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Purpose: The purpose of the Ceramatec family of galvanic oxygen sensors is to be the oxygensensing component in a finished medical device that monitors oxygen concentration.

Function: The Ceramatec galvanic oxygen sensors are used in finished medical device products such as oxygen monitors, oxygen analyzers, ventilators and humidifiers.

Target Patient Population: The target patient population consists of those patients who require the oxygen concentration in their breathing environment to be monitored.

Environment of Use: The Ceramatec family of galvanic oxygen sensors is used in finished medical devices (i.e., oxygen monitors, oxygen analyzers, ventilators, etc.) in patient environments whose temperatures range from 5 ℃ - 40 ℃ and from 5% - 95% relative humidity (non-condensing).

Device Claims: The Ceramatec family of galvanic oxygen sensors consists of oxygen sensing components in finished medical devices that have the indication or claim of monitoring oxygen concentration in the patients' breathing environment.

Ceramatec galvanic oxygen sensors are lead-oxygen batteries consisting of a lead anode and an oxygen cathode. The oxygen cathode is to be made up of gold and an aqueous electrolyte solution.

The gold electrode is in close proximity to a non-porous fluoropolymer membrane. Oxygen permeating through the membrane is reduced electrochemically at the gold electrode. An electronic network, consisting of one or more resistors and/or thermistors for temperature compensation, is connected between the cathode and anode which allows the lead-oxygen battery to continually discharge in the presence of oxygen. The said network may reside either within the sensor or be incorporated in an attached analyzer.

The current that flows through the device is proportional to the partial pressure of oxygen of the gas in contact with the fluoropolymer membrane. An attached analyzer detects the oxygen concentration by measuring the voltage between the ends of the resistor network.

Here's a breakdown of the acceptance criteria and the study details for the Ceramatec MAXCELL and CAG Galvanic Oxygen Sensors, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria were established by comparison to a predicate device (Seatronics Company, Inc. family of galvanic oxygen sensors). The "reported device performance" reflects that the Ceramatec devices meet or exceed the predicate device's specifications. The summary explicitly states "SAME" for most categories, indicating equivalence. For "Operating Life" and "Temperature Range", the Ceramatec device performance is slightly different but deemed equivalent or better.

Note on Temperature Range: The document clarifies that the operating temperature range of 5°C-40°C for the Ceramatec devices is considered equivalent to the predicate's 0°C-40°C range because "the patient breathing environment is a temperature-controlled setting, the galvanic oxygen sensors are not typically used at 0℃ to 5℃."

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

The provided 510(k) summary does not specify a sample size for a test set in the traditional sense of a clinical trial or performance study on a specific cohort of devices. Instead, the performance is stated as product specifications that apply to all devices in the family.

The data provenance is implied to be internal testing by Ceramatec, Inc., to confirm that their devices meet the listed specifications. There is no mention of country of origin for specific test data, nor whether it was retrospective or prospective, as this is a device design and engineering specification comparison rather than a human-subject study.

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

This information is not applicable and therefore not provided in the 510(k) summary. The "ground truth" for these technical specifications would be established by validated measurement equipment and engineering standards, not by expert consensus in a medical diagnostic context.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert reviewers evaluate cases. For technical device specifications, performance is typically measured against established benchmarks using instruments and protocols, not subjective adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI diagnostic tool on human reader performance for tasks like image interpretation. The Ceramatec oxygen sensors are hardware components for measuring oxygen concentration, not diagnostic AI software.

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

Yes, a form of standalone performance evaluation was done. The entire 510(k) submission describes the standalone performance of the Ceramatec galvanic oxygen sensors against specific technical specifications (accuracy, response time, linearity, etc.). These devices operate as described in their "Method of Operation" to produce a current proportional to oxygen partial pressure, without human intervention in the core sensing mechanism. The "reported device performance" in the table above stands as the standalone performance of the devices.

7. The Type of Ground Truth Used

The "ground truth" for the device specifications (e.g., accuracy, linearity, response time) would be established by validated measurement standards and reference gases/conditions. For instance, accuracy would be verified against certified oxygen gas mixtures, and temperature performance against calibrated thermostatic chambers. It is not expert consensus, pathology, or outcomes data in the medical diagnostic sense.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The Ceramatec galvanic oxygen sensors are not AI algorithms that require a "training set" of data for machine learning. They are physical devices that operate based on electrochemical principles.

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

This information is not applicable and therefore not provided, as the device does not use a training set in the context of machine learning.

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