(47 days)
The Spectrum Designs Projection Malar Implant is intended to augment or reconstruct the malar region of the face.
Spectrum Designs Projection 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 document is a 510(k) summary for a medical device called the "Spectrum Designs Projection Malar Implant." This type of document is a pre-market notification submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, not a detailed study report proving the device meets specific acceptance criteria through clinical trials or performance studies as one might expect for a new, higher-risk device.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, study design, sample sizes, expert involvement, and ground truth derivation is not present in this type of regulatory submission. The 510(k) process primarily relies on demonstrating equivalence to an existing device rather than presenting novel performance data.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent:
Acceptance Criteria and Device Performance Study (Based on 510(k) Submission)
The provided document is a 510(k) summary for a malar implant. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies against explicitly defined acceptance criteria. Therefore, the document does not contain the level of detail regarding acceptance criteria and performance study results typically associated with a clinical trial or a novel device submission.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not specify quantitative acceptance criteria or clinical performance metrics. The "performance" described relates to the intended function and substantial equivalence, not detailed clinical outcomes or efficacy rates from a study.
| Acceptance Criterion (Type) | Reported Device Performance (as implied by 510(k)) |
|---|---|
| Material Composition | Manufactured from solid silicone elastomer (same as predicate). |
| Intended Use | To augment or reconstruct the malar region of the face (same as predicate). |
| Surgical Implantation Method | Implanted in a pocket created by the surgeon in the malar-zygomatic region (implied same as predicate). |
| Identified Risks/Complications | Potential for displacement, positioning errors, tissue necrosis, bone resorption, fibrous encapsulation, infection, neural damage, hematoma, poor wound healing, patient intolerance to foreign body (same as or similar to predicate). |
| Substantial Equivalence | Deemed substantially equivalent to legally marketed predicate devices (Spectrum Designs Silhouette Malar Implant). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" or a formal clinical study with a determined sample size. The 510(k) process is typically based on a comparison to a predicate device and may involve bench testing, but not clinical trials with human subjects for performance evaluation unless specifically required for novel aspects. Therefore, information on sample size and data provenance (e.g., country of origin, retrospective/prospective nature) is not available in this summary.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Since a formal clinical "test set" and corresponding ground truth establishment for performance evaluation are not described in this 510(k) summary, there is no information on the number or qualifications of experts used for this purpose.
4. Adjudication Method for the Test Set
As there is no described "test set" or clinical study for performance evaluation, an adjudication method is not applicable or mentioned in this document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study is typically relevant for interpretative devices (e.g., imaging AI). This device is a physical implant. The document does not mention or imply any MRMC study, nor does it refer to human readers or AI assistance.
6. Standalone (Algorithm Only) Performance Study
This device is a physical implant, not an algorithm or software. Therefore, a "standalone (algorithm only)" performance study is not applicable and not mentioned.
7. Type of Ground Truth Used
Given the nature of a 510(k) submission for a physical implant, and the absence of a detailed clinical study for performance evaluation, the concept of "ground truth" as typically used for diagnostic or AI-driven devices is not directly applicable or described. The "ground truth" for substantial equivalence often relates to material properties, intended use, and known safety/performance characteristics of the predicate device.
8. Sample Size for the Training Set
The document does not describe a "training set" as this is not an AI/ML device. The 510(k) process relies on demonstrating equivalence to an existing device, not training a novel algorithm.
9. How the Ground Truth for the Training Set Was Established
As there is no training set described for this physical implant, the method for establishing "ground truth" for a training set is not applicable or mentioned.
§ 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.