(169 days)
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No
The description focuses on delivering a pre-defined therapeutic program (ACT/CBT) through a digital interface with interactive activities. There is no mention of the device learning from user input or adapting the therapy based on individual patient data using AI/ML techniques. The performance studies evaluate the effectiveness of the fixed program, not the performance of an AI/ML algorithm.
Yes
The device is indicated for the treatment of fibromyalgia symptoms, making it a therapeutic device.
No
Explanation: The device is described as a "prescription digital therapeutic" that provides "treatment for fibromyalgia symptoms." It delivers a self-guided program of Acceptance and Commitment Therapy and does not mention any diagnostic functions.
Yes
The device description explicitly states it is a "smartphone-based digital therapy" and is downloaded from app stores, indicating it is software running on a general-purpose computing platform (smartphone). There is no mention of dedicated hardware components included with the device.
Based on the provided information, Stanza is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: Stanza's intended use is for the treatment of fibromyalgia symptoms through the delivery of a digital therapeutic program (Acceptance and Commitment Therapy). IVDs are used to diagnose or aid in the diagnosis of diseases or conditions by examining specimens from the human body.
- Device Description: Stanza is a software-based program that delivers therapy sessions and interactive activities. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Using reagents or laboratory equipment
- Providing diagnostic information based on biological markers
Stanza falls under the category of a digital therapeutic, which is a software-based intervention used to treat medical conditions. While it is a medical device and requires a prescription, its function is therapeutic, not diagnostic.
N/A
Intended Use / Indications for Use
Stanza is a prescription digital therapeutic that provides Acceptance and Commitment Therapy, a form of Cognitive Behavioral Therapy, and is indicated for the treatment of fibromyalgia symptoms in adult patients.
Product codes (comma separated list FDA assigned to the subject device)
OWI
Device Description
Stanza is a prescription-only smartphone-based digital therapy that delivers a self-guided program of Acceptance and Commitment Therapy (ACT), a form of Cognitive Behavioral Therapy (CBT), for patients with fibromyalgia.
Stanza is designed to be a 12-week treatment, followed by open access to the program materials for a period of time. Stanza contains 42 unique daily sessions, organized into 8 chapters, which comprise the core program. Once the core program is completed, patients have access to reinforcement sessions, organized into playlists, to strengthen the skill building and reinforce the core program.
To use Stanza, patients first download Stanza from the App store or Google Play store and then securely log in and are authorized. Patients go through a brief tutorial of Stanza's major features and exit the tutorial onto the Today page , which is a patient's home base for the treatment program.
The core program is organized into eight chapters (Table 1). Each of the eight chapters are intended to train the patient on the core ACT skills: Acceptance, Values, Mindfulness, Defusion, Self-as-Context, and Willingness/Committed Action.
Each daily Session may include the following types of interactive activities:
- A lesson to build an ACT skill .
- A guided audio awareness activity
- A journaling activity to help patients reflect on incorporating ACT skills in their daily lives .
- Self-guided pacing or exercise activity to help patients gradually increase their activity level and physical functioning
The subject device is a mobile medical application (MMA) intended to be accessed via any patient's smartphone and downloaded from the Apple App Store or Google Play Store. No accessories are included for this system and a phone is not provided by the sponsor.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adult patients.
Intended User / Care Setting
prescription only device, smartphone-based, self-guided program.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The sponsor provided the following clinical evidence for Stanza's safety and effectiveness: a pivotal randomized control trial (RCT) (PROSPER-FM), a pilot RCT (SMART-FM), and an ongoing real-world evidence (RWE) trial (REACT-FM), representing data from 211 patients meeting the 2016 : American College of Rheumatology (ACR) criteria for fibromyalgia.
PROSPER-FM Study
- Study Type: multicenter, randomized, active-controlled, non-significant risk device study
- Sample Size: 90 randomized subjects (44 subjects randomized to the digital ACT arm and 46 to the digital ST arm) out of 159 participants screened.
- Key Results: The results of primary endpoint analyses at interim indicate treatment with Stanza Digital ACT resulted in improved fibromyalgia management as compared to treatment with the Digital Symptom Tracker comparator. At Week 12, 64.7% of ACT arm participants reported improvement on the Patient Global Impression of Change versus 21.0% of Digital Symptom Tracker arm participants. There were no device-related adverse events observed in this study, and safety assessments and observations were comparable across intervention groups.
SMART-FM Study
- Study Type: multicenter, randomized-controlled, non-significant risk pilot study
- Sample Size: 67 enrolled participants out of 106 participants screened. (39 in Tempo Digital ACT, 28 in Tempo Digital ST)
- Key Results: The combined results of primary endpoint analyses indicate the Tempo Digital ACT treatment resulted in improved fibromyalgia symptom management as compared to treatment with the Tempo Digital ST control. The between-arm effect size for the primary endpoint of change from baseline to Week 12 in FIQ-R total scores in the intent-to-treat population was 0.44, corresponding to a least square mean score difference of -5.7. The CFB to Week 12 LS mean score change in FIQ-R total scores was -8.7 (SE, 2.03) for the Tempo Digital ACT group and -3.0 (SE, 2.40) for the Tempo Digital ST group. There were no device-related Adverse Events observed.
REACT-FM STUDY
- Study Type: virtual, single-arm investigation (Real-World Evidence)
- Sample Size: ongoing, assessment performed on the first 95 enrolled patients; 54 completers analyzed.
- Key Results: 77.8% of total participants were considered "responders" to the treatment as defined by participants who scored "Very Much Improved," "Much Improved," and "Minimally Improved" on the dichotomized the 7-point PGIC scale. Furthermore, 59.35% of participants reported clinically meaningful improvement on FIO-R (> 20% improvement).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
PROSPER-FM Study:
- At Week 12, 64.7% of ACT arm participants reported improvement on the Patient Global Impression of Change versus 21.0% of Digital Symptom Tracker arm participants.
SMART-FM Study:
- Between-arm effect size for the primary endpoint (change from baseline to Week 12 in FIQ-R total scores): 0.44.
- Least square mean score difference: -5.7.
- CFB to Week 12 LS mean score change in FIQ-R total scores: -8.7 (SE, 2.03) for Tempo Digital ACT group; -3.0 (SE, 2.40) for Tempo Digital ST group.
REACT-FM Study:
- PGIC Responder: 77.8%
- PGIC Continuous: 2.7 +/- 1.0
- FIQ-R total, CFB to Week 12: -17.0 +/- 16.3
- FIQ-R Responder (>=20% Improvement on FIQ-R total): 59.3%
- FIQ-R Function, CFB to Week 12: -14.4 +/- 15.5
- FIQ-R Impact, CFB to Week 12: -7.9 +/- 5.1
- FIQ-R Symptoms, CFB to Week 12: -14.2 +/- 15.6
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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N/A
0
DE NOVO CLASSIFICATION REQUEST FOR STANZA
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Computerized behavioral therapy device for the treatment of fibromvalgia symptoms. A computerized behavioral therapy device for the treatment of fibromyalgia symptoms is a prescription only device intended to provide a computerized version of a behavioral therapy for the treatment of fibromyalgia symptoms.
NEW REGULATION NUMBER: 21 CFR 882.5804
CLASSIFICATION: Class II
PRODUCT CODE: OWI
BACKGROUND
DEVICE NAME: Stanza
SUBMISSION NUMBER: DEN220083
DATE OF DE NOVO: November 21, 2022
CONTACT: Swing Therapeutics, Inc. 548 Market Street #63989 San Francisco, CA 94104
INDICATIONS FOR USE
Stanza is a prescription digital therapeutic that provides Acceptance and Commitment Therapy, a form of Cognitive Behavioral Therapy, and is indicated for the treatment of fibromyalgia symptoms in adult patients.
LIMITATIONS
The sale, distribution, and use of the Stanza are restricted to prescription use in accordance with 21 CFR 801.109.
The device is contraindicated for use by patients who have severe, untreated depression and patients who are at risk of harming themselves.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS.
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DEVICE DESCRIPTION
Stanza is a prescription-only smartphone-based digital therapy that delivers a self-guided program of Acceptance and Commitment Therapy (ACT), a form of Cognitive Behavioral Therapy (CBT), for patients with fibromyalgia.
Stanza is designed to be a 12-week treatment, followed by open access to the program materials for a period of time. Stanza contains 42 unique daily sessions, organized into 8 chapters, which comprise the core program. Once the core program is completed, patients have access to reinforcement sessions, organized into playlists, to strengthen the skill building and reinforce the core program.
To use Stanza, patients first download Stanza from the App store or Google Play store and then securely log in and are authorized. Patients go through a brief tutorial of Stanza's major features and exit the tutorial onto the Today page , which is a patient's home base for the treatment program.
The core program is organized into eight chapters (Table 1). Each of the eight chapters are intended to train the patient on the core ACT skills: Acceptance, Values, Mindfulness, Defusion, Self-as-Context, and Willingness/Committed Action.
| Chapter | Session
Number | Title | ACT Skill | ACT Skill | Description |
|---------|-------------------|---------------------------|---------------------------------|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | 1-6 | Dropping the rope | Acceptance | Acceptance | Acceptance is taught as an alternative to avoidance. It involves approaching
unwanted, yet often uncontrollable experiences with openness and present
moment awareness. Acceptance skills teach patients how to resist avoiding
activities or stimuli that evoke unwanted feelings, and instead approach and
experience them when they align with the patient's values. For example,
fibromyalgia patients are encouraged to let go of the struggle with pain and
engage in activities they may have previously avoided. |
| 2 | 7-11 | Identifying your values | Values | Values | Values refer to personally held beliefs about who the patient wants to be and
what provides them meaning in life. Patients identify their personal values,
which are used throughout the therapy as motivation and ongoing treatment
targets. Values are not goals that can be accomplished; rather values act as a
compass to help the patient make choices that enrich their life. Patients are
guided to take actions that align with who they want to be and how they
envision their life being meaningful. |
| 3 | 12-15 | Finding your rhythm | Acceptance, Willingness | Defusion | Defusion skills help patients change the way they interact with or relate to
their thoughts, emotions, and urges. This is taught via methods of de-
identifying with unhelpful cognitions and unwanted experiences and
observing these experiences rather than letting them dictate actions. Defusion
is used as a skill to facilitate values-based action as an alternative to fusion-
based action (e.g., emotion-driven or avoidance-driven behaviors). |
| 4 | 16-21 | You are not your thoughts | Defusion, Mindfulness | Self as Context | Self-as-Context enables patients to experience a separation between observed
thoughts and feelings and the patient themselves. This skill helps patients
learn to observe their experiences and thoughtfully respond, rather than
quickly react, to symptoms or unhelpful beliefs about themselves. It supports
patients in building stronger mindfulness skills to observe and choose which
experiences to respond to and which to let go of. |
| 5 | 22-26 | Thoughts are not facts | Defusion, Mindfulness | Mindfulness | Mindfulness is present moment awareness without judgment. It enables
patients to be more aware and focused on difficult or negative thoughts and
feelings. This allows for such thoughts and feelings to have less of an impact
and influence over the patient. Mindfulness is taught through a variety of
meditations in the program. |
| 6 | 27-31 | Moving with fibro | Willingness / Committed Action | Willingness/
Committed Action | Committed action is a step-by-step process which allows the patient to honor
their identified values, even in the presence of obstacles or unwanted
discomfort, because they enrich the patient's life in personally meaningful
ways. |
| 7 | 32-36 | Daily mindfulness | Mindfulness and Self-as-Context | | |
| 8 | 37-42 | Living your values | Willingness / Committed Action | | |
Table 1: Stanza Program Organization
A summary of each skill is copied below from the submission.
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Each daily Session may include the following types of interactive activities:
- A lesson to build an ACT skill .
- . A guided audio awareness activity
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- A journaling activity to help patients reflect on incorporating ACT skills in their daily lives .
- . Self-guided pacing or exercise activity to help patients gradually increase their activity level and physical functioning
Third-party Components and Accessories:
The subject device is a mobile medical application (MMA) intended to be accessed via any patient's smartphone and downloaded from the Apple App Store or Google Play Store. No accessories are included for this system and a phone is not provided by the sponsor.
NONCLINICAL/BENCH STUDIES
SOFTWARE
The submission contained all the elements of software documentation corresponding to a "Moderate" level of concern, as outlined in the FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". issued May 11, 2005 (https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/guidance-content-premarket-submissions-software-contained-medicaldevices). Adequate documentation describing the software, firmware, software specifications, architecture design, software development environment, traceability, revision level history, unresolved anomalies and cybersecurity provides the foundation that the software will operate in a manner as described in the specifications. A hazard analysis was performed to characterize software risks including device malfunction and measurement related errors. The submission included verification and validation (V&V) testing to address the hazards presented by the device with satisfactory result. The submission included a breakdown of each hazard and how the collective hazards are mitigated as well as the impact of the hazard before and after mitigation. The sponsor includes all mitigation techniques, and the analysis is in accordance with ISO 14971. The device level of concern matches the acceptability of the hazards identified by the sponsor and no gaps were identified in their risk analysis.
SUMMARY OF CLINICAL INFORMATION
Overview
The sponsor provided the following clinical evidence for Stanza's safety and effectiveness: a pivotal randomized control trial (RCT) (PROSPER-FM), a pilot RCT (SMART-FM), and an ongoing real-world evidence (RWE) trial (REACT-FM), representing data from 211 patients meeting the 2016 : American College of Rheumatology (ACR) criteria for fibromyalgia.
Subject Selection
Subject selection was identical across all clinical studies.
Inclusion Criteria
Eligible participants included patients aged 22 to 75 years with primary fibromyalgia meeting the requirements as defined by the 2016 American College of Rheumatology Preliminary Diagnostic Criteria, a mean baseline FIQ-R total score ≥ 35 and ≤ 80, and a
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mean baseline score ≥ 4 and ≤ 9 on the 11-point FIO-R pain intensity items with no score > 9
Participants were allowed to continue ongoing permitted medications, provided the dose and regimen was stable for 30 days prior to screening and would remain stable throughout the study period.
Permitted concomitant medications included non-steroidal anti-inflammatory drugs (NSAIDS), triptans, ergotamines, and antidepressants, as well as FDA approved FM medications.
Exclusion Criteria
Exclusion criteria included lifetime history of bipolar or other psychotic disorders, those already receiving psychotherapy, at increased risk of suicide, and medical conditions or medications that could endanger the patient or interfere with the evaluation of the study device's safety and efficacy.
PROSPER-FM Study
The PROSPER-FM study was a multicenter, randomized, active-controlled, non-significant risk device study to evaluate the safety and effectiveness at 12 weeks of daily therapy with Stanza in participants with fibromyalgia (FM). Up to 300 eligible subjects were planned to be recruited from up to 30 North American sites and randomized in a 1:1 fashion to treatment with either the Digital ACT (Stanza) or the Digital Symptom Tracker (ST).
The provided results for the PROSPER-FM study were based on the pre-specified interim look which occurred when first 90 randomized subjects completed 12-week follow-up by October 10. 2022. At the interim look, 44 subjects were randomized to the digital ACT arm and 46 were randomized to the digital ST arm.
The primary efficacy endpoint was the difference between the Stanza Digital ACT Arm (ACT Arm) and the Digital Symptom Tracker application arm (DST Arm) in the Patient Global Impression of Change (PGIC) assessment at Week 12. Participants were randomized at a 1:1 ratio to treatment with either ACT or DST. Digital ACT arm participants were asked to complete an ACT-based program consisting of 42 core sessions, with a goal of completing 5-7 sessions per week. Through the DST application. DST Arm participants were prompted throughout their 12-week participation period to answer daily questions focused on symptoms and related functioning. DST Arm participants also had access to digital fibromyalgia educational resources provided by the app. All participants were required to complete weekly Patient Reported Outcomes (PROs) as well as 6 study visits performed in clinic or via telehealth (phone or videoconferencing). Safety assessments were conducted in clinic or via videoconference at the Screening (C1), Baseline (C2), and Week 12 (C6) visits, and via phone or videoconferencing at the Week 2 (C3). Week 4 (C4), and Week 8 (C5) visits. At interim, a total of 159 participants were screened at 13 study sites with the 90 randomized participants comprising the early efficacy and early safety populations. The primary analysis of the primary endpoint at interim evaluated the early efficacy population and dichotomized the 7-point PGIC scale into responders and non-responders
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using "Very Much Improved," "Much Improved," and "Minimally Improved" as responders and all other responses as non-responders.
The results of primary endpoint analyses at interim indicate treatment with Stanza Digital ACT resulted in improved fibromyalgia management as compared to treatment with the Digital Symptom Tracker comparator. At Week 12, 64.7% of ACT arm participants reported improvement on the Patient Global Impression of Change versus 21.0% of Digital Symptom Tracker arm participants (Fig. 1).
Figure 1 PGIC Responder Analysis at Week 12
Image /page/5/Figure/3 description: The image is a bar graph titled "PGIC Responder Analysis at Week 12 Minimally Improved or Better as Responders Early Efficacy Population P1 Please note that the Stanza device was previously referred to as "Tempo". The only difference between the tested device and the final device is the name. Therefore, all supporting and clinical evidence are still applicable and representative of the Stanza device.
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(TAU) plus daily interaction with either 1) one of three Tempo Digital ACT versions, or 2) one of two Tempo Digital symptom tracker versions for 12 weeks. The study was performed with 2 cohorts in and were randomized at a 1:1 ratio into Tempo Digital ACT (Group A) and Tempo Digital ST (Group S) arms similar to the PROSPER-FM Study. The primary effect size assessment was the difference between the Tempo Digital ACT arm and the Tempo Digital ST arm in mean change from baseline to Week 12 in Revised Fibromyalgia Impact Questionnaire (FIQ-R) total scores analyzed in the intent to treat patient population. A total of 106 participants were screened and 67 participants were enrolled. All enrolled participants were randomized and included in the safety and intention-to-treat (ITT) populations.
The combined results of primary endpoint analyses indicate the Tempo Digital ACT treatment resulted in improved fibromyalgia symptom management as compared to treatment. with the Tempo Digital ST control. The between-arm effect size for the primary endpoint of change from baseline to Week 12 in FIQ-R total scores in the intent-to-treat population was 0.44, corresponding to a least square mean score difference of -5.7. The CFB to Week 12 LS mean score change in FIQ-R total scores was -8.7 (SE, 2.03) for the Tempo Digital ACT group and -3.0 (SE, 2.40) for the Tempo Digital ST group (Fig. 2).
Image /page/7/Figure/2 description: The image is a title for a figure. The title reads "Figure 2 FIQ-R Total Scores: Least-Squares Mean Change from Baseline to Week 12, Intention -to Treat Population". The title describes the contents of the figure.
Image /page/7/Figure/3 description: The image is a bar graph that shows the FIQ-R total scores for the ITT population. The p-value is .074. The y-axis is labeled "LS Mean CFB to Week 12" and ranges from -15 to 0. The graph compares "Tempo Digital ACT" and "Tempo Digital ST", with the former having a score of around -8 and the latter having a score of around -3.
The SMART-FM trial shared a similar safety profile with that of PROSPER-FM. There were no device-related Adverse Events observed. In total, 15 AEs were reported throughout the study period; none were attributed to the study treatment, and none resulted in study discontinuation (Table 3), The treatment did not negatively impact participant psychological status as assessed by the Beck Depression Inventory I and II (BDI-II) and Columbia Suicide Severity Rating Scale (C-SSRS) instruments.
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| Treatment-Emergent Adverse Event: | Tempo
Digital ACT
(N=39) | Tempo
Digital ST
(N=28) |
|-------------------------------------------|--------------------------------|-------------------------------|
| Any TEAE, n (%) | 10 (25.6) | 5 (17.9) |
| Anxiety, n (%) | 1 (2.6) | 0 (0) |
| Broken foot, n (%) | 1 (2.6) | 0 (0) |
| Cellulitis in face, n (%) | 0 (0) | 1 (3.6) |
| COVID-19 infection, n (%) | 0 (0) | 2 (7.1) |
| Exacerbation of FM pain, n (%) | 1 (2.6) | 0 (0) |
| Exacerbation of gastroparesis, n (%) | 1 (2.6) | 0 (0) |
| Fever, n (%) | 1 (2.6) | 0 (0) |
| Headache, n (%) | 1 (2.6) | 0 (0) |
| Left side rib contusions, n (%) | 1 (2.6) | 0 (0) |
| Post-COVID-19 vaccination syndrome, n (%) | 1 (2.6) | 0 (0) |
| Sinus infection, n (%) | 0 (0) | 1 (3.6) |
| Urinary tract infection, n (%) | 0 (0) | 1 (3.6) |
| Vertigo, n (%) | 1 (2.6) | 0 (0) |
| Worsening anemia, n (%) | 1 (2.6) | 0 (0) |
Table 2: Treatment-Emergent Adverse Events (TEAEs) Reported During the 12-week treatment Period
ACT = acceptance and commitment therapy; COVID-19 = coronavirus disease-2019; ST = symptom tracker; TEAE = treatment-emergent adverse event.
REACT-FM STUDY
The "Real-World Evidence from Smartphone-Based Acceptance and Commitment Therapy in Fibromyalgia (REACT-FM)" Trial is a virtual, single-arm investigation intended to assess the effectiveness of the Stanza in a real-world setting with reduced trial visit activity with clinical study staff. The trial is currently under execution. An ongoing assessment was performed on the first 95 enrolled patients in the REACT-FM trial.
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All participants who have completed the end of treatment outcome data collection were analyzed (N=54, completer analysis). 77.8% of total participants were considered "responders" to the treatment as defined by participants who scored "Very Much Improved," "Much Improved," and "Minimally Improved" on the dichotomized the 7-point PGIC scale (Table 4). Furthermore, 59.35% of participants reported clinically meaningful improvement on FIO-R (> 20% improvement), which is greater than that observed for the PROSPER-FM interim analysis (42.7%) and the SMART-FM study (40.5%).
Table 4: Summary of Effectiveness Results for REACT-FM Study
| Measures | Stanza
(N=54) |
|------------------------------------------------------|------------------|
| PGIC Responder | 77.8% |
| PGIC Continuous | $2.7 \pm 1.0$ |
| FIQ-R total, CFB to Week 12 | $-17.0 \pm 16.3$ |
| FIQ-R Responder (≥20% Improvement on
FIQ-R total) | 59.3% |
| FIQ-R Function, CFB to Week 12 | $-14.4 \pm 15.5$ |
| FIQ-R Impact, CFB to Week 12 | $-7.9 \pm 5.1$ |
| FIQ-R Symptoms, CFB to Week 12 | $-14.2 \pm 15.6$ |
Pediatric Extrapolation
In this De Novo request, existing clinical data were not leveraged to support the use of the device in a pediatric patient population.
LABELING
The labeling is sufficient and satisfies the requirements of 21 CFR § 801.109 Prescription devices.
The labeling provides information to users describing the clinical data showing the safety and effectiveness of the Stanza device in the intended patient population. It also includes instructions for operating the device and navigating the user interface. Appropriate warnings and precautions are included to avoid hazardous situations and ensure safe use of the device as intended.
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RISKS TO HEALTH
The table below identifies the risks to health that may be associated with use of the computerized behavioral therapy device for the treatment of fibromyalgia symptoms and the measures necessary to mitigate these risks.
| Risks to Health | Mitigation Measures |
|---|---|
| Worsening of condition due to device providing ineffective treatment | Clinical data |
| Labeling | |
| Delayed access to treatment due to device software failure | Software verification, validation, and hazard analysis |
| Ineffective treatment due to use error/ improper use of device | Labeling |
SPECIAL CONTROLS
In combination with the general controls of the FD&C Act, the computerized behavioral therapy device for treatment of fibromyalgia symptoms is subject to the following special controls:
- (1) Clinical data must demonstrate that the device performs as intended under the anticipated conditions of use and include the following:
- (i) Evaluation of improvement in the symptoms of fibromyalgia; and
- (ii) Evaluation of relevant adverse events.
- (2) Software verification, validation, and hazard analysis must demonstrate that the device performs as intended.
- (3) Physician and patient labeling must include the following
- (i) Recommended treatment regimes, including frequency and duration of use; and
- (ii) A summary of the clinical data for the device, including a discussion of adverse events.
BENEFIT/RISK DETERMINATION
The probable risks of the Stanza device were established with data collected in nonclinical studies (e.g., software testing) as well as data collected in the clinical trials described above and are generally well understood. Specifically,
- The results of the nonclinical testing demonstrated that the Stanza device performed as per a. specifications and the results did not raise concerns regarding risks to the patients.
- b. There were no serious adverse events reported in the studies.
- c. The indications for use and labeling (i.e., description of clinical study results) will guide physicians towards prescribing Stanza to treat the patient population demonstrated to be most responsive to the therapy.
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- d. Patient populations that were not demonstrated to be responsive to therapy with the device are described in the labeling to aid in physician prescribing.
Furthermore, no device-related AEs or SAEs were recorded during all three studies. All AEs that occurred during the treatment period were classified as mild or moderate. Thus, Stanza raised no additional safety concerns during treatment.
The probable benefits of the device are also based on data collected in the clinical studies as described above. The clinical evidence from the PROSPER-FM, SMART-FM, and REACT-FM analyses collectively demonstrates the robust and clinically meaningful benefit of Stanza for improvement in the symptoms of fibromyalgia with no observed risk (device-related adverse events). The PROSPER-FM and SMART-FM results demonstrated that treatment with the Stanza device resulted in significantly superior PGIC response rates compared to an active control. Response on the FIQ-R was clinically meaningful as well, with over 40% of Stanza treated patients demonstrating a ≥20% improvement from baseline on the FIQ-R total score across all studies. The observed results in the REACT-FM real world evidence study were also consistent with the results from the PROSPER-FM and SMART-FM studies, demonstrating the effectiveness of Stanza in a real-world population. In addition to demonstrating a statistically significant improvement in PGIC scores. Stanza also showed numerically greater improvement in all secondary and exploratory endpoints of the PROSPER-FM pivotal study, further supporting that Stanza can provide a beneficial contribution to a patient's fibromyalgia symptoms and overall quality of life.
Sources of uncertainty in the benefits include the use of an imperfect comparator in the control arm. However, the sponsor provided additional clarification in the user manual to fully describe the control arm in the device labeling. Additionally, the clinical data showed a greater improvement in the Stanza treatment group compared to the control group.
Patient Perspectives
Patient perspectives considered for the Stanza included information provided by the sponsor about patient reported outcomes (PROs) that assess patients' impressions about the treatment effectiveness and disease impact. Specifically, the sponsor includes the following PROs as part of their submission: Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 6a score; Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance- Short Form 6a score: PIPS (Psychological Inflexibility in Pain Scale) total score and fusion and avoidance subscales; Committed Action Questionnaire (CAQ-8); Mean mHealth App Usability Questionnaire (MAUQ) Modules E and I for Standalone mHealth Apps Used by participants; and the Beck Depression Inventory (BDI-II)
Compared to the Active Control arm, the Stanza arm exhibited greater improvement trending towards significance (p = 0.027) on committed action, a key ACT process (CAO-8). Additional improvements on clinically relevant symptoms of fibromyalgia patients11 numerically favored the Stanza group and approached significance, including fatigue (PROMIS Fatigue, T-score, effect size of 0.38), sleep (PROMIS Sleep, T-score, effect size of 0.39), and depressed mood (BDI-II, effect size of 0.28). Specifically, the Stanza group exhibited an average post-treatment improvement of 3.1 and 2.7 points on the PROMIS Fatigue and Sleep T-score, respectively.
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Benefit/Risk Conclusion
In conclusion, given the available information above, the data support that the probable benefits outweigh the probable risks for the Stanza device for the following indications statement:
Stanza is a prescription digital therapeutic that provides Acceptance and Commitment Therapy, a form of Cognitive Behavioral Therapy, and is indicated for the treatment of fibromyalgia symptoms in adult patients.
The Stanza provides benefits, and the risks can be mitigated by the use of general controls and the identified special controls.
CONCLUSION
The De Novo request for the Stanza is granted and the device is classified under the following:
Product Code: QWI Device Type: Computerized behavioral therapy device for the treatment of fibromyalgia symptoms Class: II Regulation: 21 CFR 882.5804
REFERENCE
Wolfe F, Clauw DJ, Fitzcharles MA, et al. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). May 2010;62(5):600-10.