(86 days)
The Daralastic Anatomical Nasal Implants are intended to be used to augment or reconstruct the nasal bridge and nasal profile for cosmetic or reconstructive surgery.
Duralastic Nasal implants are "L" shaped or straight with concave convex dorsal aspect which reached from the alar catilage to the radix. These silicone elastomer rubber implants are made from specially formulated silicone elastomers designed for implantation. The LSR 30 Implant Grade elastomer is Masterfiled at FDA and has thoroughly tested for biocompatibility, mutagenicity, carcinogenicity, and cytotoxicity. These referenced material characterizations are found in Applied Silicone's Master File MAF-562. The Duralastic Nasal Implants will be provided sterile and nonsterile. Several biocompatible pigments are used to make the white and flesh tone versions of these implants.
The provided text describes a 510(k) premarket notification for Duralastic Nasal Implants, focusing on their substantial equivalence to previously cleared devices. It does not contain information typically found in a study proving a device meets acceptance criteria, such as specific performance metrics, test methodologies, or statistical analyses. The document is primarily concerned with regulatory approval based on material equivalence and intended use.
Therefore, many of the requested details about acceptance criteria, study design, and performance are not available in the provided text.
Based on the available information, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in the form of performance metrics for the device’s clinical efficacy or safety, nor does it report specific device performance results from a study designed to meet such criteria.
The "physical properties" listed can be considered inherent characteristics of the material used, not performance criteria from a clinical study.
| Acceptance Criteria (Inferred from Material Properties) | Reported Device Performance (Material Properties) |
|---|---|
| Durometer | 30 Shore A |
| Elongation | 650% |
| Tensile Strength | 950 PSI |
| Tear Strength (Tear Die C) | 150 PSI |
| Specific Gravity | 1.12 |
| Modulus (at 200% Elongation) | 300 PSI |
| Surface | Smooth and Textured |
| Biocompatibility | Thoroughly tested (referenced in Applied Silicone's Master File MAF-562) |
| Mutagenicity | Thoroughly tested (referenced in Applied Silicone's Master File MAF-562) |
| Carcinogenicity | Thoroughly tested (referenced in Applied Silicone's Master File MAF-562) |
| Cytotoxicity | Thoroughly tested (referenced in Applied Silicone's Master File MAF-562); Pigments also tested for cytotoxicity |
| Sterility (Post-sterilization) | Achieved via gamma radiation (2.5 - 4.2 Megarads) per ANSI/AAMI/ISO 1137-1994 Method 1 Testing |
2. Sample size used for the test set and the data provenance
Not applicable. The document describes a regulatory submission based on substantial equivalence, not a clinical performance study with a test set of patient data. The biocompatibility, mutagenicity, carcinogenicity, and cytotoxicity are mentioned as "thoroughly tested" material characterizations referenced in a Master File (MAF-562), but no sample sizes or data provenance for these tests are provided in this K971481 submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This information pertains to studies establishing clinical performance, which is not detailed in this regulatory submission.
4. Adjudication method for the test set
Not applicable. There is no described test set requiring adjudication in this document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a silicone implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a silicone implant, not an algorithm.
7. The type of ground truth used
For the material properties (biocompatibility, etc.), the "ground truth" would be established through specific laboratory tests and assays designed to evaluate these characteristics, as per the standards referenced (e.g., those implicitly followed for MAF-562). For sterility, the ground truth is established through validation of the sterilization cycle according to ANSI/AAMI/ISO 1137-1994.
8. The sample size for the training set
Not applicable. This information is relevant for machine learning models, not for this type of medical device submission.
9. How the ground truth for the training set was established
Not applicable. This information is relevant for machine learning models, not for this type of medical device submission.
Summary of what the document focuses on:
The document primarily focuses on establishing Substantial Equivalence (SE) to a predicate device (Applied Biomedical nasal implants, previously cleared under K952705). This means that instead of conducting new clinical trials to prove safety and effectiveness, the manufacturer argues that their device is as safe and effective as a legally marketed device due to similar technology, materials, and intended use.
Key arguments for SE:
- Same molds and materials: The Duralastic nasal implants use the "very same molds and materials" as the Applied Biomedical nasal implants.
- Material Characterization: The silicone elastomer (LSR 30 Implant Grade) and pigments are supported by a Master File (MAF-562) which details their biocompatibility, mutagenicity, carcinogenicity, and cytotoxicity tests.
- Intended Use: The intended use for augmentation and reconstruction of the nasal contour is consistent.
- Sterilization: The sterilization process (gamma radiation) is validated according to recognized standards (ANSI/AAMI/ISO 1137-1994).
In essence, the "proof" the device meets acceptance criteria is primarily through its similarity to a previously approved device and the established safety of its constituent materials and sterilization process, rather than a standalone clinical study detailed within this summary.
§ 878.3680 Nose prosthesis.
(a)
Identification. A nose prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the nasal dorsum.(b)
Classification. Class II.