(75 days)
Ecusit Composite Repair is indicated for intra-oral repair of dental composite restorations.
The Ecusit Composite Repair material is a single-component, methyl methacrylate-based, light-curing bonding agent specifically developed for use in intra-oral repair of poor or damaged dental composite restorations.
Here's an analysis of the provided text regarding the Ecusit Composite Repair device, focusing on acceptance criteria and study details.
Based on the provided K992879 document, the submission is a 510(k) Pre-Market Notification for a dental device, Ecusit Composite Repair. These types of submissions typically rely on substantial equivalence to a predicate device rather than extensive human clinical trials with strict acceptance criteria for AI or diagnostic accuracy as seen in medical imaging or diagnostic tests.
Therefore, many of the requested points regarding AI performance metrics (like sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, and training set details) are not applicable to this type of device and submission.
The "acceptance criteria" for a 510(k) for a device like this revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved through comparisons of materials, design, and performance characteristics, often involving bench testing.
Here's a breakdown of the information that is applicable:
Acceptance Criteria and Device Performance for Ecusit Composite Repair
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Material Composition and Design | |
| (Equivalent to predicate device in foundational properties) | The materials, performance specifications, and essential design characteristics of the Ecusit Composite Repair are equivalent to those of the predicate devices (One Coat Bond Dentin/Enamel Adhesive System, K974906). |
| Biocompatibility/Safety | |
| (No new safety concerns compared to predicate) | The device is deemed "safe and effective for its intended use" based on substantial equivalence and performance testing, implying no new safety concerns. |
| Performance Characteristics | |
| (Equivalent mechanical/bonding properties) | "Shear strength and composite penetration depth data were presented for the Ecusit Composite Repair material," suggesting these metrics were comparable and acceptable relative to the predicate. |
| Intended Use | |
| (Matches predicate) | "Ecusit Composite Repair is indicated for intra-oral repair of dental composite restorations," matching the scope of predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document. The performance data mentioned (shear strength, composite penetration depth) would have been generated from laboratory bench tests on material samples, not human subjects.
- Data Provenance: Not specified, but generally, for dental material testing, this would be laboratory-generated data by the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable. For a dental material like this, "ground truth" is established through standardized laboratory testing protocols (e.g., ISO standards for dental materials) rather than expert consensus on diagnostic images or clinical outcomes. The "experts" would be materials scientists and engineers conducting the tests.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of data by multiple human readers, not for bench testing of material properties.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is not relevant for this type of device. There is no human-in-the-loop diagnostic interpretation involved that would necessitate such a study.
6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable. This is not an AI/algorithm-based diagnostic device. Performance is inherent to the material properties.
7. The Type of Ground Truth Used
- Laboratory Bench Test Results. The "ground truth" for the performance evaluation of this material would be objective measurements from laboratory tests, such as:
- Shear bond strength measurements (e.g., in MPa).
- Composite penetration depth measurements (e.g., in micrometers).
- Material characterization (e.g., chemical composition, physical properties).
8. The Sample Size for the Training Set
- Not Applicable. This device does not involve an AI algorithm with a distinct "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no AI algorithm, there is no training set and therefore no ground truth establishment for it.
Summary of the Study Proving Acceptance:
The "study" proving the device meets acceptance criteria for a 510(k) submission like this is primarily bench testing and a detailed comparison of material specifications and performance characteristics against a legally marketed predicate device.
The document states:
- "Substantial equivalence for this device was based on similarities in design and performance characteristics as well as performance testing."
- "The materials, performance specifications and essential design characteristics of the Ecusit Composite Repair are equivalent to those of the predicate devices."
- "In addition, shear strength and composite penetration depth data were presented for the Ecusit Composite Repair material."
This indicates that internal laboratory testing data (shear strength, composite penetration depth) was generated for the Ecusit Composite Repair. This data, along with a comprehensive comparison of its chemical composition, physical properties, and intended use, was then used to demonstrate that it performed equivalently to the predicate device (One Coat Bond Dentin/Enamel Adhesive System, K974906). The FDA's clearance signifies their agreement that this evidence was sufficient to establish substantial equivalence, thereby deeming the device "safe and effective for its intended use."
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.