Search Results
Found 3 results
510(k) Data Aggregation
(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.
Ask a specific question about this device
(593 days)
To correct the shape of overcurved and/or painful nails without operation. To loosen and to give shape to thickened nails, overcurved nails and pincer nails without operation.
Oniko nail brace is a device for correcting the shape for painful and/or overcurved nails without the use of any operation or anesthesia. Oniko nail brace is composed of metal hooks and silicone bands. The metal hooks grasp the nail sides open to correct the shape or painful and/or overcurved nails.
This document does not contain the specific information required to answer your request in detail about acceptance criteria and a study proving device performance. The provided text is a 510(k) summary for the "Oniko nail brace," which focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria, sample sizes, and ground truth establishment.
However, based on the Performance Data section, I can infer a general type of "acceptance criteria" for biocompatibility and mention the clinical results used as evidence.
Here's what I can extract and what is missing from the provided text:
Inferred/Extracted Information:
| Section | Description |
|---|---|
| Acceptance Criteria (Inferred from Performance Data) | Biocompatibility: Non-cytotoxicBiocompatibility: Non-sensitizerBiocompatibility: Non-irritantClinical Effectiveness: Demonstrated by "clinical results" (specific metrics or thresholds are not provided) |
| Reported Device Performance | The device was found to be non-cytotoxic.The device was found to be non-sensitizer.The device was found to be non-irritant.Supported by "clinical results" (no specific performance metrics given). |
| Type of Ground Truth Used | For the biocompatibility claims: likely laboratory testing (in vitro/in vivo assays). For clinical effectiveness: "clinical results" likely refer to expert assessment of nail conditions or patient-reported outcomes, but the specific type of ground truth is not detailed. |
Missing Information (Not available in the provided text):
- A table of acceptance criteria with specific numerical thresholds and the reported device performance against those thresholds. The document only broadly states "non-cytotoxic, non-sensitizer, and non-irritant" and "supported with clinical results" but lacks quantitative criteria or metrics.
- Sample size used for the test set and data provenance: No details on the number of patients/nails, country of origin, or whether the study was retrospective or prospective.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not mentioned. The device is a physical brace, not an AI-assisted diagnostic tool, so an MRMC study would be highly unlikely for this product.
- Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an algorithm.
- Sample size for the training set: Not applicable and not mentioned.
- How the ground truth for the training set was established: Not applicable and not mentioned.
Conclusion based on the provided text:
The 510(k) summary for the "Oniko nail brace" emphasizes substantial equivalence to a predicate device (K960843 - Stop-n-grow). The performance data section briefly mentions that the device demonstrated non-cytotoxicity, non-sensitization, and non-irritation, supported by "clinical results." However, it does not provide detailed acceptance criteria, specific study designs, sample sizes, data provenance, ground truth establishment methods, or expert qualifications necessary to answer most of your detailed questions. The document aims to show that the device is as safe and effective as a legally marketed predicate, rather than providing an in-depth scientific study report.
Ask a specific question about this device
(165 days)
Ask a specific question about this device
Page 1 of 1