(304 days)
ET Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
The ET Prosthetic System is device made of titanium and titanium alloy intended for use as an aid in prosthetic restoration. It consists of Abutments and Abutment Screws. It's surfaces are partially TiN coated and uncoated. The ET Prosthetic System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The ET Prosthetic System is substantially equivalent in design, function and intended use to the Prosthetic System(K110308) and ET/SS Implant System (K120847)of Osstem Implant Co., Ltd. These proposed abutments are compatible with the HIOSSEN Implant fixture only. HTIII SA Fixture (K101096).
Here's an analysis of the provided text regarding the acceptance criteria and study for the OSSTEM ET Prosthetic System:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Fatigue testing compliant with "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" and ISO 14801 Dentistry. | |
| Worst-case scenario testing. | "The results are in compliance with it and were similar to previously cleared predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of typical AI/ML studies involving patient data. The nonclinical testing revolves around fatigue testing of the physical device.
For the nonclinical fatigue testing:
- Sample size for test set: Not explicitly stated, however, the phrase "worst case scenario" implies a focused, rather than large-scale, selection of samples for mechanical testing.
- Data provenance: Not applicable in the context of patient data. The tests were performed on the physical dental abutment devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for the nonclinical fatigue testing is defined by the established international and national standards (ISO 14801 and FDA guidance) for mechanical performance of dental implants and abutments. This is a physical engineering standard, not an interpretation of medical images by human experts.
4. Adjudication Method for the Test Set
Not applicable. This is not a study where human disagreement would require adjudication. The compliance is determined by adherence to a defined mechanical testing protocol and performance metrics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "No clinical studies are submitted." An MRMC study is a type of clinical study involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a way that is relevant to a medical device and not just software. The core of the evidence is standalone nonclinical (mechanical) testing of the ET Prosthetic System. This is an "algorithm only" in the sense that the device's inherent mechanical properties were evaluated without human intervention in the device's functional performance during the test.
7. The Type of Ground Truth Used
The ground truth used for the nonclinical testing is compliance with established international and FDA standards for fatigue testing of endosseous dental implants and abutments (ISO 14801 and specific FDA Guidance Document).
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set of data. It is a physical dental prosthetic system.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.)