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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: "<============================================================================================================================================================= Similar, conforms to ISO 23747". For "Volume (FEV1, FEV6 and FVC) Accuracy" it states for the subject device: "< ± 2.5% Similar, conforms to ATS 2019 and ISO 26782."

This suggests that the acceptance criteria for these parameters are derived from the referenced standards, and the device's performance is stated to conform to these standards, but the exact numerical reading from a specific test showing "X% accuracy was achieved" is missing.

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

Not available in the provided text. The document mentions "Non-clinical tests were conducted," but offers no details about sample size (if applicable to non-clinical tests in this context, which often involves equipment calibration/verification rather than biological samples), data provenance, or study design.

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)

Not applicable/Not available in the provided text. The document describes non-clinical tests for device performance verification against standards. There is no mention of human experts establishing ground truth for a test set, as would be common in diagnostic AI studies.

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

Not applicable/Not available in the provided text. As there's no mention of a test set with human-established ground truth, an adjudication method is irrelevant here.

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. This device is a "Pulmonary Function Tester" (a medical device for measuring lung function), not an AI-powered diagnostic imaging tool or a system designed to assist human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not relevant to this device's function and is not mentioned.

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

Yes, in essence. The "non-clinical tests" described are essentially standalone performance evaluations of the device's ability to measure physiological parameters according to engineering specifications and international standards like ISO 26782 and ISO 23747. The device itself performs the measurements and calculates the parameters. Performance is assessed on its ability to accurately and precisely perform these measurements, not on an algorithm's diagnostic output.

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

For the "non-clinical tests," the ground truth would be established by reference standards and calibrated instruments used to generate known flow and volume inputs for the device. For example, precisely controlled flow generators and volume syringes would be used, and the device's measurements would be compared against these known inputs to determine accuracy. The specific methods are implied by the referenced ISO standards.

8. The sample size for the training set

Not applicable/Not available in the provided text. This device is a hardware-based pulmonary function tester with associated software; it is not presented as an AI/ML device requiring a training set in the conventional sense of machine learning for pattern recognition or prediction. Its fundamental operation relies on physical principles of flow and volume measurement described under "Technology."

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

Not applicable/Not available in the provided text. See answer to #8.

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