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The Divan is intended to ventilate patients as an integrated part of a North American Dräger anesthesia workstation.
The Divan is indicated for ventilating patients as an integrated part of specific North American Dräger anesthesia machines. Federal law restricts this device to sale by or on the order of a physician.

The Divan is an electronic ventilator with an integrated breathing system , and operator control panel.
The Divan is an integral subassembly of Narkomed Anesthesia Systems. They are both volume preset, time cycled, pressure limited ventilators with electronic timing, pneumatic circuitry, and independent controls for frequency, inspiratory to expiratory (I:E) ratio, inspiratory flow rate, tidal volume, and inspiratory pressure limit.
Both the Divan and AV2+ are microprocessor controlled. The Divan utilizes a keypad and incremental encoder as compared to the individual knobs and switches on the AV2+ for adjusting ventilation parameters.
The Divan and the AV2+ provide automatic, manual, and spontaneous modes of patient ventilation. Additionally, the Divan offers synchronized intermittent mandatory ventilation (SIMV), and pressure mode.
The Divan's inspiratory to expiratory (I.E) ratios are adjustable from 1:3 to 2:1.
The Divan incorporates an integrated breathing system, while the AV2+ works with the breathing system of the Narkomed anesthesia workstation.
In place of the bellows assembly of the AV2+, the Divan uses a piston assembly. Both the bellows assembly of the AV2+ and the piston assembly of the Divan control the amount of tidal volume delivered to the patient during automatic ventilation based on parameters selected by the operator.
The Divan differs from the AV2+ in that: It provides a heater to maintain the warmth of the patient gas in the breathing circuit. During mechanical ventilation the Divan provides more precise control of tidal volume delivery through internal calculations, stops inspiration and starts expiration if the airway pressure increases by more than 5cmH2O over the set maximum pressure (e.g. if the patient coughs), and automatically performs a periodic leak check. While power is on, the Divan performs self checks. If it detects the same equipment fault twice within 5 minutes it attempts to change to it's "safe state". The safe state allows the user to continue to ventilate the patient using the reservoir bag provided with the Divan. If a fault condition occurs that renders the Divan incapable of ventilation, the user can override the Divan and use the reservoir bag to continue ventilating the patient.

This document is a 510(k) premarket notification for the Divan Anesthesia Ventilator. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving the device meets them, particuarly related to AI/algorithm performance, is not available in these provided excerpts.

Here's a breakdown of what can be gleaned:

1. A table of acceptance criteria and the reported device performance

This document does not provide a table of acceptance criteria with corresponding performance data in the typical sense (e.g., sensitivity, specificity, accuracy). Instead, it focuses on asserting substantial equivalence through comparison of features and functional descriptions with a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This document describes a medical device's design and intended use for regulatory clearance, not the results of a clinical study or an algorithm's performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth establishment is typically associated with performance studies involving diagnostic or prognostic algorithms.

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 device is an anesthesia ventilator, not an AI-assisted diagnostic or imaging device. There is no mention of AI assistance for human readers.

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

Not applicable. The Divan is a physical medical device, not a standalone algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" in the context of an algorithm.

9. How the ground truth for the training set was established

Not applicable.

Information that is available or implicitly addressed:

• Device Description: The Divan is an electronic ventilator with an integrated breathing system and operator control panel.
• Intended Use: "The Divan is intended to ventilate patients as an integrated part of a North American Dräger anesthesia workstation."
• Substantial Equivalence Claim: The Divan is claimed to be substantially equivalent to North American Dräger's (NAD's) AV2+ Anesthesia Ventilator (AV2+).
• Key Differences & Improvements (compared to AV2+):
  • Utilizes a keypad and incremental encoder for adjusting parameters (vs. individual knobs/switches).
  • Offers Synchronized Intermittent Mandatory Ventilation (SIMV) and pressure mode (in addition to automatic, manual, and spontaneous).
  • Has an integrated breathing system.
  • Uses a piston assembly (vs. bellows assembly).
  • Provides a heater for patient gas warmth.
  • Offers more precise control of tidal volume delivery through internal calculations.
  • Stops inspiration and starts expiration if airway pressure increases by >5cmH2O over set maximum (e.g., for patient coughs).
  • Automatically performs a periodic leak check.
  • Performs self-checks and attempts to change to a "safe state" upon detecting repeated equipment faults, allowing continued patient ventilation via a reservoir bag.
• Qualification Activities: "Qualification of the Divan included hazard analysis, functional testing, communication testing, environmental testing, and electromagnetic compatibility." (While specifics are not given, these imply the types of tests done to ensure the device performs as intended and safely).

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