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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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This device is intended to monitor a patient's Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV 1) at home. The device is designed for adults and children over 5 years of age with caregiver supervision. The device is intended for monitoring respiratory conditions such as asthma.

Smart Peak Flow Meter (Model: B1) is a new type of hand-held pulmonary function testing device that measures peak expiratory flow (PEF) and forced expiratory Volume in 1 second (FEV1). Regular measurement is beneficial to the controlling of pulmonary disease such as asthma. The accuracy meets American Thoracic Society (ATS) Standard 2005 Revision.

The Smart Peak Flow Meter (Model: B1) is mainly composed of the main unit and removable mouthpiece. The use of B1 is very simple, user can master it quickly after reading the product user manual. It adopts mouth blowing method. After mouthpiece installation and powering on, keep breath steady, take a deep breath, hold the breath while put the mouthpiece into mouth, then exhale quickly and forcefully, taking as much time as possible. The results will be shown on the display screen and smart phone App. The mouthpiece should be removed regularly for cleaning.

The device can store 100 sets of data which can be transmitted to smart phone App through Bluetooth transmission mode for permanent storage. User can check the previous measurement records on the smart phone App.

The provided text describes the acceptance criteria and a study for the Smart Peak Flow Meter (Model: B1).

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

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

• Performance Test (Accuracy, Repeatability, Flow Resistance): The document states "All of the tested parameters meet the requirements in the standards," but it does not specify the sample size used for the performance testing.
• Human Factor Engineering Study:
  • Sample Size: 20 participants
  • Data Provenance: Not specified, but likely a prospective study conducted for regulatory submission.

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)

The document refers to conformance with the American Thoracic Society (ATS) Standard 2005 Revision for performance testing. For such standards, the "ground truth" is typically defined by the standard's specifications and measurement methods using reference equipment. No information is provided about human expert involvement in establishing a ground truth for the performance test itself. For the human factors study, the "ground truth" would be the observed user interaction and satisfaction, not expert medical opinion.

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

Not applicable. The performance testing relies on comparison to standardized measurements against the ATS 2005 standard, not human adjudication of medical findings. The Human Factor study measures user performance and feedback, not a diagnostic outcome requiring adjudication.

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

Not applicable. The device is a "Smart Peak Flow Meter" for spirometry, which directly measures physiological parameters (PEF and FEV1). It does not involve "human readers" or AI assistance in interpreting images or data in a way that an MRMC study would be relevant.

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

The primary performance tests (accuracy, repeatability, flow resistance) are effectively standalone tests of the device's measurement capabilities against a standard. The human factors study evaluates the user interface and overall device usability for human users, making it a human-in-the-loop evaluation for that aspect. However, the core measurement functionality is standalone.

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

The ground truth for the performance tests (PEF and FEV1 accuracy) is based on the American Thoracic Society (ATS) Standard 2005 Revision. This standard defines the acceptable range and methodology for measuring these physiological parameters, likely involving calibrated reference equipment.

8. The sample size for the training set

Not applicable. The device is a measurement device for spirometry, not a machine learning or AI-driven diagnostic tool that requires a "training set" in the conventional sense.

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

Not applicable, as there is no "training set" in the context of this device.

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