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The Spectrum Designs Cleft Chin Implant is intended to augment or reconstruct the mandibular or chin area of the face.

The Spectrum Designs Cleft Chin Implant is manufactured from solid silicone elastomer which is implanted in a pocket created by the surgeon, either intraorally or extraorally, in the mandibular region of the facial skeleton.

This K980461 document is a 510(k) summary for the Spectrum Designs Cleft Chin Implant. It is important to note that this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document serves as a premarket notification for a Class II medical device, establishing substantial equivalence to previously marketed devices. It outlines:

• Submitter's Data: Company and contact information.
• Device Name, Classification: "Spectrum Designs Cleft Chin Implant," Class II, Product Code 79FWP, 21 CFR 879.3550.
• Identification of Substantially Equivalent Devices: Refers to the same device by name.
• Device Description: Made from solid silicone elastomer, implanted in the mandibular region.
• Indications for Use: To augment or reconstruct the mandibular or chin area of the face.
• Contraindications for Use: Presence of infection, particularly in the implant region.
• Warnings, Precautions: Potential complications (displacement, errors in positioning, tissue necrosis, bone resorption, fibrous encapsulation, infection, neural damage, hematoma, poor wound healing, foreign body intolerance).

The FDA's response letter (pages 1-2) confirms that the device is "substantially equivalent" to predicate devices marketed before May 28, 1976. This determination is based on the device conforming to general controls provisions of the Act, including annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration, and compliance with the Quality System Regulation (QS) for Medical Devices.

Therefore, I cannot provide the requested information regarding acceptance criteria or a study proving the device meets acceptance criteria because this information is not present in the provided text. The 510(k) process for this device type typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials to establish safety and effectiveness against explicit performance acceptance criteria in the manner that might be seen for novel high-risk devices or software.

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