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510(k) Data Aggregation
(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.
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