(356 days)
Dental Implant Abutments are intended to provide support for prosthetic reconstructions. Prosthetic applications can include individual crowns, bridges, partial or total prostheses.
Abutments can be used in single tooth replacements and multiple tooth restorations.
The Dental Implant Abutments OKTAGON® are intended to be compatible to OKTAGON® implants (Dental Implant OKTAGON®) with diameters 3.3mm, 4.1mm and 4.8mm in the variation Regular Platform, Wide Platform and Tapered Design with the lengths 8mm, 10mm, 12mm and 14mm.
The OKTAGON® Dental Implant System is an integrated system of endosseous dental implants which are designed to support prosthetic devices for partially of fully edentulous patients. The devices covered in this submission are abutments in different version including the corresponding screws. The abutments are made of Titanium Grade 4, Titanium Alloy or POM; the connection to the implants is achieved by an internal octagon and a metric thread.
Here is an analysis of the provided text regarding the acceptance criteria and study for the "Dental Endosseous Implant Abutment OKTAGON®":
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Device Performance (as reported) |
|---|---|
| Fulfills requirements of ISO 14801 (Fatigue Test for Endosseous Dental Implants) | "The performed test fulfills the requirements listed in ISO 14801" |
| Fulfills requirements of "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Abutments, Chapter 8" | "The performed test fulfills... the Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Abutments, Chapter 8." |
| Substantial Equivalence to Predicate Devices: |
- Identical intended use
- Equivalent material composition
- Equivalent connection to implants
- Identical principal design and measurements | "The intended use for Endosseous Dental Implant Abutment OKTAGON® is identical to the named predicated devices. The abutments have the same indications for use, material composition and the connection to implants is equivalent. In addition the principal design including measurements of abutments is identical to the previously cleared predicated devices." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text only explicitly mentions a "performance test (fatigue test)" conducted for the Dental Implant Abutments OKTAGON®. It does not specify a separate "test set" in the context of a statistical study with a specific sample size. The fatigue test itself would involve a sample of the abutments, but the exact number is not detailed.
- Sample Size for Test Set: Not explicitly stated for the fatigue test.
- Data Provenance (e.g., country of origin, retrospective/prospective): Not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable to the submission for a dental implant abutment, as the evaluation relies on physical performance testing against established engineering standards (ISO 14801) and comparison with predicate devices, rather than expert interpretation of medical images or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as in point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI/CAD systems that assist human readers in tasks like image interpretation, which is not relevant for a dental implant abutment.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. The device is a physical medical device (dental implant abutment), not an algorithm or AI system. Its performance is evaluated through physical tests like fatigue testing, not computational algorithms.
7. The Type of Ground Truth Used
For the fatigue test, the "ground truth" would be the objective mechanical properties and failure criteria defined by the ISO 14801 standard and the FDA's special controls guidance document. The abutments' ability to withstand specified cyclic loading without failure to a certain threshold is measured against these established engineering benchmarks.
For the substantial equivalence claim, the "ground truth" is the characteristics (intended use, material, connection, design, measurements) of the legally marketed predicate devices, which the OKTAGON® abutment is compared against.
8. The Sample Size for the Training Set
This information is not applicable as the device is a physical medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device is a physical medical device and does not utilize a training set or machine learning.
§ 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.)