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The Spectrum Designs Profile Malar Implant is intended to augment or reconstruct the malar region of the face.

Spectrum Designs Profile Malar Implant is manufactured from solid silicone elastomer. The implant is implanted in a pocket created by the surgeon in the malar-zygomatic region of the facial skeleton to augment the existing facial structure.

The provided text is a 510(k) summary for the "Spectrum Designs Profile Malar Implant". It describes the device, its indications for use, and identifies substantially equivalent devices. However, the document does not contain information regarding acceptance criteria or a study proving the device meets said criteria.

Therefore, I cannot populate the table or answer the questions as the information is not present in the provided text. The document primarily focuses on the regulatory submission process and the characteristics of the device itself, not on performance studies or acceptance criteria.

Missing Information:

• Acceptance Criteria and Reported Device Performance: No acceptance criteria or performance metrics are mentioned.
• Sample size and data provenance: No study details are provided, so sample size and data provenance are unknown.
• Number of experts and qualifications: No study details are provided, so expert information is unknown.
• Adjudication method: No study details are provided, so adjudication method is unknown.
• MRMC comparative effectiveness study: No such study is mentioned.
• Standalone algorithm performance: This is a physical implant, not an algorithm, so this question is not applicable.
• Type of ground truth: No study details are provided, so ground truth type is unknown.
• Training set sample size: No study details are provided, so training set information is unknown.
• How ground truth for training set was established: No study details are provided, so training set ground truth establishment is unknown.

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