(300 days)
NailLift is an ingrown toenail corrector that corrects nail curvature by lifting the curved toenails into a more natural shape upon application. The correction of nail curvature results in decreased pain.
The NailLift is a device for correcting the shape for painful and/or deformed nails without surgery. The NailLift device utilizes Nitinol alloy wires to lift the outer edges of the ingrown or deformed nail. The device uses steel clips to attach the wire form to the nail.
Here's an analysis of the provided text regarding the NailLift device, focusing on its acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pain relief upon NailLift application | 99% of patients experienced pain relief upon NailLift application |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 149 patients.
- Data Provenance: Not explicitly stated, but the context of "Before coming into the clinic" suggests it was a clinical study, likely prospective, where patients were evaluated at specific intervals. The country of origin is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The ground truth for the test set (pain relief) was established directly by patient self-reporting using a Visual Analogue Scale (VAS), not by experts.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was based on patient self-reported pain levels using a VAS, not expert adjudication of findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs Without AI Assistance
Not applicable. The NailLift is a physical medical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. As noted above, the NailLift is a physical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used was patient-reported outcomes (PROs), specifically pain levels measured via a Visual Analogue Scale (VAS).
8. The Sample Size for the Training Set
Not applicable. The NailLift is a physical device, not a machine learning algorithm that requires a training set. The clinical feedback from 149 patients served as the performance evaluation data, not a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
Summary of the Study:
The study evaluated the effectiveness of the NailLift device in providing pain relief for ingrown toenails.
- Study Design: Clinical feedback was collected from 149 patients.
- Methodology: Patients rated their pain on a Visual Analogue Scale (VAS) from 0 to 10 at various intervals:
- Before coming into the clinic
- Immediately after NailLift application
- After NailLift removal
- Performance Metric: The primary metric was the "difference of pain" between these intervals.
- Results: The study showed that "99% of patients experienced pain relief upon NailLift application" (comparing pain before clinic vs. immediately after application). Further data presented in a table illustrates the distribution of pain differences across the patient cohort at different stages of the treatment.
Conclusion:
The study demonstrated that the NailLift device significantly reduces patient-reported pain associated with ingrown toenails upon application, meeting the implied acceptance criterion of providing pain relief.
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