(303 days)
The 4plus6Line Abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation.
The abutment is available in several diameters and angulations. The straight and the 17° angled versions are available as compatible with implant bodies in diameters of 3.8mm, 4.1, and 5.0. A 30° angled version is also available for the 4.1mm and 5.0 diameter implant bodies. All abutments are made from titanium grad 5 acc. to ASTM F-136. The abutments are compatible with implant bodies contained in the OT-F" Implant System. The abutment system contains both titanium and POM cylinders as well as healing abutments.
This document is a 510(k) premarket notification for a dental abutment system. It does not describe a study involving device performance concerning AI or reader performance. Therefore, I cannot provide the requested information about acceptance criteria for AI performance, sample sizes for test sets, expert qualifications, MRMC studies, or standalone algorithm performance.
The document primarily focuses on demonstrating substantial equivalence to a predicate device through:
- Comparison of technological characteristics: This involves comparing material, angle, geometry, socket heights, surface treatment, sterilization, and accessories between the new device and predicate devices.
- Non-clinical testing: This includes validation of sterilization, packaging validation (aging studies), and surface analysis (cytotoxicity and cleaning validation).
- Engineering studies: Fatigue testing was conducted according to ISO 14801:2003 (E).
Here is a summary of the provided information related to the device and its testing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for device performance in the form of a table that would be common for AI/diagnostic devices. Instead, the "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to predicate devices and meeting relevant ISO standards for dental implants.
| Category | Reported Device Performance / Assessment |
|---|---|
| Technological Characteristics Comparison | The technological characteristics (Material, Abutment Angle, Exterior geometry, Socket heights, surface treatment, Sterilization, Accessories, Indications) of the 4plus6Line Abutment System were found to be "comparable" to the predicate devices (Nobelactive Multi Unit Abutment K072570). Key differences noted: |
- Material: Predicate has Titan Grade 1 for straight abutments vs. New device: All Titanium Grade 5.
- Socket heights: Predicate offers more options (1.5, 2.5, 3.5, 4.5 mm) vs. New device (1.5, 3 mm).
- Surface treatment: New device has anodization in implant-connecting-area; predicate has pure machined surface. |
| Sterilization Validation | - Microbiological Performance MDS Test 103706-10 (Submitted Oct. 19, 2011) - Dose mapping (Submitted Dec 04, 2012) |
| Packaging Validation | - Ageing Study over 5 years by MDS, Test 094466-10 (Submitted Oct. 19, 2011) - Ageing Study real time aging 5 years by MDS, Test 142775-10 (dye penetration test) (Submitted June 04, 2014)
- Ageing Study real time aging 5 years by MDS, Test 151504-10 (microbial properties) (Submitted April 09, 2015) |
| Surface Analysis | - Test Cytotoxicity abutments, MDS report no. 123335-20 (Submitted July 30, 2012) - Report cleaning validation_2013RV02-2010 (Submitted Sept 18, 2013) |
| Engineering Studies (Fatigue) | Conducted as per ISO standard 14801:2003 (E) – (Dentistry – Fatigue test for endosseous dental implants). Testing revealed a stable screw joint at the highest forces tested. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable in the context of an AI/diagnostic device. For the non-clinical and engineering studies, specific sample sizes are not explicitly stated, but the studies refer to standard tests (e.g., ISO 14801 for fatigue testing, MDS reports for cytotoxicity, sterilization, and packaging). These typically involve a defined number of units to meet statistical significance for the specific test.
- Data Provenance: The document is a submission to the FDA from a German company (OT medical GmbH, Bremen, Germany). The non-clinical and engineering study reports are listed with submission dates, indicating they were conducted retrospectively for the purpose of this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/diagnostic device that requires expert-established ground truth for a test set. The validation relies on laboratory and engineering testing standards.
4. Adjudication method for the test set
Not applicable. This is not an AI/diagnostic device that involves human reader adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
No. This is not an AI/diagnostic device; therefore, an MRMC study related to AI assistance for human readers was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This is not an AI algorithm.
7. The type of ground truth used
For the engineering studies, the "ground truth" is adherence to the performance requirements outlined in the ISO standard (ISO 14801:2003 (E)) for fatigue testing, aiming to demonstrate a "stable screw joint." For non-clinical tests, the ground truth relates to meeting established criteria for sterilization effectiveness, packaging integrity, cytotoxicity, and cleaning validation as per relevant standards and test methods.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device; there is no training set in the conventional sense.
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.)