(29 days)
Parallel™ is a prescription-only digital therapeutic intended to provide cognitive behavioral therapy for adults aged 22 years of age and older who have been diagnosed with Irritable Bowel Syndrome (IBS). Parallel is indicated as a 3 month treatment for patients with IBS. Parallel treats IBS by reducing the severity of symptoms and is intended to be used together with other IBS treatments.
Parallel is a Prescription Digital Therapeutic (PDT) mobile application designed to deliver Cognitive Behavioral Therapy (CBT) to patients with Irritable Bowel Syndrome (IBS). PDTs are a new class of treatment using software to treat medical diseases. The Parallel CBT program has been tailored for patients with IBS. The rationale for applying CBT to treat IBS is grounded in the biopsychosocial model. This model states that one's biology, thoughts, and behaviors influence IBS symptom expression in a bidirectional way. The biological substrate of these interactions that affect IBS outcomes is the "brain-gut axis". The brain-gut axis underlies the pathways (e.g., psychological, behavioral functioning, and physiological interactions) that contribute to IBS symptom manifestation. CBT allows patients to influence brain-gut communication in order to reduce the severity of IBS. Parallel is available by prescription only and is intended to provide 3 months of cognitive behavioral therapy for adult patients, aged 22 years and older, with IBS. Parallel is intended to provide CBT, as an adjunct to any other IBS treatments. The Parallel mobile application uses the patient's mobile phone or tablet to deliver therapy on demand as a complement to the provider's care. Typical length of the therapy period is 3 months and is composed of ten (10) sessions. The first session explains IBS symptoms, the key features of the brain-gut axis, and the personalization of the rationale for CBT. The next nine (9) sessions provide personalized treatment for IBS by asking patients and getting them to complete interactive tasks. Each session contains several pages of content which may be text, audio files, video files, or interactive components. During the program, patients are provided short tasks to complete during the week. Patients are also asked to complete questionnaires from time to rate the severity of their IBS symptoms and the impact symptoms are having on their life and mood.
This document is a 510(k) premarket notification decision letter from the FDA to Mahana Therapeutics, Inc. for their Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS). It primarily outlines the FDA's determination of substantial equivalence to a predicate device and the regulatory controls that apply.
Crucially, this document states that "no additional clinical studies are necessary to establish substantial equivalence between the web and mobile versions of Parallel, and to provide reasonable assurance of safety and effectiveness." This means that this 510(k) submission does not contain new clinical study data proving the device meets specific acceptance criteria based on performance. Instead, it relies on the predicate device's existing evidence and demonstrates that the mobile version's changes do not impact safety or effectiveness.
Therefore, I cannot provide the detailed information requested in the prompt's points 1 through 9 regarding acceptance criteria and a new study demonstrating the device meets those criteria. The document explicitly states that such studies were not deemed necessary for this particular submission due to the nature of the changes from the predicate device.
To answer your request, I will explain what would be provided if the document did contain the information, and then explicitly state what is missing based on this document.
What is present in the document (and why other information is absent for this 510(k) submission):
- Device Name: Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)
- Regulation Number: 21 CFR § 876.5960
- Regulation Name: Computerized Behavioral Therapy Device for Treating Symptoms of Gastrointestinal Conditions
- Regulatory Class: II
- Product Code: OMY
- Indications for Use: Parallel™ is a prescription-only digital therapeutic intended to provide cognitive behavioral therapy for adults aged 22 years of age and older who have been diagnosed with Irritable Bowel Syndrome (IBS). Parallel is indicated as a 3 month treatment for patients with IBS. Parallel treats IBS by reducing the severity of symptoms and is intended to be used together with other IBS treatments.
- Predicate Device: Parallel - DEN200029 (web version)
- Reason for no new clinical studies: "The core CBT skills that constitute the clinical basis of the predicate Parallel (web version) are unchanged and remain identical in the subject Parallel (mobile version). There is no impact to clinical functionality, and no new introduced or modified existing risks."
Based on the provided document, the following requested information cannot be extracted because the submission relies on the predicate device's data and asserts that no new clinical studies were necessary due to the nature of the changes from web to mobile:
- A table of acceptance criteria and the reported device performance: This document does not present any new performance data against acceptance criteria. It states that the device is substantially equivalent to the predicate, implying it meets the predicate's established safety and effectiveness.
- Sample sized used for the test set and the data provenance: No new clinical test set data is presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no new clinical test set data is presented.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no new clinical test set data is presented.
- 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. This is a digital therapeutic for IBS, not an imaging AI diagnostic aid.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a prescribed therapeutic, used by patients to deliver CBT. Its performance is directly tied to user engagement and clinical outcomes, not an "algorithm-only" performance in the diagnostic sense. No new study of its direct performance is presented.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable as no new clinical test set data is presented. Performance relies on the predicate's established efficacy.
- The sample size for the training set: Not applicable as no new clinical test set data from the mobile version's development is presented.
- How the ground truth for the training set was established: Not applicable as no new clinical test set data from the mobile version's development is presented.
In summary, this 510(k) submission for the Mahana Parallel Digital CBT Mobile Application asserts substantial equivalence to a previously cleared web-based version. It explicitly states that "no additional clinical studies are necessary" because the changes are technological (web to mobile platform) and minor content adjustments that do not impact clinical functionality or introduce new risks. Therefore, the document does not contain the details of acceptance criteria or a study proving the device meets these criteria as if it were a novel device requiring new clinical evidence.
§ 876.5960 Computerized behavioral therapy device for treating symptoms of gastrointestinal conditions.
(a)
Identification. A computerized behavioral therapy device for treating symptoms of gastrointestinal conditions is a prescription device intended to provide a computerized version of condition-specific therapy as an adjunct to standard of care treatments to patients with gastrointestinal conditions.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical data must be provided to fulfill the following:
(i) Describe a model of therapy for the indicated gastrointestinal conditions;
(ii) Validate the model of therapy as implemented by the device using a clinically defined endpoint; and
(iii) Evaluate all adverse events.
(2) Software must be described in detail in the software requirements specification and software design specification. Software verification, validation, and hazard analysis must be performed. Software documentation must demonstrate that the device effectively implements the behavioral therapy model.
(3) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.
(4) Labeling:
(i) Labeling must include instructions for use, including images that demonstrate how to interact with the device;
(ii) Patient and physician labeling must list the minimum operating system requirements that support the software of the device;
(iii) Patient and physician labeling must include a warning that the device is not intended for use in lieu of a standard therapeutic intervention or to represent a substitution for the patient's medication;
(iv) Patient and physician labeling must include a warning to seek medical care if a patient has feelings or thoughts of harming themselves or others; and
(v) Physician and patient labeling must include a summary of the clinical testing with the device.