(10 days)
RN SynOcta Temporary Meso Abutments are for use in RN Straumann Dental Implants for temporary restoration of single crowns in the anterior and posterior region for use up to six months.
Description of these Abutment is a temporary abutment made of medical grade plastic structure for immediate temporization by the clinician. This can be customized by the clinician and serves as a base for direct veneering or cemented restoration. The abutment is strengthened by an inlay of Titanium alloy that fits precisely into the Straumann Regular Neck (RN) implants.
The provided text is a 510(k) summary for the "RN synOcta Temporary Meso Abutment." This document is a premarket notification to the FDA for a medical device and therefore describes the device, its intended use, and claims substantial equivalence to previously cleared devices. It does not contain an acceptance criteria table, detailed study results, or information about the performance evaluation of a device against specific acceptance criteria in the way a research paper or a clinical trial report would.
Here's an analysis based on the provided text, addressing the points where information is available and noting where it is not:
The document explicitly states that the device is "substantially equivalent" to a predicate device, which is the primary method of approval for 510(k) submissions. This means a new study to prove specific acceptance criteria is often not required if substantial equivalence can be demonstrated.
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as a table of numerical performance criteria. The acceptance criterion for a 510(k) device is primarily "substantial equivalence" to a predicate device. This implies that the new device must perform as safely and effectively as the predicate device.
- Reported Device Performance: The document states: "The Abutment is a temporary abutment... for immediate temporization by the clinician. This plastic structure can be customized by the clinician and serves as a base for direct veneering or cemented restoration. The abutment is strengthened by an inlay of Titanium alloy that fits precisely into the Straumann Regular Neck (RN) implants. It is substantially equivalent in design and intended use with the previously cleared synOcta Post for temporary restoration, K990342." This describes the device's function and composition, but not specific performance metrics or comparative data against a set of numerical acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided in the 510(k) summary. For a substantial equivalence claim, detailed testing data (like sample sizes for a clinical trial) might not be necessary if the design and material are sufficiently similar to the predicate and non-clinical bench testing or engineering analysis is deemed sufficient by the FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not provided. This type of detail is typical for studies involving human interpretation or subjective assessment, which is not the primary focus of this 510(k) summary for a physical medical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided. Adjudication methods are relevant for studies where multiple experts interpret data, which is not described in this document.
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 provided. MRMC studies are typically for diagnostic imaging devices or AI-assisted diagnostic tools. This device is a dental implant abutment, a physical component used in dental restoration, not an imaging or AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not provided. This question is relevant to AI or automated diagnostic systems, not a physical dental abutment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- This information is not provided. For a physical medical device submitted via 510(k), the "ground truth" to establish safety and effectiveness is often based on engineering principles, materials science, biocompatibility testing, mechanical testing, and comparison to the predicate device's established safety and efficacy. Direct clinical "ground truth" in the sense of pathology or outcomes data from a de novo study is not typically required if substantial equivalence can be demonstrated through other means.
8. The sample size for the training set
- This information is not applicable/not provided. There is no mention of a "training set" because this device is not an AI or machine learning model.
9. How the ground truth for the training set was established
- This information is not applicable/not provided. As above, there is no "training set."
Summary of available information from the document:
The provided document is a 510(k) summary for a physical medical device (dental abutment). The primary "study" that proves the device meets acceptance criteria is the demonstration of substantial equivalence to an existing, legally marketed predicate device (synOcta Post for temporary restoration, K990342). This typically involves:
- Comparison of intended use: Both the new device and the predicate device are indicated for temporary restorations in the anterior and posterior region for up to 6 months.
- Comparison of design and materials: The new device is described as "very similar" in design to the predicate and made of "medical grade plastic structure" strengthened by a "Titanium alloy inlay."
- Engineering and performance testing (implied): While not detailed in this summary, a 510(k) submission for such a device would include non-clinical testing (e.g., mechanical, biocompatibility) to demonstrate that the new device performs as safely and effectively as the predicate, especially given similar materials and design.
The document does not describe a clinical trial, a study with human subjects, or an AI/software performance evaluation. Therefore, most of the questions relating to specific study methodologies, expert opinions, or AI performance metrics are not addressed in this 510(k) summary.
§ 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.)