(68 days)
The intended use for the AART Pectoralis Implant is augmentation of the chest to add definition to the pectoralis muscle by placing submuscular. It may also be used for reconstruction of the pectoralis depression caused by Poland's Syndrome (congenitally absent pectoralis muscle).
The AART Pectoralis Implants are manufactured from a medical grade silicone elastomer that has been molded into various convex oval shapes. They are provided in three styles, each with a right and left mirror image. Dimensions of the implants will range from 14.4 cm to 17.6 cm in length with widths from 10.0 cm to 13.5 cm and projection (height) from 1.6 cm to 3.2 cm. The AART Pectoralis Implants are intended to be used for augmentation of the chest by placing the implant submuscular of the pectoralis muscle. They can also be used to reconstruct the pectoralis depression caused by Poland's Syndrome (congenitally absent pectoralis muscle). The surface characteristic of the implants is smooth. The AART Rectoralis. Implants will be offered non-sterile.
The provided document is a 510(k) summary for the AART Pectoralis Implant. It primarily focuses on demonstrating substantial equivalence to predicate devices and does NOT contain information about acceptance criteria, a specific study proving device performance against acceptance criteria, or any of the detailed study parameters requested in your prompt (such as sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance).
The document is a regulatory approval notice based on substantial equivalence, meaning the device is considered safe and effective because it is similar to devices already legally marketed. It does not typically involve detailed performance studies with acceptance criteria in the way you've described for AI models or diagnostic devices.
Therefore, I cannot provide the requested table and study information based on the given text.
However, I can extract the following relevant information:
- Device Name: AART Pectoralis Implant
- Intended Use: Augmentation of the chest to add definition to the pectoralis muscle by placing submuscular. It may also be used for reconstruction of the pectoralis depression caused by Poland's Syndrome (congenitally absent pectoralis muscle).
- Predicate Devices: Pectoralis Implant marketed by Allied Biomedical Corporation and the Seare Biomedical Pectoralis Implant marketed by Seare Biomedical Corp.
- Regulatory Basis: Substantial equivalence based on similarity in function, design, performance, and materials to the predicate devices.
§ 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.