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The 760 Ventilator System is used to provide continuous ventilation to patients requiring respiratory support. This device is used for a wide range of patients from pediatric to adult and for a wide variety of clinical conditions.

The device is a low-cost, critical care ventilator intended to provide continuous ventilation for pediatric and adult patients. The 760 Ventilator is the second in a planned series of ventilators to be developed by Puritan-Bennett Corp., the "700 Series Ventilators", with the first being the 740 Ventilator. As such the 760 Ventilator encompasses all the basic functionality and modes of operation of the 740 Ventilator. The major difference between the two ventilators is that the 760 Ventilator adds Pressure Control Ventilation (PCV) as a mandatory breath type and offers adjustable rise time factor and exhalation sensitivity setting in Pressure Support Ventilation (PSV). Additionally, the 760 Ventilator also offers the ability to perform respiratory mechanics calculations and maneuvers as a standard feature using the EXPIRATORY PAUSE (expiratory pause) key to calculate auto-PEEP and the INSPIRATORY PAUSE (inspiratory pause) key to calculate patient resistance and compliance. These modifications are implemented on the 760 Ventilator through additional functionality in software and by adding keypads on the User Interface panel. The pneumatic design, breath delivery control algorithms and the electrical circuitry (apart from the User Interface printed circuit board) have remained unchanged from 740 to 760 models.

The provided text describes the regulatory submission for the Nellcor Puritan Bennett 760 Ventilator System. However, it does not contain the detailed information required for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the format requested.

The document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics.

Specifically, the document mentions:

• Performance testing was conducted using the ASTM F1100-90 standard as a guidance and per internal, company requirements. This indicates that some form of performance testing was done, but the specific acceptance criteria and the results are not provided.
• The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use. This is a general statement of compliance, not a detailed report of performance against specific criteria.
• Software design and development, (including verification and validation testing, test and software quality procedures) was conducted using FDA's Guidance for the Content of Premarket Submissions for Software contained in medical devices, dated May 29 1998, as a guidance and per internal company requirements. This refers to software V&V processes, but not specific device performance metrics.

Therefore, I cannot fulfill the request using only the provided text. The information requested typically comes from a detailed test report or clinical study report, which is not present here.

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