(78 days)
The IBS Implant System II is intended to replace missing teeth to restore chewing function. The IBS Implant System II can be placed in support of single or multiple-unit restorations including; cement retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.
This submission is to add new magic Motion Abutment to the previously cleared device, IBS Implant System II (K162099).
The Magic Motion Abutment system is composed of Magic Motion Abutment, Housing and O-ring. The Magic Motion Abutment is a device made of a material such as Ti-6AL-4V Eli (Conforming to ASTM Standard F-136). Magic Motion is an attachment-retained prosthetic product, which is used with patients with a fully edentulous maxilla. It is a one-piece structure. Various collar heights of the magic motions can be selected based on the gingival height. Magic motion does not have movement and it is a solid type.
This FDA 510(k) K200753 letter is for a dental device, specifically an endosseous dental implant abutment called "IBS Implant System II" with an added component called "Magic Motion Abutment". As such, the approval is based on substantial equivalence to a predicate device, not on clinical performance criteria like those typically found in AI/ML device clearances. The document focuses on mechanical and material properties rather than AI model performance metrics.
Therefore, many of the requested elements for an AI/ML device study are not applicable or cannot be extracted from this documentation.
Here's an attempt to answer the questions based on the provided text, while highlighting what is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
Not directly applicable as this is a dental implant abutment, not an AI/ML device. The "acceptance criteria" here relate to meeting standards for mechanical properties, biocompatibility, and manufacturing, rather than statistical performance metrics like sensitivity/specificity for an AI model.
The document discusses demonstration of substantial equivalence with the predicate device through design control activities and specific tests.
| Acceptance Criteria Type | Reported Device Performance | Comments (Not AI/ML specific) |
|---|---|---|
| Design/Dimensional Comparison | Subject device's diameter and hex are larger; neck and head diameter are larger and more round compared to the predicate. Magic Motion Housing height and diameter are larger. | Stated that these differences "don't impact product's substantial equivalence" as they improve connection. This implies the design changes still fall within acceptable parameters for function and safety compared to the predicate. |
| End User Steam Sterilization (AAMI TIR12:2010) | Tests performed on predicate device and leveraged for subject device; "met the criteria of the standards". | Confirms the device can be effectively sterilized by the end-user. |
| Biocompatibility (ISO 10993-1, -10, -11) | Tests performed on predicate device and leveraged for subject device; "met the criteria of the standards". | Confirms the device material is safe for contact with biological tissues. |
| Material Composition (Ti-6AL-4V Eli, ASTM F-136, Silicon rubber) | Confirmed materials used. | Demonstrates adherence to recognized material standards for medical implants. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable for an AI/ML device. This is a mechanical device.
- Test set sample size: Not specified in terms of clinical samples. Testing refers to mechanical and material property assessments on manufactured parts.
- Data Provenance: Not mentioned in the context of clinical data. The tests performed are laboratory-based.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable as this is not an AI/ML device relying on human-established ground truth. Testing involves engineering standards and laboratory analyses.
4. Adjudication Method for the Test Set
Not applicable. This refers to methods for resolving discrepancies in expert labeling for AI/ML ground truth, which is not relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC study was not done. This type of study is specifically for evaluating the effectiveness of an AI system with human readers, 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
Not applicable. There is no "algorithm" or "standalone performance" for this mechanical dental device.
7. The Type of Ground Truth Used
Not applicable in the context of AI/ML. For this device, "ground truth" would correspond to established engineering standards, material specifications, and regulatory requirements that the device's characteristics (dimensions, material, sterility, biocompatibility) must meet.
8. The Sample Size for the Training Set
Not applicable for an AI/ML device. There is no "training set" for a mechanical dental implant.
9. How the Ground Truth for the Training Set Was Established
Not applicable for an AI/ML device. There is no "training set ground truth" for this mechanical device. The design, materials, and manufacturing processes adhere to established engineering principles and regulatory guidelines for dental implants.
§ 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.)