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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:

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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The Tivic Health ClearUP(TM) Sinus Pain Relief device is intended to be used for the temporary relief of sinus pain associated with Allergic Rhinitis.

Clear UP™ Sinus Pain Relief is a handheld microcurent stimulation device used for the temporary relief of sinus pain associated with allergic rhinitis. The unit applies a low level electrical current to the facial sinus passages.

The ClearUP Sinus Pain Relief unit provides a customized treatment with the following features:

• Microcurrent waveforms to relieve sinus pain associated with allergic rhinitis
• Patent-pending algorithm to locate the optimal treatment points
• Simple-to-use system of lights and vibrations to guide the user
• Small handheld shape for easy holding and comfort

Here's an analysis of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative table with specific thresholds for performance metrics. Instead, the document describes the successful completion of various tests and then presents clinical study results.

Implicit Acceptance Criteria (Inferred from sections 9, 10, and 11):

2. Sample Sizes Used for the Test Set and Data Provenance

• Labeling Validation Study (Usability/Label Comprehension):

  • Sample Size: 71 participants.
  • Data Provenance: Not explicitly stated, but typically these studies are prospective and often conducted within the country of the regulatory submission (USA in this case, implicitly).

• Clinical Validation Study:

  • Sample Size: 81 subjects (27 chronic rhinosinusitis + 49 allergic rhinitis + 5 other sinus conditions). The study compares "active subjects" (microcurrent device) to "sham subjects." The mean age for sham subjects was 44 and for active subjects 45, both groups had approximately 2:1 ratio of females to males.
  • Data Provenance: Conducted at the Stanford Sinus Center. This implies prospective clinical data from the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• For the Labeling Validation Study: No "experts" in the sense of medical professionals establishing a ground truth for a diagnosis. The ground truth here is user comprehension and ease of use, established directly from the feedback of the 71 participants who are representative of the intended over-the-counter (OTC) user population.

• For the Clinical Validation Study: The "ground truth" for sinus pain and allergic rhinitis would have been established by the clinicians at the Stanford Sinus Center who enrolled the patients. While the exact number and qualifications are not specified in this document, it's implied that these would be medical professionals specializing in rhinology/ENT. The study assessed the patients' self-reported pain levels using a Visual Analog Pain Scale, so the ground truth for pain reduction is the patient's subjective experience, quantified by this recognized scale during the course of the study by clinical staff.

4. Adjudication Method for the Test Set

• Labeling Validation Study: No formal "adjudication" in the medical sense for this study. Participant feedback on comprehension and ease of use was directly collected.

• Clinical Validation Study: This was a double-blinded randomized controlled clinical validation study. This means:

  • Double-blinded: Neither the participants nor the clinical staff administering the treatment (or potentially assessing results) knew whether the device was active or sham. This helps minimize bias.
  • Randomized Controlled: Participants were randomly assigned to either the active device group or the sham/placebo device group, allowing for a controlled comparison.
  • Adjudication on outcome: The primary outcome (reduction in sinus pain on the visual analog scale) was a patient-reported outcome. While not explicitly stated, the data collection from the visual analog scale would have been directly recorded by the study staff without further 'adjudication' on the pain score itself. The statistical analysis of these scores would determine the significance of the results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study typically applies to diagnostic devices where multiple readers interpret cases with and without AI assistance. The ClearUP device is a therapeutic device for pain relief, and its clinical validation focused on direct patient outcomes (pain reduction) compared to a sham device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, in essence, the clinical validation study represents a standalone evaluation of the device's therapeutic effect. The "algorithm" here refers to the device's operating principles (microcurrent waveforms to relieve sinus pain and a patent-pending algorithm to locate optimal treatment points). The study evaluated the device's performance on its own (when used as directed by patients) in reducing pain, compared to a sham device, without a human-in-the-loop in terms of diagnostic interpretation or decision-making. The interaction is solely between the user and the device for treatment application.

7. The Type of Ground Truth Used

• For Labeling Validation: User feedback/comprehension.
• For Clinical Validation: Subjective patient-reported outcomes using a validated scale (Visual Analog Pain Scale for sinus pain reduction). The diagnosis of "sinus pain associated with Allergic Rhinitis" for patient inclusion would have been clinical diagnosis by medical professionals.

8. The Sample Size for the Training Set

The provided text does not specify a training set sample size. This is common as the device is a direct treatment device, not a machine learning model that requires a discrete training phase on labeled data in the same way a diagnostic AI would. The "patent-pending algorithm to locate the optimal treatment points" likely refers to an embedded logic or heuristic, not a deep learning model trained on a large dataset. The development and refinement of such an algorithm would typically fall under engineering and design verification, not a separate "training set" in the context of clinical validation.

9. How the Ground Truth for the Training Set Was Established

Since no explicit training set for a machine learning algorithm is detailed, the concept of "ground truth for the training set" as it applies to AI/ML development is not directly applicable here. The device's underlying "algorithm" (likely a rule-based or heuristic system) would have been developed based on scientific principles of microcurrent stimulation and anatomy related to sinus pain, and refined through engineering testing and possibly user feedback during product development, rather than a labeled training dataset.

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