(156 days)
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):
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Bench Testing | Passed predefined acceptance criteria. |
| Software Verification | All device functions perform as intended. |
| Compliance with Standards | Passed criteria as specified in various ISO, ANSI AAMI, USP, IEC, and ASTM standards (listed in Section 9), covering biological evaluation, software lifecycle, usability, basic safety, essential performance, home healthcare, electromagnetic disturbances, and material specifications. |
| Labeling Usability/Comprehension (OTC) | 93% agreed that the device is easy to understand. |
| 94% agreed that the instructions are easy to follow. | |
| 97% agreed that performing treatment was easy. | |
| 88% agreed that performing treatment was fast. | |
| (Implied acceptance is a high percentage of agreement for each statement, which was met.) | |
| Clinical Effectiveness (Pain Relief) | 74% of microcurrent device users experienced a reduction in sinus pain. |
| 24% of microcurrent device users experienced sinus pain reduction of 3 points or more on the visual analog pain scale (0 no pain to 10 severe pain). | |
| Statistically significant greater mean reduction in pain for active-treated subjects compared to sham after a single treatment. | |
| (Implied acceptance is a significant portion of users experiencing pain relief and statistically significant superiority over sham, which was met). | |
| Clinical Safety | Only one subject experienced minor reddening of the skin which disappeared within minutes. (Implied acceptance is a low incidence of adverse events and minor, transient nature of any events, which was met). |
| Preference | 82% preferred ClearUP Sinus Pain Relief device to their current sinus treatment(s). (This is a preference metric, not a strict effectiveness criterion, but indicates positive user reception). |
| Substantial Equivalence | The device has the same fundamental scientific technology, intended use, and similar output parameters compared to predicate devices. Differences do not raise new safety and effectiveness issues. |
2. Sample Sizes Used for the Test Set and Data Provenance
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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).
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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
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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.
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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
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Labeling Validation Study: No formal "adjudication" in the medical sense for this study. Participant feedback on comprehension and ease of use was directly collected.
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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.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).