(98 days)
DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.
The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system by a change in sterilization status to provide products sterile to the end user that were previously cleared to be provided non-sterile. The subject device abutments and abutment screws were cleared previously to be provided non-sterile to the end user in K170588, K191986, K212628, and K22288. All subject device components will now be provided sterile.
The subject device components include Healing Abutments, Multi-Unit Abutments (0, 17°, and 30°), and abutment screws.
The provided text is a 510(k) summary for the DESS Dental Smart Solutions, an endosseous dental implant abutment. It details the device, its intended use, and its substantial equivalence to previously cleared predicate and reference devices. However, this document does not contain the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.
The 510(k) submission for this dental abutment focuses on establishing substantial equivalence based on:
- Design and Material: The subject device components are identical in design, material (Ti-6Al-4V alloy, DLC coating), and technological characteristics to previously cleared devices.
- Manufacturing: The manufacturing process is consistent with previously cleared devices.
- Biocompatibility: Referenced from previous K-clearances.
- Sterilization: The main change in this submission is expanding the system to provide products sterile to the end-user via gamma irradiation, which was validated by referencing a previous K-clearance (K212538).
- MR Environment Testing: Non-clinical analysis was performed to evaluate the subject devices in the MR environment, referencing published literature and FDA guidance.
- Shelf Life Testing: Referenced from a previous K-clearance (K212538) for samples after accelerated aging.
Therefore, I cannot fulfill your request to describe the acceptance criteria and a study proving an AI/ML device meets them based on the provided text, as this document is not about an AI/ML medical device. It's about dental implant abutments and establishes substantial equivalence through non-clinical performance data and comparison to predicate devices, not through AI/ML performance metrics.
To provide the information you requested, I would need a document detailing the validation of an AI/ML medical device, which would include definitions of acceptance criteria (e.g., accuracy, sensitivity, specificity), details of training and test datasets, ground truth establishment, and potentially clinical effectiveness studies if applicable.
§ 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.)