(175 days)
AccelX™ Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.
All digitally designed abutments for use with AccelX™ CAD-CAM Abutments are intended to be sent to an Integrated Dental Systems validated milling center for manufacture.
AccelX™ Abutments are compatible with MegaGen AnyRidge Internal Implant System components as listed below.
| Implant System Compatibility | Implant Body Diameter, mm | Implant Platform, mm |
|---|---|---|
| MegaGen AnyRidge Internal | ||
| Implant System | 4.0 | 3.5 |
| 4.4 | 3.5 | |
| 4.9 | 3.5 | |
| 5.4 | 3.5 | |
| 5.9 | 3.5 | |
| 6.4 | 5.0 | |
| 6.9 | 5.0 | |
| 7.4 | 5.0 | |
| 7.9 | 5.0 | |
| 8.4 | 5.0 |
AccelX™ Abutments comprises conventional and CAD-CAM abutments, abutment screws, and other associated components compatible with MegaGen AnyRidge Internal Implant System.
AccelX™ conventional abutments and prosthetic components include Cover Screws. Healing Abutments. Temporary Abutments, Prepable Straight Abutments, Angled Abutments, Castable Base Abutments, and Multi-Unit Abutments. All conventional abutments and prosthetic components are manufactured from Ti-Al-4V alloy conforming to ASTM F136 except the Castable Base Abutments that are manufactured from Co-Cr-Mo alloy conforming to ASTM F1537.
AccelX™ CAD-CAM abutments include Titanium Base Abutments for use with a zirconia coping, and Titanium Blank Abutments to be milled to a final one-piece abutment. Titanium Base Abutments are twopiece abutments composed of the titanium base component and a zirconia top-half, which comprises the final abutment once the two components are cemented together using CemPlant Implant Cement. The Titanium Base Abutments and Titanium Blank Abutments are manufactured from Ti-Al-4V alloy conforming to ASTM F136. The zirconia copings for the Titanium Base Abutments will be manufactured from zirconia conforming to ISO 13356. All digitally designed abutments for use with AccelX™ CAD-CAM abutments are intended to be sent to an Integrated Dental Systems validated milling center for manufacture.
The provided text describes Integrated Dental Systems LLC's AccelX™ Abutments, detailing their intended use, materials, and substantial equivalence to predicate devices, but it does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.
The document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving performance against specific acceptance criteria in a quantitative manner for a novel AI/ML device.
Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets those criteria because it is not present in the provided text.
Based on the information provided, here's what can be extracted and what is missing:
Information NOT available in the text (and thus cannot be filled):
- A table of acceptance criteria and the reported device performance.
- Sample sizes used for the test set.
- Data provenance (e.g., country of origin, retrospective/prospective).
- Number of experts used to establish ground truth.
- Qualifications of those experts.
- Adjudication method.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
- Effect size of human reader improvement with AI vs. without AI assistance.
- If a standalone (algorithm only without human-in-the-loop) performance study was done.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for performance evaluation.
- Sample size for the training set.
- How the ground truth for the training set was established.
Information provided in the text (which does not directly answer the specific request about acceptance criteria and proof of meeting them, but describes other relevant aspects):
The "PERFORMANCE DATA" section states:
"The subject device was evaluated and tested as recommended in the FDA guidance documents Root Form Endosseous Dental Implants and Endosseous Dental Implant Abutments (issued May 12, 2004), and Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (issued September 4, 2020)."
This indicates that testing was conducted according to recognized standards and guidance, but it does not specify quantitative acceptance criteria or a study proving this device's specific performance against them.
Referenced non-clinical data includes:
- Moist heat (steam) sterilization according to ISO 17665-1 and ISO 17665-2.
- Biocompatibility data for ASTM F136 titanium alloy, ASTM F1537 Co-Cr-Mo alloy, and ISO 13356 zirconia. Confirmatory biocompatibility testing was performed for certain components according to ISO 10993-5 and ISO 10993-12.
- Testing to demonstrate compatibility to the OEM system included reverse engineering of OEM implant bodies, OEM abutments, and OEM abutment screws.
- Static compression and compression fatigue testing according to ISO 14801.
"The fatigue limit data demonstrated that constructs of the subject device abutments, including abutments fabricated to the limits stated in the proposed labeling, in combination with previously-cleared MegaGen AnyRidge Internal Implant System implants have sufficient strength for their intended use." This is the closest statement to a performance claim, implying that the device meets a "sufficient strength" criterion based on ISO 14801 fatigue testing. However, the exact numerical acceptance criteria and the specific results demonstrating compliance are not detailed.
"No clinical data were included in this submission."
§ 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.)