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BioForm's Juliesse 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. Juliesse is a temporary implant and resorbs within a period of 3-6 months.

Juliesse is a sterile, non-pyrogenic iniectable material consisting of an aqueous formulation of USP grade pharmaceutical excipients consisting of sterile water, glycerin, sodium carboxymethylcellulose and phosphate buffer.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance tables, or a study that proves the device meets specific acceptance criteria using a test set.

The document is a 510(k) summary for Juliesse™ Injectable Laryngeal Augmentation Implant, primarily focusing on its substantial equivalence to a predicate device and its pre-clinical safety evaluations. It states that "the battery of preclinical safety studies and animal implant studies show that the Juliesse™ Injectable Laryngeal Augmentation Implant is biocompatible when injected into soft tissues" and that "In vivo and In vitro tests were performed to address irritation, sensitization, cytotoxicity, acute and sub-chronic toxicity, genotoxicity and hemolysis. Results identified the Juliesse™ Injectable Laryngeal Augmentation Implant as a nonirritant, and nontoxic with no concerns for long-term safety." However, these are general summaries of pre-clinical tests and do not provide the detailed information requested regarding specific acceptance criteria, performance metrics, sample sizes for test/training sets, expert qualifications, or adjudication methods for establishing ground truth.

Therefore, I cannot fulfill your request for the specific details outlined in your prompt.

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The DRG Laryngeal Augmentation Implant Device is indicated for use in moreations for other inn for treatment of patients with unilateral vocal cord paralysis.

Laryngeal Augmentation Implant

I am sorry, but based on the provided document, there is no information about the acceptance criteria, a study proving device performance, sample sizes, ground truth establishment, or any details related to AI/MRMC studies for the Laryngeal Augmentation Implant.

The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a legally marketed predicate device. It specifies the regulation number, product code, and indications for use. However, it does not include the detailed study information typically found in a clinical trial report or a summary of safety and effectiveness.

Therefore, I cannot provide the requested table or answer the specific questions about the study design, sample sizes, expert qualifications, or ground truth without further information.

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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.

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