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The PowerCube+ Series is indicated for use in the measurement and data collection of lung function parameters. The system performs cooperation-dependent pulmonary function tests which include Spirometry/Flow-Volume measurement, Body Plethysmography measurement, Lung Diffusion measurement, Occlusive Resistance measurement and Respiratory Muscle Strength measurement. The device provides information that aids in a diagnosis by a clinician.

The PowerCube+ Series is indicated for use by a clinician in a professional healthcare setting on adult and pediatric patients who are 5 years and older that can cooperate in the testing.

The GANSHORN PowerCube+ Series is a device that performs cooperation-dependent pulmonary function tests, including Spirometry, Body Plethysmography, Lung Diffusion measurement, Occlusive Resistance measurement and Respiratory Muscle Strength measurement. The device provides information that aids in a diagnosis by a clinician.

Spirometry is a set of non-invasive pulmonary function tests where the flow of inhaled/exhaled air is measured to determine physiological parameters such as Peak Expiratory Flow and Forced Vital Capacity. The patient's breathing flow is measured with ultrasound technology inside a breathing insert. Two ultrasound transducers measure the difference in ultrasound wave transit time to calculate breathing flow direction, speed, and volume.

Body Plethysmography provides for the measurement of physiological parameters such as Functional Residual Capacity and Specific Airway Resistance. The patient is seated in an air-tight chamber which has a fixed shape and volume. Pressure sensors measure the chamber pressure and the pressure close to the mouth, which is used as a proxy for alveolar pressure when measured under a zero-flow condition. Boyle's Law is used to infer the volume in the lungs from changes in chamber pressure.

Lung Diffusion testing is a non-invasive process for measuring diffusion capacity and lung volume. The patient inhales a test gas with known concentrations of helium and carbon monoxide. The patient's breath is held for 10 seconds during which time the helium dilutes into the lungs and the carbon monoxide diffuses through the alveoli into the blood. After 10 seconds of breath-hold time, the patient exhales and the difference between inhaled and exhaled gas concentrations is measured with a gas analyzer. The differences in gas concentration are used to determine physiological parameters such as DLCO (diffusing capacity of the lungs for carbon monoxide) and Alveolar Volume.

Occlusive Resistance measurement is an established method for measuring airway resistance during tidal breathing, using a shutter and mouth pressure sensor.

Respiratory Muscle Strength measurement is an established method for measuring the maximal strength of respiratory muscles, using a shutter and mouth pressure sensor.

The PowerCube+ Series has the following product model configurations:

• . PowerCube Body+ includes Spirometry and Body Plethysmography measurement
• . PowerCube Diffusion+ includes Spirometry and Lung Diffusion measurement
• . PowerCube Body+ / Diffusion+ includes Spirometry, Body Plethysmography, and Lung Diffusion measurement

All product model configurations support Occlusive Resistance measurement and Respiratory Muscle Strength measurement.

The PowerCube+ Series is mains-powered and not intended for mobile/transportable use.

The provided text focuses on the substantial equivalence of the GANSHORN PowerCube+ Series to predicate devices for regulatory clearance. It does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria in the format requested (i.e., a clinical study with human readers and AI).

The document outlines a series of bench tests to demonstrate performance in various modalities, but these are not structured as clinical studies with acceptance criteria for device performance parameters related to a "ground truth" established by experts in a diagnostic context. Instead, the performance testing focuses on compliance with international standards (e.g., ISO 23747, ISO 26782, ATS/ERS guidelines) and comparison against a calibrated flow/volume simulator or an FDA-cleared device.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to clinical performance and AI integration, which are not detailed here.

However, I can provide what is available regarding performance testing and some related details:

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

The document mentions compliance with various standards and internal requirements, and comparative bench testing. Here's what can be extracted, focusing on quantitative performance where available:

Regarding the study that proves the device meets acceptance criteria:

The study referenced is a series of bench tests and comparative bench testing against an FDA-cleared device.

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

• Sample size for test set: Not explicitly stated in terms of number of patient cases. The "test set" for performance was described as using a "calibrated Hans-Rudolph flow/volume simulator at a range of physiological test points" and "simulated inhalation and exhalation with calibrated gas mixtures." For comparative testing with the predicate device, it mentions comparing measurements, but not a specific sample size of test points or patient data.
• Data provenance: Bench testing results and simulated data. No real-world patient data is mentioned for testing device performance against ground truth in a clinical context.

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 bench testing was established by calibrated instruments and simulators, not human experts.

4. Adjudication method for the test set

Not applicable, as ground truth was established by calibrated instruments, not human review 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. This document describes a medical device for measuring lung function parameters, not an AI-assisted diagnostic tool that involves human readers.

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

The device itself is a measurement system; its "performance" is its accuracy in providing these measurements. The document outlines standalone performance evaluations through bench testing to ensure the device accurately measures lung function parameters. There is no mention of a separate "algorithm only" performance study in the context of an AI-based diagnostic algorithm.

7. The type of ground truth used

For the performance testing, the ground truth was established by:

• Calibrated instruments and simulators (e.g., Hans-Rudolph flow/volume simulator, calibrated gas mixtures).
• Compliance with recognized international standards (e.g., ISO 23747, ISO 26782, ATS/ERS guidelines).
• Measurements from an FDA-cleared predicate device for comparative analysis.

8. The sample size for the training set

Not applicable. This is a medical measurement device, not an AI/machine learning model that requires a training set of data.

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

Not applicable, as there is no training set for an AI/machine learning model mentioned.

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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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The STS device is intended to measure lung function in adult patients while at rest (including spirometry and lung volumes). The STS device is to be used by either a physician, respiratory therapist, or technician. The STS device is intended to be used in a professional healthcare environment.

The STS is a handheld spirometer intended to measure lung function in adult patients while at rest (including spirometry and lung volumes). The STS is to be used by either a physician, respiratory therapist, or technician. The STS device is pulmonary function testing device that measures both flow/volume (spirometry), lung volume and resistance/compliance parameters. It is a multi-use device that should be used with a compatible single-use, disposable mouthpiece which incorporates a viralbacterial filter protecting the patient from the internal components of the device is battery operated allowing for approximately 40 operating hours between charges. The measurement results, which are transmitted via Bluetooth, are displayed on the physician's computer via the STS software/App.

The provided text is a 510(k) summary for the STS device, a pulmonary function data calculator. While it mentions a clinical study, the details provided are limited and do not fully address all requested points regarding acceptance criteria and study specifics for proving the device meets those criteria.

Based on the provided document, here's what can be extracted and what remains unknown:

1. Table of acceptance criteria and reported device performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating acceptance criteria values for performance. However, an implicit acceptance criterion is a "high correlation" and specific statistical thresholds mentioned in the clinical study summary.

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

• Sample Size: 161 subjects (61 females, 100 males, implicitly). This test set was used for the clinical study comparing STS to Body Plethysmography.
• Data Provenance: Not explicitly stated (e.g., country of origin). It is a prospective study as subjects were "enrolled" and "tested by both STS and BP," suggesting data was collected specifically for this study.

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

• The document states that Body Plethysmography (BP) is considered the "gold standard" for measuring lung volumes. Therefore, the BP measurements served as the ground truth.
• It does not specify the number of experts or their qualifications involved in performing or interpreting the Body Plethysmography tests. It's implied that standard clinical practice for BP was followed, which would involve trained medical professionals, but this is not detailed.

4. Adjudication method for the test set:

• No information on adjudication methods is provided. The comparison is directly between the STS device measurements and the "gold standard" Body Plethysmography measurements.

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 Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done or reported. This device is a pulmonary function data calculator and not an AI-assisted diagnostic imaging tool where human reader performance with and without AI assistance would typically be evaluated. The study focuses on the device's accuracy in measuring physiological parameters when compared to a gold standard.

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

• The clinical study described evaluates the "performance of STS technique in calculating resistance and compliance parameters" by comparing it with Body Plethysmography.
• The STS device itself is a "pulmonary function testing device that measures both flow/volume (spirometry), lung volume and resistance/compliance parameters." This implies a standalone performance evaluation of the device's measurements against the gold standard. However, the device "is to be used by either a physician, respiratory therapist, or technician" and its results are "displayed on the physician's computer via the STS software/App," indicating there's a human-in-the-loop for operation and interpretation. The study evaluates the measurement accuracy, which can be seen as a form of standalone performance for the measurement part of the device.

7. The type of ground truth used:

• The ground truth used was "gold standard" Body Plethysmography (BP) measurements of lung volumes. While BP is a clinical measurement, it serves as the established reference standard in this context.

8. The sample size for the training set:

• The document does not provide any information about the sample size used for the training set. This is a 510(k) submission, and often, proprietary training data details are not included in the public summary.

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

• The document does not provide any information on how the ground truth for the training set was established, as details about the training set itself are absent.

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The CardioWatch 287-2 System is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or their own home. It is intended for monitoring of non-acutely ill patients by trained healthcare professionals.

The CardioWatch 287-2 System is intended to provide visual and audible physiologic multi-parameter alarms.

The CardioWatch 287-2 System is intended for monitoring of skin temperature at wrist of axillary temperature with connected thermometer device.

The CardioWatch 287-2 System is intended for continuous monitoring of the following physiological indices in adults (over 22years old):

• Pulse rate
• Oxygen saturation
• Temperature
• Movement

The Cardio Watch 287-2 System is intermittent monitoring with the CardioWatch Bracelet of the following physiological indices in adults (over 22years old):

• Respiration rate.

The CardioWatch 287-2 System is intended for intermittent or spot-check monitoring, in adults, of:

• Non-invasive blood pressure
• Lung function & spirometry
• Weight

The CardioWatch 287-2 System is not in high-acuity environments, such as ICU or operating rooms.

The CardioWatch 287-2 System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The CardioWatch 287-2 system is not a substitute for an ECG monitor.

The CardioWatch 287-2 System is not intended for SpO2 monitoring of high motion or low perfusion.

The Corsano CardioWatch 287-2 System is a Remote-Patient Monitoring System that consists of a monitoring bracelet device worn on the wrist by adult patients (aged 22 years old and over), a web-based browser platform and a user mobile application operable in either Patient Mode or HealthCare Professional (HCP) Mode.

Vital signs data both on mobile devices and web-based dashboard are available to the HealthCare Provider only.

The Corsano CardioWatch 287-2 System is also integrated with third-party devices for displaying and monitoring physiological signs (spot monitoring of : non-invasive blood pressure (NIBP), lung function & spirometry (SPIRO), weight (WEIGHT) as well as continuous monitoring of axillary temperature (aTEMP).

The Corsano Bracelet is intended to continuously monitor physiological vital sign data : Pulse Rate (PR), oxygen saturation (SpO2), skin temperature (sTEMP) and activity (STEPS) and for intermittent monitoring of respiratory rate (RR) from the person being monitored and securely transmit the encrypted data via the Patient User App to the secure server.

The bracelet is intended for use in professional healthcare facilities, such as hospitals or skilled nursing facilities, or the home by trained healthcare professionals.

The Corsano CardioWatch 287-2 System's acceptance criteria and studies are detailed below, primarily focusing on Pulse Rate, SpO2, Respiration Rate, and Skin Temperature.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states that "Clinical studies were carried out to support compliance to IEC IEC 80601-2-61 and FDA Guidance on Pulse Oximeters - Premarket Notification Submissions (510(k)s], March 2013." And also that the "Respiratory Rate Validation Testing ensured RR accuracy of the Corsano CardioWatch 287-2 System in the intended patient population using the gold standard (blinded clinician, manually counted end-tidal CO2 with FDA cleared capnogram)."

However, the specific sample sizes used for these clinical studies (test set) are not provided in the given text.

The data provenance (country of origin, retrospective or prospective) is also not specified in the provided text.

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

For the Respiratory Rate Validation Testing, the ground truth was established using a "blinded clinician." The number of these clinicians (experts) is not specified, nor are their specific qualifications (e.g., years of experience).

For Pulse Oximetry (SpO2) and Pulse Rate, the ground truth would typically come from a co-oximeter and ECG, respectively, as per the mentioned standards. The document does not explicitly state the number or qualifications of experts involved in analyzing this data beyond the implied standard procedures.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set, beyond stating that a "blinded clinician" was used for respiratory rate validation.

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

No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance is present in the provided text. The device is a patient monitoring system, not explicitly an AI-assisted diagnostic tool for human readers.

6. Standalone Performance Study

The performance data presented in the table and the mention of "Clinical studies were carried out to support compliance to IEC IEC 80601-2-61 and FDA Guidance on Pulse Oximeters - Premarket Notification Submissions (510(k)s]" and "Respiratory Rate Validation Testing ensured RR accuracy of the Corsano CardioWatch 287-2 System" indicates that standalone performance (algorithm only) was assessed for the device's measurements. The performance metrics listed (e.g., Accuracy for PR, SpO2, RR, Skin Temperature) are characteristics of the device's standalone measurement capabilities.

7. Type of Ground Truth Used

• Respiratory Rate: "gold standard (blinded clinician, manually counted end-tidal CO2 with FDA cleared capnogram)." This indicates a combination of expert assessment and a validated medical device.
• Pulse Rate (PR) and Oxygen Saturation (SpO2): The document references compliance with ISO 80601-2-61 and FDA Guidance for Pulse Oximeters (2013). These standards typically involve comparison against reference devices like an arterial blood gas co-oximeter for SpO2 and an ECG for PR, established under controlled desaturation studies or stable vital sign conditions. While not explicitly stated as "pathology" or "outcomes data," this method relies on highly accurate, established medical measurement techniques.
• Skin Temperature: Bench testing in accordance with IEC80601-2-56. This implies comparison against a calibrated reference temperature measurement.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set. This suggests that if machine learning models were used, the details of their training data are not included in this summary.

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

Since the document does not specify a training set or its sample size, it also does not detail how the ground truth for any potential training set was established.

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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 Cardio Q50 / Cardio Q70 ECG Analysis System is intended to acquire, analyze, display and record ECG information from adult and pediatric populations.

• Bionet Algorithm - 3 years or older / Glasgow Algorithm - 0 years or older
  The system provides 12-lead ECG and interpretive analysis.
  The 12-Lead ECG interpretation algorithm provides analytical information about the patient's heart condition, which must be confirmed by a qualified medical professional along with other relevant clinical information.
  Sending and receiving ECG data to and from the Hospital Information System is optional.
  The Cardio Q50 / Cardio Q70 is intended to be used by personnel trained in hospitals or medical professional facilities under the direct supervision of a licensed healthcare practitioner.
  In addition, the Cardio Q50 / Cardio Q70 is intended for prescription use only to perform spirometry diagnostic tests in adults and pediatric patients aged 5 and older in general practice, specialist and hospital settings. The device is intended to be used what measures patient respiratory parameters including FVC, FEV1/FEV6, SVC, MVV.

Cardio Q50 / Cardio Q70 is a 12-channel ECG (Electrocardiogram) recording equipment that measures and records the patient's ECG. It not only provides parameters necessary for diagnosis, patient's ECG record and automatic diagnosis, but also increases chart management efficiency by providing ECG records and printing reports when patient or user information is entered. At the same time, it can transmit the saved data to a PC for file management. Its useroriented design enables ECG examination with a single push of a button. It saves, transfers and prints the data that has been acquired by automatic diagnosis.
It provides the user with the necessary parameters, which are necessary for patient diagnosis, along with the spirometry record. After spirometry tests, you can print out a report on A4/letter paper together with the spirometer record to efficiently manage the patient's or user's chart. The stored data is forwarded to a PC that is in charge of managing digital files. In addition, the battery pack, which can be stored inside as an optional component, ensures high portability and makes it possible to inspect or use the equipment in an emergency.

The provided document is a 510(k) summary for the Cardio Q50 and Cardio Q70 ECG Analysis System, which includes both ECG and spirometry functions. The document primarily focuses on establishing substantial equivalence to predicate devices and does not contain detailed information about a study proving the device meets specific acceptance criteria in the manner you've requested.

However, based on the information provided, I can infer some aspects related to acceptance criteria and how the device's performance is demonstrated:

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

The document does not provide a direct table of acceptance criteria with reported device performance metrics in terms of accuracy, sensitivity, specificity, etc., for the diagnostic algorithms. Instead, it states that the device complies with certain international standards. Compliance with these standards implicitly serves as the acceptance criteria for various aspects of the device's functionality and performance.

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

The document does not provide details on sample size, data provenance (e.g., country of origin, retrospective/prospective), or demographic information for any test sets used to validate the performance of the Bionet or Glasgow ECG analysis algorithms. It mentions "Non-Clinical Test Summary" and "Clinical Test Summary" but states "Clinical testing is not required." This implies that the device's performance regarding the ECG interpretation algorithm itself was likely established based on prior validation of the algorithms (Bionet algorithm V 3.26 and Glasgow algorithm V 30.4) outside the scope of this specific 510(k) submission, or that the FDA did not require new clinical data for this particular clearance due to substantial equivalence.

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

This information is not provided in the document because no specific clinical study data is presented for the ECG analysis algorithm. The document mentions that the interpretive analysis "must be confirmed by a qualified medical professional along with other relevant clinical information." This highlights the human-in-the-loop nature of the device's intended use rather than providing details on ground truth establishment for an algorithm's validation.

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

This information is not provided as no specific clinical study data (including ground truth establishment) is detailed in the document.

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

The document does not indicate that an MRMC comparative effectiveness study was performed or refer to any such study demonstrating the effect size of human readers improving with AI assistance. The device's clearance is based on substantial equivalence to existing devices and compliance with relevant standards, not on a demonstrated improvement in human reader performance.

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

While the document states that the ECG interpretation algorithm provides analytical information that "must be confirmed by a qualified medical professional," it also includes the algorithm as a feature. The compliance with standards like ANSI AAMI EC53 (Ambulatory ECG Recorders) might implicitly cover some standalone algorithm performance metrics, but no specific standalone performance metrics (e.g., sensitivity, specificity, accuracy of the algorithms) are explicitly provided in this 510(k) summary. The document focuses on the safety and essential performance of the electrocardiograph system as a whole, rather than the isolated diagnostic performance of its interpretive algorithms.

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

The document does not specify the type of ground truth used for the validation of the Bionet or Glasgow ECG analysis algorithms, as details of a specific validation study are not included in this submission. For ECG interpretation algorithms, ground truth is typically established through expert consensus by multiple cardiologists, often aided by correlation with other clinical data and patient outcomes.

8. The sample size for the training set

The document does not provide information on the sample size for the training set of the ECG analysis algorithms.

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

The document does not describe how the ground truth for the training set was established. This information would typically be part of the algorithm's development and validation, which precedes the 510(k) submission for a device incorporating a previously developed or updated algorithm. The document only states the versions of the Bionet (V 3.26) and Glasgow (V 30.4) algorithms being used, implying their prior establishment and validation.

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The Cardio P1 Analysis System is intended to acquire, and record ECG information from adult and pediatric populations. Pediatric population is defined as patients between the ages from 3 and less than 16 years. The system provides 12-lead ECG and interpretive analysis. The 12-Lead ECG interpretation algorithm provides analytical information about the patient's heart condition, which must be a qualified medical professional along with other relevant clinical information. Sending ECG data to and from the Hospital Information System is optional. The Cardio P1 is intended to be used by personnel trained in hospitals or medical professional facilities under the direct supervision of a licensed healthcare practitioner.

Cardio P1 is a 12-channel ECG (Electrocardiogram) recording equipment that measures and records the patient's ECG. It not only provides parameters necessary for diagnosis, patient's ECG record and automatic diagnosis, but also increases chart management efficiency by providing ECG records and printing reports when patient or user information is entered. At the same time, it can transmit the saved data to a PC for file management. Its user-oriented design enables ECG examination with a single push of a button. The Cardio P1 is installed on a standalone PC. For all configurations, an independent PC is used that can be positioned for patient convenience.

The provided text is a 510(k) summary for the Cardio P1 device, which is a 12-channel ECG recording equipment. The summary states that clinical testing is not required and that the substantial equivalence is based on non-clinical testing demonstrating similar technological characteristics to the predicate device (Cardio10, K220535). Therefore, the document does not contain information regarding acceptance criteria and a study proving the device meets those criteria for clinical performance.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on intended use, target population, and technical specifications, along with compliance with electrical safety, EMC, usability, and software validation standards.

Specifically, it states:

• "Clinical testing is not required" (page 9)
• "The non-clinical testing demonstrates the subject device (Cardio P1) is substantially equivalent in terms of technological characteristics to the predicate device (K220535)." (page 9)

Given this, I cannot provide the requested table or details about a clinical study's sample size, ground truth, expert qualifications, or MRMC study results because such information is explicitly stated as not being required or performed for this submission. The device performance listed in the comparison table on page 5-6 refers to the technical specifications of the ECG device rather than diagnostic accuracy or clinical outcomes.

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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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