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The spirometer (LA104, LA105) is a diagnostic tool to measure the maximal volume and flow of air that can be moved in and out of a patient's lungs. The system is intended for use with pediatric (5 to 21 years and older) patients in hospitals, physician's offices, laboratories, and occupational health environments.

The spirometer is used to detect the ventilatory conditions of patients using a flow sensor. Basic test items include: Forced Vital Capacity (FVC), Slow Vital Capacity (SVC), Maximum Ventilator Volume (MVV), and Minute ventilation (MV). The device also provides bronchial diastolic and bronchial provocation tests comparison before and after medication along with time-volume and time-flow curves of the above tests.

The device comes in two models: LA104 and LA105. There are no differences between the two models apart from a minor software function. LA104 includes software incentive animations to encourage children to follow breathing instructions. The spirometer (model: LA104, LA105) consists of the main body, handle, power adapter and a single-use flow sensor. In order to conduct simple spirometry testing, the spirometer is used with a commercially available single-use disposable filter with integrated mouthpiece. This device is compatible with 30mm diameter filters.

The fundamental technology to measure flow is differential pressure. While the patient breathes, the air flows through both ends of the flow probe and produces different pressures. Then the sensor detects the pressure gap between both ends and converts it to electrical signals. The electrical signals are converted into digital signals of the pressure gap. Then digital signals are input into the computer system, which outputs values of pulmonary function related parameters after digital signal processing and data analysis.

The provided document is a 510(k) summary for a Spirometer (models LA104, LA105). It outlines the device's technical specifications, comparison to a predicate device, and performance data to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document primarily focuses on demonstrating equivalence to the predicate device (CardioTech Spirometry Model System, K090646) and compliance with recognized standards. The acceptance criteria are implicit in these standards and the predicate comparison.

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

The document does not specify exact "sample sizes" in terms of number of patient cases for the performance testing. Instead, it refers to compliance with standards (ATS/ERS 2005, ISO 26782:2009) for spirometry performance. These standards themselves define the test methodologies, which typically involve simulating various flow and volume patterns using calibrated equipment.

• Spirometry Performance: "Testing demonstrated equivalence to the predicate device with regards to performance of forced vital capacity (FVC), slow vital capacity (SVC), maximum ventilator volume (MVV) and minute ventilation (MV) spirometry tests." This implies a non-clinical test set using simulated conditions or calibration checks rather than human patient data.
• Biocompatibility Testing: Tests like Cytotoxicity, Sensitization, Irritation, Particulate Matter, and Volatile Organic Compounds are conducted on material samples according to ISO standards, not on patient data.
• Electrical Safety and EMC Testing: Conducted on the device itself to ensure compliance with relevant safety and electromagnetic compatibility standards.
• Software Verification and Validation: Performed on the software system of the device.

The document does not explicitly state the country of origin for the performance data or whether it was retrospective or prospective, but given it's a 510(k) submission from "MeHow Innovative Ltd" in China, the testing likely occurred in China or at certified testing labs globally.

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):

This information is not applicable or not provided for this device and evaluation. The performance testing relies on engineering and laboratory measurements against established international standards (ATS/ERS, ISO) for lung function testing, biocompatibility, electrical safety, and EMC, rather than human expert interpretation of clinical cases. The "ground truth" for these tests is defined by the parameters and limits set by these standards.

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

This is not applicable or not provided. Since the primary performance evaluations are based on objective measurements against engineering standards and a predicate device (rather than clinical interpretation or diagnosis), an adjudication method for a test set (like those for image-based AI studies) is not relevant to this submission.

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:

This is not applicable. The device is a diagnostic spirometer, which directly measures lung function parameters. It is a standalone measurement device, not an AI-powered assistive tool for human readers or clinicians that would necessitate an MRMC study to evaluate improved diagnostic performance.

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

Yes, the performance testing described (spirometry performance against ATS/ERS standards, biocompatibility, electrical safety, EMC, software V&V) constitutes standalone testing of the device. The spirometer itself, as a piece of medical equipment, is evaluated for its inherent accuracy, safety, and functionality without human intervention being part of the core measurement process. The device's output (measurements of flow and volume) is the primary performance endpoint, which is generated by the algorithm/hardware of the device.

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

The ground truth for the performance evaluations is based on:

• Reference Standards: For spirometry performance, the ground truth is defined by the requirements and test methods outlined in the ATS/ERS 2005 guidelines and ISO 26782:2009. These standards specify the acceptable accuracy and precision for flow and volume measurements.
• Predicate Device Equivalence: Another aspect of "ground truth" is demonstrating that the proposed device performs comparably to the legally marketed predicate device (K090646) in terms of key technical specifications and measured parameters.
• Material Science/Biological Standards: For biocompatibility, the ground truth refers to established safety thresholds and methodologies outlined in ISO 10993-1 and ISO 18562 for material safety and gas pathway purity.
• Engineering Standards: For electrical safety and EMC, the ground truth is defined by the compliance requirements of ANSI AAMI ES60601-1 and IEC 60601-1-2.

8. The sample size for the training set:

This is not applicable or not provided. The spirometer is a traditional medical device that involves hardware measurements and signal processing, not a machine learning or AI-driven system requiring a "training set" in the conventional sense. The "software" aspect mentioned refers to control logic, user interface, and data processing, which undergo verification and validation, but not statistical training with a data set.

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

This is not applicable. As stated above, the device does not employ a machine learning model that requires a training set and associated ground truth labeled data.

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