracorporeal Blood Gas Monitoring System. The device is a modification of previously cleared devices, specifically the application of a heparin coating.

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "The performance characteristics of the 3M CDI OUIK-CELLS with Heparin Treatment were exhaustively tested and compared with the performance characteristics of the currently marketed 3M CDI OUIK-CELLS. All new and existing performance characteristics of the 3M CDI Heparin Coated QUIK-CELLS have been validated."

However, specific numerical acceptance criteria (e.g., minimum accuracy, precision, or specific thresholds for chemical or physical properties) and the corresponding reported performance values are not detailed in this summary. The "Nonclinical Performance" section provides a general statement of validation without quantifiable results.

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

• Sample Size: Not specified. The document states "exhaustively tested" but provides no numbers for the test set.
• Data Provenance: Not specified. Given the nature of the device (a component for blood gas monitoring during cardiopulmonary bypass) and the "Nonclinical Performance" section, the testing was likely conducted in a laboratory setting (in vitro or ex vivo), rather than involving human subjects. The country of origin is not mentioned.

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

Not applicable. The study described is a non-clinical performance evaluation comparing the modified device to a predicate device, not one requiring expert interpretation of medical images or patient data to establish ground truth.

4. Adjudication Method for the Test Set:

Not applicable. The study is a non-clinical performance evaluation, not a human reader study requiring adjudication.

5. 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 a 510(k) submission for a medical device component (blood gas sensor) involving non-clinical performance testing. It does not involve AI or human readers for diagnostic interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The "Nonclinical Performance" section describes the testing of the device's characteristics in a standalone manner, comparing it to the predicate device. The device itself is a measurement component, not an algorithm, so "standalone algorithm performance" is not the correct terminology, but the device's inherent performance was evaluated independently.

7. The Type of Ground Truth Used:

The ground truth for the non-clinical performance study would have been established by accepted laboratory measurement standards and validated methods for assessing the performance of blood gas monitoring components (e.g., accuracy against known blood gas compositions, stability, biocompatibility). The document implies that the predicate device's established performance served as a benchmark for the modified device's equivalence.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI algorithm that requires a training set. It's a physical medical device.

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

Not applicable. This device is not an AI algorithm that requires a training set.

Ask a specific question about this device