(10 days)
Abutments are intended to be placed into dental bridges to provide support for prosthetic reconstructions such as crowns or bridges.
The ITI Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially, or fully edentulous patients. The system consists of a variety of dental implants, abutments, and surgical and prosthetic parts and instruments. The device covered by this submission is an abutment.
The basal portion of the abutment has an inset octagonal design. The abutment is seated in the implant with a screw, which is mounted in the basal portion of the abutment. The abutment is used for cemented and screw restorations.
The provided document is a 510(k) summary for a dental implant abutment (Straumann RN synOcta UCLA Gold Abutment). It focuses on establishing substantial equivalence to a legally marketed predicate device rather than presenting a study demonstrating the device meets specific acceptance criteria based on performance metrics.
Therefore, most of the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance), and training set information is not applicable or available in this document.
Here's a breakdown of the information that can be extracted and a clear indication of what is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
Not applicable. The document does not describe performance-based acceptance criteria or provide specific performance metrics for the device. The basis for substantial equivalence is "intended use, material, and design" to a predicate device, not a new performance study against defined criteria.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. There is no "test set" in the context of a performance study described in this document. The submission is based on comparison to a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. No ground truth establishment for a test set is described.
4. Adjudication Method for the Test Set:
Not applicable. No test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
Not applicable. No MRMC study is mentioned.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This device is a physical dental abutment, not an algorithm or AI system.
7. The Type of Ground Truth Used:
Not applicable. There is no performance study against a ground truth described in this document.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical dental abutment, not an AI system that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, no training set or ground truth for it is relevant to this submission.
Summary of what is present in the document relevant to a regulatory submission:
- Device Name: Straumann RN synOcta UCLA Gold Abutment
- Intended Use: To be placed into dental implants to provide support for prosthetic restorations such as a crown or bridge.
- Basis for Substantial Equivalence: The device is substantially equivalent in intended use, material, and design to the 1.5mm synOcta abutments and gold copings cleared under K022859 (the predicate device). The intended use is stated to be identical.
- Regulatory Classification: Class III, Product Code NHA (Endosseous Implant).
- 510(k) Number: K041295
In conclusion, this document is a 510(k) summary for a medical device that establishes substantial equivalence based on fundamental design, material, and intended use comparison to a predicate device, rather than through a new performance study against specific acceptance criteria. Therefore, the detailed information about studies, sample sizes, experts, and ground truth for performance evaluation is not included.
§ 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.)