(60 days)
The intended use of the AART Nasal Implant is for cosmetic augmentation and reconstruction of the nasal contour during rhinoplasty. They are intended for insertion via an intraoral or nasal sill incision.
The AART Nasal Implants are manufactured from a medical grade silicone elastomer that has been molded into various "L" or straight shapes with concave convex dorsal aspects which reach from the alar cartilage to the radix. They are provided in seven styles with dimensions varying in length, width, and height. Titanium Oxide and Iron Oxide pigments may be added to the silicone to make the implant opaque if requested by the physician. These pigments are widely used in cosmetic surgery implant applications and will be lot tested for cvtotoxicity. The AART Nasal Implants are intended to be used for augmentation and reconstruction of the nasal contour during rhinoplasty. The surface characteristic of the implants is smooth. The AART Nasal Implants will be offered sterile and non-sterile.
This 510(k) submission (K021418) for the AART Nasal Implant details its substantial equivalence to previously marketed predicate devices rather than providing a study demonstrating specific performance acceptance criteria for the device itself. Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set ground truth) are not applicable as they relate to performance studies, which are not present in this document.
Here's a breakdown based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material: Medical grade silicone elastomer | Material: Manufactured from medical grade silicone elastomer; Titanium Oxide and Iron Oxide pigments may be added (lot tested for cytotoxicity). |
| Design: Molded into various "L" or straight shapes with concave-convex dorsal aspects, reaching from alar cartilage to radix. Seven styles with varying length, width, and height. Smooth surface. | Design: Matches the description; seven styles with varying dimensions; smooth surface. |
| Function/Intended Use: Cosmetic augmentation and reconstruction of the nasal contour during rhinoplasty, intended for insertion via intraoral or nasal sill incision. | Function/Intended Use: Identical to predicate devices: "cosmetic augmentation and reconstruction of the nasal contour during rhinoplasty. They are intended for insertion via an intraoral or nasal sill incision." |
| Performance: Substantially equivalent to predicate devices in material, design, function, and performance. | Performance: "Substantially equivalent in function, design, performance and materials to the Duralastic Anatomical Nasal Implant marketed by Allied Biomedical Corporation of Ventura, CA and the Seare Biomedical Nasal Implant marketed by Seare Biomedical Corp. of Salt Lake City, Utah." All products have identical intended uses and are offered in similar shapes and sizes. |
| Sterilization: Sterilized by Gamma radiation, following ANSI/AAMI/ISO 11137-1994 standard. | Sterilization: "Will be sterilized by Gamma radiation. The sterilization cycle will be determined and validated following the ANSI/AAMI/ISO 11137-1994 standard 'Sterilization of health care products - Requirements for validation and routine control -Radiation sterilization'." |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission is based on substantial equivalence to predicate devices, not a new performance study requiring a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See point 2.
4. Adjudication method for the test set
- Not Applicable. See point 2.
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 physical nasal implant, not an AI or imaging device that would involve human readers or comparative effectiveness studies with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- Substantial Equivalence: The "ground truth" for this submission is the established safety and effectiveness record of existing, legally marketed predicate nasal implants (Duralastic Anatomical Nasal Implant and Seare Biomedical Nasal Implant). The AART Nasal Implant demonstrates that it is substantially equivalent in material, design, function, and performance to these predicates.
8. The sample size for the training set
- Not Applicable. As this is not an AI or machine learning device, there is no training set in the conventional sense.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.