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The Spectrum Designs Curvilinear Chin Implant is a silicone facial implant, designed to augment or reconstruct the mandibular or chin area of the face.

The Spectrum Designs Curvilinear Chin Implant is manufactured from medical grade solid silicone elastomer. It is provided non-sterile and available in three sizes.

This document, K980463 for "Spectrum Designs Curvilinear Chin Implant," is a 510(k) summary from 1998 for a medical device. This type of submission is for demonstrating substantial equivalence to a predicate device already on the market, rather than proving safety and effectiveness through clinical studies. Therefore, the information typically found in modern AI/ML device submissions regarding acceptance criteria, performance studies, sample sizes, expert ground truth, and adjudication methods will not be present in this document.

The document primarily focuses on:

• Identifying the submitter and device.
• Classifying the device.
• Identifying substantially equivalent predicate devices.
• Describing the device and its intended use and contraindications.
• Listing warnings and precautions.

No study is described in this document that establishes performance against acceptance criteria. The FDA's decision is based on the device being "substantially equivalent" to legally marketed predicate devices, not on a detailed performance study as would be required for a novel AI/ML device.

Therefore, most of the requested fields cannot be filled from the provided text.

Here is the information that can be extracted, along with explanations for the missing fields:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: This document does not establish specific performance acceptance criteria for the "Spectrum Designs Curvilinear Chin Implant" nor does it report device performance against such criteria. The 510(k) process for this type of device in 1998 primarily focused on demonstrating substantial equivalence to a predicate device, rather than novel performance claims from detailed clinical studies.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. No test set or performance study is described.
Data Provenance: Not applicable. No test set or performance study is described.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. No test set or ground truth establishment is described.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No test set or adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study Done: No. This is a medical implant, not an AI/ML diagnostic or assistive device.
Effect Size: Not applicable.

6. Standalone Performance Study (Algorithm Only)

Standalone Study Done: No. This is a medical implant, not an AI/ML algorithm.

7. Type of Ground Truth Used

Type of Ground Truth: Not applicable. No ground truth is established as no performance study is described. The relevant "truth" for this 510(k) is the existing safety and effectiveness profile of the predicate devices.

8. Sample Size for the Training Set

Sample Size: Not applicable. This document is for a physical implant, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Method: Not applicable. This document is for a physical implant, not an AI/ML algorithm.

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