(70 days)
B1P Adhesive is an adhesive designed to be used for all direct and indirect applications including, but not limited to, the following:
Direct Applications
- Direct bonding to dentin and/ or enamel .
- Bonding composite to composite, porcelain and/ or metal .
- . Opaquing metal (used in conjunction with an opaque resin stain or cement)
- Bonding with dual cure and self cure composite resins, such as cements and core build up . materials
- Amalgam sealing
- Dentin sealing ●
Indirect applications
- Indirect bonding of all composite, all ceramic, PFM and alloy crowns, bridges, inlays, ● onlays and veneers (used in conjunction with resin luting agents)
- Bonding of fiber and metal posts (in conjunction with resin luting agents) ●
B1P Adhesive is a fifth generation dental bonding agent that is intended to be used for direct composite bonding and indirect restoration in combination with a dental restorative material. The formula is used based on a total etch technique and combines the primer and adhesive into one component. The application procedure requires steps of acid etching and rinsing, followed by the application of the B1P Adhesive. It is a light curable adhesive with the option of being dual cured when mixed with the dual cure activator.
Here's an analysis of the provided text, focusing on acceptance criteria and supporting studies for the B1P Adhesive device:
The documentation for K111431, B1P Adhesive, does not explicitly define quantitative acceptance criteria in a table format as often seen in medical device submissions for diagnostic or AI-driven devices. Instead, the "acceptance criteria" are implied through the concept of "substantial equivalence" to predicate devices, supported by specific bench test results (bonding strengths) and biocompatibility.
The study presented is not a typical clinical study with a defined test set, ground truth experts, or complex statistical analysis for performance metrics akin to an AI device. It's a submission for a dental bonding agent, and the evaluation is primarily focused on demonstrating physical and chemical properties similar to existing, legally marketed devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, explicit, quantitative acceptance criteria in a table format are not present in the provided text. The overall "acceptance criterion" is achieving substantial equivalence to the predicate devices. The performance data is presented qualitatively and comparatively.
| Acceptance Criterion (Implied) | Reported Device Performance (Comparative) |
|---|---|
| Biocompatibility | Meets ISO 10993 standards; safe for intended use. |
| Direct Bonding Strength | Evaluated through bench testing and demonstrated performance comparable to predicates. (Specific values not provided) |
| Indirect Bonding Strength | Evaluated through bench testing and demonstrated performance comparable to predicates. (Specific values not provided) |
| Functional Equivalence | Functions similarly to predicate devices (Dentin Conditioning and Adhesive (Bond 1), Optibond Solo Plus 2, lBond Total Etch) in application and intended use. |
| Technological Characteristics | Similar characteristics to predicates (e.g., acetone-based, single-coat application, ambient temperature storage, filler technology, glutaraldehyde as desensitizer). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document refers to "bench testing used to evaluate the performance characteristics of B1P Adhesive compared to the predicate devices" for bonding strengths. Details on the number of samples or specimens tested are not provided.
- Data Provenance: Not explicitly stated, but assumed to be from laboratory bench testing conducted by the manufacturer, Sybron Dental Specialties, Inc. (or affiliated labs). The data is retrospective in the sense that it's generated for this submission, not from a prospective clinical trial. Country of origin not mentioned but likely US-based given the submitter's location.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable/not provided in the context of this submission. The "ground truth" for bonding strengths would be derived directly from the physical measurements obtained during the bench tests, not from expert consensus or interpretation.
4. Adjudication Method for the Test Set
This is not applicable/not provided. There was no expert-based adjudication process for the bench tests described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This is not applicable/not provided. The device is a dental bonding agent, not an AI-driven diagnostic or assistive technology. Therefore, no MRMC study or AI-related comparative effectiveness analysis was performed or is relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable/not provided. The device is a physical product (a dental bonding agent), not a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation (bonding strengths) was based on direct laboratory measurements from bench testing. For biocompatibility, it was based on adherence to ISO 10993 standards. There was no pathology, expert consensus, or outcomes data used as ground truth in the way it might be for a diagnostic device.
8. The Sample Size for the Training Set
This is not applicable/not provided. There is no "training set" in the context of this device and its evaluation. The product's formulation and development would involve research and development, but this is not framed as a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable/not provided as there is no training set mentioned or implied. Product development for a chemical formulation relies on chemical principles, materials science, and iterative testing, not establishing ground truth for a training set in the AI sense.
Summary of Device Evaluation Approach:
The submission for B1P Adhesive relies on a predicate device comparison and bench testing to demonstrate substantial equivalence. The key evidence provided includes:
- Biocompatibility: Conformance to ISO 10993 standards.
- Technological Characteristics Comparison: Detailed descriptions of similarities and differences with three legally marketed predicate devices, highlighting how B1P Adhesive functions similarly for the same intended use.
- Bench Testing Data: Evaluation of direct and indirect bonding strengths, confirming performance characteristics comparable to the predicate devices (though specific quantitative results are not included in the summary).
Crucially, the document explicitly states: "Clinical testing has not been conducted on this product." This means the demonstration of substantial equivalence is entirely based on non-clinical data and comparison to existing products.
§ 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.