(140 days)
The CreoDent Solidex® Customized Abutment and Screw is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous. The device can be used for single or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant.
The CreoDent Solidex® Customized Abutment and Screw are compatible with the following:
- Straumann Tissue Level Standard Plus RN 3.3 and WN 6.5
The Solidex® Customized Abutment and Screw is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 standard and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. Solidex® Customized Abutment and Screw are compatible with:
- . Straumann Tissue Level Standard Plus RN 3.3 and WN 6.5
The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist. Customization is limited by the minimum and maximum dimensions for wall thickness, diameter, height, collar height and angulation.
The provided text describes a 510(k) premarket notification for a medical device, the "CreoDent Solidex® Customized Abutment and Screw." This document focuses on demonstrating substantial equivalence to already legally marketed devices, rather than presenting a de novo clinical study with specific acceptance criteria, comprehensive performance data from a test set, or details about training sets, expert adjudication, or MRMC studies typical for AI/ML device submissions.
Therefore, the requested information cannot be fully extracted from the provided text in the manner typically asked for AI/ML device descriptions. The document does not include:
- A table of acceptance criteria and reported device performance in the context of an AI/ML algorithm.
- Details about sample sizes for a test set, data provenance, ground truth establishment for a test or training set.
- Information about expert numbers, qualifications, or adjudication methods for ground truth because the safety and effectiveness are established through physical performance testing and comparison to predicate devices, not through diagnostic performance in an AI/ML context.
- Any mention of MRMC comparative effectiveness studies or standalone algorithm performance.
The study described is primarily a non-clinical, in-vitro performance study focusing on mechanical strength and material compatibility to demonstrate equivalence.
Here's what can be extracted and inferred based on the provided text, while acknowledging the limitations for an AI/ML context:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present "acceptance criteria" and "reported device performance" in the way one would for diagnostic accuracy of an AI/ML device. Instead, it details technical specifications and performance characteristics that demonstrate the device's functional integrity and equivalence to predicate devices. The study's "acceptance" is implicitly that the device performs mechanically at least as well as, or comparably to, the predicate devices, particularly under "worst-case scenario" conditions.
| Acceptance Criteria (Implicit by testing standard and comparison) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Strength & Fatigue Resistance | Static/Fatigue Testing: Conducted in accordance with ISO 14801:2007E Dentistry-Implants-Dynamic fatigue test for endosseous dental implants, specifically targeting the "worst case scenario for the Solidex® Customized Abutment and Screw connection platform." |
Result: "These results demonstrated that the Solidex® Customized Abutment and Screw have sufficient mechanical strength for their intended clinical application." This implies that the device met the performance requirements or thresholds defined by the ISO standard for dental implants. |
| Dimensional Compatibility | Reverse Engineering Dimensional Analysis: Conducted using OEM implant bodies, OEM abutments, and OEM abutment screws.
Result: Demonstrated the device's "compatibility with Straumann Tissue Level Standard Plus RN 3.3 and WN 6.5 for which they are intended." The document also notes that safeguards and limitations in the design software will be imposed according to specified design limitations built into the abutment designer (e.g., minimum/maximum dimensions for wall thickness, diameter, height, collar height, and angulation). The less extreme maximum angulation compared to a reference predicate was "mitigated by fatigue testing and reverse engineering dimensional analysis." |
| Sterilization Efficacy | Sterilization Testing: Conducted according to ISO 17665-1.
Result: Sterilization was performed, implying that the protocol was effective and the device can be sterilized as intended. |
| Biocompatibility | Biocompatibility information is "leveraged from our previous 510k (K150012)," indicating that the material properties for biocompatibility are previously established and accepted for the predicate device, and the current device uses the same or an equivalent material (Ti-6Al-4V Eli titanium alloy). |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of "samples" for a "test set" in the context of an AI/ML study. For mechanical testing, the number of units tested per standard (ISO 14801:2007E) is typically small (e.g., 5-10 samples per test condition), but this specific number is not provided.
- Data Provenance: The testing is described as "Non-clinical Testing Data," which typically means in-vitro lab testing. The materials for the abutment blanks and screws are sourced from specific suppliers (T.Strong INC in Korea, who obtains materials from US suppliers). The final manufacturing occurs at CreoDent's facility in New York. This is not "clinical data" provenance in terms of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth in this context is established by engineering specifications, material standards (ASTM, ISO), and performance under mechanical stress tests, not by expert human interpretation of medical images or clinical outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. There are no human adjudicators for the mechanical and material performance tests 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 component, not an AI/ML diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. There is no AI algorithm involved. The device itself is a physical medical device. The "CAD/CAM Work Flow" is a manufacturing process using software to design the custom abutment, but this is not an AI/ML algorithm for making clinical decisions or performing diagnostics.
7. The type of ground truth used:
The "ground truth" for this device's performance validation is based on:
- Engineering Standards: Adherence to ISO 14801:2007E for dynamic fatigue testing, ISO 17665-1 for sterilization, and ASTM F-136/F-67 for material (titanium alloy) specifications.
- Predicate Device Performance: Demonstrating that the subject device's performance is equivalent to or better than that of the listed predicate devices (CreoDent Solidex Customized Abutments K150012, Straumann Tissue Level Standard Plus K171784) in terms of mechanical strength and compatibility for its intended use.
- Design Specifications: Meeting internal design limitations (Min/Max dimensions for wall thickness, diameter, height, collar height, angulation).
8. The sample size for the training set:
Not applicable. No AI/ML training set is mentioned or relevant for this device.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.)