(23 days)
The ACE CONNECT™ Internal Connection Screw Dental Implant System is intended to be used 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 ACE Surgical Internal Connection Screw Dental Implant System is a machined commercially pure titanium screw form implant intended to be implanted into the upper or lower jaw to serve as an anchor for a fixed dental prosthesis or single tooth restorations, constructed with an internal hexagon feature for inserting the implant into its surgical site, and to stabilize the prosthesis for rotational load, used to reconstruct the dentition of a patient who is wholly edentulous, supplied in diameters of 3.75. 4.0. 4.75, and 5.75 mm, and in lengths of 8, 10, 11.5, 13, and 15 mm. The implant raw materially pure titanium CP-4 as specified in ASTM F67-95 - Standard Specification for Unalloyed Titanium for Surgical Implant Applications. The implant surface is roughened by means of a blast media process to aid in implant adhesion. The candidate devices are identical in materials and characteristics to that cleared under K954513.
The ACE Surgical Internal Connection Screw Dental Implant System is a comprehensive system retaining prosthetic components, auxiliary components, and surgical tools as does the predicate ACE Surgical Screw Dental implant to assist with the implant's insertion and final prosthetic fabrication.
The provided text describes a 510(k) submission for a dental implant system and focuses on demonstrating substantial equivalence to a predicate device, rather than proving a specific performance metric against pre-defined acceptance criteria through a clinical study. Therefore, much of the requested information (like sample sizes, expert qualifications, adjudication methods for clinical data, MRMC studies, or standalone algorithm performance) is not applicable or not present in this document.
The "acceptance criteria" for this device's submission revolves around demonstrating that its technological characteristics and performance are "substantially equivalent" to an already cleared predicate device.
Here's a breakdown of the information that is available and addresses as much of your request as possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstration of Equivalence) | Reported Device Performance (as claimed in submission) |
|---|---|
| Mechanical Performance: No difference in performance, safety, or effectiveness compared to the predicate device in bench testing. | Bench testing demonstrated there was no difference in the performance, safety, or effectiveness between the ACE Surgical Internal Connection Screw Dental Implant System and the specified predicate devices. |
| Material Composition: Use of identical materials as the predicate device and adherence to ASTM standards. | Implant raw material is commercially pure titanium CP-4 as specified in ASTM F67-95. The candidate devices are identical in materials and characteristics to the predicate (K954513). |
| Intended Use: The modified device's intended use has not changed from that of the predicate. | The indication/intended use of the modified device has not changed from that of the predicates. |
| Device Description & Characteristics: Similarity in design, dimensions, and features to the predicate. | The device is a "machined commercially pure titanium screw form implant... constructed with an internal hexagon feature... supplied in diameters of 3.75, 4.0, 4.75, and 5.75 mm, and in lengths of 8, 10, 11.5, 13, and 15 mm." These characteristics are effectively claimed to be equivalent to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This submission relies on bench test results for mechanical performance comparison, rather than a clinical "test set" of patient data. The document does not specify the number of implants or test cycles used in the bench tests.
- Data Provenance: Not applicable for clinical data. The performance data comes from bench testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. As this is a 510(k) submission primarily relying on bench testing and comparison to a predicate, there is no mention of "ground truth" established by experts in the context of a clinical test set. The "ground truth" for the submission is the regulatory requirement of substantial equivalence, judged by the FDA.
4. Adjudication Method for the Test Set
- Not applicable. There was no clinical "test set" requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study was not done. This device is a dental implant, not an imaging or diagnostic AI device that would typically undergo such a study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This is a physical medical device (dental implant), not a software algorithm.
7. The Type of Ground Truth Used
- The "ground truth" in this context is the established performance and safety profile of the predicate device (ACE Surgical Screw Dental Implant System, K954513). The study's goal was to demonstrate that the new device met this "ground truth" of performance through bench testing and design comparisons.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical dental implant, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, 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.