(42 days)
The intended use of the AART Gluteal Implant (Silicone Carving Block) is for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary. It may be used in body contouring to minimize muscular defects.
The AART Gluteal Implants (Silicone Carving Blocks) are manufactured from a medical grade silicone elastomer that has been molded into various convex oval or round shapes. They are provided in four styles with dimensions varying in length, width, height and initial shape. The AART Gluteal Implant (Silicone Carving Block) is intended to be used for augmentation and reconstructive surgery where additional shaping by the surgeon may be necessary.
Here's an analysis of the provided text regarding the AART Gluteal Implant, focusing on acceptance criteria and study details.
Based on the provided document, there is no information about specific acceptance criteria or an associated study that proves the device meets such criteria.
The document is a 510(k) Summary and an FDA clearance letter for a medical device called the "AART Gluteal Implant (Silicone Carving Block)." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a dedicated study.
Therefore, most of the requested information cannot be extracted from this document. However, I can still fill in what's available and explain why other sections are blank.
Analysis of Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The 510(k) submission focuses on substantial equivalence rather than explicit performance criteria for this specific device. | Not specified in the document. Performance is inferred to be similar to the predicate device due to substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample size for test set: Not applicable. The document describes a 510(k) submission based on substantial equivalence, not a clinical study involving a test set of data.
- Data provenance: Not applicable. No clinical data is presented for this device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of experts: Not applicable. No test set requiring ground truth establishment is described.
- Qualifications of experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication method: Not applicable. No test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC study performed: No. The document does not describe any MRMC comparative effectiveness study. The submission is for substantial equivalence.
- Effect size of human readers with vs. without AI assistance: Not applicable. This device is a physical implant, not an AI-assisted diagnostic or therapeutic tool.
6. Standalone (Algorithm Only) Performance Study
- Standalone study performed: No. This device is a physical implant, not an algorithm.
7. Type of Ground Truth Used for the Test Set
- Type of ground truth: Not applicable. No test set is described.
8. Sample Size for the Training Set
- Sample size for training set: Not applicable. As this is a physical implant and not an AI-based system, there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
- Method of ground truth establishment: Not applicable.
Summary Explanation:
The provided document is a 510(k) clearance for a Class II medical device (ear, nose, and throat synthetic polymer material, although the device is a gluteal implant, it was classified under this regulation number for some reason, as noted in the FDA letter). The core of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing material properties, design, intended use, and performance characteristics to show they are sufficiently similar, meaning the new device is as safe and effective as the predicate.
For devices cleared through the 510(k) pathway, especially those like physical implants, extensive clinical trials with strict acceptance criteria and performance data (as would be seen in a PMA submission or for AI/diagnostic devices) are often not required if substantial equivalence can be adequately demonstrated. The document clearly states: "The AART Gluteal Implant is substantially equivalent in function, design, performance and materials to the Silimed Gluteal Implant marketed by Silimed LLC." This statement, along with the device description and comparison to the predicate, forms the basis of the FDA's clearance, not performance against specific, pre-defined acceptance criteria.
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.