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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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