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AirWatch II Zoneless is a medical instrument which is intended to be used for the monitoring of asthma and other chronic respiratory diseases. The instrument measures both Peak Expiratory Flow (PEF) and Forced Expiratory Volume-One Second (FEV1). The instrument is designed for use by consumers from 5 years of age to adults.

The AirWatch II Zoneless is a pocket-sized, personal electronic device which monitors respiratory status by measuring peak expiratory flow (PEF) rate in liters per minute and forced expiratory volume in one second (FEV1) in liters. The AirWatch II Zoneless includes an LCD for displaying PEF and FEV1 information to the user, three control buttons, a removable mouthpiece, and an RJ-11C telephone connector which can be used to transfer data stored in the AirWatch to a remote computer.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: AirWatch II Zoneless (K982675)
Predicate Device: ENACT Products, Inc. AirWatch Monitor (K941226)

Acceptance Criteria and Reported Device Performance

Study Details:

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

   • Test Set Size: 20 subjects for each of the following studies: Validation/Measurement Quality Study; Home Use Study; User Guide Study; and Quick Reference Guide Study.
   • Data Provenance: Not explicitly stated, but the studies were conducted by the submitter (ENACT Health Management Systems, Inc.) and are described as testing on "study subjects," implying prospective data collection for the purpose of the submission. The country of origin is not specified, but the company is based in Mountain View, CA, suggesting U.S. participants.

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

   • The document does not specify the number or qualifications of experts used to establish ground truth for the clinical studies. The focus appears to be on the device's ability to measure PEF/FEV1, identify suspect quality, and be usable by consumers, rather than on expert interpretation of results for ground truth.

3. Adjudication method for the test set:

   • The document does not mention an adjudication method (like 2+1 or 3+1) for the clinical studies. The nature of the device (a direct measurement tool with an effort check) means adjudication of readings by experts would be less relevant than the device's direct performance against known standards or its usability.

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 study was done. This device is a direct measurement tool (peak flow meter), not an AI-assisted diagnostic imaging or interpretation system that would involve human readers. Therefore, the concept of "improving human readers with AI" is not applicable here.

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

   • The "Validation/Measurement Quality Study" essentially represents the standalone performance of the device's measurement and "effort check" algorithm. It demonstrated that the device "can appropriately provide information regarding a subject's PEF and FEV1 measurements and can appropriately identify PEF measurement of suspect quality."
   • Other studies focused on human-in-the-loop aspects (usability, interpretation), but the core measurement and warning functionality is standalone.

6. The type of ground truth used:

   • For physical/electrical conformances (non-clinical): Ground truth was established by conformance to the "Reviewers Guidance for Premarket Notification Submissions, Appendix A," "National Asthma Education Program's Statement on Technical Standards for peak flow meters," and "American Thoracic Society 1994 Standards for accuracy, precision, linearity, and back pressure." These are established technical and clinical standards.
   • For clinical performance (PEF/FEV1 measurement and suspect quality identification): The primary ground truth would likely be established through comparison to a gold standard spirometry device or carefully controlled maneuvers, though the document doesn't explicitly detail the methodology for the "Validation/Measurement Quality Study." The device's "effort check warning feature" inherently sets its own ground truth for "suspect quality" based on predefined algorithmic criteria.
   • For usability studies: Ground truth was established by observing and evaluating consumers' ability to safely and effectively use the device, interpret readings, and interact with the physical design and documentation. This would typically involve user observation and feedback.

7. The sample size for the training set:

   • The document does not mention a training set in the context of device development or performance evaluation. This device is a hardware-based measurement instrument with an embedded "effort check" algorithm, not a machine learning model that typically requires a large training dataset.

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

   • As no training set is mentioned or implied for this type of device, this question is not applicable. The "effort check" feature is likely based on pre-defined physiological or technical criteria rather than a trained AI model.

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AirWatch II Zone is a medical instrument which is intended to be used for the monitoring of asthma and other chronic respiratory diseases. The instrument measures both Peak Expiratory Flow (PEF) and Forced Expiratory Volume-One Second (FEV1). The instrument is designed for use by consumers from 5 years of age to adults.

The AirWatch II Zone is a pocket-sized, personal electronic device which monitors respiratory status by measuring peak expiratory flow (PEF) rate in liters per minute and forced expiratory volume in one second (FEV1) in liters. The AirWatch II Zone includes an LCD for displaying PEF and FEV1 information to the consumer, three control buttons, a removable mouthpiece, and an RJ-11C telephone connector which can be used to transfer data stored in the AirWatch to a remote computer.

The AirWatch II Zone is a pocket-sized, personal electronic device designed to monitor respiratory status by measuring peak expiratory flow (PEF) rate and forced expiratory volume in one second (FEV1). It includes an LCD display, control buttons, a removable mouthpiece, and an RJ-11C telephone connector for data transfer to a remote computer.

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

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Sample Size for Test Set: 20 study subjects were used for each of the four studies: Validation/Measurement Quality Study, Home Use Study, User Guide Study, and Quick Reference Guide Study.
• Data Provenance: The document does not explicitly state the country of origin. The study appears to be prospective, as it involved "study subjects" and "testing."

3. Number of Experts and their Qualifications

The document does not provide information on the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). This type of detail is often omitted for devices like peak flow meters where the "ground truth" might be established by other calibrated devices or established physiological measurements, rather than expert interpretation.

4. Adjudication Method

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

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

No MRMC comparative effectiveness study was done. This type of study is more common for diagnostic imaging AI systems where human readers interpret medical images. The AirWatch II Zone is a direct measurement device rather than an interpretative one in the same vein as imaging diagnostics.

6. Standalone Performance Study

A standalone performance study was done for the device, specifically the "Validation/Measurement Quality Study." This study aimed to demonstrate that the device itself could:

• Appropriately provide information regarding a subject's PEF and FEV1 measurements.
• Appropriately identify PEF measurements of suspect quality.

7. Type of Ground Truth Used

For the AirWatch II Zone, the ground truth for performance assessment would likely be established using:

• Calibrated reference instruments: For accuracy and precision of PEF and FEV1 measurements (e.g., comparing the device's readings to those from a highly accurate and calibrated spirometer).
• Established physiological criteria: For the "effort check" feature, the ground truth would be based on physiological parameters that indicate a valid vs. suspect respiratory effort.
• User feedback and observation: For user interface, ease of use, and interpretability (as indicated by the Home Use, User Guide, and Quick Reference Guide studies).

The document states the device "meets the American Thoracic Society 1994 Standards for accuracy, precision, linearity, and back pressure." These standards inherently define the ground truth for those technical performance aspects.

8. Sample Size for the Training Set

The document does not mention a training set, as the AirWatch II Zone is a traditional medical device (peak flow meter) and not an AI/machine learning-based device that typically undergoes a training phase.

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

Not applicable, as there is no mention of a training set for an AI/machine learning algorithm.

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