(266 days)
Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations.
The subject devices represent a line extension of the Straumann Dental Implant System (SDIS). The subject devices are an assembly of a noble metal alloy (Ceramicor®) Abutment Base and a polymer (POM) Modeling Aid. The Modeling Aid is attached to the abutment base by means of a friction fit. The subject devices employ the same Modeling Aid (catalog no. 049.217) as the identified predicate devices. The subject devices use the same Basal Screw for fixing the finished restoration to the implant (catalog no. 049.128) as the identified predicate devices. The subject devices interface with Straumann Tissue Level (TL) implants having the Regular Neck (RN) or Wide Neck (WN) implant-to-abutment interface. The subject devices do not engage the anti-rotation features within the TL implants. The non-engaging design makes these devices suitable for the fabrication of bar and bridge superstructures by the dental laboratory using either casting or soldering techniques.
This document is a 510(k) Premarket Notification for a dental abutment, specifically the "Straumann® synOcta Gold Abutments for Bridge." The purpose of this notification is to demonstrate that the new device is substantially equivalent to existing predicate devices already on the market, rather than proving a new medical claim or performance characteristic that would require extensive clinical trials. Therefore, the information provided focuses on the device's design, material, and mechanical performance compared to a predicate, not on complex acceptance criteria for a diagnostic algorithm or a clinical outcome.
Here's an analysis of the provided text in the context of the requested information, understanding that this is for a physical medical device (dental abutment) and not an AI/diagnostic tool:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of "acceptance criteria" in the way one would for a diagnostic device (e.g., sensitivity, specificity, accuracy thresholds). Instead, it relies on demonstrating substantial equivalence to a predicate device through conformity to existing standards and showing comparable mechanical performance.
| Acceptance Criterion (from Guidance/Standard) | Reported Device Performance (Subject Device) |
|---|---|
| Conformity with FDA Guidance: Root-form Endosseous Dental Implants and Endosseous Dental Abutments (May 12, 2004) | Substantial equivalence satisfactorily addressed. |
| Conformity with ISO 14801 (Dynamic Fatigue Test for dental implants) | Dynamic fatigue test data consistent with FDA guidance and ISO 14801 have been referenced. |
| Material Properties (Type 5 material per ISO 22674) | Ceramicor alloy has 0.2% Proof Strength of 780 N/mm² (as delivered) and 635 N/mm² (after processing), satisfying Type 5 material requirements of ISO 22674. |
| Biocompatibility | Not required; materials are the same as the identified predicate device. |
| Sterilization | Not required; methods of manufacture are the same as the identified predicate device. |
| Indications For Use | Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. (Compared to predicate: "Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges.") The document states this difference does not materially change the intended uses. |
| Shared Features with Predicate | Same implant-to-abutment connection (RN, WN), platform (RN, WN), materials (Ceramicor, POM, Ti-6Al-7Nb alloy), primary package, and sterilization method (non-sterile, terminal sterilization via moist heat). |
| Designed for multi-unit (bridge) restorations | Non-engaging design, suitable for multi-unit (bridge) restorations. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Dynamic fatigue test data" in support of the submission. However, it does not specify:
- The sample size for these tests.
- The specific data provenance (country of origin, retrospective or prospective).
- Details about a "test set" in the context of diagnostic performance. The testing here is mechanical (fatigue).
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 question is not applicable to this submission. The device is a physical dental abutment, and its "performance" is evaluated through mechanical bench testing and material characterization, not by expert interpretation or ground truth establishment in a clinical imaging or diagnostic context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. There is no "adjudication" in the sense of reconciling expert opinions for a diagnostic outcome. Mechanical tests are typically performed according to standardized protocols.
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 question is not applicable. MRMC studies are used for diagnostic devices involving human readers and AI. This submission is for a physical dental abutment.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, "ground truth" is established through:
- Mechanical standards: Adherence to international standards like ISO 14801 for dynamic fatigue testing.
- Material specifications: Conforming to material standards like ISO 22674 for metallic dental materials.
- Biocompatibility and Sterilization: Relying on the established safety of the materials and manufacturing methods used in the predicate devices.
8. The sample size for the training set
This question is not applicable. There is no "training set" as this is not an AI/machine learning device. The design, materials, and manufacturing processes are developed through engineering and materials science, not by training an algorithm on data.
9. How the ground truth for the training set was established
This question is not applicable for the reasons stated 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.)