(92 days)
The Locator Implant Anchor abutment for endosseous dental implants is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla.
The Locator Implant Anchor is an abutment for endosseous implants.
Here's an analysis of the provided text regarding the Locator Implant Anchor, broken down by your requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Threshold | Reported Device Performance (Locator Implant Anchor) | Reported Device Performance (Predicate: ZAAG Implant Anchor) |
|---|---|---|---|
| Removal Retention Force | 3.0 lbs to 5.0 lbs | Mean: 4.7 lbs (SD = 0.207) | Mean: 4.2 lbs (SD = 0.483) |
| Fatigue Strength | ≥ 175 lbs (after 5M cycles) | ≥ 175 lbs (shared component) | ≥ 175 lbs (shared component) |
2. Sample Size Used for the Test Set and Data Provenance
- Removal Retention Force: The sample size is not explicitly stated. It mentions "Mean values were 4.7 pounds (SD = .207) for the Locator Implant Anchor, and 4.2 pounds (SD = .483) for the ZAAG Implant Anchor," implying that multiple measurements were taken for each device, but the number of devices or measurements is not provided.
- Fatigue Strength: The sample size for fatigue testing is not explicitly stated. It refers to "the Angle Correction Base," indicating a specific component was tested.
- Data Provenance: Not specified. The document does not indicate the country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable to this submission. The device is a physical medical device (implant abutment), and the testing described involves objective physical measurements (retention force, fatigue strength) rather than subjective expert assessment of data like images or patient outcomes.
4. Adjudication Method for the Test Set
- This information is not applicable. As a physical device with objective measurements, there is no need for expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- This information is not applicable. The device is an implant abutment, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is outside the scope of this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This information is not applicable. The device is a physical implant abutment and does not involve an algorithm.
7. The Type of Ground Truth Used
- The ground truth for the performance testing is based on objective physical measurements rather than expert consensus, pathology, or outcomes data in the traditional sense.
- For removal retention force, the ground truth is the direct measurement of force required to remove the anchor.
- For fatigue strength, the ground truth is the direct measurement of the force sustained after a specified number of cycles.
8. The Sample Size for the Training Set
- This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The comparison is made against a predicate device.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as there is no training set for this device.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.