(193 days)
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
| Testing Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Non-Clinical Testing | ||
| CBS Design Verification (Functional) | All functional requirements met, product specifications satisfied. | The CBS passed all functional testing and met all product specification requirements. |
| CBS Integration Testing | Accurate and successful transmission of RR, EtCO₂, and error information to the CBS software. | RR, ETCO₂ and error information were successfully and accurately transmitted to the Nexus tablet running the CBS software. |
| Software Verification and Validation | All requirements of the Software Requirements Specification (SRS) met. | The Canary CO₂ Sensor Software met all requirements of the SRS. |
| Capnometer Equivalency Verification (Accuracy) | Performance equivalent to the predicate LoFlo C5 CO₂ capnometer for EtCO₂ and respiratory rate. | The performance of the Canary CO₂ Sensor is equivalent to the LoFlo predicate device, for EtCO₂ and respiratory rate measurements. |
| Electrical Safety and Electromagnetic Compatibility | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-1-11 standards. | The CBS met all acceptance criteria in accordance with: IEC 60601-1:1988, IEC 60601-1-2:2007, IEC 60601-1-4:2000, IEC 60601-1-11:2010. |
| Clinical Testing | ||
| Efficacy for Panic Disorder (Adjunctive Treatment) | Long-lasting reductions in panic attack frequency/severity, anxiety, avoidance behaviors; improvements in mood/quality of life; normalization of CO₂. | "Findings of these empirical studies have shown that completing the CART training led to long-lasting reductions in panic attack frequency and severity, anxiety symptoms, avoidance behaviors, along with improvements in mood and quality of life in the majority of patients. Causal analysis linked the normalization in CO2 to the observed improvements." |
| Safety | No adverse events reported. | "Respiratory training using the CART protocol is safe, and no adverse events associated with the use of the device have been reported." |
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.
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.