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Coaptite™ Laryngeal Augmentation System is intended as an injectable, space-occupying implant for vocal fold medialization and augmentation.

The Coaptite™ Laryngeal Augmentation System consists of a single use, nonpyrogenic, space-occupying implant contained in a prefilled syringe with an injection needle for laryngeal vocal fold augmentation and medialization.

Coaptite™ is available in 1.0cc syringes that are filled with either 1.0cc or a 0.5 cc volume. Coaptite™ contains calcium hydroxylapatite (Cas(PO4)3OH)2 particles (75-125 microns) suspended in a gel of USP glycerin, sterile water for injection and sodium carboxymethylcellulose (NaCMC). The calcium hydroxylapatite meets ASTM F1185. The excipients glycerin, sterile water, and NaCMC are both pharmaceutical USP grade and listed as GRAS. Calcium hydroxylapatite is radiopaque.

The properties of Coaptite™ facilitate ingrowth of surrounding tissue-over time. The implantation procedure uses direct injection to the laryngeal augmentation site with direct visualization via nasopharyngoscope.

The provided text does not contain information about specific acceptance criteria or a study that directly proves the device meets those criteria for the Coaptite™ Laryngeal Augmentation System. Instead, the document is a 510(k) Premarket Notification Submission, which focuses on demonstrating substantial equivalence to predicate devices already on the market.

Therefore, I cannot populate the table or answer the questions regarding acceptance criteria and performance study details based on the provided text.

Here's why the information is not present:

• 510(k) vs. Clinical Trial Reports: A 510(k) submission primarily relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive new clinical trials with predefined acceptance criteria for efficacy and safety. While some submissions may include limited performance data, a comprehensive clinical study report with detailed acceptance criteria is generally not a core component of a 510(k) unless specifically requested by the FDA or if the device introduces significantly different technology or indications.
• Focus on Substantial Equivalence: The document explicitly states its purpose is to demonstrate substantial equivalence (section 4.3). This involves comparing the new device's technological characteristics, materials, and intended use to those of predicate devices.

What the document does provide:

• Intended Use: "Coaptite™ Laryngeal Augmentation System is intended as an injectable, space-occupying implant for vocal fold medialization and augmentation."
• Product Description: Details on its composition (calcium hydroxylapatite particles in a gel), form (injectable), and mechanism ("facilitate ingrowth of surrounding tissue").
• Predicate Devices: Lists several predicate devices (Smith & Nephew VoCoM, Gore ReVox Thyroplasty Implant, Xomed Silicone Pre-form Blocks) and explains why Coaptite™ is considered substantially equivalent to them based on material, form, and biological action.

Without specific performance data from a clinical study, providing information on acceptance criteria, sample sizes, expert qualifications, or comparative effectiveness studies is not possible from the given text.

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