(29 days)
The 3i Locator Implant Anchor Abutment for Endosseous Dental Implants is appropriate for use with overdentures retained in whole or in part by endosseous implants in the mandible or maxilla.
The 3i Locator Abutment System consists of a titanium alloy socket that is attached to a dental implant having an internal threaded socket. Both devices have a nylon component that has a shape on one end that mates into the socket. The other end of the nylon component is attached to the denture. This arrangement provides snap-fit retention of the denture. The system is identical to the predicate devices, except for a modification to allow use with 3i's Osseotite implant, and a modification of the system prior to distribution by 3i.
This document describes modifications to the "3i Locator Abutment System," which is a component of a dental implant system. The submission is a 510(k) premarket notification, indicating that the manufacturer is seeking to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness. Therefore, the "acceptance criteria" and "device performance" are framed in terms of demonstrating equivalence to the predicate device, the "Zest Locator® Anchor System."
Here's an analysis of the provided information, addressing your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrates Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Retention and Withstanding Occlusal Forces: Performance must be equivalent to the Zest Locator Anchor System. | "All previously submitted bench testing of the Zest Locator Anchor System has established its effectiveness in retention and withstanding occlusal forces." The modifications "would not demonstrate significantly different results." |
| Fatigue Strength of Attachment Components: Fatigue strength must be at least 175 pounds after 5 million cycles. | "The system was also fatigue tested to 5 million cycles, and demonstrated that the fatigue strength of the attachment components is still at least 175 pounds." |
| Sterilized Component Performance: Sterilized Nylon 101 components (replacement males) must perform equivalently to non-sterilized components. | "Sterilized Nylon 101 components (replacement males) were fatigue tested in 2001, and found to be substantially equivalent to non-sterilized components." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "Sterilized Nylon 101 components (replacement males)" were fatigue tested in 2001, but does not specify the sample size used for this particular test set.
- Data Provenance: The testing appears to be retrospective in the sense that it relies on "previously submitted bench testing" for the predicate device and internal testing done by the company (or a contracted lab) for the modified components. The country of origin is not explicitly stated, but given it's an FDA submission, the testing would generally need to adhere to US regulatory standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This type of information is not applicable to this submission. The "ground truth" for demonstrating substantial equivalence here is based on engineering principles and objective physical measurements (retention, occlusal forces, fatigue strength), not on expert clinical interpretation of data like images or patient outcomes.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or subjective assessments where discrepancies need to be resolved. This submission relies on objective bench testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation (e.g., radiologists reading images) to assess the impact of AI assistance on reader performance. This submission is for a mechanical dental device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in essence. The performance data presented is "standalone" in the sense that it's the device's inherent mechanical performance measured through bench testing, not influenced by human interaction or interpretation beyond setting up the test. There is no "algorithm" in the AI sense; rather, it's the physical device's mechanical performance.
7. The Type of Ground Truth Used
The ground truth used is primarily engineering specifications and benchmarked mechanical performance. Specifically:
- Established effectiveness in retention and withstanding occlusal forces, as demonstrated by the predicate device's prior testing.
- A specific fatigue strength threshold (at least 175 pounds after 5 million cycles).
- Equivalence in performance between sterilized and non-sterilized components.
8. The Sample Size for the Training Set
Not Applicable. There is no "training set" in the context of this device. This is a mechanical device, not an AI/ML algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set, this point is not relevant.
§ 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.