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The Spirotel spirometer and pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician or paramedic to test lung function in people of all ages. It is also intended to be used as a singlepatient device and can be used in any setting - home, factory, pharmacy, hospital or physician's office.

Spirotel is a pocket spirometer that can also feature a pulse oximeter function (optional). It measures a range of functional respiratory parameters, and the oxygen saturation and pulse rate. The device can operate completely autonomously or can be connected to a personal computer by means of various types of connections: USB, Bluetooth, GSM.

Here's a breakdown of the acceptance criteria and the study information for the Spirotel device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set Sample Size: The document does not specify the exact sample sizes used for the spirometry or oximetry accuracy tests, nor for the safety and environmental testing, or data transmission tests. It states that "Testing was done" and "The results obtained were within the range of accuracy required."
• Data Provenance:
  • Spirometry: The spirometry testing was performed "according with American Thoracic Society (ATS) Standards." This suggests an in-house evaluation against established clinical standards.
  • Oximetry: The oximetry accuracy was "verified in-house using an optical simulator." This indicates an in-house, lab-based study.
  • Safety and Environmental: Testing was conducted in accordance with EN 60601-1:2006 and EN 60601-1-2:2007, implying adherence to international standards.
  • Battery, USB, Bluetooth, GSM: These were "carried out in-house" or by "a third party laboratory" (for Bluetooth FCC certification) or "by the manufacturer of the module" (for GSM integration). The data is retrospective, as the tests were completed before submission.
  • Country of Origin: The submitter is MIR Medical International Research, located in Rome, Italy. The testing was largely "in-house," implying it was conducted by MIR.

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

• The document does not specify the number of experts or their qualifications used to establish the ground truth for the device's performance tests.
• For spirometry, the implicitly accepted ground truth is the performance criteria set by American Thoracic Society (ATS) Standards.
• For oximetry, the implicitly accepted ground truth is the performance criteria set by FDA guidelines on Pulse Oximeters and ISO 9919:2005, realized via an "optical simulator."

4. Adjudication Method for the Test Set

• The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set results. The evaluations seem to be direct comparisons against established technical and clinical standards.

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

• No MRMC comparative effectiveness study is mentioned. The submission focuses on device performance against technical standards and equivalence to a predicate device, not on human reader performance with or without AI assistance.

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

• The device itself (Spirotel) is a measurement device that provides physiological data (spirometry and oximetry parameters). The testing described focuses on the accuracy and reliability of these measurements in a standalone fashion, adhering to technical and clinical standards. There is no "algorithm only" performance separate from the device's inherent function, as it is not an AI-driven interpretive system in the sense of image analysis, for example. The various communication modules (USB, Bluetooth, GSM) facilitate data transmission, and their standalone performance for data integrity was tested.

7. Type of Ground Truth Used

• Spirometry: Ground truth is implicitly defined by American Thoracic Society (ATS) Standards for volume and flow rate accuracy.
• Oximetry: Ground truth is implicitly defined by FDA guideline on Pulse Oximeters and ISO 9919:2005, implemented and verified using an optical simulator.
• Safety & Environmental: Ground truth is based on compliance with international standards EN 60601-1:2006 and EN 60601-1-2:2007.
• Data Transmission: Ground truth is the integrity of data transmission (i.e., no corruption), verified by in-house testing.

8. Sample Size for the Training Set

• The document does not refer to any "training set." The Spirotel device is a measurement instrument, not a machine learning or AI algorithm that requires a training set in the typical sense. Its performance is validated against established physical and clinical standards rather than through learning from data.

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

• As there is no mention of a "training set" for the device's core functionality, this question is not applicable to the information provided.

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The Minispir and Spirolab III spirometers and pulse oximeters are intended to be used by either a physician, respiratory therapist or technician. The devices are intended to test lung function and can make: - spirometry testing in people of all ages, excluding infants and neonates. . - oximetry testing in people of all ages. ● They can be used in any setting.

Minispir is a spirometer and pulse oximeter (optional) connected to a Personal Computer using a USB cable. The device measures a range of respiratory parameters, and the saturation of oxygen in the blood and the heart pulse rate.

The provided text describes a 510(k) premarket notification for the Minispir device, which functions as both a spirometer and a pulse oximeter. The submission aims to demonstrate substantial equivalence to a predicate device (Minispir, K082766).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly refers to industry standards as acceptance criteria rather than explicitly listing them.

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

• Spirometry: No specific sample size for a test set is mentioned. The document states "Spirometry testing was performed according with American Thoracic Society (ATS) Standards." This implies a set of tests conforming to ATS guidelines, but the number of subjects or tests is not provided.
• Oximetry: A "clinical investigation" was carried out for oximetry, but no sample size for this investigation is provided.
• Data Provenance: Not explicitly stated, but given the applicant is "MIR Medical International Research" located in "Roma - Italy," it is reasonable to infer the studies might have been conducted in Italy or other European locations. The document does not specify if the data was retrospective or prospective.

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

• The document does not mention the use of experts or a ground truth established by experts for either spirometry or oximetry testing.
• For spirometry, the ground truth is implicitly defined by the ATS Standards, which govern the expected physical characteristics and accuracy of the device.
• For oximetry, the "clinical investigation" validated the accuracy, but the method for establishing the true oxygen saturation for comparison (the "ground truth") is not detailed. Typically, this would involve a co-oximeter or arterial blood gas analysis, but this is not stated.

4. Adjudication Method:

• Not applicable/Not mentioned. The testing described for spirometry and oximetry appears to be direct device performance measurement against a standard or a reference, rather than a subjective assessment requiring adjudication.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. This type of study typically assesses the improvement in human reader performance (e.g., radiologists interpreting images) with AI assistance. The Minispir is a diagnostic device for measuring physiological parameters, not an AI-powered image interpretation tool.

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

• Yes, the studies described are essentially standalone performance evaluations.
  • Spirometry: The device's spirometry function was tested against ATS standards, meaning the algorithm's measurements were compared to the accuracy requirements.
  • Oximetry: A "clinical investigation... to validate the new oximetry board" also implies evaluation of the device's output (SpO2, pulse rate) directly against a reference, without human intervention in the measurement process itself, although a human operates the device.

7. Type of Ground Truth Used:

• Spirometry: Indirectly, the "ground truth" is derived from the American Thoracic Society (ATS) Standards. These standards define the expected accuracy and performance range for spirometers, so the device's measurements are compared against these established technical and physiological benchmarks rather than individual patient-specific "ground truth" established by an expert or pathology.
• Oximetry: For the clinical investigation, the ground truth for oximetry (SpO2 and pulse rate) would typically be established by a reference method such as an arterial blood gas analyzer or a co-oximeter. However, the document only states that "results demonstrated required accuracy" without specifying the reference method used to establish this truth.

8. Sample Size for the Training Set:

• The document does not provide any information about a training set. This is consistent with the nature of the device, which relies on established physiological measurement principles and algorithms rather than machine learning models that require training data. The algorithms for spirometry and oximetry are stated to be the "same algorithms" as the predicate device, implying they are well-established.

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

• Not applicable, as no training set is mentioned or implied for a device of this nature.

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The MIROxi pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician or paramedic. The device is intended to test oximetry in people of all ages.

It can be used in any setting.

MIROxi is a pulse oximeter, designed for use by specialist who require a simple, portable and compact device, yet at the same time being capable of calculating more than 30 statistical parameters derived from the SpO2 and pulse rate.

Its connectivity capability (USB, Bluetooth, internal modem for acoustic coupling to telephone, RS232) makes it suitable also for telemedicine applications.

Here's a breakdown of the acceptance criteria and the study details for the MIROxi device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The accuracy validation mentions "in vitro testing using an optical simulator," which means the testing was conducted in a laboratory setting, not on human subjects or clinical data.

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

Given that the accuracy validation was "in vitro testing using an optical simulator," there were no human experts used to establish ground truth for the SpO2 and pulse rate measurements. The optical simulator itself served as the "ground truth" by providing known, precise optical signals corresponding to specific SpO2 and pulse rate values.

4. Adjudication Method for the Test Set

Not applicable, as the ground truth for accuracy was established by an optical simulator, not human assessment.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study typically involves human readers assessing medical images or data with and without AI assistance to measure the AI's impact on human performance. The MIROxi device is a pulse oximeter, not an imaging device, and the testing described is focused on the device's standalone accuracy, not on its assistance to human interpretations.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance

Yes, a standalone performance evaluation was conducted. The accuracy of SpO2 and pulse rate was "validated by in vitro testing using an optical simulator, under normal conditions." This testing assessed the device's ability to accurately measure these parameters independently, without human interaction influencing the measurement process (beyond operating the device and simulator).

7. Type of Ground Truth Used

For the SpO2 and pulse rate accuracy measurements, the ground truth used was established by an optical simulator. This is a calibrated instrument that can generate precise optical signals corresponding to known physiological parameters.

8. Sample Size for the Training Set

The provided text does not mention or specify any training set sample size. Given the nature of a pulse oximeter (which relies on established physiological principles and optical absorbance), it's highly probable that a "training set" in the machine learning sense was not applicable or explicitly documented for this type of device. The device likely relies on a fixed algorithm embedded based on known physics and physiological models, rather than a machine learning model trained on a dataset.

9. How Ground Truth for the Training Set Was Established

As no training set is mentioned or implies to be used in the machine learning sense, this question is not applicable. The device's underlying principles are based on established scientific understanding of light absorption by oxygenated and deoxygenated hemoglobin.

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The MIR Minispir - Spirolab III spirometers and pulse oximeters are intended to be used by either a physician, respiratory therapist or technician.

The devices are intended to test lung function and can make:

• spirometry testing in people of all ages, excluding infants and neonates.
• oximetry testing in people of all ages.

They can be used in any setting.

MIR Minispir - Spirolab III are instruments for the analysis of respiratory function, which carries out three different spirometric tests, FVC, VC(insp/exp) and MVV, with a calculation of the main spirometric parameters, predicted values and percentage deviations compared to the measured values. Plus Flow/Volume and Volume/time curves and the interpretation of the FVC test following the international spirometry standards (ATS/ERS). What is more Minispir - Spirolab III with their integrated oximetry option, can calculate both Oxygen Saturation (expressed as %SpO2) and Pulse Rate (expressed as Beats Per Minutes- BPM). In additon Minispir - Spirolab III calculate several (up to 20) additional statistical parameters derived from the SpO2 and the pulse rate.

The provided 510(k) summary for the MIR Minispir - Spirolab III describes performance testing related to safety, environmental factors, spirometry accuracy, and oximetry accuracy. However, it does not present acceptance criteria and performance in the format of a table with specific quantitative metrics. The summary focuses on equivalence to a predicate device and adherence to general standards rather than detailed acceptance criteria for specific clinical performance.

Here's a breakdown of the available information based on your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with explicit acceptance criteria and corresponding device performance metrics for diagnostic accuracy. Instead, it states qualitative outcomes:

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified, but the testing was "in-house" for oximetry and generally refers to compliance with international standards (ATS, EN 60601-1) rather than a specific clinical test set from a particular country or population. The document is for an Italian company, so it's likely the testing occurred in Italy or by a third-party laboratory. The studies are described as verification and validation of compliance, not a clinical trial with patient data.

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

This information is not provided. The testing described for spirometry and oximetry appears to be technical validation against standards and simulators, not a clinical study involving expert interpretation of patient data to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable, as the tests described are technical compliance checks against established standards or simulator outputs, not a clinical study requiring adjudication of expert interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study is not mentioned or described in the summary. The submission focuses on substantial equivalence based on technical characteristics and compliance with performance standards, not on demonstrating improved human reader performance with AI assistance. The device itself is a measurement tool (spirometer and oximeter), not an AI-powered diagnostic tool for interpretation.

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

The device's core function is to directly measure and calculate spirometric and oximetric parameters. The performance described—spirometry calculations per ATS standards and oximetry accuracy verified with an optical simulator—is essentially "standalone" algorithm performance in terms of its ability to accurately measure and process physiological data. There isn't a human-in-the-loop component for the device's output itself; the device provides raw measurements and calculated parameters for a clinician to interpret.

7. The Type of Ground Truth Used

• Spirometry: The "ground truth" implicitly refers to the accuracy requirements and established norms of the American Thoracic Society (ATS) Standards. This suggests a comparison against known, calibrated inputs or reference methods defined by ATS.
• Oximetry: The "ground truth" was established "in-house using an optical simulator." This indicates a controlled, simulated environment where the expected SpO2 and pulse rate values are known and used to test the device's accuracy.

8. The Sample Size for the Training Set

Not applicable. This device is a measurement instrument with established algorithms based on physiological principles related to spirometry and oximetry, not a machine learning model that requires a "training set" in the conventional AI sense. The algorithms are static and pre-defined based on physics and physiology.

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

Not applicable, as there is no "training set" for this type of device. The algorithms are based on established scientific principles rather than machine learning from data.

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The Spirobank G spirometer is intended to be used by a physician or by a patient under the instruction of a physician or paramedic. The device is intended to test lung function and can make spirometry testing in people of all ages, excluding infants and neonates. It can be used in any setting.

Spirobank G is a spirometer designed to facilitate the total valuation of lung function. It is designed for use by specialist who require a simple, portable and compact device, yet at the same time being capable of calculating more than 30 spirometric parameters. Its connectivity capability (USB, Bluetooth) makes it suitable also for telemedicine applications.

The Spirobank G is a spirometer intended for lung function testing. The provided document focuses on demonstrating substantial equivalence to predicate devices (Spirobank and Spirobank II) rather than presenting a standalone study with detailed acceptance criteria and performance metrics for a novel AI-powered device.

However, based on the information provided, we can infer the acceptance criteria and the study performed:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the spirometry accuracy testing or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "Spirometry testing was performed according with American Thoracic Society (ATS) Standards."

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

This information is not provided in the document. For spirometry, the "ground truth" typically refers to precise measurements from a highly calibrated reference spirometer or simulated lung. Expert review would typically be for interpretation of results rather than establishing the raw spirometry ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

No, an MRMC comparative effectiveness study was not done. The device is a spirometer, not an AI-assisted diagnostic tool that would typically involve human readers.

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

Yes, the testing described is effectively a standalone performance evaluation of the device itself (hardware and embedded software) against established standards. The spirometer performs its measurements and calculations without continuous human intervention during the measurement process.

7. The Type of Ground Truth Used

For spirometry accuracy: The implied ground truth is the "range of accuracy required by ATS" standards, which would be based on comparison to highly accurate reference spirometry measurements or simulated lung volumes/flow profiles.

For safety and environmental criteria: Ground truth is compliance with the specific technical standards (e.g., EN 60601-1:1990, EN 60601-1-2:1993).

8. The Sample Size for the Training Set

This information is not applicable and not provided. The Spirobank G is a medical device that measures physiological parameters based on established physical principles, not a machine learning model that requires a "training set" in the conventional sense. Its "training" would involve calibration and engineering design based on physical and physiological principles.

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

This information is not applicable and not provided for the reasons stated above.

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The MIR Minispir spirometer and Spirolab III spirometer and pulse oximeter are intended to be used by either a physician, respiratory therapist or technician. The devices are intended to test lung function and can make:

• spirometry testing in people of all ages, excluding infants and neonates .
• oximetry testing in people of all ages. .

They can be used in any setting.

MIR Minispir - Spirolab III are instruments for the analysis of respiratory function, which carries out three different spirometric tests, FVC, VC(insp/exp) and MVV, with a calculation of the main spirometric parameters, predicted values and percentage deviations compared to the measured values. Plus Flow/Volume and Volume/time curves and the interpretation of the FVC test following the international spirometry standards (ATS/ERS). What is more Spirolab III with its integrated oximetry option, can calculate both Oxygen Saturation (expressed as %SpO2) and Pulse Rate (expressed as Beats Per Minutes- BPM). In additon Spirolab III calculates several (up to 20) additional statistical parameters derived from the SpO2 and the pulse rate.

Acceptance Criteria and Study for MIR Minispir - Spirolab III

1. Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample size for the "test set" used for spirometry or oximetry performance evaluation. It generally states that "testing was done."

The data provenance is not specified (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. The document refers to compliance with "American Thoracic Society (ATS) Standards" for spirometry, implying a recognized standard as the benchmark rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set.

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

No, an MRMC comparative effectiveness study is not mentioned. The study focuses on demonstrating that the device meets established technical standards (ATS) and safety regulations, rather than comparing its performance against humans or human performance with/without AI assistance.

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

Yes, the testing described appears to be a standalone performance evaluation. The device's spirometry function was tested "according with American Thoracic Society (ATS) Standards," which implies an assessment of the device's accuracy in measuring and calculating spirometric parameters. The safety and environmental testing also pertains to the standalone device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For spirometry, the ground truth was based on the American Thoracic Society (ATS) Standards. This implies an objective, standardized set of criteria and acceptable ranges for spirometric measurements and calculations.

For safety and environmental testing, the ground truth was compliance with EN 60601-1:1990 and EN 60601-1-2:1993 (safety and EMC standards) and the device's own specifications.

8. The Sample Size for the Training Set

The document does not mention a training set. This is not an AI/ML device in the modern sense that would typically involve a "training set" for model development. The algorithms for spirometry and oximetry calculation are stated to be the same as the predicate devices, suggesting pre-existing, validated algorithms rather than newly trained ones.

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

As no training set is mentioned in the context of this device, this question is not applicable. The device relies on established algorithms and compliance with regulatory standards.

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The Spirobank II spirometer and pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician or paramedic. The device is intended to test lung function and can make:

• spirometry testing in people of all ages, excluding infants and neonates .
• oximetry testing in people of all ages. .
  It can be used in any setting.

MIR Spirobank II is a spirometer and pulse oximeter, designed to facilitate the total valuation of lung function. It is designed for use by specialist who require a simple, portable and compact device, yet at the same time being capable of calculating more than 30 spirometric parameters, and monitors the oxygen saturation and pulse rate. It also calculates several additional statistical parameters derived from the SpO2 and the pulse rate. Its connectivity capability (USB, Bluetooth, internal modem for acoustic coupling to telephone, RS232) makes it suitable also for telemedicine applications.

The MIR Spirobank II is a spirometer and pulse oximeter. It was deemed substantially equivalent to MIR Spirobank (K983909) and MIR Spirotel (K043528).

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

Note: The specific numerical acceptance criteria for ATS standards and oximetry specifications are not detailed in the provided summary.

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

The document does not specify the exact sample size for the clinical testing of spirometry and oximetry functions. It only states that "Testing of device performance included clinical testing of both spirometry and pulse oximetry functions."

The data provenance (e.g., country of origin, retrospective or prospective) is not explicitly mentioned.

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 summary.

4. Adjudication method for the test set

This information is not provided in the summary.

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

An MRMC comparative effectiveness study is not mentioned. This device is a diagnostic tool (spirometer and oximeter) 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

The device is a standalone spirometer and pulse oximeter. The testing described (spirometry and oximetry) inherently evaluates the device's performance in a standalone capacity without direct human-in-the-loop AI assistance. The measurements are taken by the device, and the results are then interpreted by a physician or patient under physician instruction.

7. The type of ground truth used

• Spirometry: The ground truth for spirometry testing was based on compliance with American Thoracic Society (ATS) Standards. This implies that the device's output parameters were compared against accepted physiological ranges and accuracy requirements defined by the ATS.
• Oximetry: The ground truth for oximetry testing was established through a "desaturation trial." This typically involves inducing controlled desaturation and comparing the device's readings to known, accurate reference measurements (e.g., from a co-oximeter or arterial blood gas analysis), although the specific reference method is not detailed.

8. The sample size for the training set

This information is not provided in the summary. This device is a traditional medical device and not explicitly an AI/ML-based device that would typically involve a separate training set in the machine learning context. The "training" for such devices is usually the engineering design and calibration processes based on known physiological principles and standards.

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

As noted in point 8, the concept of a "training set" as understood in AI/ML is not directly applicable here. The device's algorithms and performance are established through adherence to recognized medical standards and engineering specifications rather than through supervised learning from a labeled training dataset.

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The Spirolab and Spirolab II spirometers are intended to be used by either a physician, respiratory therapist or technician to test lung function in people of all ages excluding infants and neonates. They can be used in any setting.

The device carries out three different spirometric tests, FVC, VC(insp/exp) and MVV, with predicted values and percentage deviations calculation of the main parameters plus Flow/Volume and Volume/time curves and the interpretation of the measured values following the international spirometry standards (ATS/ERS).

The provided document describes the MIR Spirolab and Spirolab II, which are spirometers intended to measure lung function. The document details the device's technical characteristics, intended use, and the testing performed to demonstrate its safety and effectiveness.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device was tested to ensure it performs safely and accurately within its intended environments and that it complies with American Thoracic Society (ATS) Spirometry standards. This implies that the ATS standards define the acceptance criteria for spirometry performance. However, the specific quantitative acceptance criteria (e.g., accuracy ranges for FVC, FEV1, etc.) and the precise reported device performance against these criteria are not explicitly listed in a table format.

The document generally states: "The results demonstrates that the MIR Spirolab and Spirolab II are durable, safe (operator and patient), and perform within its specifications."

Without explicit quantitative values from the ATS standards and the device's exact measurements against them, a detailed comparison is not possible from this document alone.

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

The document states: "Spirometry testing was performed according with American Thoracic Society (ATS) Spirometry standards." However, it does not provide any details regarding:

• The sample size used for the spirometry performance testing.
• The data provenance (e.g., country of origin, retrospective or prospective nature of the 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 spirometer, the "ground truth" would generally refer to an established reference standard for lung function measurements, often using highly calibrated and accurate spirometry equipment, overseen by qualified personnel. The document only mentions compliance with ATS standards, which inherently include best practices for measurement.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication typically applies when multiple human readers interpret data, which is not directly applicable to the automated measurements of a spirometer in the same way.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this document. This type of study is relevant for AI systems that assist human readers in interpreting complex images or data, which is not the primary function of a spirometer. The device is a standalone measurement tool.

6. Standalone Performance Study

Yes, a standalone performance study was done for the device. The document explicitly states: "Testing was done to ensure that the MIR Spirolab/Spirolab II would perform safely and accurately within the environments for which it is to be marketed." And "Spirometry testing was performed according with American Thoracic Society (ATS) Spirometry standards." This indicates that the algorithm and hardware's performance were evaluated directly against established standards.

7. Type of Ground Truth Used

The ground truth used for performance comparison was based on American Thoracic Society (ATS) Spirometry standards. This implies that the device's measurements were compared against accepted reference ranges and accuracy requirements defined by these international standards, which are expert consensus-driven.

8. Sample Size for the Training Set

The document does not mention a training set. This is because the MIR Spirolab and Spirolab II are described as using "the same algorithms for spirometry parameters calculation" as a predicate device and performing standard spirometric tests (FVC, VC, MVV). This suggests a rule-based or established algorithmic approach rather than a machine learning model that would require a dedicated training set.

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

Since there is no mention of a training set or machine learning algorithms, the establishment of ground truth for a training set is not applicable in this context. The device relies on established scientific principles and algorithms for spirometry.

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The Spirotel spirometer and pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician or paramedic to test lung function in people of all ages. It is also intended to be used as a single-patient device and can be used in any setting – home, factory, pharmacy, hospital or physician's office.

MIR Spirotel is a simple to operate precise pocket spirometer and pulse oximeter (weight only 100g). It measures the most important functional respiratory parameters and monitors the oxygen saturation and pulse rate.

The provided document is a 510(k) summary for the MIR Spirotel device, which combines a spirometer and a pulse oximeter. It details the device's characteristics, intended use, and comparison to predicate devices, but it does not contain detailed acceptance criteria or a multi-reader multi-case (MRMC) comparative effectiveness study.

However, it does mention standalone performance testing. Here's what can be extracted and inferred based on the provided text:

Acceptance Criteria and Reported Device Performance

The document generally states compliance with standards rather than specific numerical acceptance criteria.

Study Details

The document describes performance testing for both spirometry and pulse oximetry.

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

• Test Set Sample Size: Not specified for either spirometry or pulse oximetry. The document only mentions "clinical testing."
• Data Provenance: Not specified. It's unclear if the testing was retrospective or prospective, or the country of origin of the data.

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

• Not specified. The document only states that spirometry testing was against "American Thoracic Society (ATS) Standards" and oximetry results were "within specification," implying comparison to a reference standard, but it doesn't detail human expert involvement in establishing ground truth for the test data itself.

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

• Not applicable/Not specified. The testing described focuses on device performance against established standards rather than diagnostic agreement adjudicated by multiple experts.

4. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

• No. The document does not describe an MRMC study comparing human readers with and without AI assistance. The device is a measurement tool (spirometer and pulse oximeter), not an AI-based diagnostic interpretation tool.
• Effect size improvement without AI: Not applicable, as no MRMC study was conducted, and the device itself is a measurement tool, not an AI for human reader assistance.

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

• Yes. The described clinical testing for both spirometry and pulse oximetry appears to be standalone performance testing of the device itself against established standards or specifications. The document states:
  • "Testing of device performance included clinical testing of both spirometry and pulse oximetry functions."
  • "Spirometry testing was performed according with American Thorotic Society (ATS) Standards. The results obtained were within the range of accuracy required by ATS."
  • "For oximetry testing a desaturation trial was conducted. The results obtained were within specification."

6. The type of ground truth used:

• Spirometry: Inferred to be a reference standard compliant with "American Thoracic Society (ATS) Standards." This typically involves a highly accurate and calibrated spirometer as a reference.
• Pulse Oximetry: Inferred to be a reference standard for oxygen saturation measurement during a "desaturation trial." This usually involves co-oximetry (blood gas analysis) for accurate SpO2 reference values.

7. The sample size for the training set:

• Not applicable/Not specified. The Spirotel described here is a hardware device for measurement, not an AI/machine learning algorithm that requires a training set in the conventional sense.

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

• Not applicable. (See point 7).

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Device is a spirometer for lung-function testing. For testing lung-function in all people from children to adults, generally used by a physician or by a respiratory therapist or technician. Device is portable and thus can be used at home, in the factory, in the hospital, in the doctor's office.

Device is a spirometer for lung-function testing. Device is portable.

This document is an FDA 510(k) clearance letter for the MIR Spirobank Spirometer, dated December 21, 1998. It primarily confirms the device's substantial equivalence to predicate devices and allows it to be marketed.

However, this document does NOT contain the detailed information necessary to answer the questions about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.

The document states:

• Device Name: MIR Spirobank Spirometer (Page 2)
• Intended Use: "Device is a spirometer for lung-function testing. For testing lung-function in all people from children to adults, generally used by a physician or by a respiratory therapist or technician. Device is portable and thus can be used at home, in the factory, in the hospital, in the doctor's office." (Page 2)
• Regulatory Class: II (two) (Page 1)
• Product Code: 73 BZG (Page 1)

Therefore, I cannot provide the requested information based on the provided text. This type of information is typically found in the 510(k) submission itself, often in sections detailing device performance testing or clinical studies, which are not part of this clearance letter.

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