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510(k) Data Aggregation
(98 days)
Accelx Implant System
Accelx Implant System implants are indicated for use in partially or fully edentulous patients to support maxillary and mandibular single-unit, multiple-unit, and overdenture dental restorations. Accelx Implant System implants are indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implant diameters larger than 6.0 mm are dedicated for the molar region and are indicated for delayed loading.
Accelx Implant System implants are compatible with Accelx Implant System abutments.
Accelx Implant System implants are compatible with MegaGen AnyRidge Internal Implant System titanium abutments as listed below.
| Implant System Compatibility | Platform Diameter, mm | Maximum Angulation |
|---|---|---|
| MegaGen AnyRidge Internal Implant System | 3.5, 4.0, 4.25, 5.0 | 25° |
Accelx Implant System cover screws 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, 4.0 | |
| 5.4 | 3.5, 4.25 | |
| 5.9 | 3.5, 4.25 | |
| 6.4 | 5.0 | |
| 6.9 | 5.0 | |
| 7.4 | 5.0 | |
| 7.9 | 5.0 | |
| 8.4 | 5.0 |
The Accelx Implant System comprises Accelx dental implants, Accelx abutments previously cleared in K203240. The Accelx Implant System is compatible with the MegaGen AnyRidge Internal Implant System, regardless of the implant platform; this compatibility is due to the internal taper connection.
Accelx dental implants have an internal taper abutment interface connection and an internal hexagonal feature for abutment anti-rotation and instrument. The internal threaded section is for mating to the corresponding Accelx cover screws, abutments and screws previously cleared in K203240, and MegaGen AnyRidge Internal Implant System restorative devices.
Accelx dental implants are provided in ten body diameters ranging from 4.0 mm to 8.4 mm, and in total lengths ranging from 7.7 mm to 14.2 mm. Implants with a body diameter of 4.0 mm and 4.4 mm have a platform diameter of 3.5 mm. Implants with a body diameter of 4.9 mm have a platform diameter of 3.5 mm or 4.0 mm. Implants with a body diameter of 5.4 mm to 5.9 mm have a platform diameter of 3.5 mm. Implants with a body diameter of 6.4 mm to 8.4 mm have a platform diameter of 5.0 mm. The implants are manufactured from titanium alloy conforming to ASTM F136. The endosseous surface of the implant is aluminum oxide-blasted arom the implant collar to the apex. All Accelx dental implants are intended to be placed 0.5-1.0 mm sub crestal.
Accelx cover screws are provided with a coronal diameter of 3.5 mm in overall lengths of 5.7 mm, 6.5 mm and gingival heights (cuff heights) of 0.8 mm, 1.6 mm, respectively. The cover screws are manufactured from titanium alloy confirming to ASTM F136 and anodized. The cover screws are single use only. The smallest cover screw is provided sterile within the Subject device implant packaging. They are also provided individually as replacement or alternative parts in the same non-sterile packaging configuration as cleared in K203240.
The provided document is a 510(k) premarket notification for the Accelx Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance data and a comparison of technological characteristics. It does not contain information about clinical studies, AI/algorithm performance, multi-reader multi-case (MRMC) studies, or any form of human-in-the-loop performance evaluation.
Therefore, I cannot provide a table of acceptance criteria or details about a study proving the device meets those criteria in the context of an AI/ML-driven device, as the submission is for a medical device (dental implant system) that does not incorporate AI/ML.
However, I can extract the non-clinical acceptance criteria and reported device performance from the document.
Non-Clinical Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criterion / Test Method (as recommended in FDA guidance) | Reported Device Performance |
|---|---|---|
| Modified Surfaces | Evaluation by scanning electron microscope (SEM) and energy dispersive X-ray spectroscopy (EDS) following media blasting and cleaning. | "Implant surfaces were evaluated after media blasting and cleaning by scanning electron microscope (SEM) and energy dispersive X-ray spectroscopy (EDS) characterization meeting acceptance criteria." |
| Biocompatibility | Cytotoxicity testing according to ISO 10993-5. | |
| Bacterial endotoxin testing to ANSI/AAMI ST72, USP and USP . | ||
| Material mediated pyrogenicity per USP Pyrogen Test. | "Cytotoxicity testing according to ISO 10993-5, bacterial endotoxin to ANSI/AAMI ST72, USP and USP and material mediated pyrogenicity per USP Pyrogen Test was performed on representative devices." (Implies successful completion as per general context of 510(k) submission for substantial equivalence). | |
| Sterilization | Gamma sterilization validation for implants according to ISO 13004. | |
| Moist heat (steam) sterilization for non-sterile cover screws according to ISO 17665-2. | "Gamma sterilization validation was performed according to ISO 13004 was performed for implants; moist heat (steam) sterilization according to ISO 17665-2 for non-sterile cover screws." (Implies successful validation as per general context of 510(k) submission for substantial equivalence). | |
| Magnetic Resonance Imaging (MRI) Safety | Non-clinical worst-case MRI review performed using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795). | |
| Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque. | "Non-clinical worst-case MRI review was performed to evaluate the subject device components in the MRI environment using scientific rationale and published literature... rationale addressed parameters per the FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, including magnetically induced displacement force and torque." (Implies favorable assessment supporting MRI safety, likely "MR Conditional" labeling although not explicitly stated here for all components). The document also states the results demonstrate the device is suitable for intended use. | |
| Reverse Engineering | To demonstrate physical compatibility with MegaGen AnyRidge Internal Implant connection. Testing performed on OEM implant bodies, OEM abutments, and OEM abutment screws. | "Reverse engineering of the MegaGen AnyRidge Internal Implant connection was performed to demonstrate physical compatibility. This testing was performed on OEM implant bodies, OEM abutments, and OEM abutment screws." (Implies successful demonstration of physical compatibility). |
| Mechanical Performance | Mechanical performance testing according to ISO 14801:2016, "Dentistry – Implants – Dynamic loading test for Endosseous Dental Implants." | |
| Worst-case scenario chosen based on FDA guidance document "Root Form Endosseous Dental Implants and Endosseous Dental Implant Abutments." | "The fatigue limit data demonstrated that constructs of the previously cleared Accelx abutments (K203240) and previously cleared MegaGen AnyRidge Internal Implant System OEM abutments in combination with Accelx implants have sufficient strength for their intended use." |
Since the device described is not an AI/ML device, the following points are not applicable and thus, the document does not contain information on them:
- Sample sizes used for the test set and data provenance (e.g., country of origin of the data, retrospective or prospective): No clinical test set data from patients is referenced. The "test set" here refers to the physical units tested in non-clinical lab settings.
- 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, as no ground truth for image interpretation or diagnosis is relevant here. The ground truth for mechanical testing is established by engineering standards and measurements.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Ground truth is based on engineering specifications, material science standards (ASTM, ISO), and validated test methods for physical properties.
- The sample size for the training set: Not applicable, as there is no AI/ML model for training.
- How the ground truth for the training set was established: Not applicable.
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