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Intended use:
The Datex-Ohmeda S/5 Single-width airway module, M-miniC is intended to be used with Datex-Ohmeda S/5 modular monitors; S/5 Anesthesia Monitor, S/5 Compact Anesthesia Monitor, S/5 Critical Care Monitor and S/5 Compact Critical Care Monitor for monitoring CO2 and respiration.

Indications for use:
The Datex-Ohmeda S/5 Single-width airway module, M-miniC and accessories is indicated for monitoring CO2 and respiration rate of all hospital patients. M-miniC is indicated for monitoring patients weighing more than 5kg (11 lbs.). The device is indicated for use by qualified medical personnel only.

The M-miniC is used in the Datex-Ohmeda S/5 modular family which consists of four different types of monitors: Anesthesia Monitor, Compact Anesthesia Monitor, Critical Care Monitor and Compact Critical Care Monitor. An monitor consists of four basic elements: display, keyboard, Central unit and modules. The display shows up to eight waveforms, real-time data and trends. With keyboard you can control the monitor. The keyboard consists of membrane keys and a comwheel. By pushing a key you can open a menu in which you can move by turning the comwheel.

The M-miniC module consists of miniCO2 infrared measuring sensor for measuring CO2. It is assembled in a Single-width module, which occupies one slot in a Datex-Ohmeda S/5 modular monitor frame. The main accessories include airway gas sampling lines, mini D-fend water traps and airway adapters The module is first plugged into the frame of the monitor. The sampling line is attached to the module connector. The monitor is switched on and the gas sampling line is attached to the airway adapter. The airway adapter is attached between ventilator Y-piece and Heat and moisture exchanger (HME) of the patient's intubation tube. The monitor displays measurements from the M-miniC module in the form of numeric values, curve and trends. The monitor also generates audible and visual alarms for this module and indicates the priorities and sources of alarms.

The Datex-Ohmeda S/5™ Single-width Airway Module M-miniC is a carbon dioxide gas monitor. The provided text outlines its intended use, technological characteristics, and a summary of nonclinical testing, but does not contain specific acceptance criteria or an explicit study proving device performance against such criteria.

However, based on the nonclinical testing summary, we can infer that the device was tested to comply with relevant safety and performance standards. The text states: "The Datex-Ohmeda S/5TM Single-width Airway Module M-miniC and accessories complies with the safety standards below and is therefore safe and effective for the intended use. The device has been thoroughly tested including electrical safety, electromagnetic compatibility, mechanical and environmental tolerance, software validation and verification of specifications."

The standards listed represent the implicit acceptance criteria that the device had to meet. The "reported device performance" then is its successful compliance with these standards.

Here's an attempt to structure the information conceptually, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text only mentions "thoroughly tested" for various aspects but does not specify sample sizes for test sets or data provenance (e.g., country of origin, retrospective/prospective). This document is a 510(k) summary, which is a high-level overview. Detailed testing protocols and results would be in the full submission, which is not provided here.

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

This document does not mention the use of experts to establish "ground truth" in the context of a test set, nor does it specify their number or qualifications. The testing described focuses on compliance with technical and safety standards, rather than clinical efficacy studies requiring expert interpretation of results.

4. Adjudication Method for the Test Set

As there's no mention of expert-established ground truth or a clinical test set requiring adjudication, there is no adjudication method described in this summary.

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

No MRMC comparative effectiveness study is mentioned. The submission focuses on demonstrating substantial equivalence to a predicate device through technical comparisons and compliance with safety standards, not a comparative clinical study with human readers.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done

This device is a medical monitoring module, not an AI algorithm. Its performance is inherent to its sensors and software. The validation of its "software" and "verification of specifications" can be considered a standalone assessment of the device's technical performance. However, it's not an "algorithm only" study in the modern sense of AI.

7. The Type of Ground Truth Used

The "ground truth" for the nonclinical testing described would be based on:

• Engineering specifications and regulatory standards: The device's performance was compared against established technical requirements and the benchmarks set by the listed IEC, EN, CAN/CSA, ASTM, and UL standards.
• Reference measurements/devices: For CO2 measurement accuracy and response times, highly accurate reference instruments would have been used to establish the "true" values against which the M-miniC's readings were compared.

8. The Sample Size for the Training Set

This document does not mention a "training set" as the device is not based on a machine learning model that requires a training phase with a distinct dataset. Its software, while validated, is likely deterministic or rule-based, rather than learned.

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

Since there is no mention of a training set, this information is not applicable/provided.

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