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The 840 Ventilator System with BiLevel Option is used to provide continuous ventilation to patient's requiring respiratory support. This device is used for a wide range of patients from infant to adult and for a wide variety of clinical conditions.

The 840 Ventilator System is a Class II device, "Continuous Ventilator", per 21 CFR Part 868.5895. This device is designated a Class I Type B equipment per IEC 601-1. The 840 Ventilator's gas delivery system consists of two proportional solenoid valves (PSOLs) and an active expiratory valve. Previosly cleared modes of ventilation include Assist Control (AC), Synchronized Intermittent Mandatory Ventilation (SIMV), and Spontaneous (SPONT). The 840 Ventilator System supplies mandatory or spontaneous breaths with a preset level of positive end expiratory pressure (PEEP), trigger sensitivity, and oxygen concentration. A mandatory breath can be pressure- or volume-controlled, except in the optional BiLevel mode, when it is always pressure-controlled. A spontaneous breath mode allows the patient inspiratory flows of up to 200 L/min, with or without pressure support. The 840 Ventilator modification is the addition of two new features for this device, the BiLevel Option and Inspiratory Pause. The BiLevel mode and Inspiratory Pause features are implemented on the 840 Ventilator through additional functionality in software and by using the existing User Interface panel. "BiLevel" has been added as a mode choice in the touch screen MODE menu. The INSP PAUSE key on the user interface, is activated to perform the inspiratory pause function. The pneumatic design and the electrical circuitry (apart from the User Interface printed circuit board) has remained unchanged functionally.

This document describes a 510(k) premarket notification for the Puritan-Bennett 840 Ventilator System with a new BiLevel Option and Inspiratory Pause features. The submission focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics.

Therefore, many of the requested sections (Table of acceptance criteria, sample size, number of experts, adjudication method, MRMC study, standalone performance, sample size for training, ground truth for training) cannot be extracted from the provided text as they are not present in this type of regulatory submission for a modification to an existing device.

Here's what can be extracted and inferred based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document as it is a 510(k) submission for a modification to an existing device, focusing on substantial equivalence rather than primary functional performance testing against novel acceptance criteria.

The submission states: "Puritan-Bennett Corp. asserts that a) the intended use of the 840 Ventilator with BiLevel Option, as described in its labeling, has not changed from that of the cleared device, the 840 Ventilator, and b) the fundamental scientific technology of the 840 Ventilator with BiLevel Option has not changed from that of the 840 Ventilator."

It also mentions that "The BiLevel mode and Inspiratory Pause features are currently included in cleared predicate devices, providing justification for substantial equivalence." This implies that the 'acceptance criteria' are implicitly met if the device functions equivalently to these predicate devices for the new features.

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

This information is not provided in the document. The submission references "verification and validation testing, test and software quality procedures" but does not detail the size or nature of the test sets used for these activities, nor the provenance of data. This type of detail is typically internal to the company's design control documentation rather than explicitly stated in a 510(k) summary.

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

This information is not provided in the document. The assessment described is based on engineering verification and validation against design specifications and comparison to predicate devices, not typically through expert-adjudicated ground truth as would be common for diagnostic AI algorithms.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

No, an MRMC comparative effectiveness study was not mentioned or relevant to this 510(k) submission. This type of study is more common for diagnostic imaging or AI devices where human reader performance is augmented or compared. The 840 Ventilator is medical equipment; the submission focuses on its functional equivalence and safety.

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

This concept is not directly applicable to a ventilator. While the device contains software algorithms, the "standalone performance" is integrated into the device's overall function and directly assessed as part of its verification and validation. The submission does not describe a separate "algorithm only" performance study in the context of typical AI device evaluations.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering specifications, functional testing against those specifications, and demonstrated equivalence to previously cleared predicate devices. For example, the device must accurately deliver a preset tidal volume or maintain a target pressure. This would be verified through direct measurement with calibrated equipment during testing, rather than through expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic devices.

8. The Sample Size for the Training Set

This information is not provided in the document. The device's operation is based on deterministic algorithms and control systems, not learning models that require a "training set" in the machine learning sense.

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

This information is not provided in the document, as it doesn't describe a machine learning model with a training set. The "ground truth" for its development would be the fundamental principles of respiratory mechanics, engineering design standards, and pre-defined performance parameters derived from clinical requirements for ventilators.

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