(90 days)
The Spectrum Designs Anatomical Chin Implant is intended to augment or reconstruct congenital or traumatic chin deficiencies.
The Spectrum Designs Anatomical 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 two sizes.
Here's a breakdown of the acceptance criteria and study information for the Spectrum Designs Anatomical Chin Implant, based on the provided text.
Based on the provided document, the "study" that proves the device meets acceptance criteria is implied through the 510(k) submission process, which relies on demonstrating substantial equivalence to a previously legally marketed predicate device. This is not a traditional clinical study with defined performance metrics, but rather a regulatory pathway demonstrating that the new device is as safe and effective as existing ones.
Acceptance Criteria and Device Performance
Since this is a 510(k) submission for a Class II device relying on substantial equivalence, there isn't a table of discrete acceptance criteria with numerical performance targets in the way one might see for a diagnostic AI device. Instead, the "acceptance criteria" are met by demonstrating the device is:
- As safe and effective as legally marketed predicate devices.
- Has the same intended use as legally marketed predicate devices.
- Has the same technological characteristics as legally marketed predicate devices, or if there are differences, those differences do not raise different questions of safety and effectiveness.
The "reported device performance" is implicitly that the device performs equivalently to its predicates for the stated indications.
| Acceptance Criteria (Implied by 510(k) process) | Reported Device Performance (Implied by 510(k) Clearance) |
|---|---|
| Safety: Device is as safe as predicates. | Device is considered safe for its intended use. |
| Effectiveness: Device is as effective as predicates. | Device is considered effective for its intended use. |
| Intended Use: Same as predicates. | Augment or reconstruct congenital or traumatic chin deficiencies. |
| Technological Characteristics: Same or comparable to predicates without raising new safety/effectiveness questions. | Manufactured from medical-grade solid silicone elastomer, implanted in the mandibular region. |
Study Information (Based on 510(k) Substantial Equivalence Determination)
Given the nature of the 510(k) summary provided, the following points address the questions in the context of a substantial equivalence determination rather than a specific clinical trial.
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Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of this 510(k) summary. There is no mention of a traditional "test set" from a clinical study. The determination is based on a comparison to predicate devices already on the market.
- Data Provenance: Not applicable. The submission relies on information about the predicate devices and the physical characteristics/materials of the new device itself.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth as typically defined in the context of performance studies (e.g., for AI) is not established here. The FDA reviews the submitted documentation and makes a regulatory decision.
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Adjudication method for the test set:
- Not applicable. No "test set" and no expert adjudication process described for performance evaluation.
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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:
- Not applicable. This device is a physical chin implant, not a diagnostic AI system or a system requiring human interpretation of output.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the typical sense. The "ground truth" for a 510(k) determination is the established safety and effectiveness of the predicate devices that already have a market history, coupled with the review of the new device's engineering characteristics, materials, and intended use.
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The sample size for the training set:
- Not applicable. There is no AI model or "training set" for this device.
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How the ground truth for the training set was established:
- Not applicable. No AI model or "training set" for this device.
§ 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.