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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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Smart One is intended for home use by patients to monitor PEF (Peak Expiratory Flow) and FEVI (Forced Expiratory Volume in one second). The device is designed for children greater than five years of age, adolescent and adult subjects.

Smart One is a pocket-sized system for monitoring the following respiratory parameters: PEF (Peak Expiratory Flow) and FEV1 (Forced Expiratory Volume in 1 sec). For each of these two parameters, the result is a number shown on the smartphone screen. PEF is also associated with a three zone monitoring system that, according to the result, may be green, yellow or red. Smart One is made up of two elements - the device and a Mobile Medical Application for smartphones (or tablets) that communicate via Bluetooth Smart 4.0.

The provided text describes specific performance tests for the Smart One device, particularly focusing on non-clinical testing. Here's a breakdown based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test set sample size: Not explicitly stated for each test beyond mentioning "a Pulmonary Waveform Generator" for the performance test.
• Data provenance: The performance test was conducted "in MIR facilities" using a Pulmonary Waveform Generator. Other tests (electrical safety, EMC, mechanical durability, temperature/humidity, wireless transmission, biocompatibility, software V&V) are generally bench tests or internal company evaluations.

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

• Not applicable / Not specified. The tests described are primarily engineering and performance bench tests against established standards (e.g., ATS, IEC, ISO) rather than clinical evaluations requiring expert human interpretation of medical data. The ground truth for these tests would be the controlled outputs of the Pulmonary Waveform Generator or the specified limits within the engineering standards.

4. Adjudication method for the test set

• Not applicable / Not specified. As the tests are objective engineering and performance evaluations against predefined standards, an adjudication method for human interpretation is not relevant.

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 document does not describe an MRMC comparative effectiveness study. The device is a peak flow meter for spirometry, a diagnostic tool measuring physiological parameters, not an AI-driven image interpretation or diagnostic aid that would typically involve human readers.

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

• Yes, effectively. The performance tests described (e.g., "A performance test has been carried out on the bench according to the American Thoracic Society (ATS) Document 'Standardization of Spirometry - 2005' ... using a Pulmonary Waveform Generator.") are standalone evaluations of the device's accuracy in measuring PEF and FEV1. The device itself (including its internal algorithms) is being evaluated against known, controlled inputs from the waveform generator. The mobile medical application primarily displays and compares the device's output rather than performing the core measurement algorithm.

7. The type of ground truth used

• Standardized references and objective measurements:
  • For accuracy of PEF and FEV1: The "Standardization of Spirometry - 2005" document from the American Thoracic Society (ATS) and a "Pulmonary Waveform Generator" which provides known, controlled respiratory flow patterns.
  • For electrical safety and EMC: IEC 60601-1:2005 and IEC 60601-1-2:2007 standards.
  • For biocompatibility: ISO 10993-1:2009.
  • For software: FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

8. The sample size for the training set

• Not applicable / Not specified. This document describes a medical device (a peak flow meter) which is based on physical measurement principles (turbine flow meter, infrared interruption) rather than a machine learning or AI algorithm that would require a distinct "training set" in the context of deep learning. The "training" here would be the engineering calibration and firmware development of the device based on physics and physiological principles.

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

• Not applicable / Not specified. See point 8. The device operates on established physical principles for flow measurement. Its "training" or calibration would involve ensuring the sensor accurately translates physical airflow into digital values that conform to spirometry standards, likely using highly accurate reference instruments and controlled flow sources, rather than a "ground truth" derived from expert labeling of a dataset for machine learning.

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