(191 days)
The Healing Cap Multi-unit Titanium is a premanufactured prosthetic component to be directly connected to the dental abutment during soft tissue healing to protect the internal connection of the abutments and prepare the soft tissue for the prosthetic procedure. Maximum intra-oral use is 180-days.
The Healing Cap Multi-unit Titanium is a transmucosal extension secured to Nobel Biocare Multiunit Abutments. It is intended to be used during intra-oral soft tissue healing to protect the internal connection of the MUA Multi-unit Abutments and prepare the soft tissue for the prosthetic procedure (temporary and final restoration). It has a maximum intra-oral use of 180-days. The Healing Cap Multi-unit titanium portfolio consist of 6 healing cap variants. There are two different caps designs, two heights, and three diameters to accommodate the gingival anatomy and to provide the dentist with options for abutment shoulder visibility and soft tissue retraction.
The provided text is a 510(k) Premarket Notification for a medical device called "Healing Cap Multi-Unit Titanium". This document outlines the device description, indications for use, comparison to predicate devices, and a summary of non-clinical testing to demonstrate substantial equivalence.
However, it does not contain information about the acceptance criteria and the study that proves the device meets those criteria in the context of device performance related to a specific outcome measure (e.g., diagnostic accuracy for an AI device).
Instead, the "performance data" section states:
"Since the subject device does not represent a new worst case, data from the predicate device was leveraged in the following aspects of the 510(k)."
This indicates that, for this particular medical device (a passive, mechanical component for dental implants), comprehensive new performance studies beyond leveraging predicate device data and standard manufacturing/sterilization validations were not required for this 510(k) submission. Therefore, it does not describe:
A table of acceptance criteria and the reported device performance
Sample sized used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Adjudication method for the test set
If a multi reader multi case (MRMC) comparative effectiveness study was done
If a standalone performance study was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established
The document focuses on demonstrating substantial equivalence based on:
- Design Features: One-piece Healing Cap - Titanium with integrated screw, Materials (Titanium alloy Ti6Al4V ELI), Heights (4.1 and 5.5 mm), Diameters (5.0, 6.0, 6.9 mm), Compatible abutments.
- Intended Use: To be used with Multi-unit abutments during soft tissue healing.
- Non-Clinical Testing leverage: Sterilization method, Device Packaging, Shelf Life, and Biocompatibility were leveraged from the predicate device as the subject device did not represent a new worst case.
In summary, this document describes a 510(k) submission for a physical medical device (dental healing cap) and demonstrates substantial equivalence primarily by showing that its technological characteristics, materials, and intended use are highly similar to an existing predicate device, and that standard manufacturing and sterilization processes are validated or leveraged. It does not present performance data in the context of an "AI/algorithm" type device that would typically involve acceptance criteria, test sets, ground truth establishment, and human reader studies as detailed in your prompt.
§ 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.)