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A dental matrix band is a non-sterile single use disposable device intended to be place around a tooth to keep filling material from bonding onto the other tooth. Matrix bands are used to form missing walls of prepared teeth. They shape and confine restorative materials to areas prepared to receive restorations.

The Dental Matrix Band is made of medical grade stainless steel with a tin coating. The dental matrix bands are offered non-sterile single use.

This document describes a 510(k) premarket notification for a Dental Matrix Band, a Class I medical device. The information provided is primarily focused on establishing substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria in the way one would for a novel, higher-risk device or an AI/ML powered medical device.

Therefore, the requested AI/ML-specific information (expert consensus, training/test set details, MRMC studies, standalone performance, etc.) is not applicable to this submission. This is a conventional medical device that relies on material testing and comparison to an existing product.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This is not a study involving human data or a "test set" in the context of an AI/ML algorithm. The "testing" referred to is materials testing for biocompatibility.

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

Not applicable. Ground truth for a test set (in an AI/ML context) is not relevant for this device.

4. Adjudication Method for the Test Set

Not applicable.

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

No such study was conducted or is relevant for this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

Not applicable in the context of AI/ML. The "ground truth" for this device's performance is established by its material properties meeting ISO 10993 standards and its physical characteristics (intended use, size, configuration, material) being comparable to a legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Study that Proves the Device Meets the Acceptance Criteria:

The "study" referenced for this device is a "Summary of Testing" which states:

• Materials were tested per ISO 10993 Biological Evaluation for Medical Devices for a surface indicating, skin, limited exposure device.

This indicates that biocompatibility testing was performed according to internationally recognized standards for medical devices. The specific results of this testing (e.g., passing specific cytotoxicity, sensitization, or irritation tests) are not detailed in this summary but are implicit in the claim of testing per ISO 10993.

The primary proof of the device meeting its acceptance criteria (beyond biocompatibility) is its substantial equivalence to a predicate device, the Dentsply, Inc., Dental Matrix Band. The argument for substantial equivalence is based on the new device sharing the same:

• Intended use
• Size and configuration
• Base material

The FDA's decision to clear the device (K071858) confirms that they found sufficient evidence of substantial equivalence to the predicate device, implying that the provided testing and comparative analysis were deemed adequate.

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