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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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The intended use of the Ceramatec® Handi oxygen analyzer is to monitor the oxygen concentration in the patient-breathing environment.

The Ceramated Handi oxygen analyzer is comprised of a galvanic oxygen sensor and an analyzer module. The galvanic oxygen sensor produces a millivolt output that is proportional to the partial pressure of oxygen in the monitored gas. The analyzer module contains an electronic circuit that converts the millivolt output of the sensor to a digital percent-oxygen reading on a liquid-crystal display (LCD).

Here's an analysis of the Ceramatec Handi Oxygen Analyzer based on the provided text, focusing on acceptance criteria and the study that proves its adherence:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Ceramatec Handi Oxygen Analyzer are implicitly established by demonstrating substantial equivalence to a legally marketed predicate device, the MSA Miniox® IA oxygen analyzer. The device performance is then compared against these criteria, which are the specifications of the predicate device.

Note on "Acceptance Criteria" interpretation: In the context of a 510(k) submission, "acceptance criteria" for a new device are primarily defined by its substantial equivalence to a predicate device. The new device must meet or exceed the performance specifications of the predicate, or any differences must not raise new questions of safety or effectiveness. The table above reflects this comparison.

Study Details Proving Device Meets Acceptance Criteria

The document provided does not describe a traditional "study" in the sense of a clinical trial or a formal research study with a test set, experts, and adjudication methods. Instead, the "proof" that the device meets acceptance criteria is based on a demonstration of substantial equivalence to a predicate device (MSA Miniox® IA oxygen analyzer, K935370).

This is a regulatory pathway for medical devices in the United States, where a new device is deemed safe and effective if it is substantially equivalent to a device already legally marketed. The core of this demonstration involves a detailed comparison of the technological characteristics, intended use, and performance specifications between the new device and the predicate.

Based on the provided text, the following information is not applicable or not explicitly detailed as it would be in a typical clinical or performance study:

2. Sample size used for the test set and the data provenance: Not applicable. The submission relies on a comparison of technical specifications, not a test set of patient data or samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a test set is not established in this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a measurement instrument, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of a "test set." The ground truth for the device's accuracy and linearity would be established through laboratory calibration and testing against gases of known oxygen concentrations, as implied by the "calibration potentiometer" feature. The reported accuracy and linearity specifications are assumed to be derived from such internal testing by the manufacturer.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

Summary of "Study" and "Proof" for Substantial Equivalence:

The "study" in this context is the detailed technical comparison presented in section 15.0 of the submission, "Comparison of Technological Characteristics." This comparison systematically evaluates:

• Intended Use: The device shares the same intended use as the predicate: "to monitor the oxygen concentration in the patient-breathing environment."
• Technological Characteristics: A side-by-side comparison of numerous specifications (display range, resolution, operating temperature, accuracy, linearity, sensor type, battery life, weight, etc.) is provided between the Ceramatec Handi and the MSA Miniox® IA.
• Performance Data: The manufacturer asserts that for critical performance metrics like accuracy, linearity, sensor operating life, shelf life, and response time, the Ceramatec Handi's performance is equivalent to or better than the predicate device. Minor differences (e.g., display range, resolution, battery type, weight) are discussed and deemed not to raise new safety or effectiveness concerns. For instance, the operating temperature range difference is justified by referring to ANSI standards, stating that the Handi's range is "well within the ANSI specification."

Conclusion: The device's compliance with acceptance criteria is established by demonstrating that its specifications and intended use are substantially equivalent to a legally marketed predicate device, implying that it is as safe and effective. The evidence provided is primarily a technical specification comparison, rather than data from a clinical or performance study with a dedicated "test set" or "training set" as might be seen for more complex or novel devices.

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