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The Pulmonary Function Tester (Model: A9) is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent flow-volume measurements shall be performed under the direction of a physician in the clinic, doctors' office or hospital. The Pulmonary Function Tester (Model: A9) is intended for use in patients from 4 years of age and older who can understand and perform instructions of the physician.

The Pulmonary Function Tester (Model: A9) is a hand-held pulmonary function testing device which can be used by patients older than 4 years old under the direction of a physician in the clinic, doctors' office or hospital. The Pulmonary Function Tester (Model: A9) is comprised of the main unit (display screen, sensor and communication module), USB cable, application software (computer software, mobile software), and a power supply. The device use is very simple, it adopts mouth blowing method. The device uses a flow sensor to measure the air flow and volume of the patient's exhaled or inhaled air. According to the volume-time curve and the flow-volume curve, the pulmonary ventilation indicators of human respiratory physiology, such as slow vital capacity, maximum minute ventilation and forced vital capacity, are estimated and reported on the LCD screen and computer/mobile software. The pulmonary Function Tester is powered by lithium battery (DC 3.7V, 1500mAh) or tablet/computer USB port, or the equipped power supply.

The provided text is a 510(k) Summary for a Pulmonary Function Tester. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed acceptance criteria for specific performance metrics nor the results of a specific clinical study used to prove the device meets those criteria.

Instead, the document states that "Non-clinical tests were conducted to verify that the Pulmonary Function Tester (Model: A9) meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device." It then lists the standards the device complies with. While these standards define acceptable performance ranges and test methods, the actual acceptance criteria and the device's reported performance against these criteria for each specific lung function parameter are not explicitly detailed in a table or narrative form in the provided text.

Therefore, I cannot populate the requested table and answer questions 2-9 with specific information from the provided document, as that level of detail is not present. The document focuses on demonstrating compliance with recognized standards rather than presenting a detailed study report of the device's performance against specific, pre-defined acceptance criteria.

Key Missing Information for Your Request:

• Specific Acceptance Criteria: While compliance with standards like ISO 26782 and ISO 23747 implies certain performance expectations, the document does not list explicit numerical acceptance criteria for parameters like FVC accuracy, FEV1 accuracy, PEF accuracy, etc., for the subject device itself.
• Reported Device Performance: Relatedly, the document does not provide a table or narrative of the subject device's measured performance (e.g., "FVC accuracy achieved X%") against these (unspecified) acceptance criteria.
• Detailed Study Design: There is no description of a clinical or non-clinical study with details about sample size, ground truth establishment, expert involvement, or adjudication methods. The "non-clinical tests" are mentioned as being conducted to verify design specifications and compliance with standards, but the specifics of these tests are not provided beyond the standards themselves.

Based on the provided text, here is what can and cannot be stated:

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

Cannot be fully provided as the specific acceptance criteria and reported device performance (e.g., FVC accuracy = X%, PEF accuracy = Y%) are not explicitly stated in a table or narrative form in the provided text.

The document references standards that contain performance requirements. For example, under "Flow (PEF) Accuracy" it states for the subject device: "

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