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The Vitalograph Model 6600 COMPACT is intended for use by or on the order of a physician in a hospital or clinic setting. The product is designed for use on adults and paediatrics, 5 years and older. The device is intended to be used as a spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC or connected to compatible Vitalograph or third party devices to acquire, view, store and print the device output.

Vitalograph Model 6600 Compact, running Vitalograph Model 7000 Spirotrac software, ref 510(k) K141546, shall provide a mains-powered desktop spirometer for creating, adding and recalling subjects and performing Spirometry testing on those subjects to aid in the measuring the effect of lung disease on pulmonary function. Model 6600 Compact will also, via the Spirotrac software, connect to compatible third party devices to read and display the output from these devices to allow the information to be retained with the subject. All connected compatible third party devices are those cleared via Model 7000 510(k) K141546. The intended use of the Compact is in the simple assessment of respiratory function through the measurement of dynamic lung volumes i.e. spirometry. Its primary functions are: 1. Interaction will be via the touch Screen interface. 2. Running the Spirotrac software, as cleared in K141546, The model 6600 Compact performs spirometric measurements using the established fleisch Pneumotachograph, using single breath and multiple-breath testing techniques, to display and record lung volumes and flow rates (including FVC, FEV1, FEV6, PEF, MVV and VC) and their sub-divisions to aid in the measuring the effect of lung disease on pulmonary function 3. Record subject demographic data. 4. Produce printed reports to external printers.

This document describes a 510(k) premarket notification for the Vitalograph Model 6600 Compact, a diagnostic spirometer. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of quantitative acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy, as might be seen for AI/ML devices. Instead, the acceptance criteria for this spirometer are based on adherence to established international performance and safety standards, and equivalency to predicate devices.

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

The document refers to "performance testing against international standards" (ISO 26782, ATS/ERS 2005, ISO 23747) and "Mechanical shock testing". However, it does not specify the sample size (e.g., number of spirometry maneuvers, number of devices tested for mechanical shock) used for these tests.
The data provenance is internal testing performed by Vitalograph Ireland Ltd. It implies prospective testing conducted for regulatory submission, rather than retrospective analysis of patient data.

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

This information is not provided in the document. For a diagnostic spirometer, "ground truth" typically refers to accurately generated airflow and volume signals from a calibration syringe or a mechanical lung simulator, which are then compared to the device's measurements. The document mentions "bench tested against performance standards," suggesting such methods were used, but details on expert involvement in setting these "ground truths" or validating the testing methodology are absent.

4. Adjudication Method for the Test Set:

This information is not provided. Given that the testing involves adherence to objective performance standards for measuring physiological parameters (airflow, volume), typical "adjudication" in the sense of resolving discrepancies between human readers or algorithm outputs is not directly applicable. The device's measurements are compared against the known, controlled inputs from the test equipment.

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:

A MRMC comparative effectiveness study is not applicable to this device. This is a standalone diagnostic spirometer, not an AI/ML-driven interpretive system that would assist human readers in, for example, image interpretation. The device's function is to objectively measure lung parameters, not to provide interpretations that human readers would then review or augment.

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

Yes, a standalone performance assessment was done. The entire submission focuses on the device's (Vitalograph Model 6600 Compact) ability to accurately measure respiratory parameters (FVC, FEV1, FEV6, PEF, MVV and VC) independently, against international performance standards described in point 1. The device itself performs the measurements; it's not described as having an AI algorithm requiring human interaction for its primary function.

7. The Type of Ground Truth Used:

The ground truth used for performance testing (bench testing) would have been precisely known, controlled flow and volume inputs generated by calibration equipment (e.g., a calibration syringe, flow generator, or mechanical lung simulator) that comply with the requirements of the mentioned ISO and ATS/ERS standards. This is an objective, physical ground truth.

8. The Sample Size for the Training Set:

This information is not applicable as the Vitalograph Model 6600 Compact is a hardware device based on established physical measurement principles (Fleisch Pneumotachograph) and software logic, not a machine learning or AI algorithm that typically requires a "training set." The software (Spirotrac Model 7000) was previously cleared (K141546), implying its development and validation occurred prior, but no training set for an AI model is mentioned for this device.

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

This information is not applicable for the same reason as point 8.

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The device is a spirometer which measures patient respiratory parameters including FVC, FEV1, FEV6, PEF, MVV and VC. The Vitalograph Pneumotrac is a desktop spirometer designed for lung function testing for use on adults and pediatrics, 5 years and older, in a variety of environments such as hospital wards, health centers and private homes under the supervision of a healthcare provider.

The intended use of the Vitalograph Pneumotrac desktop spirometer, which connects to Vitalograph Model 7000 Spirotrac software, ref 510(k) K141546, shall provide a USB-powered desktop spirometer for creating, adding and recalling subjects and performing Spirometry testing on those subjects to aid in the measuring the effect of lung disease on pulmonary function. Spirometry is in the simple assessment of respiratory function through the measurement of dynamic lung volumes. Its primary functions are; 1. Standalone spirometric measures using single breath or multiple-breath testing techniques, display and record lung volumes and flow rates (including FVC, MVV, VC) and it's subdivisions, Display a single subject's demographic data entered by the user. 2. Produce reports In a clinical setting, the measurements obtained from a lung function test form part of the various findings of a physician in the detection, diagnosis and monitoring of chest diseases.

The Vitalograph Model 6800 Pneumotrac is a diagnostic spirometer. The device was studied through validation bench testing against several international standards to demonstrate its performance.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample size of a "test set" for data provenance in terms of patient data. The study primarily involved validation bench testing against international performance standards. This implies controlled laboratory testing rather than a clinical study with patient data. Therefore, the data provenance would be from laboratory experiments rather than patient data from a specific country or collected retrospectively/prospectively.

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 as the described study is a series of bench tests against engineering standards, not a study involving human interpretation of data where "ground truth" would be established by experts.

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

This information is not applicable as the study did not involve expert adjudication of results. The performance was assessed against predefined numerical and technical 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:

This is not applicable. The device is a spirometer, which measures physiological parameters. It is not an AI-assisted diagnostic tool that would be evaluated in a MRMC study involving human readers and AI assistance.

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

The device itself is a measurement instrument. The "standalone" performance was assessed through bench testing against international standards (ISO, ATS/ERS). This is the functional equivalent of standalone performance for such a device, ensuring its accuracy and precision in measuring respiratory parameters independent of human interpretation during the measurement process.

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

For the bench tests, the "ground truth" was established by the international performance standards themselves (e.g., ISO 26782, ATS/ERS 2005, ISO 23747) which define acceptable ranges and accuracy for spirometry measurements. These standards are developed through scientific consensus and extensive validation.

8. The sample size for the training set:

This is not applicable as the device is not an AI/machine learning algorithm requiring a training set in the conventional sense. Its functionality is based on established physiological measurement principles.

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

This is not applicable for the same reason as point 8.

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The Vitalograph Model 7000 Spirotrac is intended for use by or on the order of a physician in a hospital or clinic setting. The product is designed for use on both adult and pediatric patients. The device is a PC based software application which is intended to be used as a spirometer or connect to compatible Vitalograph or third party devices to acquire, view, store and print the device output.

Spirotrac shall provide a secure PC based medical device software application for creating, adding and recalling subjects and performing Spirometry testing on those subjects. Spirotrac will also link to compatible third party devices to read and display the output from these devices to allow the information to be retained with the subject. Spirotrac will integrate and read / display information from Pulse Oximetry devices, Blood Pressure and Weight measurements devices, and ECG test devices. Its primary functions are: 1. Spirometry measurements using single breath and multiple-breath testing techniques, the display and recording of measured lung volumes and flow rates (including VC, FIVC, FVC) and it's subdivisions, The unit also allows for the measurements of Inspiratory and Expiratory Flow rates (PEF, FEFx, etc), indirect measures (e.g. MVV) and Pre-post testing (e.g. Challenge, work shift). 2. Record subject demographic data as input. Interact with existing Vitalograph and compatible third party devices via standard PC communication methods for download of data for storage within the Spirotrac database. 3. Navigation is allowed via the use of a standard PC keyboard and mouse or touchscreen.

Here's a breakdown of the acceptance criteria and study information for the Vitalograph Model 7000 Spirotrac, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, not typically a detailed clinical study report proving device performance against specific, pre-defined acceptance criteria in the same way a PMA or de novo submission might. Therefore, some information, especially regarding detailed sample sizes, expert qualifications, and specific "reported device performance" metrics against acceptance criteria (beyond general compliance checks), is not explicitly stated in this type of document.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device underwent validation testing to ensure performance according to its specifications against current standards. The mentioned standards serve as the de-facto acceptance criteria. The "Reported Device Performance" is generally stated as "All tests and validations demonstrated satisfactory results." Specific numerical performance metrics against each standard are not provided in this summary.

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

The document does not specify a sample size for any clinical test set. The validation appears to be primarily engineering and bench testing against international standards, rather than a clinical study with a patient cohort.

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified, but likely from laboratory testing and calibration rather than patient data from a specific country or retrospective/prospective study type, given it's a spirometer software.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided as the validation described is against established international technical standards for spirometry. There wasn't a ground truth established by human experts in the typical sense of a diagnostic imaging study.

4. Adjudication Method for the Test Set

Since the validation is described as performance testing against international standards, an "adjudication method" in the context of expert review for ground truth determination is not applicable or described. The standards themselves define the criteria for "correctness" or acceptable performance.

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

An MRMC study was not mentioned or performed. The device is a spirometer software application; its performance is typically evaluated for measurement accuracy and consistency, rather than its impact on human reader interpretation.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance evaluation was done. The document explicitly states: "The Vitalograph Model 7000 Spirotrac underwent validation testing to ensure performance according to its specifications against current standards." This refers to the software's ability to accurately acquire, process, and display spirometry measurements as determined by the listed ISO and ATS/ERS standards.

7. Type of Ground Truth Used for the Test Set

The ground truth for the test set was defined by international technical standards and norms for spirometry (ISO 26782, ATS/ERS 2005, ISO 23747). This implies that the device's measurements were compared against established reference values or methods defined by these standards, likely using simulated lung functions or calibrated devices.

8. Sample Size for the Training Set

The document does not mention a training set size. This device is a spirometer software, and its primary function is measurement and data handling. While it might include algorithms for interpretation (e.g., predicted values, flagging out-of-range results), these are typically based on well-established physiological models and clinical guidelines, not necessarily a machine learning model that requires a "training set" in the modern AI sense.

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

Since a "training set" in the machine learning sense is not mentioned, the method for establishing its ground truth is not applicable or described. The algorithms and computations within the spirometer software would be based on established physiological principles and clinical guidelines rather than learned from a labeled dataset.

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The Model 7100 is a non-invasive battery operated device intended to acquire, record and store ambulatory cough sounds from patients for up to 24 hours. The device stores the data on a removable memory card for later playback, review, and analysis on a windows based PC.

The Model 7100 is a non-invasive battery operated device intended to acquire, record and store ambulatory cough sounds from patients for up to 24 hours. The device stores the data on a removable memory card for later playback, review, and analysis of the cough sounds on a windows based PC.

The recording of respiratory sounds to a sound file over the two channels for up to 24 hours is achieved by:
a) The contact sensor channel, which records the data for later analysis.
b) An air microphone channel. This is used to monitor and to ascertain the validity of the data obtained in the channel described in (a.) above. This can be achieved by listening, or otherwise determining, signals such as speech and other noises that will be ignored when examining channel (a) data.
These two individual analogue signals are electronically conditioned and then digitally sampled. The sampled information data is then stored to a suitable internal memory module. The data will be transferred to the PC by removing the memory card from the VitaloJAK.

The provided document, K110525 for the Vitalograph Model 7100 VitaloJAK, is a 510(k) summary for a medical device. As such, it describes the device's intended use and technological characteristics, and compares it to a predicate device to establish substantial equivalence. However, it does not contain the detailed study results, acceptance criteria, or performance metrics that would typically be presented in a dedicated clinical validation or performance study report.

The document states: "Safety and effectiveness have been assured through the extensive testing in relation to IEC 60601 standards for electrical safety and EMC/EMI, as well as device specific performance testing. ... As with the predicate device the Vitalograph Model 7100 underwent validation testing to ensure performance according to its specifications. All tests demonstrated satisfactory results. Evidence of successful validation has been provided with this submission." This indicates that such testing was performed and submitted to the FDA, but the details are not included in this publicly available summary.

Therefore, many of the requested details cannot be extracted from the provided text. Below is an attempt to address the points based only on the available information, with explicit statements where information is missing.

Acceptance Criteria and Device Performance Study for Vitalograph Model 7100 VitaloJAK

The provided 510(k) summary for the Vitalograph Model 7100 VitaloJAK does not explicitly state quantitative acceptance criteria or detailed device performance results in a comparative table format. Instead, it attests that "All tests demonstrated satisfactory results" and that "Evidence of successful validation has been provided with this submission." The focus of this 510(k) summary is on comparing the device's characteristics to a predicate device to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

• Sample Size for Test Set: This information is not provided in the 510(k) summary.
• Data Provenance (country of origin, retrospective/prospective): This information is not provided in the 510(k) summary. The document focuses on the technical characteristics and regulatory compliance, not on clinical study data.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

• This information is not provided in the 510(k) summary. Since the device itself is not diagnostic and "The user identifies each incident of coughing," the role of experts in establishing a ground truth for device performance (beyond general technical specifications) is not detailed. If a study involved expert review of the recorded data, it is not mentioned here.

4. Adjudication Method for the Test Set

• This information is not provided in the 510(k) summary.

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

• No evidence of an MRMC comparative effectiveness study is presented in this 510(k) summary. The device is explicitly stated to not perform diagnosis and requires a user to identify cough incidents. Therefore, a study comparing human readers with and without AI assistance would not be applicable to this device's stated function.

6. Standalone Performance Study (Algorithm Only)

• A standalone performance study (algorithm only) was not performed or is not detailed in this 510(k) summary for automated cough detection or analysis. The device's stated function is solely to "acquire, record and store ambulatory cough sounds," and for "later playback, review, and analysis of the cough sounds on a windows based PC" where "The user identifies each incident of coughing." The device itself does not contain an algorithm for automatic cough identification or diagnosis.

7. Type of Ground Truth Used

• The 510(k) summary does not mention a specific type of ground truth used to evaluate the device's core function of recording. The "validity of the data obtained" (from the contact sensor) is stated to be ascertained by the air microphone channel, but this refers to technical signal validity rather than a clinical ground truth for cough events. For the analysis phase, where the user identifies coughs, the ground truth would implicitly be human expert identification, but this is a post-recording step leveraging the user, not an automated function of the device that requires an inherent ground truth during device operation.

8. Sample Size for the Training Set

• This information is not applicable and not provided. The device is a data recorder, not an AI-driven diagnostic or analytical tool that requires a training set (in the machine learning sense). Its functionality is based on hardware and firmware for signal acquisition and storage.

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

• This information is not applicable and not provided. As mentioned above, the device does not use a training set in the machine learning context.

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The device is a battery operated spirometer which measures three basic patient respiratory parameters {FVC, MVV and VC}. The model 2120 is a hand held spirometer designed for lung function testing in a variety of environments such as hospital wards, health centres and private homes. The model 2120 can be configured as a stand-alone spirometer or connected to a printer.

The Vitalograph Model 2120 is intended to be used, as its predecessor, as a battery operated spirometer which measures three basic patient respiratory parameters {FVC, MVV and VC}. The model 2120 is a hand held spirometer designed for lung function testing in a variety of environments such as hospital wards, health centres and private homes. The model 2120 can be configured as a stand-alone spirometer or connected to a printer.

The Model 2120 series has been available to the marketplace for over 15 years {ref K946075}. This device is a hand held electronic Spirometer, used in the simple assessment of respiratory function through the measurement of dynamic lung volumes i.e. Spirometry. This revised design is an upgrade to the existing product in terms of modernising its look and feel {i.e. changes to ergonomics and user interface}. The intended uses and operating principles in relation to its measurement of respiratory function remain unchanged.

Its primary functions are:

1. Spirometry measurements using single breath and multiple-breath testing techniques, the display and recording of measured lung volumes and flow rates (including FVC, VC, MVV) and it's subdivisions,
2. Record subject data. Storage of data and test results on unit for later printing or export to Spirotrac {see K912412}.
3. The flowhead will be a Fleisch Pneumotachograph type flowhead, the operating principle of which has been well established in the existing Model 2120 {K946075} and various other spirometers. {e.g. Vitalograph Compact Ref K854526. Vitalograph Alpha ref K873562, Vitalograph Escort K925085}

All variants of the Model 2120 {e.g. including In2itive, e-Diary} will use very same operating principle, LCD, Buttons, optional Touchscreen, and Mouldings. Items that may vary within the range are the list of parameters that the different variants display.

Navigation is allowed via the use of five buttons {Up, Down, Enter/Select, Cancel /Esc and power On/Off} or an optional touch screen.

Here's a breakdown of the acceptance criteria and study information for the Vitalograph Model 2120 Hand Held Spirometer, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document states that "Safety and effectiveness have been assured through the extensive testing in relation to IEC 60601 standards for electrical safety and EMC/EMI, as well as device specific performance testing to American Thoracic Society (ATS) and International Organisation for Standardisation (ISO) standards."

The specific standards referenced for performance are:

• ATS ERS 2005
• ISO 23747:2007 for PEF (formerly EN13826:2003)
• EN ISO 26782:2009

The table above demonstrates that the device's specifications meet the listed accuracy and range requirements, indicating compliance with these standards. The conclusion explicitly states, "Based on the above, including the successful completion of all device testing, Vitalograph conclude that this device is substantially equivalent to the legally marketed predicate devices and is safe and effective for use."

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

The 510(k) summary does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It refers to "extensive testing" but does not provide details on the testing methodology, number of subjects, or type of data used (patient data vs. simulated data). Given this is a spirometer, testing would typically involve controlled laboratory simulations with known volumes/flows and potentially human subjects, but these details are not provided.

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

This information is not provided in the 510(k) summary. For device performance testing of a spirometer, ground truth is typically established by physical reference standards (e.g., calibrated syringes) rather than expert consensus on patient data.

4. Adjudication Method for the Test Set

This information is not applicable as the ground truth for a spirometer's performance is typically based on objective physical measurements and not on expert adjudication of subjective findings. The document does not describe any such adjudication process.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for imaging devices or diagnostic tools where human interpretation is a key component and the AI assists human readers. For a spirometer that directly measures physical parameters, an MRMC study is not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-loop Performance) Was Done

Yes, implicitly. The device itself is a "standalone" spirometer designed to produce measurements directly. The performance testing "to American Thoracic Society (ATS) and International Organisation for Standardisation (ISO) standards" inherently assesses the algorithm's ability to accurately measure respiratory parameters without human interpretation in the loop. The device directly calculates and displays the FVC, MVV, and VC parameters.

7. The Type of Ground Truth Used

The ground truth used for validating the spirometer's performance would primarily be physical reference standards (e.g., highly accurate, calibrated syringes that deliver precise volumes and flows). The device's "Calibration" method is listed as "Using calibration syringe," which supports this. These standards are used to input known volumes and flows into the device, and its measured output is compared against these known values to determine accuracy.

8. The Sample Size for the Training Set

The concept of a "training set" in the context of machine learning is not applicable to this device. The Vitalograph Model 2120 is a rule-based or physics-based measurement device, using a Fleisch Pneumotachograph and established algorithms ("Same algorithm for spirometry parameters calculation"). It does not describe an AI/ML model that requires a training set.

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

As stated above, a "training set" in the context of AI/ML is not applicable to this device.

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To be used by the asthma / copd patient at home to monitor the condition. To be used in General Practitioner's clinic with disposable mouthpieces. The Model 4000 range is intended as to compete directly with competitor's electronic peak flow meters and COPD screening devices.

The Vitalograph Model 4000 series {asma-1 and copd-6} are battery powered handheld electronic spirometers used to measure expired Peak Flow and forced expired volume after one second {FEV1} .. The results can aid in the diagnosis of Asthma and COPD in patients. All variants {asma-1 and copd-6} within the range use the very same operating principle, LCD, Buttons, and Mouldings. Items that may vary within the range are the list of parameters that the different variants display. I.e. Asma-1 displays FEV 1 and PEF, whilst the copd-6 displays FEV 1 and FEV6 only. A uni-directional rotating vane with flow sensor to measure lung function is used. The measurements are taken via expiration into the unit flowhead, which is In-turn displayed onto an LCD. Navigation is allowed via the use of four buttons {Up, Down, Enter/Select and power On/Off}

Here's an analysis of the provided text to extract information regarding acceptance criteria and device performance:

1. Table of Acceptance Criteria and the Reported Device Performance:

Study Proving Device Meets Acceptance Criteria:

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing a specific clinical study for novel device performance. The acceptance criteria are primarily based on established international standards for spirometers (ATS 2005, ISO 23747:2007) and regulatory compliance (EN 60601 series, IEC 61000 series, FDA 510(k), CE marking).

The statement "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices" implies that Vitalograph submitted data demonstrating that their device meets these established performance and safety standards. However, the 510(k) summary itself does not explicitly detail the study or studies that generated the performance data (e.g., how the +/- 3% accuracy was verified). Instead, it states the specifications and that the device meets them, likely supported by internal testing reports that are part of the larger 510(k) submission, but not included in this summary.

Given the nature of a spirometer, the "study" would likely involve:

• Bench testing: Using calibrated flow and volume generators to assess the accuracy of FEV1, FEV6, and PEF measurements across the specified ranges.
• Environmental testing: Subjecting the device to various temperature and humidity conditions to verify operating and storage parameters.
• Electromagnetic Compatibility (EMC) testing: Conforming to IEC 61000 standards.
• Safety testing: Conforming to EN 60601 standards for medical electrical equipment.

Detailed Information Not Available in the Provided Text:

The document is a 510(k) summary, which often omits the granular details of testing methodologies and underlying data. Therefore, the following information is not provided in the extracted text:

2. Sample size used for the test set and the data provenance: Not specified. The performance metrics (e.g., accuracy) are stated as specifications rather than results from a particular test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/specified. For spirometer accuracy, ground truth is typically established by physical standards and calibrated equipment, not by human expert consensus or annotations in the way AI/radiology devices might.
4. Adjudication method for the test set: Not applicable/specified, as the ground truth is based on physical 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: Not applicable. This device is a standalone diagnostic spirometer, not an AI-assisted diagnostic tool that helps human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the performance metrics listed (e.g., accuracy for FEV1, FEV6, PEF) would be derived from the device's inherent measurement capabilities operating in a standalone mode, without human interpretation for the measurement itself (though human interpretation of the results is part of its intended use).
7. The type of ground truth used: For accuracy measurements (FEV1, FEV6, PEF), the ground truth would be established by calibrated spirometer verification equipment (e.g., a syringe pump or flow/volume simulator) that can deliver known volumes and flows.
8. The sample size for the training set: Not applicable. This device is a measurement instrument, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

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