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DuoLink II is a dual-cured, radio-apparent composite luting cernent.

The indications of use of DuoLink II are to cement:

• 1. All indirect restorations (ie. crowns, bridges, inlay, and onlays fabricated from metal composite, porcelain, ceramic, zirconia, alumina, etc)
• 2. All endodontic posts (ie. fiber, composite, and metal)
• 3. All abutments (ie. screws)

DuoLink II is a dual-cured, radio-apparent composite luting cement.

This document describes the DuoLink II Composite Luting Cement, a dental device cleared by the FDA. The submission for this device is a 510(k) premarket notification, which demonstrates substantial equivalence to legally marketed predicate devices rather than proving independent safety and efficacy through a standalone study with defined acceptance criteria and performance metrics.

Therefore, the requested information regarding acceptance criteria, specific study details (sample sizes, expert ground truth, adjudication, MRMC, standalone performance), and training set information is generally not applicable in the context of a 510(k) submission for a device like DuoLink II.

A 510(k) submission primarily focuses on comparing the new device's technological characteristics and performance data to established predicate devices to claim substantial equivalence.

Here's an adaptation of the requested table and explanation based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For a 510(k) submission, "acceptance criteria" are typically met by demonstrating that the new device performs "as well as or better than" its predicate devices, rather than meeting specific numerical thresholds set independently. The "reported device performance" in this context refers to the comparative data presented.

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

• Sample Size for Test Set: Not specified. The document refers to "testing" for physical/mechanical properties and biocompatibility, but the sample sizes for these tests are not provided.
• Data Provenance: The studies appear to be laboratory-based tests conducted to evaluate chemical, physical/mechanical, and biocompatibility aspects. The country of origin and whether they are retrospective or prospective are not detailed. These are likely internal or contract lab studies performed for the submission.

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

• Not Applicable. For a 510(k) submission for a dental cement, ground truth in the sense of expert consensus on clinical outcomes or diagnoses is usually not established. The "ground truth" for the performance data derives from standardized laboratory tests (e.g., ISO standards) and material science principles.

4. Adjudication Method for the Test Set

• Not Applicable. As the "test set" primarily refers to laboratory measurements, there is no expert adjudication method like 2+1 or 3+1 typically used for clinical endpoints or diagnostic accuracy.

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

• No. An MRMC study was not conducted as this is a dental cement, not a diagnostic imaging device. The "comparative effectiveness" is established through laboratory performance comparisons with predicate devices, not human reader performance.

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

• Not Applicable. This device is a material (dental cement), not an algorithm or AI system. Its performance is inherent to its physical, chemical, and biological properties, not a computational output.

7. Type of Ground Truth Used

• The "ground truth" for demonstrating substantial equivalence relies on:
  • Standardized Laboratory Testing: Adherence to standards like ISO 4049:2009 for physical/mechanical properties and ISO 10993-1 for biocompatibility.
  • Chemical Analysis: Comparison of chemical composition to established, legally marketed predicate devices.
  • Predicate Device Performance: The established performance and safety profile of the predicate devices (DuoLink K934596, Calibra K040906, Self-Adhesive Luting Cement K093338) serve as the benchmark for the new device.

8. Sample Size for the Training Set

• Not Applicable. This is a material device; there is no "training set" in the context of machine learning. The term "training set" is not relevant here.

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

• Not Applicable. As there is no training set, this question is not relevant.

Summary Explanation:

The provided document is a 510(k) summary for a dental cement. The purpose of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, not to prove de novo safety and effectiveness through extensive clinical trials with specific acceptance criteria as you might find for novel high-risk medical devices or AI/ML-based diagnostics.

The "study" in this context comprises various laboratory tests (chemical composition analysis, physical/mechanical property evaluation including ISO 4049:2009, and biocompatibility testing per ISO 10993-1) which are designed to show that DuoLink II functions similarly to and is as safe and effective as its predicate devices. The "acceptance criteria" are implicitly met by showing that the new device is "as well as or better than" the predicate devices in these measured aspects. The FDA's clearance (K101787) indicates that this substantial equivalence was successfully demonstrated.

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