(90 days)
The Spectrum Designs Concave Back Chin Implant is intended to augment or reconstruct congenital or traumatic chin deficiencies.
The Spectrum Designs Concave Back Chin Implant is manufactured from medical grade 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. It is provided non-sterile and available in six sizes.
The provided document focuses on the 510(k) summary for the "Spectrum Designs Concave Back Chin Implant" and the FDA's clearance letter. This type of submission, particularly for a Class II device like a chin implant in 1998, typically relies on substantial equivalence to a predicate device rather than extensive new clinical trials with detailed performance acceptance criteria and study designs in the way that, for example, a novel AI diagnostic device would.
Therefore, the information requested in your prompt (especially regarding AI-specific questions like MRMC studies, standalone performance, training sets, and ground truth establishment for AI models) is not applicable to this document. This document describes a physical medical implant device, not an AI or software-as-a-medical-device (SaMD).
Here's an analysis based on the information provided, recognizing the nature of the device:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of quantitative acceptance criteria or detailed performance results in the way one would for a diagnostic or AI device. For a physical implant like this, "acceptance criteria" are generally met by demonstrating:
- Substantial Equivalence: The primary "acceptance criterion" for 510(k) clearance is demonstrating that the new device is as safe and effective as a legally marketed predicate device.
- Biocompatibility: Implied by the use of medical-grade silicone and historical use of similar predicate devices.
- Manufacturing Quality: Assumed by compliance with GMP regulations (Quality System Regulation - 21 CFR Part 820).
- Intended Use: The indications for use match or are comparable to the predicate.
Reported Device Performance (based on substantial equivalence):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness comparable to predicate device | Substantially equivalent to McGhan Medical Corp. Concave Back Chin Implant |
| Material Biocompatibility | Manufactured from medical-grade solid silicone elastomer |
| Functional Augmentation/Reconstruction of Chin Deficiencies | Designed to augment or reconstruct congenital or traumatic chin deficiencies |
| Manufacturing Quality Standards | Assumed to comply with Quality System Regulation (21 CFR Part 820) |
| Presence of Contraindications | Same contraindications as routine aesthetic surgery (infection) |
| Potential Complications | Same potential complications as similar implants (displacement, tissue necrosis, bone resorption, encapsulation, infection, etc.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as there is no "test set" in the context of clinical trial data or performance evaluation for a software/AI device. The clearance is based on substantial equivalence to a predicate device, material properties, and intended use, not on a specific clinical study with a detailed test set described in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as there was no test set requiring expert ground truth for this type of device and submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there was no test set requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This is a physical implant, not an AI or diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is a physical implant, not an AI or diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this type of device, the "ground truth" for safety and effectiveness is primarily based on:
- Historical performance of predicate devices: The FDA's assessment relies on the established safety and efficacy profile of the "McGhan Medical Corp. Concave Back Chin Implant."
- Material properties: The use of "medical-grade solid silicone elastomer" with a known history of safe implantation.
- General clinical understanding of chin augmentation: The medical community's knowledge of the indications, contraindications, and potential complications of such procedures.
8. The sample size for the training set
This is not applicable as there is no training set for an AI model.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for an AI model.
§ 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.