(78 days)
The Spectrum Designs Symmetrical Chin Implant is intended to augment or reconstruct the mandibular or chin area of the face.
Spectrum Designs Symmetrical 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.
The provided document, K980138, for the Spectrum Designs Symmetrical Chin Implant is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria through performance data.
Therefore, the document does not contain the information requested for acceptance criteria and a study proving device performance as it would for a novel device or a device requiring significant clinical validation. This 510(k) relies on the established safety and effectiveness of its predicate device, the Spectrum Designs Meniscus Chin Implant.
Specifically, the following information is not available in the provided text:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set or its data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- Details of a multi-reader, multi-case (MRMC) comparative effectiveness study, including effect size.
- Standalone (algorithm-only) performance data.
- The type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for a training set.
- How ground truth for a training set was established.
The document primarily states:
- Device Name: Spectrum Designs Symmetrical Chin Implant
- Intended Use: To augment or reconstruct the mandibular or chin area of the face.
- Demonstration of Safety and Effectiveness: Through substantial equivalence to predicate devices (specifically, the Spectrum Designs Meniscus Chin Implant). This means that the device is considered safe and effective because it is similar in design, materials, and intended use to a device already legally marketed.
- Material: Solid silicone elastomer.
The 510(k) process typically doesn't require extensive new clinical studies if substantial equivalence can be demonstrated. Instead, it relies on comparisons to legally marketed predicate devices, and adherence to general controls (like Good Manufacturing Practices) for safety and effectiveness.
§ 878.3550 Chin prosthesis.
(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(b)
Classification. Class II.