(417 days)
Transfer & Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.
The Transfer & Angled Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration. It consists of Abutments and Abutment Screws. Surfaces are partially TiN coated.
The Transfer & Angled Abutment has mini connection structure that is consist two types of connection structure (Non-HEX and HEX (including A type hex)
Non-HEX connection of Transfer & Angled Abutment has a 11° Morse taper structure Hex Mini connection of Transfer & Angled Abutment has a 11° Morse taper structure and 2.08mm Hex connection structure.
Angled Abutment two types of Hex connection (A type hex, B type hex) to set direction (Double hex function)
Hex connection structure has function for anti-rotation
The provided document is a 510(k) premarket notification for a medical device called "Transfer & Angled Abutment." This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a study proving that the device meets specific acceptance criteria based on its performance characteristics.
Therefore, many of the requested categories for the description of "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable in this context.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
This document does not establish specific performance acceptance criteria for the "Transfer & Angled Abutment" as it would for a novel device requiring efficacy or safety trials. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to existing predicate devices (K130662 and K120847). The "reported device performance" is not explicitly quantified in terms of clinical outcomes, but rather inferred from the fact that its material, function, and intended use are highly similar to the predicate devices, and that it passed non-clinical fatigue testing.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate Devices) | Reported Device Performance (as per 510(k) Summary) |
|---|---|
| Material Composition (Same as predicate) | Transfer Abutment: Titanium Alloy (Ti-6Al-4V) / TiN-coating. Angled Abutment: Titanium Alloy (Ti-6Al-4V) / TiN-coating. (Matches predicate material) |
| Design / Form (Similar to predicate, with dimensional changes stated) | Transfer Abutment: 11° Morse taper internal connection, Mini Connection. Diameter Ø 4.0mm. Gingival heights: 1.0mm, 2.0mm, 3.0mm, 4.0mm, 5.0mm. Post Height: 5.5mm, 7.0mm. Angled Abutment: 11° Morse taper internal connection, Mini Connection. Diameter Ø 4.0mm. Angled: 17°. Gingival heights: 2.0mm, 4.0mm. The primary change for both is the addition of a 4.0mm diameter, while predicate devices had other specified diameters (e.g., K130662 had 4.6, 5.0, 6.0, 7.0mm; K120847 had 4.3, 4.5, 5.0, 5.5, 6.0mm). The document states, "The subject device and the predicate device... are the same except for dimensional changes. There are no changes in function and intended use..." |
| Intended Use (Same as predicate) | Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures. (Matches predicate's intended use). |
| Biocompatibility (Implied by material equivalence) | Not explicitly tested, "No biocompatibility testing... needed to be performed because the material, coating, manufacturing process and packaging are identical between the predicate and subject device." |
| Sterilization Validation (Implied by process equivalence) | Not explicitly tested, "No... sterilization validation... needed to be performed because the material, coating, manufacturing process and packaging are identical between the predicate and subject device." |
| Packaging Validation (Implied by process equivalence) | Not explicitly tested, "No... packaging validation needed to be performed because the material, coating, manufacturing process and packaging are identical between the predicate and subject device." |
| Mechanical Performance (Fatigue) | Fatigue testing was considered according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with the worst case scenario. (The document states it was "considered" and passed, although specific results are not provided here). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. This submission relies on substantial equivalence to predicate devices and non-clinical fatigue testing, not a clinical test set with human or patient data.
- Data Provenance: The fatigue testing would be laboratory-based (non-clinical). The origin of the device manufacturer is Republic of Korea.
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)
- Not applicable. No ground truth establishment by experts for a test set is described in this 510(k) summary, as it is not a clinical study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication method is described.
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
- Not applicable. This is a dental implant abutment, not an AI-powered diagnostic device. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Non-clinical testing: The "ground truth" for the fatigue testing would be the established engineering standards and guidelines for dental implant abutments (e.g., ISO 14801 or similar, as referenced by the "Guidance for industry and FDA staff Class II Special Controls Guidance Document").
- Substantial Equivalence: The "ground truth" for demonstrating substantial equivalence is the existing performance and safety profile of the predicate devices.
8. The sample size for the training set
- Not applicable. This is not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. This is not a machine learning model.
In summary:
This 510(k) submission successfully argues for substantial equivalence primarily based on:
- Identical materials, coating, manufacturing processes, and packaging to the predicate devices.
- Identical intended use to the predicate devices.
- Dimensional changes (addition of a 4.0mm diameter) which were not deemed to alter the fundamental function or safety.
- Non-clinical fatigue testing performed according to relevant guidance, confirming the mechanical integrity of the device, particularly focusing on a "worst-case scenario."
The FDA's review and clearance indicate that the provided evidence was sufficient to demonstrate that the new device is as safe and effective as the predicate devices, without requiring a detailed clinical performance study with human subjects.
§ 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.)