(42 days)
This product is a vinylpolysiloxane impression material to be used for taking intra-oral impressions.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a dental impression material named "Fusion™ Fast". This type of document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications that you are requesting for an AI/device performance study.
The letter simply states that the FDA has reviewed the premarket notification and determined that the device is substantially equivalent to legally marketed predicate devices. It confirms that the device can proceed to market subject to general controls.
Key points from the document relevant to your request (though not directly answering your detailed questions):
- Trade/Device Names: Fusion™ Fast
- Regulation Number: 21 CFR 872.3660
- Regulation Name: Impression Material
- Regulatory Class: II
- Product Codes: ELW
- Indications for Use: This product is a vinylpolysiloxane impression material to be used for taking intra-oral impressions.
- 510(k) Number: K043471
To answer your request, if this were an AI device, I would need a different type of document, such as a clinical study report or a 510(k) summary that includes performance data.
Since the information is not present in the provided document, I cannot fulfill your request for an acceptance criteria table and study details.
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).