(80 days)
The Silicone Pre-form Blocks are indicated as an implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation.
Xomed Silicone Pre-form Blocks are sterile supplied implants made from silicone elastomer molded into a pre-form sizes as specified on the product label. Metric graduations on the implant surface helps in sizing the implant for patient need. The implants are to be trimmed and shaped to size by the surgeon for individual patient needs. The devices are intended for single patient use only. As a prescription device, the surgeon should be familiar with the skills and training for laryngeal reconstruction and vocal fold augmentation with silicone implants.
This document describes the Xomed Silicone Pre-form Blocks, a medical device. However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria.
The provided text is a 510(k) summary and an FDA clearance letter from 1998 for a medical device. This type of regulatory submission primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing detailed performance data from a clinical or technical study using specific acceptance criteria as you've requested.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a detailed study because that information is not present in the provided text.
The document discusses:
- Device Name: Xomed Silicone Pre-form Blocks
- Intended Use: As an implant material for surgical reconstructions as a space-occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation.
- Substantial Equivalence: To predicate devices (Xomed silicone blocks and strips, and Montgomery Thyroplasty Implants) based on material (silicone elastomer) and intended use.
- Device Description: Sterile supplied implants made from silicone elastomer, molded into pre-form sizes, to be trimmed and shaped by the surgeon.
To answer your questions, I would need a different type of document, such as a clinical study report, a special controls guidance document, or a detailed engineering and performance validation report, which are typically more extensive than what's provided in a 510(k) summary for this type of device.
§ 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.