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Bond-1 C&B is used for adhesion to dentin and bonding various polymeric filling materials (composites). Also, Bond 1C&B is used for bonding of composite to metal, including (composited) i semi precious and non precious alloys, porcelain and glass and luting of same to Dentin and Enamel. Bond 1 C&B was approved by the FDA on March 21, 2000 under 510(k) # K994359.

We are adding a component called Bond-1 Self Cure Activator to be used in conjunction with Bond 1 C&B. The formula for Bond-1 Self Cure Activator is attached in the application. Bond-1 Self Cure Activator, when mixed with Bond-1 C&B will allow Bond-1 C&B to cure with or without the use of light.

Device Description

AI/ML Overview

This document describes a 510(k) submission for a dental bonding agent, Bond-1 C&B, with the addition of a "Bond-1 Self Cure Activator." It is a regulatory submission for a Class II medical device (Resin Tooth Bonding Agent) seeking clearance based on substantial equivalence to a previously approved device.

Crucially, this is not a study that proves a device meets acceptance criteria in the way a diagnostic AI device or a complex medical device with performance metrics would. This submission is for a dental adhesive and its self-cure activator. The "acceptance criteria" here are related to chemical composition, material properties, and functionality, primarily demonstrating that the new component (self-cure activator) does not negatively impact the established performance of the existing Bond-1 C&B and provides the intended self-curing capability.

Therefore, many of the requested categories (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training sets for AI) are not applicable to this type of device submission.

Here's how to address the request based on the provided document:

Acceptance Criteria and Device Performance Study for Bond-1 C&B with Self-Cure Activator

This 510(k) submission (K013543) details the addition of a "Bond-1 Self Cure Activator" to an existing FDA-approved dental bonding agent, Bond-1 C&B (K994359). The "study" referenced in the document is the justification for substantial equivalence, focusing on the functionality of the new activator. The acceptance criteria relate to the intended function of the self-cure activator, which is to allow Bond-1 C&B to cure with or without light.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from function)	Reported Device Performance (Inferred from submission)
Curing Mechanism	Device (Bond-1 C&B + Self-Cure Activator) must cure in the absence of light.	Bond-1 Self Cure Activator, when mixed with Bond-1 C&B, "will allow Bond-1 C&B to cure with or without the use of light." (This is the primary claim and de facto performance goal).
Compatibility	The addition of the activator should not compromise the established performance characteristics (e.g., adhesion, bond strength) of the original Bond-1 C&B.	Implied by the substantial equivalence claim. The submission adds a component to be "used in conjunction with" the existing product, suggesting compatibility. No specific performance data for adhesion or bond strength with the activator is provided in these snippets, but would typically be part of a full submission to demonstrate non-inferiority or equivalence.
Safety	The new component and combined product must be safe for intended dental use.	Implied by FDA clearance. Safety data (e.g., biocompatibility testing) would have been submitted to FDA, but is not detailed in these provided excerpts.

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

Sample Size: Not specified in the provided documents. For a chemical additive, testing would likely involve a series of material property tests (e.g., bond strength, curing time, cytotoxicity) on a certain number of samples, not a "test set" in the sense of patient data.
Data Provenance: Not specified. For a dental material, this would typically be laboratory test data generated by the manufacturer.

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

Not Applicable. For a dental bonding agent and its activator, "ground truth" is established through standardized material testing methods (e.g., ISO or ADA standards for bond strength, curing characteristics) conducted in a laboratory, rather than expert interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of subjective data (e.g., medical images). Material property testing results are objective and do not require expert adjudication in this manner.

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

Not Applicable. This is a dental bonding agent, not a diagnostic imaging device or an AI system that assists human readers. MRMC studies are for evaluating the impact of AI on human reader performance.

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

Not Applicable. This device is a chemical product, not an algorithm or AI system.

7. Type of Ground Truth Used

Material Property Testing Results: The "ground truth" for this device would be objective measurements from standardized laboratory tests, demonstrating the efficacy of the self-cure mechanism (e.g., successful polymerization in the absence of light) and maintaining the established properties of Bond-1 C&B. This would typically include chemical characterization, mechanical property testing (e.g., shear bond strength, flexural strength), and biocompatibility assays. The document states "The formula for Bond-1 Self Cure Activator is attached in the application," implying that the chemical composition itself is a key part of the ground truth and justification.

8. Sample Size for the Training Set

Not Applicable. This is a chemical product, not an AI/machine learning model that requires a training set.

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

Not Applicable. As there is no training set, this does not apply.

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K Number

K994359

Device Name

BOND 1 C & B

Manufacturer

JENERIC/PENTRON, INC.

Date Cleared

2000-03-21

(85 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K973388

Intended Use

Bond 1 C & B is used for adhesion to dentin and bonding of various polymeric filling materials (composites). Also, Bond 1 C & B is used for bonding of composite to metal, including amalgam, gold, semi precious, and non precious alloys, porcelain and glass and luting of same to Dentin and Enamel.

Device Description

Bond 1 C&B contains Alcohol and Bond 1 K973388 contains Acetone. Bond 1 C&B will reduce the technique sensitivity of bonding, increasing the working time and decreasing the potential for sensitivity.

AI/ML Overview

This document is a 510(k) summary for a dental bonding agent, Bond 1 C&B. It explicitly states that "No clinical performance investigations were conducted on Bond 1 C & B since it is substantially equivalent to Bond 1, K973388." Therefore, the document does not contain information about acceptance criteria or a study proving the device meets them.

The 510(k) process is used to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, or different technological characteristics but is as safe and effective as the predicate device and does not raise different questions of safety and effectiveness. Clinical studies demonstrating performance are often not required for 510(k) clearances if substantial equivalence can be demonstrated through other means, such as comparison of materials, design, and indications for use.

Therefore, I cannot provide the requested information from this document.

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