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TD-7301 Spirometer is intended to monitor Peak Expiratory Flow (PEF), Forced Expiratory Volume (FEV) in home and professional healthcare environments.

The device is designed for use with children over 5 years old, adolescent and adult subjects.

The TD-7301 Spirometer is a portable and handheld electronic spirometer used to measure expired Peak Expiratory Flow (PEF), Forced Expiratory Volume in one second (FEV1), Forced Expiratory Volume in six second (FEV6) and their ratio (FEV1/FEV6).

The users can transfer their measurement results from the TD-7301 Spirometer to iFORA smart on their mobile devices via Bluetooth. The iFORA smart provide an overview of users record with historical data and trend graph.

The TD-7301 Spirometer hardware is identical to the TD-7301 Peak Flow Meter cleared under K222810 (reference device).

The provided text describes the acceptance criteria and the study that proves the TD-7301 Spirometer meets those criteria. However, it does not involve AI or human readers assisted by AI, as the device is a diagnostic spirometer without AI components. Therefore, some of the requested information (e.g., number of experts for ground truth establishment, MRMC study, standalone AI performance) is not applicable to this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission details performance evaluation against recognized standards.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for the performance evaluations (e.g., number of spirometry maneuvers or individual devices tested). It generally states that "performance evaluation of the TD-7301 Spirometer was conducted."

Data provenance (e.g., country of origin, retrospective/prospective) is not detailed for the performance studies described. The manufacturer is based in Taiwan (GOSTAR Co., Ltd, New Taipei City, Taiwan).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable. The TD-7301 Spirometer is a direct measurement device for pulmonary function, not an AI or imaging device requiring expert interpretation for ground truth. The acceptance criteria are based on adherence to international standards for spirometry measurements (ATS, ISO 26782, ISO 23747).

4. Adjudication Method for the Test Set

This information is not applicable as the device measures objective physiological parameters, not interpretations 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

This is not applicable as the TD-7301 Spirometer is a diagnostic measurement device and does not involve AI assistance for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is not applicable, as the device is a physical spirometer, not an algorithm, that measures physiological parameters. The performance evaluation focuses on the accuracy and reliability of its measurements against established standards.

7. The Type of Ground Truth Used

The ground truth for the performance evaluation of the TD-7301 Spirometer is based on established international standards for spirometry measurement:

• American Thoracic Society (ATS) Document "Standardization of Spirometry -2019": This document provides expert consensus and guidelines for how spirometry should be performed and measured.
• ISO 26782:2009 (Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans): This standard defines accuracy and performance requirements for spirometers.
• ISO 23747:2015 (Anaesthetic and respiratory equipment -- Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans): This standard defines accuracy and performance requirements for peak expiratory flow meters.

The device's measurements (PEF, FEV1, FEV6) are quantitative and compared against the specifications outlined in these standards.

8. The Sample Size for the Training Set

This is not applicable as the TD-7301 Spirometer is not an AI/machine learning device that requires a "training set." Its measurements are based on a physical rotor stator design and established principles of operation for flow measurement, not data-driven learning.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no "training set" for this type of device.

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NuvoAir Air Next is intended to test lung function and spirometry in adults and children 5 years of age and older.

It can be used in hospitals, in the clinical setting, and at home.

The Air Next is not intended for use in an operating room.

The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.

Air Next is intended to perform basic lung function and spirometry testing. It measures parameters such as the forced expiratory volume in 1 sec (FEV1) and the forced vital capacity (FVC) in a forced expiratory maneuver. These measures can be used for detection, assessment and monitoring of diseases affecting the lung function, such as bronchial Asthma, COPD and Cystic Fibrosis.

Air Next is a hand-held spirometer, weighing 75g and it is powered by 2 AAA alkaline 1.5V batteries. It consists of 3 main components: the Air Next device, the NuvoAir disposable turbine (delivered in one package) and the Air Next mobile application downloadable from Apple's and Google's Play Stores.

The provided text describes the 510(k) premarket notification for the "Air Next" diagnostic spirometer. While it extensively details the device's characteristics, comparison to a predicate device, and compliance with various standards (electrical safety, EMC, usability, biocompatibility), it does not contain a specific section detailing acceptance criteria for performance, nor a study report proving the device meets these criteria with quantitative results from a test set.

The document states that the device "Meets ATS accuracy requirements" and "Air Next complies with the currently recognized safety and EMC standards," but it does not provide the measured performance data or the specific acceptance criteria in a quantifiable table as requested.

However, based on the information provided, we can infer some criteria and the general approach:

Inferred Acceptance Criteria based on Comparison to Predicate and Standards:

The document repeatedly references compliance with ISO 26782:2009 for spirometers and the Standardization of Spirometry 2019 Update (ATS/ERS guidelines). These standards and guidelines define accuracy requirements for spirometry parameters.

From the "SUMMARY OF TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO PREDICATE DEVICE" table, we can infer the acceptance criteria are likely to match or exceed the predicate device's performance and meet the relevant standards for the following parameters:

• Volume accuracy: ±3% of reading or ±0.050 L, whichever is greater
• Flow accuracy: ±5% or 200 mL/s (likely for PEF)
• Flow resistance: <0.5 cmH2O/L/s
• Volume range: Up to 10 L
• Flow range: 0-15L/s (for Air Next, predicate 0-16 L/s)

Regarding the Study Proving Device Meets Acceptance Criteria:

The document mentions that the device "Meets ATS accuracy requirements" and "Air Next complies with the currently recognized safety and EMC standards." This implies that testing was performed against these standards. However, the specific details of the performance study (methodology, results, sample size of test set, ground truth derivation, expert involvement, etc.) are not explicitly provided in the given text.

Therefore, many parts of your request cannot be answered from the provided document.

Here's a breakdown of what can be extracted or inferred, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing: Specific quantitative results (e.g., actual measured accuracy values, standard deviations, confidence intervals) from a dedicated performance study. The table above only re-states the specifications it claims to meet.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing would likely be bench testing against calibrated flow/volume simulators rather than human subject data for primary accuracy claims, but specifics are missing.

3. Number of Experts and Qualifications for Ground Truth:

• Not Applicable / Not Specified: For spirometers, primary accuracy testing is typically done using mechanical test lungs and known volume/flow outputs, calibrated against highly accurate reference devices, rather than human experts establishing "ground truth" for each measurement in a test set. This type of device does not involve expert interpretation of images or signals in the same way an AI-powered diagnostic device would.

4. Adjudication Method for the Test Set:

• Not Applicable / Not Specified: Adjudication is typically for subjective expert evaluations (e.g., image review), which does not directly apply to the objective, quantitative measurements of a spirometer's mechanical accuracy.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

• No: The document does not describe an MRMC study. This type of study is more common for diagnostic AI systems where human reader performance is a key variable. The Air Next is a measurement device.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop):

• Yes, implied for Device Accuracy: The core performance measurements (volume, flow accuracy) are inherent to the device and its algorithms, independent of human interaction beyond operating it. The device itself (Air Next) calculates the spirometry parameters (FEV1, FVC, etc.) based on the turbine's readings. The stated compliance with ISO 26782 implies standalone algorithmic performance testing.
• Missing: Details of this standalone performance test.

7. Type of Ground Truth Used:

• Inferred: Reference Standards/Calibrated Outputs: For spirometers, the ground truth is established by using highly accurate, calibrated flow and volume generators (e.g., syringes or flow controllers) that produce known, precise airflows and volumes. These are the gold standard for verifying spirometer accuracy according to ISO 26782 and ATS/ERS guidelines.
• Not: Expert consensus, pathology, or outcomes data, as these are not relevant to the primary function of a spirometer.

8. Sample Size for the Training Set:

• Not Applicable / Not Specified: This device measures physical parameters (airflow, volume) using a turbine and a digital infrared interruption sensor, not a machine learning model that requires a "training set" of data in the common sense. Its "algorithm" is a conversion from rotations to airflow. If there is any internal calibration or minor adjustment based on manufacturing tolerances, it would be done during production, not through a "training set" in the AI/ML context.

9. How Ground Truth for the Training Set Was Established:

• Not Applicable / Not Specified: As explained above, there's no "training set" in the typical AI/ML sense for this device. The physical principle of operation and conversion algorithms are based on established physics and engineering, and then verified against calibrated standards.

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The Spirobank Oxi Spirometer and Pulse Oximeter is intended to be used by a physician or by a patient under the prescribed use of a physician. The equipment is intended to test lung function and can perform tests in adult and pediatric patients greater than 5 years. When used as Oximeter, the Spirobank Oxi is intended for spot-checking of functional oxygen saturation of arterial haemoglobin (SpO2) and Pulse Rate (PR) from the patient finger. The Spirobank Oxi has been designed for use in the physician's office, in hospital, or directly by the patient to monitor her/his physical conditions at home.

Spirobank Oxi is a pocket-size spirometer and oximeter. The device is made up of:

• a central unit which measures and collects information related to the state of health of the patient, using a microprocessor based system. It operates via a Bluetooth connection
• a removable sensor for the measurement of respiratory air flow and volume,
• a pulse oximetry sensor using reflective technology. -
  The device is powered by two AAA alkaline batteries.

Spirometry: the device is equipped with a plastic mouthpiece connected to a turbine flow meter based on the infrared interruption principle. The device detects the signals generated by the turbine, and measures flow and volume. At the end of the expiration, the device calculates the respiratory parameters.

Oximetry: the device measures functional oxygen saturation of arterial haemoglobin (SpO2) and pulse rate (PR) by means of a reflective light sensor. Specifically, it uses a two-wavelength sensor to measure the indicated parameters based on light reflection principles of oxygenated blood and deoxygenated blood, which generates a photoplethysmogram. From the photoplethysmogram the device calculates SpO2 and PR

Spirobank Oxi connects via Bluetooth to a device (PC, tablet or smartphone) which allows to insert patient data, perform spirometry manoeuvres and oximetry tests, as well as display the results, including the relative graphs.

Acceptance Criteria and Study for Spirobank Oxi

This document describes the acceptance criteria and a detailed study supporting the substantial equivalence of the Spirobank Oxi device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

Spirometry Testing:

• Sample Size: Not explicitly stated as a "test set" sample size of human subjects. The testing was conducted on a bench using a Pulmonary Waveform Generator.
• Data Provenance: Conducted in MIR facilities.

Pulse Oximetry Clinical Performance Testing:

• Sample Size: 10 healthy volunteers (5 males, 5 females). The study explicitly states meeting the requirement of at least 2 darkly pigmented subjects or 15% of the subject pool, whichever is larger.
• Data Provenance: Single-arm desaturation study conducted in the US, at the Clinimark Desaturation Laboratory (Louisville, CO 80027, USA). The study was prospective as it involved inducing hypoxia in volunteers for data collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Spirometry Testing:

• Ground Truth: Established by conformance to the American Thoracic Society (ATS) Statement on the "Standardization of Spirometry - 2019", ISO 26782:2009, and ISO 23747:2015, utilizing a Pulmonary Waveform Generator for bench testing. This implies widely accepted industry standards and validated equipment serve as the "ground truth" rather than individual experts.
• Experts: Not applicable in the context of expert review for ground truth, as it's a bench test against standardized waveforms and parameters.

Pulse Oximetry Clinical Performance Testing:

• Ground Truth: Established by Reference CO-Oximetry using arterial blood samples drawn from the subjects. This value was obtained as the mean of the SaO2 values measured by Radiometer ABL 80 Flex OSM and Instrumentation Laboratory IL 682.
• Experts: Not explicitly mentioned in terms of "experts establishing ground truth". However, the use of two "Reference CO-Oximeters" suggests a highly calibrated and standardized method, likely operated by qualified laboratory personnel, which serves as the gold standard for oxygen saturation measurement. The qualifications of the operators of these reference devices are not specified but are presumed to be appropriate for clinical laboratory analysis.

4. Adjudication Method for the Test Set

Spirometry Testing: Not applicable, as judgment is based on objective measurements against engineering standards.

Pulse Oximetry Clinical Performance Testing: No explicit adjudication method (e.g., 2+1, 3+1) is mentioned, as the ground truth (SaO2) is established by highly accurate chemical analysis (Reference CO-Oximetry) rather than subjective expert interpretation from multiple individuals. The methodology involves direct comparison of the device's SpO2 readings with the objective SaO2 values.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not conducted. The studies described are focused on verifying the technical performance of the device against established industry standards and, for oximetry, against a "gold standard" clinical measurement, not on comparing human reader performance with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies are explicitly standalone performance evaluations of the device's measurement capabilities.

• Spirometry: Bench testing against ATS standards.
• Pulse Oximetry: Comparison of the device's automated SpO2 calculation against reference CO-Oximetry, without human interpretation of the device's raw outputs for diagnosis. The device generates the SpO2 values directly.

7. The Type of Ground Truth Used

• Spirometry: Objective, standardized measurements against a Pulmonary Waveform Generator adhering to the American Thoracic Society (ATS) Statement on the "Standardization of Spirometry - 2019" and ISO 26782:2009, ISO 23747:2015.
• Pulse Oximetry: Physiological/Outcomes Data (Reference CO-Oximetry) from arterial blood samples, which is considered the gold standard for functional oxygen saturation (SaO2).

8. The Sample Size for the Training Set

The document does not mention any "training set" or "training data" for the device. This implies that the device's algorithms or measurement principles are based on established scientific and engineering principles rather than machine learning models that require a distinct training phase on a dataset. For example, spirometry uses infrared interruption principles, and oximetry uses reflection principles and calibration functions.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned or implied for a machine learning model, this question is not applicable. The device relies on established physical and biological measurement principles rather than learned patterns from a training dataset requiring ground truth establishment.

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The EasyOne Sky spirometer is intended to conduct diagnostic spirometry testing on adults and pediatric patients starting at age 4. The EasyOne Sky spirometer is used by general practitioners, specialists and healthcare professionals. The EasyOne Sky is used in hospitals, clinical settings, and in occupational medicine.

The product EasyOne Sky (EOS) is a medical electrical equipment for spirometry testing. It consists of the hand-held TrueFlow Sensor FT (SeNe) comprising an ultrasonic flow sensor that conducts air flow measurements, the application EasyOne Mobile (EOMA), and the breathing mouthpiece EasyOne FlowTube (EOFT). The EOS can be used with the optional accessories EasyOne Filter FT and a nose clip.

Key functions:

• . The key function of the TrueFlow Sensor FT (SeNe) is to acquire patient flow data by measuring transit-times of ultrasonic pulses and to send data wireless (via Bluetooth Low Energy) to the host system. The measurements and data transmission are performed by the firmware of the SeNe defined as MDSW with clinical functions.
• . The key function of the application EasyOne Mobile (EOMA) is to trigger the start of the measurement with the TrueFlow Sensor FT, to communicate with it and to visualize the data received from it.
• . The EasyOne FlowTube (EOFT) is an individually packaged, single-patient-use breathing tube and is intended to canalize patient breath through the flow sensor tube. The EOFT is an essential accessory to EOS.

The EasyOne Sky spirometer, as described in the provided 510(k) summary, underwent various non-clinical tests to demonstrate its substantial equivalence to its predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document specifies performance testing in accordance with ISO 26782:2009 for 13 waveforms. This refers to a standardized set of flow-volume and volume-time waveforms designed to test spirometer performance across a range of physiological conditions. The provenance of these waveforms is standardized and not patient-specific. The document does not specify additional clinical test set sizes or their provenance (e.g., country of origin, retrospective/prospective). The assessment relies heavily on compliance with recognized performance standards rather than a separate clinical test set of patient data.

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

The ground truth for the performance testing is established by international spirometry standards (ATS/ERS/ISO), which define the expected values for the 13 waveforms used in testing. These standards are developed by expert committees, but the document does not mention individual experts specifically establishing ground truth for this particular device's test set, as it relies on compliance with pre-defined standard waveforms.

4. Adjudication method for the test set

No specific adjudication method (like 2+1, 3+1) is mentioned for a test set. The evaluation is based on the device's technical performance against established international standards for spirometry.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted or reported in this 510(k) summary. The device is a diagnostic spirometer, not an AI-assisted diagnostic tool that interprets images or signals requiring human reader input for comparison.

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

Yes, a standalone performance assessment was effectively done. The spirometer's core function is to measure and calculate spirometry parameters based on patient breathing. The "Performance" section explicitly states compliance with established spirometry standards (ATS/ERS/ISO), which are machine-based performance tests using standardized waveforms. The device's firmware performs the measurements and calculates parameters independently, and this is what was tested against international accuracy standards.

7. The type of ground truth used

The ground truth used for performance testing (accuracy, repeatability, linearity) is based on established spirometry standards and guidelines (ATS/ERS/ISO). Specifically, ISO 26782:2009 includes defined "reference waveforms" for evaluating spirometers, which serve as the ground truth against which the device's measurements are compared.

8. The sample size for the training set

The document does not provide information about a "training set" in the context of machine learning. The device is a traditional medical device that performs measurements and calculations based on physics (ultrasonic transit-time measurement) and programmed algorithms derived from clinical standards, not an AI/ML-based device that requires a training set of data.

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

As there is no mention of a machine learning "training set," the concept of establishing ground truth for it is not applicable here.

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The alveoair Digital Spirometer is intended to conduct basic lung function and spirometry testing on patients aged ≥ 22 years by healthcare professionals or clinicians in any healthcare environment. The alveoair Digital Spirometer is not intended for use during patient transport.

The alveoair Digital Spirometer is used to test lung function in people of all ages ≥ 22 years. It is intended to be used by healthcare professionals or clinicians in any healthcare environment. The alveoair Digital Spirometer was designed, developed, and manufactured at Roundworks Technologies Pvt Ltd. The model number is indicated below: ALV002 alveoair Digital Spirometer Digital Spirometer to measure lung function parameters. The alveoair Digital Spirometer system includes: alveoair Digital Spirometer, alveoMD mobile application, alveofit API Cloud server backend. The alveoair Digital Spirometer is intended to be used and compatible only with the flowMIR disposable turbine and cardboard mouthpiece manufactured by the Medical International Research s.r.l. The accessories are 510k cleared under K061712 and it is single-use disposable. Roundworks Technologies Pvt Ltd recommends the user to purchase the sinqle-use disposable flowMIR turbine on their own. One sample piece of the flowMIR (Ref. code: 910004) disposable turbine sensor and disposable cardboard mouthpiece is provided in the packaging. Roundworks recommends that the user purchase the same model turbine and mouthpiece from Medical International Research s.r.l. for further use. The alveoair digital spirometer is available in two different colors. The internal components, software, and function remain the same for both devices. The only difference is the color of the case; one is completely black and the other is a combination of black and white. The alveoair Digital Spirometer is used in combination with a turbine and mouthpiece. It utilizes a smartphone with a dedicated mobile application (alveoMD) and a cloud server (alveoFit) to view and store spirometer readings. This portable spirometer operates on the principle of infrared interruption. To perform a test, the user inhales and exhales air through the mouthpiece, which then flows into the turbine. The turbine's propeller rotates in both clockwise and counterclockwise directions, depending on the airflow. The firmware within the device calculates a series of volume and flow coordinates, in liters with respect to time in seconds, every time an interrupt data is received from the IR sensor. This process continues for 20 seconds or until the flow change calculated is less than 0.025 liters per second. When the patient inhales/exhales air into the spirometer during the standard or full loop tests. Once the test is completed, all coordinates are transferred to the mobile application using BLE. From there, the data is uploaded to the alveofit API Cloud server via the internet. For the alveoMD app, an internet connection is required to initiate the spirometry test. The alveoFit cloud server takes in the coordinates to calculate all lung parameters. Once the process is completed, a test report will be generated and displayed in the alveoMD mobile application. The internal program performs all calculations for measurements to meet ATS/ERS guideline standardization of spirometry 2019.

The provided text does not contain detailed information about specific acceptance criteria for the alveoair Digital Spirometer's performance or a study proving that the device meets these criteria in the way typically found for AI/ML-based medical devices (e.g., sensitivity, specificity, or performance against human readers).

The document focuses on demonstrating substantial equivalence to a predicate device (Air Next, K183089) and a reference device (Spirobank G, K072979) primarily through comparison of technical specifications, intended use, and adherence to relevant medical device standards.

However, based on the information provided, I can infer some aspects of what would constitute "acceptance criteria" for a spirometer and what studies were referenced to show compliance.

Here's an analysis based on the provided text, addressing the points where information is available or can be reasonably inferred within the context of a spirometer's regulatory submission:

Inferred Acceptance Criteria and Reported Device Performance

The acceptance criteria for the alveoair Digital Spirometer are primarily derived from the industry standards it claims to comply with, particularly ISO 26782:2009 for spirometers and ISO 23747:2015 for peak expiratory flow meters, as well as the ATS/ERS 2019 guidelines. These standards define the required accuracy and precision for spirometry measurements.

Table of Acceptance Criteria (Inferred from Standards Compliance) and Reported Device Performance:

Note: The document explicitly states "Substantially equivalent as the subject device is compliant to the requirements of American Thoracic Society (ATS) Standardization of Spirometry 2019 update and ISO 26782: 2009" for Volume range and accuracy, and "Substantially equivalent as the subject device is compliant to the requirements of ISO 23747:2015" for Flow range and accuracy. This indicates that compliance with these standards (which contain the acceptance criteria) is the basis for demonstrating performance.

Study Details Proving Device Meets Acceptance Criteria

The provided text does not describe a specific clinical study or an AI/ML specific performance study with test sets, ground truth establishment, expert adjudication, or MRMC studies. Instead, it relies on demonstrating compliance with recognized standards.

Here's an attempt to address your points based on the available information, noting when information is not provided or not applicable to this type of device/submission:

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

   • See the table above. The acceptance criteria are inferred from the standards the device claims to meet (ISO 26782, ISO 23747, ATS/ERS 2019), and the reported performance is directly stated in the "Technical Specifications" comparison table.

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

   • Not provided. The document refers to compliance with performance standards, which typically involve testing with calibrated flow/volume simulators, not necessarily a "test set" of patient data in the AI/ML context. If simulated data was used for testing against standards, its provenance isn't specified.

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

   • Not applicable/Not provided. For spirometers, "ground truth" for performance testing is established using highly accurate, calibrated flow and volume sources that can deliver specific waveforms and volumes according to the standards (e.g., defined by ATS/ERS or ISO). It's not typically established by human experts in the same way as an imaging AI device.

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

   • Not applicable. This method is characteristic of studies involving human interpretation or annotation of data, which is not the primary method for demonstrating performance of a spirometer. Performance is verified against calibrated instruments.

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 was not done. The alveoair Digital Spirometer is a diagnostic spirometer, not an AI-assisted diagnostic tool for human interpretation. Its function is to measure lung function parameters, which are then used by healthcare professionals. No "AI assistance" to human readers is mentioned or implied.

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

   • Not applicable in the AI/ML sense. The device itself is "standalone" in that it performs the measurements digitally. However, its performance is evaluated against the technical requirements of spirometry standards, not as an AI algorithm that makes diagnostic predictions without human oversight. The device calculates parameters (FVC, FEV1, etc.) as per ATS/ERS guidelines. This is the "algorithm only" performance for a spirometer.

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

   • Calibrated mechanical/electronic simulators. For spirometers, the ground truth for performance testing is established by highly accurate, traceable calibration equipment that precisely controls and measures airflow and volume according to defined waveforms (e.g., those specified in ISO 26782 or ATS/ERS guidelines).

8. The sample size for the training set:

   • Not applicable/Not provided. This is relevant for AI/ML device development. This spirometer, based on the description, operates on an infrared interruption principle to measure physical parameters and applies direct calculations based on established physiological formulas (like those in ATS/ERS guidelines). It's not described as an AI/ML algorithm that requires a "training set" in the conventional sense.

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

   • Not applicable. As no training set for an AI/ML algorithm is described, this question is not relevant. The "ground truth" for the device's internal calculations is embedded in the standardized physiological equations and the accuracy of its physical sensors compared to calibrated references.

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The spirometer (Air Smart Extra) 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.

Not Found

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a spirometer. It confirms the device's substantial equivalence but does not contain any information about acceptance criteria, device performance metrics, study details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods), or the results of any comparative effectiveness studies (MRMC) or standalone algorithm performance studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this document.

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SpiroHome is intended to be used by adults and children over 5 years old in physician's offices, clinics and home setting to conduct basic lung function and spirometry testing.

The SpiroHome Ultrasonic Spirometer (SUS) is a portable spirometer designed to perform pulmonary function tests in patients over the age of 5 in office (clinical) and home settings. The SpiroHome spirometer is used together with a SpiroWay mouthpiece that is inserted into and lines the entire airway of the device. SpiroHome derives pulmonary function data from airflow measurements taken by its ultrasonic sensors during a spirometry test. All of the information recorded by the device is displayed on the relevant SpiroHome app running on a Bluetoothconnected device. The pulmonary function test (PFT) data recorded by the SpiroHome device during a spirometry test is also compared against the patient's predicted values which are obtained from internationally accepted PFT equations. The user interfaces with the SpiroHome app during the entire use of the SpiroHome spirometer.

The associated accessories include: SpiroWay mouthpiece

The SpiroHome Ultrasonic Spirometer's acceptance criteria and performance are detailed in comparison to predicate and reference devices, and through various performance, electrical, and biocompatibility tests.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states "Meets" for all listed performance and safety standards, implying the device successfully passed the tests conducted against these criteria.

2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size for any specific test set or the data provenance (e.g., country of origin, retrospective or prospective) for the performance data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The performance data seems to be based on compliance with established standards (e.g., ATS, ERS, ISO) rather than expert-established ground truth from a test set of patient data.

4. Adjudication Method for the Test Set:
The document does not describe any adjudication method as it appears to rely on objective testing against technical and safety standards rather than expert consensus on diagnostic outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study is not mentioned in the provided document. The study focuses on demonstrating substantial equivalence through technical and performance comparisons with predicate and reference devices, and by meeting various regulatory standards.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
The document does not specifically detail a standalone algorithm-only performance study. The performance testing section outlines functional, electrical, biocompatibility, shipping, cleaning, software, and human factors tests. For a device like a spirometer, "standalone" performance typically refers to the accuracy of its physical measurements and calculations, which are covered by the functional and electrical requirements. The software verification and validation would also assess the algorithm's performance.

7. The Type of Ground Truth Used:
For the technical performance of the device (e.g., volume and flow accuracy), the ground truth appears to be based on internationally accepted performance standards and guidelines, such as ATS guidelines and ISO 286782. For other aspects like electrical safety and biocompatibility, the ground truth is adherence to the specified IEC, AAMI, and ISO standards.

8. The Sample Size for the Training Set:
This information is not provided in the document. The document refers to the device's technological characteristics and its compliance with standards, not typically a "training set" in the machine learning sense for a diagnostic device that performs direct physiological measurements.

9. How the Ground Truth for the Training Set Was Established:
As there's no mention of a training set for an AI/ML algorithm in the context of this traditional medical device submission, the method for establishing ground truth for a training set is not applicable or provided. The device's operation is based on ultrasonic sensor technology and PFT equations, not a learning algorithm that requires a labeled training set.

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Morgan Scientific's ComPAS2 is a software application intended to be used to compatible Morgan Scientific or thirdparty devices to acquire, analyze, view, store, export, and print the device outputs including measurements of flow, volume, pressure, and gas concentrations. The product is designed for use on adults and pediatrics 4 years and older, in a variety of healthcare environments such as, but not limited to, primary care, hospitals, and research health centers under the supervision of a healthcare provider.

ComPAS2 is a software application designed to provide a secure PC based medical device for creating, adding/recalling subjects, and performing cardio-pulmonary function testing on those subjects. ComPAS2 will interface and link to compatible Morgan Scientific and third-party devices to read, analyze, and display their output to allow the information to be retained with the subject. Current compatible approved devices: TransAir (K953990), SpiroAir (K042595), Body Plethysmograph (K022636), WristOx2 (K102350), tremoFlo (K170185), Pneumotrac (K142812), Micro (K160253), Model 9100 PFT/D1CO (K221030). Data can be reported directly to a printer or communicated with hospital information systems/electronic medical records. All data are preserved in an SQL database, with key sub-systems of ComPAS2 interacting with the database through an API (Application Program Interface).

ComPAS2 is designed to operate with compatible cardio-pulmonary function testing hardware by manufacturers offering the capability to measure key pulmonary functions including, but not limited to: static and dynamic spirometry, bronchial challenge, maximum voluntary ventilation, respiratory muscle strength, cough peak flow, lung volume sub-divisions (such as but not limited to helium dilution, nitrogen washout and plethysmography), single breath diffusion, airway resistance, distribution with lung clearance index closing volume. Other features include: a task manager to manage patient data for reporting; manual entry to input additional information; and historical data review to analyze data for trending and reporting.

The ComPAS2 device, a software application for diagnostic spirometry, was found to be substantially equivalent to its predicate device, ComPAS2 v2019.1.0 (K190568). The primary "study" proving this substantial equivalence was non-clinical performance testing of the software.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a typical quantitative pass/fail format for each performance metric, but rather highlights that performance testing demonstrated that the subject device met its acceptance criteria. The "reported device performance" is implied to be equivalent to the predicate device's performance, as the core functionality and technical characteristics remain largely the same, and the software was validated against the predicate's results.

However, based on the comparison table and the general description, we can infer some performance aspects:

2. Sample Size Used for the Test Set and the Data Provenance

• Test Set Sample Size: Not explicitly stated as a number of patients or cases. The testing involved "developing test cases and test runs for the performance of end-to-end testing with both biological and mechanical controls." This suggests a series of functional tests and expected outcomes rather than a traditional patient-based clinical study with a specific sample size.
• Data Provenance: The document does not specify the country of origin for any data used in this non-clinical testing. The nature of the testing (bench testing, software validation) suggests it's primarily synthetic or controlled data generated internally, or data from mechanical/biological controls (e.g., spirometer calibration syringes, simulated lung models). The testing was against "existing results from ComPAS2 v2019.1.0," indicating a retrospective comparison to previously established performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. The ground truth for this software validation was established by comparing the results of the ComPAS2 v2022.1.0 software to the "existing results from ComPAS2 v2019.1.0," the predicate device, and ensuring compliance with recognized standards (ATS/ERS guidelines). Expertise would have been in the form of engineers, quality assurance personnel, and potentially pulmonologists for clinical interpretation of the standards and expected outputs, but the document does not specify a panel of experts for "ground truth" establishment in the sense of a diagnostic interpretation study.

4. Adjudication Method for the Test Set

Not applicable. This was a software verification and validation study, not a clinical study requiring adjudication of diagnostic outcomes. Validation involved ensuring consistency and accuracy of the new software's outputs against the predicate and established standards.

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 or described. The device is a software application intended to acquire, analyze, view, store, export, and print device outputs, not to provide AI-assisted diagnoses that impact human reader performance.

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

Yes, the performance testing described is a standalone evaluation of the ComPAS2 software application. The "Bench" section explicitly states "software testing activities" and "system level testing to ensure that the product is capable of meeting the intended use." This indicates the algorithm's performance (i.e., the software's ability to process and display data) was tested independently. The software interfaces with hardware devices that generate the raw data, but its own function of processing and presenting that data was evaluated as described.

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

The ground truth used for the validation of ComPAS2 v2022.1.0 was primarily:

• Existing results from the predicate device (ComPAS2 v2019.1.0): The new software's outputs were compared against the established, cleared performance of the previous version.
• Current standards for Lung Function Testing: Compliance with standards issued by the American Thoracic Society (ATS) and European Respiratory Society (ERS) (e.g., Laszlo, 2006; Macintyre et al., 2005; Miller, Crapo, Hankinson, et al., 2005; Pellegrino, et al., 2005; Wanger et al., 2005; ERS/ATS 2017 & 2019 standards).

8. The Sample Size for the Training Set

Not applicable. This is a software update to an existing device, and the testing described is primarily verification and validation against established standards and the predicate's performance. There is no mention of a machine learning or AI component requiring a "training set" in the context of this submission. The software performs calculations and displays data based on established algorithms in pulmonary function testing.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a training set for machine learning or AI.

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The intended use of the Vitalograph Model 6000 Alpha is the simple assessment of respiratory function through the measurement of dynamic lung volumes i.e. spirometry. The device measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC. The device is designed to be operated by medical professionals trained in respiratory and lung function testing on adults and pediatrics, 5 years and older, in a variety of professional healthcare environments, e.g. primary care, hospitals and occupational health centers.

The Vitalograph Alpha Model 6000 is a desktop spirometer which measures the following lung function parameters FVC, FEV1, FEV6, PEF, MVV and VC in professional healthcare environments, e.g., primary care, hospitals and occupational health centers. It is externally powered from a Class II, IEC 60601-1 compliant medical power supply. It contains a rechargeable battery powered from the external supply. The device also contains an integral 4 inch thermal printer. The device has a USB port for connection to other devices and an SD card slot for backup of stored data. The device also has wired ethernet and Wi-Fi for connection to a hospital network. Its primary functions and technology are: - Spirometry measurements using single breath and multiple-breath testing techniques, the display and recording of measured lung volumes and flow rates (including FVC, FEV1, FEV6, PEF, MVV and VC) are identical to the predicate device - Record subject data - Storage of data and test results on unit for later printing or export to Spirotrac software which was cleared under 510(k) K201562. The Flowhead utilizes a Fleisch Pneumotachograph. The operating principle is identical to the predicate K200550 - User Interface navigation via touch screen display

The provided text describes the regulatory clearance of the Vitalograph Model 6000 Alpha spirometer and details its comparison to a predicate device. It primarily focuses on the device's technical specifications, regulatory compliance, and non-clinical performance testing rather than a study proving the device meets acceptance criteria in the context of an AI/ML model for clinical decisions.

Based on the provided document, here's an analysis of the acceptance criteria and study that proves the device meets them:

This document is for a diagnostic spirometer, which is a physical medical device that measures lung function. It is not an AI/ML device for clinical decisions. Therefore, many of the typical "acceptance criteria" and "study types" associated with AI/ML devices (like MRMC studies, ground truth establishment by experts, adjudication, sample size for training sets, etc.) do not apply in this context.

The "acceptance criteria" for a physical diagnostic device like a spirometer primarily revolve around its technical performance specifications, electrical safety, EMC, and compliance with relevant international standards.

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

The document doesn't present a formal "acceptance criteria" table in the AI/ML sense. Instead, it provides a "Comparison of Subject and Predicate Devices" (Table 1) which implicitly serves as a comparison against established performance benchmarks and standards for spirometers. The performance data section further details the testing performed to demonstrate compliance.

Here's an attempt to derive "acceptance criteria" from the Specifications reported in the comparison table and the Performance Data section:

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

• Test Set Sample Size: Not applicable in the context of patient data or clinical test sets for AI/ML validation. The testing described is bench testing using standardized methods and controlled inputs (e.g., flow/volume simulators, environmental chambers).
• Data Provenance: Not applicable as it's not a data-driven AI/ML study. The "data" here comes from direct measurements by the device itself under test conditions.

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

• Not applicable. Ground truth for device performance (e.g., whether a spirometer accurately measures volume) is established by calibration against known, traceable standards and instruments, not by human expert interpretation of results. The "ground truth" for spirometry measurements comes from the physical and engineering principles of the measurement itself and the standards against which it is calibrated and tested.

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

• Not applicable. Adjudication is a process used in studies where human interpretation or clinical judgment is involved, particularly for establishing a consensus "ground truth" from multiple readers. This is a technical device performance test, not a reader study.

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. An MRMC study is relevant for AI/ML diagnostic aids where human readers interpret medical images or data. This is a fundamental diagnostic device, not an AI assistance tool for human readers.

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

• The device itself is a "standalone" diagnostic instrument. Its performance is evaluated intrinsically through bench testing against specified standards and its predicate, rather than being an "algorithm only" being evaluated for clinical decision support. Its core function is to measure parameters directly, not to provide an automated clinical interpretation that would fall under "algorithm only" performance in the AI/ML sense.

7. The type of ground truth used:

• The "ground truth" for the device's technical performance is based on established engineering standards and reference measurements, such as those defined by ATS/ERS (2019), ISO 23747, and ISO 26782. These standards specify how spirometers should measure flow and volume and define the acceptable accuracy limits. For electrical safety and EMC, the ground truth is compliance with the relevant IEC/AAMI standards.

8. The sample size for the training set:

• Not applicable. This device does not use machine learning, so there is no "training set."

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

• Not applicable. As there is no training set for machine learning.

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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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