(52 days)
The Gluteal Implants (Silicone Carving Blocks) are for augmentation and reconstructive surgery. The Implantech Gluteal Implants are carvable to allow the surgeon to shape the device should additional shaping be desired.
Gluteal Implants (Silicone Carving Blocks)
This document is a 510(k) premarket notification letter from the FDA regarding a Gluteal Implant. This type of document, particularly one from 2005, is highly unlikely to contain the detailed study information, acceptance criteria, or performance metrics typically requested for AI/ML-based medical devices.
The information provided is primarily an FDA clearance letter for a physical medical device (gluteal implant made of silicone) and not an AI or software-as-a-medical-device (SaMD). Therefore, most of the requested fields are not applicable.
Here's a breakdown based on the provided text, highlighting what is not applicable (N/A):
| Information Requested | Response |
|---|---|
| 1. Table of Acceptance Criteria and Reported Performance | N/A. This document does not contain acceptance criteria for an AI/ML system or reported device performance metrics in that context. It's a clearance letter for a physical implant based on substantial equivalence. |
| 2. Sample size and data provenance for test set | N/A. This is a physical gluteal implant, not an AI/ML device tested with data. The 510(k) clearance is based on substantial equivalence to a predicate device, not on clinical study performance data for an AI algorithm. |
| 3. Number of experts and qualifications for ground truth | N/A. Ground truth establishment by experts is not relevant for a physical implant submission unless it involved an assessment of images for which the implant was used, which is not the case here. The ground truth for device safety and effectiveness is largely based on material properties, design, and clinical use of predicate devices for substantial equivalence. |
| 4. Adjudication method for test set | N/A. Not applicable for a physical implant. |
| 5. MRMC comparative effectiveness study | N/A. This applies to diagnostic devices or those involving human interpretation, not a physical implant. |
| 6. Standalone (algorithm only) performance study | N/A. This is not an algorithm. |
| 7. Type of ground truth used | N/A. While the safety and effectiveness of the implant would be supported by general medical knowledge, material science, and clinical experience with similar implants, the concept of "ground truth" as used in AI/ML performance evaluation does not apply directly. |
| 8. Sample size for the training set | N/A. Not an AI/ML device with a training set. |
| 9. How ground truth for the training set was established | N/A. Not an AI/ML device with training data. |
Summary of the Document's Actual Content:
The document is an FDA 510(k) clearance letter dated November 4, 2005, for a device named "Gluteal Implant" (Trade/Device Name) under the product code MIB (Ear, nose, and throat synthetic polymer material, although the device is for gluteal augmentation, the regulation number 21 CFR 874.3620 typically covers synthetic polymer materials used in ENT, implying a material-based classification rather than anatomical region).
- Indications for Use: The Gluteal Implants (Silicone Carving Blocks) are for augmentation and reconstructive surgery. They are carvable to allow the surgeon to shape the device.
- Regulatory Status: The device was found substantially equivalent to legally marketed predicate devices, allowing it to proceed to market under general controls.
- Applicant: Implantech Associates, Inc., submitted the 510(k) (K052504).
- Classification: Class II device.
The information you are seeking about acceptance criteria for an AI/ML device is not present in this physical device clearance letter.
§ 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.