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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device

The PVDF Effort Sensor is intended to measure and output respiratory effort signals from a patient for archival in a sleep study. The sensor is an accessory to a polysomnography system which records and conditions the physiological signals for analysis and display, such that the data may be analyzed by a qualified sleep clinician to aid in the diagnosis of sleep disorders.

The PVDF Effort Sensor is intended for use on both adults and children by healthcare professionals within a hospital, laboratory, clinic, or nursing home, or outside of a medical facility under the direction of a medical professional.

The PVDF Effort Sensor does not include or trigger alarms, and is not intended to be used alone as, or a critical component of,

• an alarm or alarm system;
• an apnea monitor or apnea monitoring system; or
• life monitor or life monitoring system.

The PV01 PVDF Effort Sensor is a respiratory effort monitoring accessory designed for use during sleep studies to assess breathing patterns by measuring chest and abdominal wall movement. The device functions as an accessory to polysomnography (PSG) systems, enabling qualified sleep clinicians to analyze respiratory data for the diagnosis of sleep disorders.

The sensor consists of two main components: a PVDF (polyvinylidene fluoride) sensor module and an elastic belt. The sensor module contains two plastic enclosures connected by a piezoelectric PVDF sensing element encased in a silicone laminate. The PVDF material generates a tiny voltage that is output through the lead wire to the sleep amplifier. The change in voltage as the tension on the PVDF film fluctuates corresponds to the breathing of the patient. Since the PVDF material generates voltage, the sensor does not require a battery or power from the amplifier. The output signal is processed by the sleep recording system for monitoring and post-study analysis.

The PV01 PVDF Effort Sensor is intended for prescription use only by healthcare professionals in hospitals, sleep laboratories, clinics, nursing homes, or in home environments under medical professional direction. The device is designed for use on both adult and children participating in sleep disorder studies. The sensor is intended to be worn over clothes and not directly on the patient's skin.

The 510(k) clearance letter for the PV01 PVDF Effort Sensor does not contain the specific details required to fully address all aspects of your request regarding acceptance criteria and the study proving the device meets them. This document is a regulatory approval letter, summarizing the basis for clearance, not a detailed study report.

However, based on the provided text, here's an attempt to extract and infer the information:

Overview of Device Performance Study

The PV01 PVDF Effort Sensor underwent "comprehensive verification and validation testing" including "functional and performance evaluations" and "validation studies" to confirm it meets design specifications and is safe and effective. Additionally, "comparative testing against the Reference Device" was performed.

This suggests that the performance evaluation primarily focused on:

1. Safety Tests: Compliance with UL 60601-1 standards to ensure electrical and liquid ingress safety.
2. Usability and Validation Test: Assessment of user experience and comfort during a simulated sleep study.
3. Performance Comparison Test: Electrical signal output comparison to a legally marketed predicate device under simulated breathing conditions.
4. Temperature Range Test: Verification of signal output performance at extreme operating temperatures.

Acceptance Criteria and Reported Device Performance

Based on the "Summary of Tests Performed" section, the following can be inferred:

Missing Information and Limitations:

The provided FDA 510(k) clearance letter is a high-level summary and does not contain the granular details typically found in a full study report. Therefore, most of the following requested information cannot be extracted directly from this document.

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

   • Test Set Size: Not specified for any of the performance tests. For the usability test, it mentions "Participants" (plural), but no number. For the performance comparison test, it states "Both devices were placed on a rig," implying a comparison, but no human subject or case count.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The usability test mentions "participants," potentially implying prospective data collection, but this is a broad inference.

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

   • Not Applicable/Not Specified: The device is a "PVDF Effort Sensor" that measures and outputs respiratory effort signals. Its purpose is to provide raw physiological data for a "qualified sleep clinician to aid in the diagnosis of sleep disorders." The device itself does not provide a diagnosis or interpretation that would require expert ground truth labeling in the traditional sense of an AI diagnostic device (e.g., image-based AI). The performance assessment appears to be against expected signal characteristics and comparison to a known device, not against clinical ground truth established by experts.

3. Adjudication method for the test set:

   • Not Applicable/Not Specified: Given the nature of the device (a sensor outputting physiological signals) and the described tests, a formal adjudication process (like for interpreting medical images) is not mentioned or implied.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

   • No: This type of study (MRMC for AI assistance) is not mentioned. The device is a sensor, not an AI interpretative tool designed to assist human readers directly. It provides raw data for clinicians to analyze.

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

   • Partially Yes (for the sensor itself): The "Performance Comparison Test" and "Temperature Range Test" assess the device's signal output performance independently without a human in the loop for interpretation. The "Safety Tests" are also standalone tests on the device's physical and electrical properties.

6. The type of ground truth used:

   • Physiological Simulation / Device Output Comparison: For the "Performance Comparison Test," the ground truth was essentially the simulated breathing patterns produced by a "rig" and the expected output signals of a known predicate/reference device.
   • User Feedback / Self-Reported Metrics: For the "Usability and Validation Test," the ground truth was the participants' subjective feedback on comfort and ease-of-use, and the absence of reported use errors or adverse events.
   • Compliance with Standards: For "Safety Tests," the ground truth was compliance with the specified clauses of the UL 60601-1 standard.

7. The sample size for the training set:

   • Not Applicable/Not Specified: The PV01 PVDF Effort Sensor is described as a passive hardware sensor ("generates a tiny voltage," "does not require a battery or power from the amplifier") that measures physical movement. It is not an AI/ML algorithm that requires a "training set" in the computational sense.

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

   • Not Applicable: As stated above, there is no mention or implication of a training set as this is a hardware sensor, not an AI/ML algorithm.

In summary, the provided document gives a high-level overview of the acceptance criteria met for regulatory clearance, primarily focusing on safety, basic functional performance relative to another device, and usability. It does not delve into the detailed statistical methodology and independent ground truth establishment typical of AI/ML device studies.

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The Sunrise Air is a non-invasive home care aid in the evaluation of obstructive sleep apnea (OSA) in patients 18 years and older with suspicions of sleep breathing disorders.

The Sunrise Air consists of the Sunrise software (v1.28.00), which analyzes data from one of three compatible sensors (Sunrise sensor 1, Sunrise sensor 2, or Sunrise Air) placed on the patient's chin. Sunrise sensor 1 was approved through DEN210015, while Sunrise sensor 2 was cleared through K222262. The current version of the Sunrise device introduces a new sensor, Sunrise Air. The Sunrise device is intended to detect respiratory events, identify sleep stages and position, and generate key sleep parameters—such as the apnea-hypopnea index ("Sunrise AHI") and positional states classifications. The collected data is compiled into a report for further interpretation by a healthcare provider.

The provided FDA 510(k) clearance letter for the Sunrise Air device primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailing a comprehensive clinical study to prove the device meets specific acceptance criteria for its claimed indications.

The document highlights bench testing for technical equivalence, but lacks the detailed clinical study information typically provided for direct performance claims against established ground truth. Specifically, it states that "No modifications have been made to the Sunrise algorithm used to generate sleep parameters," and that a "validation study of SpO₂ and pulse rate accuracy for the subject device was conducted using raw PPG data acquired during the clinical validation for the Sunrise sensor 2 (K222262)." This suggests reliance on prior clearances for core algorithm performance and a specific re-validation for only the PPG data processing change.

Therefore, many of the requested details about acceptance criteria, clinical study design, and ground truth establishment for the overall device performance (e.g., AHI calculation, OSA evaluation) are not explicitly present in this summary.

Given the information in the provided document, here's what can be extracted and inferred:

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

Based on the information provided, the "acceptance criteria" are implied by the comparisons to the predicate and reference devices, and some specific performance metrics are given for SpO2 and pulse rate. The primary acceptance criterion for the device's main function (evaluation of OSA via AHI) is that "No modifications have been made to the Sunrise algorithm used to generate sleep parameters," implying continued equivalence to the predicate's performance.

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The SV600, SV800 Ventilator is intended to be used in intensive care situations for long-term or during transport within a professional healthcare facility. The SV600, SV800 Ventilator is intended to provide ventilation assistance and breathing support for adult, pediatric and neonate patients with a minimum body weight of 0.5 kg. The SV600, SV800 Ventilator should be operated by properly-trained and authorized medical personnel. This equipment is not suitable for use in an MRI environment.

The SV600 and SV800 Ventilators are pneumatically-driven and electronically-controlled ventilators. The Ventilators consists of a main unit (including pneumatic circuit, electronic system, mechanical structure, display, CO2 module, SpO2 module), trolley and support arm. The device also includes a neonatal flow sensor and neonatal flow sensor cable, which are used to measure the patient inspiration/expiration flow in neonatal ventilation modes.

The provided FDA 510(k) Clearance Letter for the SV600, SV800 Ventilator describes modifications to an existing device, primarily the addition of neonatal ventilation capabilities and updated monitoring modules. However, the document does not contain the level of detail typically found in a clinical study report for evaluating acceptance criteria and device performance in the way you've requested for studies involving AI algorithms, image analysis, or expert consensus with specific metrics like sensitivity, specificity, or AUC.

This document focuses on providing evidence of substantial equivalence to predicate devices through technical comparisons and various forms of bench testing, software verification, and compliance with consensus standards. It does not present a performance study with acceptance criteria specific to an AI device's output (e.g., accuracy against ground truth, reader performance improvements).

Therefore, I cannot fill out your requested table and answer many of your specific questions as the information is not present in the provided text.

Here's what can be extracted based on the document's content:

Acceptance Criteria and Device Performance (Based on available information)

The document doesn't define "acceptance criteria" in terms of specific performance metrics (like sensitivity, specificity, accuracy) that would be typically found for an AI or diagnostic device. Instead, "acceptance criteria" are implied by compliance with various technical specifications and international standards. Device performance is generally reported as "meets specifications" or "is equivalent to the predicate."

Study Details (Based on available information in the 510(k) Summary)

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

   • The document does not specify sample sizes for test sets in the context of clinical performance evaluation (e.g., number of patients, number of readings). The "testing" mentioned refers to engineering, software, and standards compliance evaluations.
   • Data provenance is not provided, as this is not a clinical study report.

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

   • Not applicable. The document describes engineering and standards compliance testing, not a clinical study involving expert-established ground truth for performance evaluation of an AI component or diagnostic output.

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

   • Not applicable. This is not a clinical study with an adjudication process for ground truth.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC comparative effectiveness study was done. This document describes a ventilator, not an AI diagnostic or assistance tool in that context. While it includes "Intellicycle" and "Lung Recruitment (SI)" features, these are not presented as AI assistance augmenting human reader performance in a diagnostic capacity.

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

   • The document implies standalone performance testing for various technical aspects of the ventilator and its integrated modules (CO2, SpO2 sensors) against their respective specifications and standards. For example, SpO2 sensor accuracy is stated as "Measurement accuracy: 70 to 100%: ±2% (adult/pediatric mode)" for the Mindray SpO2 module. However, this is for sensor performance, not a complete "algorithm only" evaluation in the context of AI diagnostic output as typically measured.

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

   • For the technical and performance testing, the "ground truth" would be established by reference standards, calibrated equipment, and design specifications. For example, a flow sensor's accuracy would be tested against a known, precise flow rate. For biocompatibility, the ground truth is defined by the toxicological profiles dictated by the ISO standards. For software, the ground truth is the functional requirements and design specifications.
   • There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for clinical performance evaluation of an AI component.

7. The sample size for the training set:

   • Not applicable. This document does not describe the development or validation of an AI algorithm with a training set. The "Intellicycle" feature is mentioned, but no details regarding its development, training data, or validation as an AI algorithm are provided.

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

   • Not applicable, as no AI training set is described.

Summary Limitations:

The provided text is a 510(k) summary, which aims to demonstrate substantial equivalence to legally marketed predicate devices. It details technical changes, compliance with regulatory standards (e.g., biocompatibility, electrical safety, EMC, software V&V), and functional testing results. It does not outline a clinical performance study with the types of metrics and methodologies commonly associated with evaluating AI-driven diagnostic devices or those requiring expert consensus for ground truth. Therefore, many of your specific questions are not addressed by the provided document.

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The Medical Gas Analyzer is intended to be connected to other medical devices for monitoring of the breathing gases CO2, N2O and the anesthetic agents Halothane, Enflurane, Isoflurance, Sevoflurance and Desflurane.

It is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit and patient room for adult, pediatric and infant patients.The CO2 may also be used in the emergency medical services environment and road ambulances.

Note: The Medical Gas Analyzer shall only be connected to medical devices approved by Prior-care.

The Medical Gas Analyzer is a mainstream respiratory gas analyzer based on infrared gas spectrometry. It is intended to be connected to another medical host device for display of respiratory parameters. It is connected to the patient breathing circuit via the Airway Adapter. This premarket submission adds the C50 Multi-parameter Patient Monitor as a host backboard display to AG200. The C50 Multi-parameter Patient Monitor produced by Shenzhen Comen Medical Instruments Co., Ltd., which has obtained FDA's 510K clearance (K191106).

The concentrations of CO2, N2O, Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane can be determined together with derived parameters such as waveform data and inspired / expired concentrations of all gases.

The mainstream probe airway adapter is inserted between the endotracheal tube and the breathing circuit, and the gas measurements are obtained through the windows in the sides of the adapter. Running on a standard low voltage DC 5V, the mainstream probe is designed with portability in mind and has low power consumption.

The mainstream gas analyzers are characterized by the following features:

• Low system integration complexity
• Low power consumption
• Fast startup time
• Low weight

The provided document is a 510(k) clearance letter and summary for the Medical Gas Analyzer (AG200). It does not contain information about a study proving the device meets its acceptance criteria.
The document states: "the subject device does not require clinical test data to support substantial equivalence." This means that the device was cleared based on its similarity to existing devices and bench testing, rather than a clinical study demonstrating its performance against specific acceptance criteria in a real-world setting.

Therefore, I cannot provide the requested information about the study proving the device meets acceptance criteria, the sample sizes, data provenance, expert details, adjudication methods, MRMC study results, standalone performance, or training set details as they are not present in the provided text.

However, I can extract the acceptance criteria as reported in the document through comparison with the predicate device, although these are not explicitly presented as "acceptance criteria" but rather as "device performance" parameters.

1. Table of Acceptance Criteria and Reported Device Performance (as implied by comparison to predicate/reference devices):

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The Portable Oxygen Concentrator provides a high concentration of supplemental oxygen to adult patients requiring respiratory therapy on a prescriptive basis. It may be used at home, in institution, vehicle, train, airplane, boats and other transport modalities. This device is to be used as an oxygen supplement and is not intended to be life sustaining or life supporting.

Users should follow their doctor's advice on setting the oxygen flow rate and should not adjust the flow rate without consulting a healthcare professional.

Note: Patients should regularly consult with their physician to evaluate the need for adjustments in their oxygen therapy settings.

The Portable Oxygen Concentrator is a Class II, low-risk medical device designed to provide a high-concentration oxygen supply (87%-95.5%) to adult patients requiring supplemental oxygen therapy as prescribed by a healthcare professional. It is intended for use at home, in institution, vehicle, train, airplane, boats and other transport modalities and complies with FAA regulations for in-flight use. The device is not intended for life-support or life-sustaining purposes.

The Portable Oxygen Concentrator utilizes Pressure Swing Adsorption (PSA) technology, which extracts oxygen from ambient air by selectively adsorbing nitrogen through molecular sieve beds. Oxygen is delivered through a pulse dose mechanism, synchronizing oxygen release with the patient's inhalation cycle to optimize efficiency and minimize waste.

The series consists of four models, each offering different pulse dose settings:

• W-R1 (MAX): 1, 2, 3, 4, 5, 6, S
• W-R1: 1, 2, 3, 4, 5, 6
• W-R2: 1, 2, 3, 4, 5
• W-R2 (Lite): 1, 2, 3, 4

The device operates in pulse flow mode and supports multiple power sources, including 100–240V AC (50–60Hz) and a rechargeable lithium-ion battery (14.4V / 6500mAh). While the hardware supports 13.0–16.8V DC input, DC operation is not currently supported, as no DC accessories are provided or authorized. A single battery charge provides up to 4.5 hours of continuous use, ensuring flexibility across various environments.

Designed for portability and efficiency, the W-R Series features a lightweight build (1.8 kg), low noise operation, and an intuitive LCD display. Its ergonomic and user-friendly design has been internationally recognized with six global design awards, including iF, Red Dot, and IDEA, for its usability, portability, and patient-centered innovation.

The device is suitable for operation within a temperature range of -5°C to 40°C (23°F to 104°F), humidity levels of 5% to 90% (non-condensing), and atmospheric pressure from 54kPa to 106kPa. It can function at altitudes up to 5,000 meters (16,400 feet).

The Portable Oxygen Concentrator consists of a casing, compressor, molecular sieve system, solenoid valve, battery, cooling fan, control board, and display screen.

Note: The device does not include a nasal cannula; patients should purchase one separately. The oxygen outlet follows international standards, and recommended cannula specifications can be found in Section 2.12: Cannula Use of the user manual.

The provided FDA 510(k) clearance letter is for a Portable Oxygen Concentrator. This device is not an AI/ML-enabled device. The information requested in the prompt (acceptance criteria, study details, sample size, ground truth, expert adjudication, MRMC studies, etc.) is typically associated with the rigorous evaluation of AI/ML software as a medical device (SaMD) or AI-enabled medical devices, especially those using diagnostic imaging.

Medical devices like portable oxygen concentrators are evaluated primarily on their physical performance characteristics, safety standards, and conformity to established regulations for mechanical and electrical safety. The clearance letter outlines the non-clinical tests performed (safety and performance testing, biocompatibility testing, electrical safety and EMC testing, battery safety testing, and software verification/validation), but these are not the types of studies that involve expert readers, ground truth consensus, or MRMC comparative effectiveness specific to AI diagnostics.

Therefore, I cannot extract the requested information (acceptance criteria in the context of an AI study, sample sizes for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML) directly from this document, as it pertains to a different type of medical device evaluation.

To directly answer your request based on the provided document, which is for a Portable Oxygen Concentrator (not an AI/ML diagnostic device):

The FDA 510(k) Clearance Letter for the Portable Oxygen Concentrator focuses on demonstrating substantial equivalence to a predicate device through:

• Same Intended Use: Providing supplemental oxygen to adult patients on a prescriptive basis for respiratory therapy.
• Similar Technological Characteristics: Utilizing breath detection, molecular sieve/pressure swing adsorption, and a pulse dose mechanism.
• Performance Data: Presenting specifications like oxygen concentration, pulse volumes, sound levels, and mechanical/electrical safety.
• Compliance with Recognized Standards: Adhering to various international IEC and ISO standards for medical electrical equipment, biocompatibility, and oxygen concentrators.

The "acceptance criteria" for a device of this type are generally meeting the performance specifications and safety standards outlined in the non-clinical testing section, and demonstrating that any differences from the predicate device do not raise new questions of safety or effectiveness.

Here's a breakdown of the closest equivalents to your requested categories, given the nature of the device and the document:

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

For a portable oxygen concentrator, acceptance criteria are generally related to its physical and performance specifications like oxygen purity, flow rates, noise levels, and battery life, rather than diagnostic accuracy metrics.

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InSee is an accessory to the Vyaire Medical AirLife Incentive Spirometer (2500 mL and 4000 mL). InSee is indicated to flag and digitally record successful incentive spirometry attempts, use-related data and provide reminders to patients who are prescribed the Vyaire Medical AirLife Incentive Spirometer. It is intended to be used in a hospital environment by clinicians and patients.

InSee is an accessory to the Vyaire Medical AirLife incentive spirometer. InSee consists of a plastic enclosure which attaches to the base of the AirLife incentive spirometer and records the following parameters: the number of attempts above 250 ml (AT), the Target Volume (TA), the number of successful attempts (SU) and the maximum target volume (MX). The InSee device also provide patient reminders. This device is only compatible with the Vyaire AirLife Volumetric Incentive Spirometer- 2500 & 4000 mL. InSee is intended for use in the Hospital environment by clinicians and patients. The device is non-invasive, reusable, and intended for use by one patient at a time.

The InSee device, an accessory for incentive spirometers, underwent rigorous performance evaluation to demonstrate its safety and effectiveness. The following details outline the acceptance criteria and the study that validated the device's performance:

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Sample Size for Test Set: 30 subjects
• Data Provenance: The study was a "prospective, IRB-approved performance validation study," implying the data was collected specifically for this study. The location of the study (e.g., country of origin) is not explicitly stated, but an IRB approval suggests it was conducted in a regulated clinical setting.

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

• Number of Experts: Not explicitly stated, but the ground truth was established by "blinded physician observation." It is implied that at least one, and likely multiple, physicians were involved in the observation to ensure blinding and robust ground truth establishment.
• Qualifications of Experts: "Physician" is stated, but further specific qualifications (e.g., medical specialty, years of experience) are not provided in the document. The blinding suggests an objective assessment.

4. Adjudication Method for the Test Set

• The document states "100% agreement with blinded physician observation." This implies that the physician's observations served as the direct ground truth for comparison, and no specific multi-reader adjudication method (e.g., 2+1, 3+1) beyond this single (or implicit consensus of multiple) blinded observation is detailed.

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 conducted. The study focused on the accuracy of the InSee device's detection capabilities against human observation, rather than comparing human reader performance with and without AI assistance. The InSee device is an accessory that records data and provides reminders, not an AI interpretation tool that assists human readers in making diagnoses.

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

• Yes, the performance validation study evaluated the InSee device's ability to "accurately detect when the IS piston crossed the target mark, activated its audiovisual alert, and logged the inspiratory volume" in an automated fashion. The "blinded physician observation" served as the independent ground truth to verify the device's standalone accuracy in these functions.

7. The Type of Ground Truth Used

• Expert Consensus/Observation: The ground truth was established by "blinded physician observation" of the incentive spirometry attempts, serving as the gold standard for verifying the InSee device's accuracy in detecting successful attempts and logging inspiratory volume.

8. The Sample Size for the Training Set

• The document does not provide information regarding a distinct training set sample size. The description of the performance evaluation focuses on the "prospective ... performance validation study" of the device, which is typically a test or validation set for a final product. Given the nature of this device (an accessory that records physical parameters rather than an AI model learning from vast datasets), a separate, explicit "training set" might not be applicable in the traditional machine learning sense, or its "training" might be based on engineering principles and calibration rather than data-driven model training.

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

• As the document does not mention a distinct training set in the context of an algorithm or AI model, there is no information provided on how ground truth for such a set would have been established. The device appears to rely on sensors and predefined logic to detect spirometer events, rather than a learned AI model requiring labeled training data.

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