Search Results

This device 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, and to restore the patient's chewing function.

The Quantum Versatility Implants are screw-type endosseous dental implants with design and manufacturing concepts, materials, surgical procedures, and intended uses quite similar to the preamendment device and to others rated substantially equivalent to the preamendment device. The Quantum Implant system is most similar the DB Precision Implant system cleared in K-853788 which is very similar to the Titanaloy submersible implant system cleared in K-830414. Like many commercial implants, the Quantum devices are manufactured of high-purity (99+%) titanium, or titanium alloy (ASTM F 136-84 titanium - 6 aluminum - 4 vanadium). Quantum Implants also are available in coated form, either hydroxyapatite or titanium plasma spray. These devices are equivalent to various coated endosseous implants on the market, for example the Sabertech implants of Genentech, Inc., which were cleared under K-924112.

This document describes a 510(k) submission for the Quantum Versatility Implant System, a dental implant device. It primarily focuses on demonstrating "substantial equivalence" to predicate devices rather than proving performance against specific acceptance criteria through novel studies. Therefore, many of the requested sections (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance) are not applicable or cannot be extracted directly from this type of regulatory submission.

The core of this submission is a claim of equivalence to existing devices that have already been proven safe and effective.

Here's an analysis based on the provided text, addressing the points where information is available or noting where it's not applicable:

Analysis of Acceptance Criteria and Study for Quantum Versatility Implant System

This 510(k) submission for the Quantum Versatility Implant System relies on demonstrating substantial equivalence to predicate devices rather than conducting a new efficacy study against specific, novel acceptance criteria. Therefore, the "acceptance criteria" are implicitly met by demonstrating that the device is functionally and materially similar to legally marketed devices. The "study that proves the device meets the acceptance criteria" in this context is the literature review and comparison to established predicate devices and their historical performance.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) submission for substantial equivalence, formal, quantitative acceptance criteria and device performance metrics (e.g., sensitivity, specificity, accuracy for an AI device) as typically understood are not explicitly stated or measured for the Quantum Versatility Implant System itself in this document. Instead, the acceptance criteria are implicitly derived from the established performance and safety of the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a "test set" or a new study of the Quantum Versatility Implant System with a specific sample size. The substantial equivalence argument relies on a comprehensive literature review and comparison to predicate devices, which collectively represent decades of clinical experience.

• Data Provenance: The "data" provenance is primarily from published scientific literature (Medline search, Consensus Development Conference on Dental Implants, 10-year study by Zarb on Branemark implants), regulatory records of predicate devices cleared by the FDA, and market history of preamendment devices. This data would generally be considered retrospective in the context of this submission, as it looks back at prior studies and existing devices. The country of origin of the data is primarily international and US-based for the literature, given the context of dental implant research and regulatory approvals.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable as there was no new "test set" and a corresponding "ground truth" established specifically for the Quantum Versatility Implant System's performance within this submission. The "ground truth" for the safety and effectiveness of dental implants in general implicitly comes from the vast body of scientific literature and consensus among the dental and medical community over many years. The 1988 Consensus Development Conference on Dental Implants (NIH) cited in the document would involve multiple experts, though their specific qualifications beyond being part of such a conference are not detailed here.

4. Adjudication Method for the Test Set

This is not applicable as there was no new "test set" requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable. The device is a physical dental implant, not an AI or imaging diagnostic device where MRMC studies would typically be performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable. The device is a physical dental implant, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the safety and effectiveness of endosseous implants, on which the substantial equivalence argument rests, is based on:

• Expert Consensus: Highlighted by the "Consensus Development Conference on Dental Implants" (NIH, 1988), which summarized available scientific data.
• Outcomes Data: Referenced through the "detailed Toronto 10-year study by Zarb" concluding predictability and reliability of the Branemark implant technique, which serves as a benchmark for the field.
• Literature Review: A comprehensive Medline search (653 entries + 111 new review articles) providing a summary of scientific data on dental implants.
• Historical Clinical Experience: The document frequently refers to implants being "proved safe and effective through the years" and "wide-spread usage."

8. Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this 510(k) submission for a physical medical device. The "training" for the substantial equivalence claim comes from the collective body of scientific literature and clinical experience with dental implants over decades.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the reasons stated above. The "ground truth" for the broader field of dental implantology, as derived from the literature review, was established through traditional clinical research, long-term follow-up studies, and expert consensus.

Ask a specific question about this device