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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

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.

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