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The 840 Ventilator System with ET/Tracheostomy Tube Compensation, TC, Option is used to provide continuous ventilation to patients 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 "Continuous Ventilator", a Class II device, per 21 CFR Part 868.5895. This device is designated as 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. Previously 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 either pressure or volume controlled, except in the optional BiLevel mode, when it is always pressure-controlled. A spontaneous breath type allows patient inspiratory flows of up to 200 L/min, with or without pressure support. This 840 Ventilator modification comprises the addition of a new ET/Tracheostomy Tube Compensation, "TC", feature. This feature is implemented on the 840 Ventilator through additional functionality in software and by using the existing User Interface panel. "TC" has been added as a Breath Type choice in the Touch Screen SPONT Type menu. The ventilator's pneumatic design and electrical circuitry remain functionally unchanged.

The provided text is a summary of a 510(k) submission for a medical device, the Puritan-Bennett 840 Ventilator System with ET/Tracheostomy Tube Compensation Option. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study in the way one might for a novel diagnostic AI.

The document does not contain information about acceptance criteria or a study designed to prove the device meets those criteria in the context of a new diagnostic algorithm. Instead, it focuses on demonstrating that the modified ventilator is substantially equivalent to existing predicate devices.

Therefore, many of the requested sections (Table of acceptance criteria, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, sample size for training set, how training ground truth was established) cannot be answered from the provided text. These are typically elements of studies designed to validate the performance of new diagnostic or predictive algorithms, which is not the primary purpose of this 510(k) submission.

The relevant information from the document pertains to the device's intended use and the regulatory pathway.

Here's a breakdown of what can be extracted based on the nature of the submission:

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

This information is not present in the provided document. The document describes the device modification and its intended use, emphasizing its substantial equivalence to predicate devices. It does not lay out specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity for a diagnostic claim) or report detailed numerical performance metrics for the modified feature. The assessment in a 510(k) is about safety and effectiveness in comparison to predicates, not usually a standalone performance trial against specific numerical targets.

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

This information is not present in the provided document. The 510(k) does not describe a clinical study with a "test set" in the context of evaluating a new algorithm's performance. The review focuses on design controls, verification, and validation testing (software, etc.) to ensure the modification is safe and effective compared to predicates, but details of such testing, including sample sizes for clinical data, are not provided.

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):

This information is not present in the provided document, as no such "test set" and ground truth establishment are described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not present in the provided document, as no such "test set" and adjudication process are described.

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:

This information is not present in the provided document. This type of study is relevant for AI-powered diagnostic aids, which is not the nature of this ventilator modification.

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

This information is not present in the provided document. The device is a ventilator, not an AI-only algorithm. The "TC" feature is an integrated software function.

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

This information is not present in the provided document.

8. The sample size for the training set:

This information is not present in the provided document. The "TC" feature is described as an "additional functionality in software" using the existing user interface. It's not presented as a machine learning model requiring a discrete "training set" in the common sense of AI development.

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

This information is not present in the provided document.

Summary of what is known from the document:

• Device: Puritan-Bennett 840 Ventilator System with ET/Tracheostomy Tube Compensation (TC) Option.
• Modification: Addition of a new ET/Tracheostomy Tube Compensation, "TC", feature implemented via additional software functionality using the existing User Interface.
• Regulatory Pathway: 510(k) Pre-market Notification, asserting substantial equivalence to predicate devices (Puritan-Bennett 7200 Series Ventilator and Drager Evita 4 Ventilator).
• Basis for Equivalence: The intended use, materials, and design are similar to predicate devices. The technical characteristics of the modification do not introduce new questions of safety or effectiveness. Compensation for ET/Tracheostomy Tube resistance via positive pressure support is common clinical practice.
• Software Development: Followed FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 29, 1998) and internal company requirements for verification and validation testing.
• Intended Use: To provide continuous ventilation for infant, pediatric, and adult patients (tidal volume 25 - 2500 mL) requiring respiratory support in hospitals and hospital-type facilities. Not for transport between facilities or in the presence of flammable anesthetics. For use and servicing by trained and qualified clinicians/persons only, and by prescription.

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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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