(74 days)
The iMARK™ Internal Hexagon Dental Implant System is used in indications for oral endosseous implants in the maxilla and/or mandible as part of a functional and aesthetic oral rehabilitation in partial or fully edentulous patients.
The IMARK™ Internal Hexagon Dental Implant System is designed for use in totally edentulous mandibles or maxillae or as a terminal or intermediary abutment for fixed or removable bridgework. The system can also be used for single tooth restorations. The IMARK™ Internal Hexagon Dental Implant System uses a two-stage implantation process.
The iMARK™ Internal Hexagon Dental Implant System is compatible with Zimmer® Tapered Screw Vent prosthetics.
The ACE Surgical iMARK™ Internal Hexagon Dental Implant System is a screw type dental implant system designed with technology established with the ACE Surgical Screw Dental Implant System (K954513) and the Zimmer® Tapered Screw Vent Dental Implant (K011028). The ACE Surgical iMARK™ Internal Hex dental implant screw raw material is made of Ti-6-AL-4V ELI per ASTM F13& standard and surface treated with resorbable blast media (RBM). The self tapping internal horning and features tapered external thread geometry consistent with industry standard screw implant fixtures. The implants are provided sterile and sterility is achieved by gamma radiation pursuant to ISO 11137
The provided text describes the 510(k) summary for the ACE Surgical iMARK™ Internal Hexagon Dental Implant System. This document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, rather than an AI-based device's performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) is not applicable to this type of submission.
However, I can extract the relevant performance characteristics that were tested and the type of ground truth used (in this case, mechanical test standards and predicate device performance).
Here's the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance/Comparison (Implied Acceptance) |
|---|---|---|
| Mechanical Performance | Torsional Insertion | Conducted to support substantial equivalence to predicate devices (K954513 and K011028). |
| Shear (Coaring) | Conducted to support substantial equivalence to predicate devices (K954513 and K011028). | |
| Compressive Bending | Conducted to support substantial equivalence to predicate devices (K954513 and K011028). | |
| Fatigue Strength | Conducted to support substantial equivalence to predicate devices (K954513 and K011028). | |
| Material Composition | Ti-6-AL-4V ELI per ASTM F13 standard | Stated as the raw material for the implant screw. |
| Surface Treatment | Resorbable Blast Media (RBM) | Applied to the implant screw, comparable to predicate devices. |
| Sterilization | Gamma radiation pursuant to ISO 11137 | Provided sterile, achieved by gamma radiation, identical to predicate device methods. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated in the document (typical for mechanical testing, usually a small number of samples per test type to meet standard requirements).
- Data Provenance: Not specified, but generally, mechanical testing is performed in a controlled laboratory environment. Retrospective/prospective distinction is not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The "ground truth" for mechanical testing is established by adherence to recognized industry standards (e.g., ASTM F13, ISO 11137) and comparison to predicate device performance, not by expert consensus on data interpretation.
4. Adjudication method for the test set
- Not applicable. Adjudication methods (like 2+1, 3+1) are used for expert review of clinical data, not for mechanical performance testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI-based device, and therefore no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" or reference for the mechanical testing was primarily based on:
- Industry Standards: Adherence to established mechanical testing standards (e.g., relevant ASTM standards for materials and ISO standards for sterilization).
- Predicate Device Performance: Comparison of the new device's mechanical performance to that of legally marketed predicate devices (ACE Surgical Screw Dental Implant System K954513 and Zimmer® Tapered Screw Vent Dental Implant K011028) to demonstrate "substantial equivalence."
8. The sample size for the training set
- Not applicable. This is a medical implant, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable. There is no training set.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets its acceptance criteria involved a series of mechanical tests designed to demonstrate the material properties, structural integrity, and functional performance of the ACE Surgical iMARK™ Internal Hex Dental Implant System. These tests included:
- Torsional insertion: To assess the torque required for placement/insertion.
- Shear (coaring): To evaluate resistance to shearing forces.
- Compressive bending: To test the implant's ability to withstand compressive and bending loads.
- Fatigue strength: To determine the implant's durability under repeated stress cycles, simulating physiological conditions over time.
These tests were performed to support the substantial equivalence of the iMARK™ system to two predicate devices: the ACE Surgical Screw Dental Implant System (K954513) and the Zimmer® Tapered Screw Vent Dental Implant (K011028). The implicit "acceptance criteria" for these tests were that the new device's performance characteristics must be comparable to or better than those of the predicate devices, thereby demonstrating that it is as safe and effective.
Additionally, material composition (Ti-6-AL-4V ELI per ASTM F13 standard) and sterilization methods (gamma radiation per ISO 11137) were confirmed to meet recognized standards, further supporting the device's safety and effectiveness. The successful completion of these tests, leading to a determination of substantial equivalence by the FDA, indicates that the device met the necessary performance characteristics for market clearance.
§ 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.