(174 days)
Inclusive Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. Inclusive Titanium Abutments are compatible with Dentsply Implants Ankylos® C/X in 3.5, 4.5, 5.5, 7.0 mm sizes.
Inclusive Titanium Abutments are endosseous implant abutments which are placed into the dental implant to provide support for a prosthetic restoration. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. Abutments and screws are made of titanium alloy (Ti-6AL-4V ELI) and meet ASTM F-136 Standard. Inclusive Titanium Abutments are compatible with Dentsply Implants Ankylos C/X in 3.5 mm, 4.5 mm, 5.5 mm, and 7.0 mm Ø sizes.
The provided document is a 510(k) summary for a medical device called Inclusive® Titanium Abutments. This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing novel safety and effectiveness through clinical trials. As such, it does not detail a clinical study with acceptance criteria in the manner typically associated with AI/ML device evaluations.
Instead, the document details non-clinical testing to show equivalence. Here's a breakdown based on the information provided, reinterpreting "acceptance criteria" and "study" in the context of this regulatory submission:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present "acceptance criteria" in a quantitative, measurable table as one might expect for a diagnostic AI/ML device. However, the overall acceptance criterion for this submission is substantial equivalence to predicate devices. This is demonstrated by comparing key characteristics and performance aspects.
Here's a table based on the "Comparison of Devices" section, where "performance" is reinterpreted as "similarity to predicate devices" and "acceptance" is implied by the "Same" outcome, indicating that the characteristic is equivalent or acceptable compared to the predicate.
| Characteristic | Proposed Device Performance (Inclusive® Titanium Abutments) | Predicate 1 (Atlantis Abutment for Dentsply Ankylos Implant) | Predicate 2 (Inclusive Titanium Abutment Blanks) | Acceptance (Similarity) |
|---|---|---|---|---|
| Intended Use | Premanufactured prosthetic components directly connected to endosseous dental implants and intended for use as an aid in prosthetic rehabilitation. Compatible with Dentsply Implants Ankylos® C/X in 3.5, 4.5, 5.5, 7.0 mm sizes. | Intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. Supports single and multiple tooth prosthesis, cement or screw retained. Abutment screw secures abutment. | Intended to be used in conjunction with endosseous implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdenture prostheses. Prosthesis can be cement retained. Abutment screw secures abutment. | Same Intended Use |
| Dimensions of Abutment | Cylinder Ø 9.43mm, 11.5° Taper, 2.84 Gage Point | 11.5° Taper, 2.84 Gage Point | Cylinder Ø 9.43mm | Same |
| Abutment Screw | Detached and removable | Integrated fastening screw (mobile, not removable) | Detached and removable | Same (with Predicate 2) |
| Platform Compatibility | Ankylos C/X 3.5mm, 4.5mm, 5.5mm, 7.0mm | Ankylos C/X 3.5mm, 4.5mm, 5.5mm, 7.0mm | Various (Straumann Bone Level, NobelActive, Branemark) | Same (with Predicate 1) |
| Connection | Unigrip | Unigrip | Hexagon | Same (with Predicate 1) |
| Material | Ti-6AL-4V ELI (ASTM F-136) | Ti-6AL-4V ELI (ASTM F-136) | Ti-6AL-4V ELI (ASTM F-136) | Same |
| Design / Construction | Machined | Machined | Machined | Same |
| Abutment Angle | 0°-30° | 0°-30° | 0°-20° | Same (with Predicate 1) |
| Implant Seat | Taper | Taper | Taper | Same |
| Screw Seat | Taper | Taper | Flat | Same (with Predicate 1) |
2. Sample size used for the test set and the data provenance
The document describes non-clinical testing for mechanical performance, not a clinical test set with human subjects or patients.
- Sample Size: Not explicitly stated as "sample size" in terms of number of patients or cases. The testing involved "finished assembled implant/abutment systems" and considered "worst case scenarios." The specific number of abutments or systems tested for Reliability Calculation and Testing, Fatigue Strength Testing, and Static Load Failure Testing is not provided in this summary.
- Data Provenance: Not applicable in the context of clinical data provenance. The data comes from internal device testing performed by Prismatik Dentalcraft, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is an endosseous dental implant abutment, a mechanical component. Ground truth is established through engineering and material science standards and physical testing, not expert interpretation of medical images or patient outcomes.
4. Adjudication method for the test set
Not applicable. There is no "adjudication method" in the traditional sense for this type of non-clinical device testing. Performance is evaluated against engineering standards and methods.
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 not an AI/ML device or a device that impacts human reading performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device. The device performs as a standalone mechanical component for dental implants.
7. The type of ground truth used
The "ground truth" for the non-clinical testing is based on:
- Engineering Standards: Specifically, "FDA Guidance 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments'".
- Physical Measurements and Mechanical Testing: Reliability Calculation and Testing, Fatigue Strength Testing, and Static Load Failure Testing.
- Material Specifications: Adherence to "Ti-6AL-4V ELI (ASTM F-136) Standard."
- Sterilization Standards: ANSI/AAMI ST79 and ISO 17665-1.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" as it is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth established for one.
§ 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.)