(140 days)
The LW UCLA Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
The LW UCLA Abutment is compatible with the LW Fixture and LW Abutment Screw in the LW Implant System, K223924. The Abutment is used as a support of prosthesis to restore the patient's chewing function. It is made of Co-Cr-Mo alloy (ASTM F1537) in the main body and POM (ASTM F1855) in the plastic sleeve, and it is provided non-sterile, which are required to be sterilized by the enduser before use. The dimensions are O 4.5 (D) x 10.0 mm (P/H, when the main body and plastic sleeve are connected.).
The provided document is a 510(k) summary for a medical device called "LW UCLA Abutment," which is an endosseous dental implant abutment. It describes the device's indications for use, technological characteristics, and non-clinical test data to demonstrate substantial equivalence to a predicate device.
However, the document does not contain the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies for demonstrating the device meets performance criteria in the context of an AI/ML powered device.
The non-clinical tests mentioned are:
- End User Sterilization Validation: Conducted according to ISO 17665-1 and ISO 17665-2 to ensure the device can be properly sterilized by the end-user.
- Biocompatibility Tests: Performed according to ISO 10993-1:2009 and FDA guidance to demonstrate the biocompatibility of the materials used.
The conclusion states that "The non-clinical testing results have met the acceptance criteria and demonstrated the substantial equivalence with the predicate device." However, the specific acceptance criteria values for these tests are not provided in the document, nor are the detailed study results that prove these criteria are met (only that they "met the acceptance criteria").
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance or the other detailed study information, as it is not present in the provided text. The document focuses on establishing substantial equivalence based on material, design, and non-clinical safety aspects for a dental implant abutment, not on the performance evaluation of an AI-powered diagnostic or predictive device.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)