Search Results

The Customized Contour Implant is intended for augmentation, reconstructive and cosmetic surgery. The Customized Contour Implant is pre-shaped to the surgeon's specification to meet the needs of a particular patient, for example facial implants, gluteal implants, calf implants, or pectoralis implants.

The Customized Contour Implant is a patient-matched device intended for augmentation, reconstructive and cosmetic surgery. The device is a single use implant intended for long term implantation as a space occupying device to form a contoured feature. The customized implant is made of medical grade silicone elastomer, in a range of durometers as specified by the surgeon.

This document is about the FDA 510(k) clearance for Implantech Associates Inc.'s Customized Contour Implant. It is a premarket notification, and as such, it does not typically contain detailed studies with acceptance criteria in the same way a clinical trial for a new drug or a more complex medical device would. The purpose of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device.

Therefore, the information regarding acceptance criteria and studies proving the device meets them, especially in the context of AI/ML performance, human readers, sample sizes for test/training sets, and ground truth establishment, is not applicable to this document.

The document primarily focuses on:

• Device Description: A patient-matched device made of medical-grade silicone elastomer for augmentation, reconstructive, and cosmetic surgery (facial, gluteal, calf, pectoralis implants).
• Predicate Device Identification: Listing several previously cleared Implantech implants (K191130, K052504, K052505, K952708) with similar materials and intended uses.
• Non-Clinical Testing: The only "studies" mentioned are non-clinical tests to demonstrate safety based on industry standards, including:
  • Sterilization validation per ISO 17655-1 and ANSI/AAMI/ISO 20857
  • Packaging validation per ISO 11607
  • Shelf life validation with accelerated and real-time aging studies
  • Cytotoxicity testing per ISO 10993-5
  • 3D printer validation
• Conclusion: These non-clinical tests indicate that the device does not raise new issues of safety or effectiveness compared to the predicate device and is substantially equivalent.

No information is provided in the document regarding:

1. A table of acceptance criteria and reported device performance (in the context of clinical/AI performance): Not applicable for this type of device and submission.
2. Sample sizes used for the test set and data provenance: No clinical test set discussed.
3. Number of experts used to establish ground truth and their qualifications: Not applicable; no ground truth establishment for AI performance.
4. Adjudication method for the test set: Not applicable.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not done; this is not an AI-assisted diagnostic device.
6. Standalone (algorithm only) performance: Not applicable; this is a physical implant, not an algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable; there is no training set for an AI algorithm.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The Customized Contour Implant is intended for augmentation, reconstructive and cosmetic surgery of the facial regions. The Customized Contour Implant is pre-shaped to the surgeon's specification to meet the needs of a particular patient.

The Customized Contour Implant is a patient-matched for augmentation, reconstructive and cosmetic surgery of the facial regions, specifically the nasal contour, the malar cheek contour, and the chin contour. The device is a single use implant intended for long term implantation as a space occupying device to form a contoured feature. The customized implant is made of medical grade silicone elastomer, in a range of durometers as specified by the surgeon.

The patient's own medical imaging (e.g., Computerized Tomography (CT) scan) is translated into a digital model of the patient's skull using VSP® Software from 3D Systems. At the recommendation of the surgeon, the VSP® Software is used either to 3D-print a skull model for the surgeon to fashion a solid implant model with commercially available plaster or silicon kits, or to create a digital implant model as an STL file. Implantech Associates manufactures the customized molds from the solid implant model provided by the surgeon, or the digital implant model provided by 3D Systems, using plaster molds or 3D-printed molds as appropriate. The Customized Contour Implant is manufactured from the customized molds and provided to the surgeon, sterile or non-sterile.

The provided text describes a 510(k) premarket notification for a medical device called the "Customized Contour Implant." This document primarily focuses on demonstrating substantial equivalence to a predicate device and includes information about non-clinical testing.

Based on the provided text, there is no information related to acceptance criteria, a study proving device meets acceptance criteria, sample size for test set, data provenance, number of experts, adjudication method, MRMC comparative effectiveness study, standalone performance, type of ground truth used, sample size for training set, or how ground truth for training set was established, as these typically pertain to studies involving AI/ML-driven devices or clinical trials, which are not detailed here.

The document describes non-clinical testing for the Customized Contour Implant:

1. A table of acceptance criteria and the reported device performance
No specific acceptance criteria or reported device performance in terms of metrics like sensitivity, specificity, accuracy, etc., are provided, as this document focuses on non-clinical testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This information is not provided in the context of the non-clinical tests performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not a study requiring expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.

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
No MRMC study was done, nor is there any mention of AI assistance in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a physical medical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the non-clinical tests described, "ground truth" would relate to established standards or validated measurements. For example, for "3D printer validation," the ground truth would be the known dimensions of the predetermined shape (1 inch cube, 1 inch diameter sphere).

8. The sample size for the training set
Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.

Summary of Non-Clinical Testing Performed (as reported in the document):

The manufacturer conducted the following non-clinical tests to demonstrate safety based on current industry standards:

• Sterilization validation: Per ISO 17655-1 and ANSI/AAMI/ISO 20857.
• Packaging validation: Per ISO 11607.
• Shelf life validation: Included accelerated and real-time aging studies.
• Cytotoxicity testing: Per ISO 10993-5.
• Bacterial endotoxins testing: Per ANSI/AAMI ST72.
• 3D printer validation: The Fortus 360MC 3D Printer and its ancillary equipment were validated to accurately print a 3D image of a predetermined shape (1 inch cube, 1 inch diameter sphere) using STL file inputs. STL file creation using the VSP® software was validated prior to the 3D printer validation.

Conclusion: The results of these tests indicated that the Customized Contour Implant is substantially equivalent to the predicate device and does not raise different questions of safety or effectiveness.

Ask a specific question about this device