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Freespira is intended for use as a relaxation treatment for the reduction of stress by leading the user through guided and monitored breathing exercises. The device is indicated as an adjunctive treatment of symptoms associated with panic disorder (PD) and/or posttraumatic stress disorder (PTSD), to be used under the direction of a healthcare professional, together with other pharmacological and/or non-pharmacological interventions.

Freespira® is intended for use as a relaxation treatment for the reduction of stress by leading the user through guided and monitored breathing exercises. The device is indicated as an adjunctive treatment of symptoms associated with panic disorder (PD) and/or posttraumatic stress disorder (PTSD), to be used under the direction of a healthcare professional, together with other pharmacological and/or nonpharmacological interventions. Freespira is authorized and overseen by a licensed healthcare provider. Patients are trained to use the Freespira Sensor and the Freespira Mobile App to measure and display their exhaled carbon dioxide (EtCO₂) level and respiration rate (RR) and how different breathing habits affect EtCO2 levels.

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

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

The document refers to a "prospective, single arm, un-blinded investigation of Freespira". While a specific sample size for a "test set" (implying a separate validation cohort) is not explicitly stated in the context of AI device testing, the clinical study enrolled patients with a primary diagnosis of PTSD. The number of participants in this clinical study is not directly specified by a single number, but results are presented as percentages and confidence intervals, implying a participant cohort. Given the confidence intervals provided (e.g., 95% CI between 77-99% for 93% response), the sample size is likely small, potentially in the range of 20-40 participants for this type of study.

The data provenance is prospective clinical data collected from patients with PTSD. The country of origin is not explicitly stated, but the company, Palo Alto Health Sciences, Inc., is based in Kirkland, WA, U.S.A., which suggests the study was likely conducted within the United States.

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

The ground truth was established using the Clinician Administered PTSD Scale (CAPS-5). This is a clinician-administered assessment, implying that a qualified clinician (an "expert") was involved in administering and scoring the scale. The document does not specify the exact number of clinicians involved in assessing each patient or their specific qualifications (e.g., years of experience, specific medical specialty), but it implies the use of healthcare professionals capable of administering and interpreting this validated psychiatric assessment tool.

4. Adjudication method for the test set

The document does not detail an adjudication method for the CAPS-5 scores (e.g., 2+1, 3+1). Since CAPS-5 is a standardized, clinician-administered scale, it's typically administered by a single trained clinician. If there were multiple clinicians involved in assessments over time, standard clinical practice would involve training and inter-rater reliability checks, but these are not explicitly described as formal adjudication steps for the ground truth in this submission.

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, an MRMC comparative effectiveness study involving human readers and AI assistance was not mentioned or presented in this document. The study evaluates the Freespira device as a standalone treatment, not as an assistive tool for human readers.

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

Yes, a standalone performance study was done in the context of the device's clinical effectiveness. The Freespira device, which guides users through breathing exercises and measures EtCO2 and RR, was evaluated in a clinical trial to determine its efficacy as an adjunctive treatment for PTSD symptoms. The primary endpoint related to the reduction in CAPS-5 scores directly measures the outcome of using the device.

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

The primary ground truth used was clinically validated outcome data based on the Clinician Administered PTSD Scale (CAPS-5) scores. This scale is administered by clinicians and reflects a standardized assessment of PTSD symptoms and severity. Additionally, patient-reported questionnaires like PHQ-9, SF-36, and PDSS were used as secondary assessments.

8. The sample size for the training set

The document does not explicitly mention a training set in the context of AI/algorithm development. The clinical study described appears to be an evaluation of the device as a whole (hardware + software + therapeutic protocol) rather than a specific validation of an AI algorithm trained on a dataset. The device's function involves measuring EtCO2 and RR and providing biofeedback, which might rely on pre-programmed logic rather than a machine learning model that requires a distinct "training set."

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

As no specific "training set" for an AI algorithm is mentioned, the method for establishing its ground truth is not applicable based on the provided text. The device primarily works by guiding users based on physiological measurements, rather than making diagnostic or predictive outputs that would require a ground truth established for an AI model.

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The Canary Breathing" System is intended for use as a relaxation treatment for the reduction of stress by leading the user through guided and monitored breathing exercises. The device is indicated as an adjunctive treatment of symptoms associated with panic disorder, to be used under the direction of a healthcare professional, together with other pharmacological and/or non-pharmacological interventions.

The CBS is a biofeedback device that provides the user with a series of tone-guided breathing exercises and an awareness of his or her physiological data. The CBS uses standard biofeedback concepts to teach the patient to regulate their end-tidal CO2 (EtCO2) and respiratory rate (RR). The user's physiological data display allows the patient to see l ) the actual rate of their breathing and 2) how changes in breathing mechanics (depth and volume) affect EtCO2 levels. The CBS consists of a biofeedback training software program (mobile app) and an EtCO2 sensor (capnometer) used with a nasal cannula. The mobile app guides the user through an exercise and displays physiological data, while the sensor collects physiological data and feeds it to the mobile application for biofeedback. The patient's EtCO2 levels and RR are relaved from the capnometer to the mobile application via Bluetooth and are displayed on a tablet device, through the mobile application.

Here's an analysis of the acceptance criteria and supporting studies for the Canary Breathing™ System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

The 510(k) summary does not describe a separate, de novo clinical test set specifically for the Canary Breathing System (CBS). Instead, it relies on previously published clinical trials of the Capnometry-Assisted Respiratory Training (CART) protocol, which the CBS aims to implement.

Therefore:

• Sample Size for Test Set: Not explicitly stated for a CBS-specific test set. The clinical efficacy claims are based on studies of the CART protocol. The general provenance is "Dr. Meuret and colleagues at Stanford University, Boston University and Southern Methodist University" in the US.
• Data Provenance: The referenced studies are "randomized clinical trials." They appear to be prospective studies conducted in the US (Southern Methodist University, Stanford University, Boston University).

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

Since no de novo clinical test set for the CBS is described, this information is not directly provided for this specific device's ground truth establishment. However, the CART protocol, which forms the basis for the CBS's clinical claims, was developed by:

• Experts: Alicia Meuret, Ph.D., a clinical psychologist and Associate Professor in the Department of Psychology at Southern Methodist University, in collaboration with colleagues at Stanford University and Boston University.
• Qualifications: Dr. Meuret is a clinical psychologist and Associate Professor. The qualifications of her colleagues are not detailed but are implied to be medical/clinical researchers in relevant fields given the academic institutions.

4. Adjudication Method for the Test Set

Not applicable, as no de novo clinical test set for the CBS is described. The referenced CART studies would have had their own methodologies for data collection and outcome assessment, but this detail is not present in the 510(k) 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

Not applicable. The Canary Breathing System is a biofeedback device that directly interacts with the user to guide breathing. It is not an AI-assisted diagnostic device where human "readers" (e.g., radiologists interpreting images) would use it to improve their performance with or without AI.

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

The device itself is a "standalone" system in the sense that the biofeedback algorithm operates without a human operator directly interpreting its output for diagnostic purposes. The "human-in-the-loop" is the patient, who follows the guided exercises.

The "clinical data" section refers to studies of the underlying CART protocol, which demonstrably showed reductions in panic disorder symptoms. The 510(k) argues that since "The CBS and CART protocol lead the user through identical exercises, however, the user interface for the CBS device is different from that used in the CART protocol studies," the clinical results of the CART protocol can be directly applied to the CBS. This is an argument for standalone clinical effectiveness based on prior research, rather than a new standalone study of the CBS as a diagnostic algorithm.

7. The Type of Ground Truth Used

For the clinical claims, the ground truth was based on:

• Clinical Outcomes: "reductions in panic attack frequency and severity, anxiety symptoms, avoidance behaviors, along with improvements in mood and quality of life."
• Physiological Correlation: "Causal analysis linked the normalization in CO2 to the observed improvements."
• This type of ground truth is best described as clinical outcomes data and physiological measurements.

8. The Sample Size for the Training Set

Not applicable. The CBS is a predetermined biofeedback system based on the CART protocol. It doesn't describe a machine-learning model that requires a "training set" in the conventional sense of AI/ML algorithm development. The "training" in this context refers to the clinical studies that established the efficacy of the CART protocol itself.

The referenced studies are:

• Meuret AE, et al. Journal of Psychiatric Research 2008;42;560-8.
• Meuret AE, et al. Journal of Psychiatric Research 2009;43;634-41.
• Meuret AE. et al. Journal of Consulting and Clinical Psychology 2010:78:691-704.

To find the exact sample sizes, one would need to consult these publications. The 510(k) summary does not provide them.

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

Since there is no "training set" in the AI/ML sense, this question refers to how the evidence for the efficacy of the underlying CART protocol was established.

• The ground truth for the efficacy of the CART protocol was established through two randomized clinical trials (as stated in the "Clinical Data" section).
• These trials involved detailed assessment of patient symptoms (panic attack frequency/severity, anxiety, avoidance behaviors), mood, quality of life, and physiological parameters (CO2 levels and respiratory rate) to demonstrate the therapeutic impact of the protocol.
• The methodology of randomized clinical trials, which often includes objective and subjective outcome measures, standardized psychological assessments, and physiological data collection, is inherently the method of establishing ground truth for therapeutic interventions.

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