(118 days)
BIOMET 3i Low Profile Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is screw retained to the abutment.
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This appears to be a 510(k) premarket notification for a dental abutment, which is a mechanical component, not a device that processes or analyzes data. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of software or AI/ML performance are not directly applicable in the way you've framed them for a data-driven device.
The information provided describes the regulatory submission for a physical medical device (Low Profile Abutment). The "acceptance criteria" for a physical device like this typically pertain to engineering specifications, material properties, biocompatibility, mechanical strength, and manufacturing quality, often demonstrated through laboratory testing, simulations, and adherence to recognized standards.
Here's why your specific questions about AI/ML performance, sample sizes for test/training sets, expert adjudication, and MRMC studies don't apply to this document:
- No AI/ML Component: The submission focuses on the mechanical function of a dental abutment (supporting a prosthetic device). There's no mention of any software, AI, or machine learning algorithms involved in its function or its regulatory review.
- Physical Device, Not Data-Driven: The "device" in question is a physical object implanted in a patient's mouth. Its performance is assessed through its physical properties and how it interacts with other physical components (implants, prostheses), not through data analysis or diagnostic interpretation.
- Regulatory Pathway: The document identifies this as a "Traditional 510(k) Pre-market Notification." This pathway assesses substantial equivalence to a predicate device, primarily focusing on similar technological characteristics and indications for use, often supported by design specifications, material testing, and sometimes bench or animal testing, rather than clinical studies of diagnostic accuracy.
Therefore, I cannot extract the requested information from the provided text because it describes a physical medical device submission, not an AI/ML-powered or data-driven device.
If you have a document related to an AI/ML or software device, I would be happy to analyze it against your criteria.
§ 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.)