(90 days)
The Silicone Carving Block is designed to be used in aesthetic, corrective or reconstructive surgery. The Silimod Silicone Carving Block allows the surgeon to carve a finished device for his own custom uso.
Silicone Carving Blocks
Here's an analysis of the provided text regarding the acceptance criteria and study, focusing on the absence of such information:
The provided document is an FDA 510(k) clearance letter for a "Silicone Carving Block." This letter is an acknowledgment of substantial equivalence to a predicate device, which allows the product to be marketed. It is not a document that details acceptance criteria for performance or a study demonstrating device performance against such criteria.
Therefore, the requested information elements cannot be extracted from this specific document.
To directly answer your request based on the provided text:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not present in the document.
- Reported Device Performance: Not present in the document.
2. Sample size used for the test set and the data provenance:
- This information is not provided because no performance study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided because no ground truth establishment for a performance study is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided because no performance study is described.
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 device is a "Silicone Carving Block," which is a physical material used in surgery, not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC study with AI assistance is not applicable, and no such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable, as no performance study requiring ground truth is described.
8. The sample size for the training set:
- Not applicable, as no training set for an algorithm is relevant to this device.
9. How the ground truth for the training set was established:
- Not applicable, as no training set for an algorithm is relevant to this device.
Explanation:
A 510(k) clearance letter typically confirms that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics as the predicate, or if it has different technological characteristics, that the new device does not raise different questions of safety and effectiveness. This process usually involves comparing the new device's specifications, materials, and (if applicable) basic performance characteristics to a predicate, but does not necessarily require de novo clinical studies with acceptance criteria for device performance as would be detailed in a separate clinical study report. The intent of this letter is to permit marketing based on equivalence, not to publish an detailed performance study report.
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.