(79 days)
The Fiber-Metal Post is indicated for use as a root canal post. The post is cemented into the prepared root canal of a tooth to support a permanent restoration.
The Fiber-Metal Post consists of central core wires twisted around polymer bristles that extend radially from the core. The post will be available is several sizes (length and OD as measured over the fibers) and configurations based on bristle arrangement (straight or tapered).
The provided text describes a 510(k) Premarket Notification for the Foremost Fiber-Metal Post, a root canal post. It does not pertain to an AI/ML powered medical device, therefore, many of the requested categories are not applicable.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Fatigue cycle strength for finished restoration (cyclic loading test - occlusal and lateral loading) | "The results of this test demonstrated that the Foremost Fiber-Metal Post, when used as directed in the device labeling, results in an acceptable fatigue cycle strength for the finished restoration." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "Performance testing for the Fiber-Metal Posts consisted of a cyclic loading test on teeth restored using the post. Both occlusal and lateral loading was evaluated." It also states, "Unrestored, caries-free endodontically-treated teeth served as the control." However, the exact number of teeth or posts tested is not provided.
- Data Provenance: Not specified, but generally, such performance testing for dental devices is conducted in a laboratory setting or on extracted human or animal teeth. The document does not specify country of origin or whether it was retrospective or prospective in the context of human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a physical root canal post, not an AI/ML system that requires expert ground truth for image interpretation or diagnosis. The "ground truth" here is the physical performance of the device under mechanical stress.
4. Adjudication Method for the Test Set
Not applicable. This is not an AI/ML or diagnostic device requiring adjudication of interpretations. The performance is measured mechanistically.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This is a physical dental device, not a diagnostic or AI system evaluated for reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a physical dental device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is the physical performance under cyclic loading, compared to a control group of "Unrestored, caries-free endodontically-treated teeth."
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML system that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is not an AI/ML system that requires a training set.
§ 872.3810 Root canal post.
(a)
Identification. A root canal post is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be cemented into the root canal of a tooth to stabilize and support a restoration.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.