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The Gemini is intended to provide continuous pressure support ventilation to patients requiring respiratory support within a sub-acute care environment. It is intended to be used on adults and children weighing at least 44 lbs (20 kq) for all modes except invasive VTV, which requires a minimum weight of 88 pounds (40 kg). The Gemini should not be used by patients requiring device performance outside the published device specifications. For example, some patients (such as those having low compliance or high resistance) will be treated more appropriately with ventilators having the ability to deliver higher pressures. Gemini is intended to be used in a variety of hospital environments including general hospital floors, emergency rooms, recovery rooms, ICUs and sub-acute environments. It may also be used in hospital-like settings such as sub-acute care centers and nursing homes. It is not intended to be used in home environments or for transport. Gemini is not intended for delivery of anesthetic gases. Volumes less than 200 ml are contraindicated when using volume ventilation.

The Gemini has been designed to target physicians treating patients with moderate respiratory insufficiencies. The Gemini provides ventilation modes, alarms and safety features (active exhalation valve) that make it a safer and more effective selection than products carrying an MNS or MNT product code at a fraction of the cost for typical ICU ventilators. Both invasive and non-invasive ventilation are indicated. The Gemini ventilator uses a blower based breath delivery system. The ventilator provides four ventilation modes. These are: 1. Pressure Support Ventilation (PSV) 2. Pressure Support Ventilation with Minimum Respiratory Rate (PSV-MR) 3. Pressure Control Ventilation (PCV) 4. Volume Targeted Ventilation (VTV) A Volume Priority option can be enabled in both the PSV-MR and PCV modes. Gemini also has a proximal exhalation valve in the patient circuit that inhibits rebreathing of air. The operator communicates with the ventilator through a user interface incorporating three membrane keys, four rotary knobs and an LCD message display window. The LCD display enhances or augments visual/audible display of alarms, settings, modes, menus, and specialized calibration and testing procedures. Safety is enhanced through a software-based settings locking mechanism and the requirement that all changes require a minimum of two actions. Gemini uses standard domestic (US) 110-115 Vac and European 220-230 Vac power. No battery is available for the device at the time of this submission. Accessories included with the ventilator are: 1. Gemini ventilator 2. soft carrying case 3. 6-foot 22 mm hose 4. 6-foot exhalation control tubing 5. 6-foot pressure monitoring tube 6. exhalation valve 7. Operator Manual 8. patient mask and harness (optional) 9. model CM 5000 low/high inspiration pressure alarm (optional) 10. model 7820 oxygen monitor (optional)

The Nellcor Puritan Bennett Gemini Ventilator system has the following acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• The document does not specify a "test set" in terms of patient data.
• The performance testing was based on comprehensive system-level functional testing and tests for each critical ventilator subsystem, along with electrical, mechanical, environmental, EMC, and software compliance testing.
• The provenance of data is not applicable in the context of patient data but relates to engineering testing on the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided as the study did not involve human experts establishing ground truth on patient data. The "ground truth" for the device's performance was established by its compliance with pre-defined technical specifications and regulatory guidance documents.

4. Adjudication method for the test set:

• Not applicable, as no external "test set" requiring expert adjudication was 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:

• No MRMC comparative effectiveness study was done. The device is a ventilator, not an AI-assisted diagnostic tool for human readers.

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

• The performance evaluation focused on the standalone device's (ventilator) ability to meet its technical specifications and regulatory requirements. No "algorithm only" performance is described, as the device is a physical medical instrument.

7. The type of ground truth used:

• The "ground truth" used was the manufacturer's stated performance specifications and regulatory guidance documents (e.g., November 1993 draft Reviewer Guidance for Premarket Notification Submissions, Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review).

8. The sample size for the training set:

• Not applicable. This device is a physical ventilator, not an AI model that requires a training set of data.

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

• Not applicable.

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