(212 days)
The RC Temporary Abutment is intended for use with the P.004 dental implant for temporary restoration of single crowns and bridges in the anterior and posterior region for use up to six months.
Healing abutments, often referred to as healing caps, are intended to be used with the P.004 dental implant to protect the inner configuration of the implant during the healing process and maintain, stabilize and form the soft tissue during this phase.
P.004 RC Temporary Abutment is indicated for use in Straumann P.004 RC Bone Level implants for temporary restorations of single crowns and bridges for up to six months.
P.004 Healing Abutment, customizable (cap) is indicated for use in Straumann P.004 RC Bone Level implants to protect the inner configuration of the implant during the healing process. Maintains, stabilizes and forms the soft tissue and should be placed out of occlusion for up to six months.
The Straumann P.004 Dental Implant System is an integrated system of endosseous bone level 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 devices covered in this submission are temporary abutments.
The basal portion of the abutments has 4 protrusions diametrically opposed that engage in the 4 grooves of the P.004 implant. The abutments are 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-retained restorations. Healing abutments protect the inner configuration of the abutment and contours the soft tissue during the healing phase.
Here's an analysis of the provided text regarding the acceptance criteria and study for the device, organized as requested:
Device: Straumann P.004 RC Temporary Abutments and P.004 Healing Abutments
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria or reported device performance metrics in a study context. Instead, the submission focuses on establishing substantial equivalence to predicate devices based on intended use, materials, basic design, and fundamental operating principles.
Based on the available information, the implicit "acceptance criteria" revolve around demonstrating substantial equivalence to the predicate devices and fulfilling the stated intended use without adverse events or deviations from established performance.
Therefore, a table would look like this, with the understanding that "reported performance" here refers to the rationale for substantial equivalence rather than explicit quantitative study results against pre-defined thresholds:
| Acceptance Criteria (Inferred from 510(k) submission) | Reported Device Performance (Rationale from submission) |
|---|---|
| Intended Use: For temporary restoration of single crowns and bridges (Temporary Abutment) and protecting inner implant configuration, maintaining, stabilizing, and forming soft tissue (Healing Abutment) with P.004 dental implants for up to six months. | The RC Temporary Abutment is "intended for use with the P.004 dental implant for temporary restoration of single crowns and bridges in the anterior and posterior region for use up to six months." Healing Abutments "are intended to be used with the P.004 dental implant to protect the inner configuration of the implant during the healing process and maintain, stabilize and form the soft tissue during this phase." The intended use is "identical to the predicate devices." |
| Materials: Material composition is safe and effective for temporary use. | The materials "are identical to the predicate devices." |
| Design and Function: Basic design and operating principles are consistent and safe. | The proposed abutments "have the same basic design and fundamental operating principles to the currently marketed devices." The basal portion has 4 protrusions engaging 4 grooves of the P.004 implant, seated with a screw. Used for cemented and screw-retained restorations. |
| Substantial Equivalence: Demonstrate equivalence to predicate devices. | "The proposed abutments are substantially equivalent to the currently marketed devices." This is the core finding of the 510(k) process by the FDA. |
2. Sample Size Used for the Test Set and the Data Provenance
The provided text does not describe a "test set" in the context of a clinical performance study with human subjects or a statistical evaluation of device performance data. The submission is a 510(k) premarket notification for substantial equivalence, which primarily relies on comparing the new device to existing, legally marketed predicate devices.
There is no mention of a traditional "sample size" for a test set, nor any specific data provenance (e.g., country of origin, retrospective/prospective) for a clinical performance evaluation. The "data" presented is largely a comparison of specifications and intended use against predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this 510(k) submission as it focuses on demonstrating substantial equivalence rather than presenting clinical study data with ground truth established by experts. The "expertise" involved would be that of the manufacturer's engineers and regulatory affairs personnel in preparing the submission, and the FDA reviewers in evaluating it against regulatory requirements and established predicate devices.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons stated above. There is no described "test set" and thus no need for an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable. The device described (dental abutments) is a physical medical device, not an AI software intended to assist human readers (e.g., in medical imaging interpretation). Therefore, an MRMC study related to AI assistance would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. As mentioned, the device is a physical dental abutment, not an algorithm or AI system.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For this 510(k) submission, the "ground truth" is established through regulatory precedent and technical specifications.
- Regulatory Precedent: The existence of already "legally marketed predicate devices" (Straumann P.004 Dental Implants, synOcta® Temporary Meso Abutment, P.004 RC Meso Abutment) serves as the primary ground truth. The new device is compared against these predicates to demonstrate it is "substantially equivalent" in terms of safety and effectiveness.
- Technical Specifications: The design, materials, and intended use of the new abutments are compared directly to those of the predicate devices. This involves engineering specifications and material data, validated against known safe and effective performance of the predicate.
There is no mention of clinical outcomes data, expert consensus on specific cases, or pathology reports used to establish ground truth for this particular submission.
8. The Sample Size for the Training Set
This information is not applicable. This submission describes a physical medical device, not a machine learning model, so there is no "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as above.
§ 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.)