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510(k) Data Aggregation
(85 days)
The QuickBridge System is intended to be mated with BIOMET 3i conical abutments for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. The QuickBridge System is intended for use to support multiple unit prostheses in the mandible or maxilla for up to 180 days during endosseous and gingival healing.
The QuickBridge provisional components consist of a non-hexed titanium alloy cylinder and a PEEK Cap. The titanium cylinder threads onto Biomet 3i Conical Abutments that have a 4.8 mm margin diameter. The QuickBridge Cap is made of PEEK and snaps over the QuickBridge Cylinder to allow it to be picked up in a provisional bridge for an immediate load restoration.
This document is a 510(k) premarket notification for a medical device called "QuickBridge Cylinder and Cap" by Biomet 3i, Inc. It describes the device, its intended use, and states that it has been determined to be substantially equivalent to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
This document does not describe specific acceptance criteria in terms of numerical performance thresholds (e.g., accuracy, sensitivity, specificity) for the QuickBridge Cylinder and Cap. Instead, the "acceptance criteria" are implied by the process of demonstrating "substantial equivalence" to a predicate device.
The reported "device performance" is not presented in quantitative metrics but rather by the successful completion of verification and validation activities under quality system design controls, leading to the conclusion of substantial equivalence.
| Item | Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|---|
| Design Control & Equivalence | Device design modifications completed under Quality System Design Controls (21 CFR 820.30). | |
| Appropriate verification and validation activities performed to ensure QuickBridge Cylinder and Cap remain substantially equivalent to the predicate (Certain Provide Temporary Cylinder, K061177). | ||
| Modifications have not changed the intended use, altered fundamental scientific technology, or safety/effectiveness. | "The design modifications for the proposed QuickBridge Cylinder and Cap were completed under Quality System Design Controls in accordance with 21 CFR 820.30. Appropriate verification and validation activities were performed to provide assurance that QuickBridge Cylinder and Cap remain substantially equivalent to the predicate Provide Temporary Cylinder with the Provide Abutment, and the modifications have not changed the intended use, altered the fundamental scientific technology or the safety and effectiveness of the device." | |
| Intended Use | The device is intended to be mated with BIOMET 3i conical abutments for use as an accessory to endosseous dental implants to support a prosthetic device in partially or fully edentulous patients, specifically for multiple unit prostheses for up to 180 days. | The stated Indications for Use in the submission and confirmed by the FDA: "The QuickBridge System is intended to be mated with BIOMET 3i conical abutments for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. The QuickBridge System is intended for use to support multiple unit prostheses in the mandible or maxilla for up to 180 days during endosseous and gingival healing." |
2. Sample size used for the test set and the data provenance
This document does not describe a clinical study or a test set in the conventional sense (e.g., a set of patient data or images). The evaluation relies on a comparison to a predicate device and engineering verification/validation activities. Therefore, there is no specific sample size mentioned for a test set, nor is there any information on data provenance (country of origin, retrospective/prospective). This is typical for a 510(k) submission for certain types of dental accessories where functional equivalence and material specifications are the primary focus, rather than diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As there is no clinical or diagnostic "test set" and ground truth establishment in the context of diagnostic performance, this information is not provided. The "ground truth" for this device would relate to its engineering specifications, material properties, and functional performance, which are evaluated by Biomet 3i's internal quality system personnel.
4. Adjudication method for the test set
Not applicable. There is no clinical or diagnostic "test set" requiring adjudication by multiple experts.
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 device is a dental implant accessory, not an AI-powered diagnostic tool, and therefore, an MRMC study is outside the scope of this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical component, not an algorithm.
7. The type of ground truth used
For this type of device, the "ground truth" is established through:
- Engineering Specifications and Design Requirements: The device must meet predefined specifications for dimensions, material properties, mechanical integrity, and compatibility with other dental components.
- Performance Standards: Compliance with relevant industry standards for dental implants and accessories.
- Predicate Device Equivalence: The primary "ground truth" for regulatory clearance is demonstrating that the new device is as safe and effective as a legally marketed predicate device, as confirmed through verification and validation activities.
8. The sample size for the training set
Not applicable. This document describes a mechanical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned in this document.
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