(186 days)
MegaGen Dental Implant Abutment is intended to be surgically placed in the maxillary or mandibular areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. It is used to restore a patient's chewing function.
All digitally designed abutments for use with TiGEN Abutment and ZrGEN Abutment are intended to be sent to a MegaGen validated milling center for manufacture
The MegaGen Dental Implant Abutment includes several components: Healing Abutment, Temporary Cylinder, EZ Post Abutment, EZ Post Cylinder, CCM Abutment, Gold Abutment, Octa Abutment, ZrGEN Abutment, TiGEN Abutment, AXA Abutment (Straight and Angled Types), and Abutment Screw. These components are made of materials such as Ti-6Al-4V-ELI, POM, Co-Cr-Mo alloy, and gold alloy, and are offered with machined or anodized surfaces. Some components are supplied sterile, while others are non-sterile and require sterilization by the user. They are intended for single use. The device provides prosthetic support for dental restorations on endosseous dental implants.
The provided text is a 510(k) summary for the MegaGen Dental Implant Abutment, seeking clearance based on substantial equivalence to predicate devices. It does not contain information about a study that proves the device meets specific acceptance criteria in terms of clinical performance, diagnostic accuracy, or effectiveness with human readers.
Instead, the document details a comparison of the subject device (MegaGen Dental Implant Abutment) with various predicate and reference devices, focusing on technical characteristics, materials, and design. The "acceptance criteria" referred to in the document are primarily related to meeting the characteristics of the predicate devices and demonstrating that any differences do not affect the fundamental function or safety of the device. The "study" that "proves" the device meets these criteria is a non-clinical testing summary, including biocompatibility, sterilization validation, accelerated shelf-life, pyrogen/endotoxin testing, performance testing (ISO 14801), and MR compatibility.
Therefore, many of the requested fields cannot be answered directly from the provided text as they pertain to clinical or diagnostic performance studies involving human subjects or AI algorithms, which are not described here.
Here's a breakdown of the information that can be extracted, and where the requested information is not available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance for each component in a consolidated manner. Instead, it discusses "similarities" and "differences" compared to predicate/reference devices, and states that "test results met the pre-set criteria" for performance testing (ISO 14801) and that biocompatibility and sterilization have been validated.
Below is a summarized representation of the comparison for one component (Healing Abutment) as an example, to illustrate the type of comparison presented in the document. The "acceptance criteria" are implied by the characteristics of the predicate/reference devices, and "reported device performance" refers to the subject device's characteristics or the outcome of non-clinical tests.
Example for Healing Abutment:
| Acceptance Criteria (Implied by Predicate/Reference Devices) | Reported Device Performance (Subject Device) |
|---|---|
| Indications for Use: Prosthetic support for dental restorations in partially or fully edentulous individuals. | Met: Same indications for use. |
| Design: Similar to predicate. | Met: Similar design. |
| Diameter (Ø, mm): Ranges like 4.2, 5.2, 6.2, 7.2 | Met: 4.2, 4.7, 5.2, 5.7, 6.2, 6.7, 7.2 (Expanded range, but similar characteristics) |
| Gingival Height (mm): Ranges like 3.5, 4.5, 5.5, 6.5, 7.5 | Met: 7.8, 8.5, 8.8, 9.5 (Different ranges, but considered practically equivalent) |
| Total Length (mm): Ranges like 8.4 ~ 14.4 | Met: 13.4 ~ 15.2 (Different range, but considered practically equivalent) |
| Connection Interface: Internal Conical Connection | Met: Internal Conical Connection |
| Material: Ti-6Al-4V ELI (ASTM F136-13) | Met: Ti-6Al-4V ELI (ASTM F136-13) |
| Surface Treatment: Anodizing or Machined | Met: Anodizing |
| Single Use: Yes | Met: Yes |
| Sterilization: Gamma sterilization | Met: Gamma sterilization (validated per ISO 11137) |
| Shelf-life: 5 years | Met: 5 years (validated per ASTM F1980) |
| Biocompatibility: Compliant with ISO 10993-1 | Met: Evaluated per ISO 10993-1 (leveraged from prior cleared devices) |
| Performance Testing (Fatigue): Meets ISO 14801 and guidance document recommendations | Met: Test results met pre-set criteria. |
| MR Compatibility: MR Conditional | Met: Assessed not to configure a new worst case; leveraged K230618. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified for any clinical or diagnostic evaluation. The evaluations are primarily non-clinical. For performance testing (ISO 14801), the sample size for individual tests like fatigue is not mentioned within this summary, only that tests were performed.
- Data Provenance: Not applicable in the context of clinical/diagnostic data. For non-clinical tests like biocompatibility and sterilization, previous 510(k) submissions (e.g., K110955, K123988, K210161, K220562, E220672, K230618) from MegaGen Implant Co., Ltd. are leveraged. The tests were performed according to international standards (ISO, ASTM, USP).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this type of medical device (dental implant abutment) is established by engineering specifications, material properties, and performance under rigorous bench testing conditions, compared to predicate devices. There is no mention of expert consensus for diagnostic ground truth.
4. Adjudication method for the test set
Not applicable. No expert adjudication process for diagnostic imaging or clinical outcomes 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 device is a dental implant abutment, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for demonstrating substantial equivalence is based on:
- Comparison to legally marketed predicate devices (their established safety and effectiveness).
- Compliance with recognized international standards (e.g., ISO 10993-1 for biocompatibility, ISO 11137 for sterilization, ASTM F1980 for shelf-life, ISO 14801 for performance/fatigue testing, and FDA guidance documents for MR compatibility).
- Confirmation through non-clinical bench testing that the device's physical and mechanical properties meet predefined criteria, demonstrating that any differences from predicate devices do not raise new questions of safety or effectiveness.
8. The sample size for the training set
Not applicable. This document describes a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This pertains to AI algorithms.
§ 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.)