(90 days)
The ReFlex Treatment System is intended for the treatment of stress incontinence and/or urge incontinence in females.
The ReFlex Treatment System is a comprehensive, behavioraliy-based program designed for independent use by incontinent people in their own home. The product kit includes a personal training device, an informational video, instructional journal, and direct clinical support via phone and internet. At the program's core is the pneumatically-based ReFlex Trainer, a handheld device which when connected to the vaginal sensor displays the magnitude of pelvic muscle contractions.
The ReFlex Treatment System is intended for the treatment of stress incontinence and/or urge incontinence in females.
Here's an analysis of the provided information regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative format as would typically be seen for a medical device seeking to demonstrate specific performance metrics (e.g., sensitivity, specificity, accuracy). However, the overall goal of the clinical study was to demonstrate the safety and efficacy of the device for its intended use and its ability to be used without licensed practitioner supervision. The reported performance is based on the outcomes of this clinical study.
| Acceptance Criteria (Inferred from study goals) | Reported Device Performance and Outcomes |
|---|---|
| Efficacy in alleviating stress and/or urge incontinence symptoms. | "The conclusive data from this clinical study demonstrated that self-selected healthy women of a wide age-range with symptoms of urge and/or stress incontinence can improve their symptoms and lower their severity index... All study participants who completed the study saw some degree of symptom improvement." This indicates overall efficacy. |
Specific outcomes:
- 43% of participants were completely cured of their symptoms of incontinence.
- 36% had over 50% improvement of their symptoms.
- This results in an overall improvement rate of 79%. |
| Safety of the device, particularly regarding biocompatibility and electrical safety. | Biocompatibility: "Extensive biocompatibility and safety testing of the silicone material used in the balloon sensors was performed... test results from all tests support the position that this material is substantially equivalent to the material used in the predicate device and indicate that the material is biocompatible, non-toxic and well tolerated by mucosal membranes." (Tests included Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity, Pyrogen, and Muscle Implantation Studies).
Electrical Safety: The device was designed and tested to meet UL2601-1, 2nd Edition, and EN 60601-1-2:1993, indicating adherence to relevant electrical safety standards. |
| Ability to be used independently by incontinent individuals in their own home (without licensed supervision). | "clinical testing of the product demonstrated that the device can be used outside the supervision of a licensed practitioner, and adequate directions for use have been prepared." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact number of participants in the clinical study. It generally refers to "all study participants who completed the study," "self-selected healthy women of a wide age-range," and percentages of "participants."
- Data Provenance: The document does not explicitly state the country of origin. The sponsor, DesChutes Medical Products, Inc., is based in Bend, OR, USA, suggesting the study was likely conducted in the US. The study is described as "clinical testing," implying a prospective nature where data was collected specifically for this evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This section is not applicable as the study evaluates the effectiveness of a treatment system directly on patient symptoms and outcomes, rather than requiring expert assessment to establish a "ground truth" for diagnostic accuracy. The ground truth, in this context, is the reported improvement or cure of incontinence symptoms by the patients themselves, likely supported by other clinical assessments, though details are not provided.
4. Adjudication Method for the Test Set:
Not applicable. This was a clinical efficacy study for a treatment device, not a diagnostic accuracy study requiring adjudication of expert readings. Patient self-reporting of symptoms and/or clinical assessments (e.g., severity index) would have formed the basis of outcome measurement.
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 ReFlex Treatment System is a biofeedback device for pelvic muscle exercises, not an AI-powered diagnostic tool requiring human reader interpretation or assessment. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. The ReFlex Treatment System is a treatment device used by individuals, not an algorithm. Its performance is inherent in its design and the patient's interaction with it, not a standalone algorithmic output.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the clinical performance data appears to be based on patient-reported outcomes (symptom improvement/cure) and potentially objective clinical assessments of symptom severity. The summary states, "All study participants who completed the study saw some degree of symptom improvement" and refers to "improve their symptoms and lower their severity index." This points towards outcomes data as the primary ground truth.
8. The Sample Size for the Training Set:
Not applicable. There is no mention of a "training set" for the ReFlex Treatment System. It is a physical treatment device, not a machine learning model that requires training data. The "training" that occurs is for the patient learning to use the device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set mentioned for the device itself.
§ 884.1425 Perineometer.
(a)
Identification. A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.(b)
Classification. Class II (performance standards).