(49 days)
BioForm's Laryngeal Augmentation Implant is indicated as a resorbable implant material to aid in surgical reconstructions as a space occupying material in laryngeal surgical procedures for vocal fold medialization and augmentation. The Laryngeal Augmentation Implant is a temporary implant and resorbs within a period of 3-6 months.
The Laryngeal Augmentation Implant is a flexible, resorbable implant used as a space filling material for soft tissue augmentation. The Laryngeal Augmentation Implant is placed via percutaneous injection under local anesthesia with direct visualization via nasopharyngoscope. The ability to place the implant without open surgery offers both safety and convenience to the surgeon and patient. The system is designed to resorb with eventual in-growth of surrounding tissue. Every component of the implant has a minimum of twenty years use as a biomaterial.
The provided text is a 510(k) summary for a medical device called the Laryngeal Augmentation Implant. This type of document is for regulatory submission to the FDA to demonstrate substantial equivalence to a predicate device, rather than a clinical study report proving performance against acceptance criteria in the context of AI/software device evaluation.
Therefore, the information required in the prompt (acceptance criteria, device performance, sample sizes for test/training sets, ground truth methodology, expert qualifications, adjudication, MRMC studies, standalone performance) is not present in this document. The document primarily focuses on:
- Product Description and Intended Use: Explains what the device is, how it works, and its purpose.
- Substantial Equivalence: Compares the device to existing, legally marketed predicate devices to argue that it is equally safe and effective.
- Biocompatibility and Sterilization: Details preclinical safety studies and sterilization methods.
- Summary: Reaffirms the device's safety and effectiveness.
- FDA Response: The FDA's letter granting 510(k) clearance based on substantial equivalence.
It is important to note: For a physical medical implant like this, "acceptance criteria" and "device performance" would typically refer to outcomes from non-clinical (e.g., in-vitro, animal studies) and clinical trials (human studies) measuring safety endpoints (e.g., adverse events, infection rates, rejection) and effectiveness endpoints (e.g., vocal fold medialization success, duration of effect, patient-reported outcomes). However, the 510(k) summary provided does not detail specific, quantitative acceptance criteria or corresponding clinical study results in the format requested for AI/software evaluations.
In summary, based on the provided document:
The document does not contain the information necessary to fulfill any of the requested points regarding acceptance criteria, device performance, study details (sample sizes, data provenance, ground truth, expert qualifications, adjudication), or AI-specific evaluations (MRMC, standalone performance). This is because the nature of a 510(k) summary for an ordinary medical device submission differs significantly from a clinical study report for an AI/software as a medical 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.