(392 days)
ClearUP Sinus Relief device is a transcutaneous electrical nerve stimulator that electrically stimulates the skin overlying the paranasal sinuses and is intended to be used for the temporary relief of moderate to severe congestion. ClearUP Sinus Relief is a treatment to be used at home by individuals 18 and older.
ClearUP Sinus Relief is an over-the-counter, handheld microcurrent stimulation reusable device to be used at home by individuals 18 and older with moderate to severe congestion (Figure 1). Note that Tivic Health Systems Inc. received a 510(k) clearance (K182025) for a similar device, ClearUp Sinus Pain Relief, for the temporary relief of sinus pain associated with Allergic Rhinitis. In the current De Novo, Tivic Health Systems made minor design changes to the device, intended to be used for the temporary relief of moderate to severe congestion. The unit applies microcurrent waves at a very low level of electrical current to the skin overlying the paranasal sinuses and continuously measures skin impedance as the user glides the electrode along the skin. When the skin impedance measurement drops below a threshold, ClearUP Sinus Relief identifies this as a treatment point in the skin overlying the paranasal sinuses which allows current to pass most easily across the skin. The device indicates a treatment point with a brief haptic vibration. These low-impedance points correlate with subcutaneous nerve fibers and foramina (holes) through which major nerve fibers pass from the sinus passages, through the skull, to areas near the skin (Figure 2).
The pear-shaped device is held in the hand, with the rounded tip of the device applied to the facial skin in the region of the paranasal sinuses. The tip is the active electrode of a monopolar design. The housing of the device serves as the return electrode. The hand holding the device completes the electrical path.
Once the haptic vibration ends, the user is instructed to glide the device along the indicated path until reaching the next low-impedance area, at which point the haptic vibration will activate again. A single treatment is 5 minutes in duration. The user may adjust the current setting of the device (low, medium, high) if they prefer more or less current intensity. The default setting for the device is low.
The device is reusable for a single user, provided non-sterile, and it is not required to be sterilized prior to use.
The provided text describes the ClearUP Sinus Relief device and two clinical studies (Study 1 and Study 2) conducted to demonstrate its safety and effectiveness for the temporary relief of moderate to severe congestion.
Here's the breakdown of the acceptance criteria and the study details:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ClearUP Sinus Relief device are not explicitly stated as quantitative metrics in a dedicated table format within the provided text. However, they can be inferred from the "SUMMARY OF CLINICAL INFORMATION" and "CONCLUSION" sections, particularly regarding the statistically and clinically significant reduction in congestion. The studies aimed to demonstrate efficacy beyond a sham/placebo effect and clinical meaningfulness.
Based on the provided information, the likely implied acceptance criteria and the reported performance are:
| Acceptance Criterion (Implied) | Reported Device Performance and Statistical Significance |
|---|---|
| Study 1: Acute Relief of Congestion | |
| Primary Endpoint (Implied for Congestion): Statistically and clinically significant reduction in congestion in active device group vs. sham for subjects with moderate to severe congestion. | For subjects with moderate to severe congestion (Modified NOSE > [b] [4] before treatment): |
| Active Group: Average Modified NOSE score reduction was [b] [4]. 70% of active-treated subjects exhibited a Modified NOSE reduction of [b] [4] points or more. | |
| Sham Group: Average Modified NOSE score reduction was [0]. | |
| Difference: [b] [4] (Active vs. Sham), which reached statistical significance (p-value: [b] [4], [b] [4]-sided Mann-Whitney test). | |
| Clinical Meaningfulness: The mean reduction of [b] [4] in Modified NOSE score was greater than the established minimum clinically important difference (MCMD) of approximately [0] ([b] [4] MCMD for the NOSE). | |
| Study 2: Longitudinal Relief of Congestion | |
| Endpoint (Implied): Statistically and clinically significant reduction in congestion over 4 weeks of use. | For subjects who enrolled with moderate to severe congestion (b) (4): |
| CQ7: |
- Week 1: [b] [4] reduction (statistically significant)
- Week 2: [b] [4] reduction (statistically significant)
- Week 3: [b] [4] reduction (statistically significant)
- Week 4: [0][0] reduction (statistically significant).
Clinical Meaningfulness (CQ7): At week 4, 21 of 24 subjects (88%) exhibited a CQ7 score reduction of three points or greater, indicating clinical meaningfulness (MCMD of 3 points for CQ7).
Modified NOSE: - Week 4: [b][4] reduction from enrollment (statistically significant).
Clinical Meaningfulness (Modified NOSE): This reduction was greater than the established minimum clinically important difference (b) (4) (likely referring to the MCMD of 10 points for the full NOSE or the approximate 6 points for the Modified NOSE). |
| Safety and Tolerability: Few and minor adverse events. | Study 1: No serious adverse events. One case (2.6%) of minor transient facial erythema (resolved in 15 mins).
Study 2: No serious adverse events. Two reports (6.7%) of minor transient facial erythema, one report (3.3%) of eyelid twitch, and one report (3.3%) of headache. All minor and resolved spontaneously. |
| User Satisfaction and Preference: High user satisfaction and preference over current methods. | Study 1 (Treatment Preference): 82% of subjects preferred ClearUP Sinus Pain Relief to their current treatment, and 87% found the therapy appropriate for treating sinus pain.
Study 2 (User Experience): 73% were somewhat or extremely satisfied, 73% preferred ClearUP to current methods, and 77% would probably or definitely recommend it. |
2. Sample Size and Data Provenance
- Study 1 (Congestion Study 1 - A User Study of ClearUP Sinus Relief):
- Total Sample Size: 71 subjects.
- Test Set (Active Group): 38 subjects.
- Test Set (Sham Group): 33 subjects.
- Data Provenance: The study was conducted in a "tertiary rhinology practice and from the surrounding community," implying a U.S. origin (given the FDA De Novo application). It was a prospective, randomized, double-blinded sham-controlled trial.
- Study 2 (Congestion Clinical Study 2 - ClearUP Longitudinal Study):
- Total Sample Size: 30 subjects.
- Test Set: All 30 subjects were treated with the active device.
- Data Provenance: Implied U.S. origin (given the FDA De Novo application). It was a prospective, single-arm, open-label study with subjects self-treating at home.
3. Number of Experts used for Ground Truth and Qualifications
The provided text does not explicitly state the number of experts used to establish ground truth for the test sets or their qualifications. The "ground truth" for congestion in these studies was established using patient-reported outcome measures (PROMs):
- Modified Nasal Obstruction Symptom Evaluation (NOSE) questionnaire: This is a validated and widely used self-report instrument. The modification (removal of questions 4 and 5) was stated to maintain psychometric validity.
- Congestion Quantifier 7 (CQ7): Another validated questionnaire for quantifying nasal congestion.
- Sinonasal Outcome Test 22 (SNOT-22): Used in Study 2 to measure broader sinonasal symptoms.
While these are established PROMs, they rely on the patient's subjective assessment rather than an expert's clinical judgment of the "ground truth." The studies were designed to evaluate the device's effect on these patient-perceived symptoms.
4. Adjudication Method for the Test Set
- Study 1: This was a double-blinded, randomized sham-controlled trial. Both subjects and study staff were blinded to the device used (active or sham). This design inherently serves as an "adjudication" by minimizing bias, rather than relying on a separate panel for post-hoc adjudication of outcomes. The outcomes (Modified NOSE scores) were directly collected patient self-reports.
- Study 2: This was a single-arm, open-label study. There was no blinding or direct comparison group within the study for "adjudication." The data collected were patient self-reports. The discussion section attempts to contextualize the findings by comparing them to a literature review of placebo effects in other CQ7 studies, but this is a post-hoc analysis, not an internal adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The provided text does not mention an MRMC comparative effectiveness study. The studies evaluated the device's effect on patient-reported symptoms, not an AI's impact on human reader performance for diagnostic tasks. This device is a treatment device for congestion relief, not an imaging analysis AI or diagnostic tool where MRMC studies are typically performed.
6. Standalone (Algorithm Only) Performance
Not Applicable. The ClearUP Sinus Relief is a physical medical device that applies electrical stimulation, not a software algorithm that performs diagnostic or analytical tasks independently. Therefore, a "standalone algorithm performance" assessment is not relevant to this type of device.
7. Type of Ground Truth Used
The primary "ground truth" used in these studies was patient-reported outcomes (PROMs). This includes:
- Modified Nasal Obstruction Symptom Evaluation (NOSE) questionnaire
- Congestion Quantifier 7 (CQ7)
- Sinonasal Outcome Test 22 (SNOT-22)
- Numeric Rating Scale (NRS) for pain (though the primary focus shifted to congestion for the De Novo)
While these are widely accepted and validated self-report instruments, they represent the patient's subjective experience of symptoms rather than an objective clinical "ground truth" established by independent expert consensus, pathology, or direct outcome measures by a clinician.
8. Sample Size for the Training Set
Not Applicable. This is a physical medical device. It does not have a "training set" in the context of machine learning or AI models. The design changes mentioned were minor and design verification occurred, not a machine learning training process.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no "training set" for a machine learning model, this question does not apply. The device's efficacy was assessed through the clinical trials described, using the patient-reported outcome measures as the primary endpoints.
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