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Compothixo is indicated for modeling of composite, occlusal modeling, fissures and removal of excess composite, layer application technique, bulk technique in small cavities, and for direct veneering. Compothixo represents the next generation composite placement and modeling instrument suitable for all classes of restorations. Compothixo technology utilizes the thixotropic properties of composites by only changing viscosity, without altering the chemical or mechanical characteristics of the material.
The Compothixo is a vibration instrument intended for composite modeling by dental professionals.

Compothixo is a hand-held, battery-operated, vibration composite modeling instrument. When the device is turned on the unit begins to vibrate at 140 Hz. It functions in the same way as a hand-operated composite modeling instrument, and also has interchangeable tips which are similar to the tips on manual composite modeling instruments. The main difference is the use of a battery-operated motor which activates vibrations in the tip, at frequencies which cannot be achieved by hand manipulation alone. Intermittent hand motion can achieve up to 4 Hz of vibration. Compothixo can also be hand operated when it is turned off. The rated voltage is 1.3V and rated current is 85 mA. Therefore, motor power consumption is 110 mW. Compothixo is composed of the changeable tips, a chuck and the handle. The DC motor M is connected to the negative polarity of the battery housed in the handpiece, on the other side of the on/off switch. The latter connect the positive polarity of the battery to the motor depending on the status. The handpiece is composed of an over molded elastomeric plastic, which encompasses the over molded plastic case.

Here's an analysis of the provided text regarding the Compothixo device's acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on functional characteristics and safety, comparing the Compothixo to a predicate device. Acceptance criteria are implicitly defined by establishing substantial equivalence based on these comparisons.

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

• Sample Size: Not applicable. The document states, "Clinical testing has not been conducted on this product." The testing performed was bench testing and biocompatibility testing.
• Data Provenance: Not applicable for a clinical test set. Bench testing data provenance is from the manufacturer's own evaluation or independent labs for EMC.

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

• Not applicable as clinical testing was not performed; therefore, no "ground truth" derived from expert assessment of patient data was established for a test set.

4. Adjudication Method for the Test Set

• Not applicable as clinical testing was not performed.

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

• Not applicable. This device is a dental hand instrument, not an AI-powered diagnostic tool, and no MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This is a physical hand tool, not an algorithm or software. The "standalone" performance refers to the device's functional characteristics (vibration frequency, amplitude) as evaluated in bench testing, separate from human use for final substantial equivalence determination.

7. The Type of Ground Truth Used

• For biocompatibility, the ground truth is established by adherence to documented international standards (ISO 10993).
• For electromagnetic compatibility, the ground truth is established by adherence to documented international standards (IEC 60601-1-2).
• For bench testing of performance characteristics (Frequency of hand movement, Activation frequency, Maximal radial amplitude of the modeling tip), the "ground truth" for comparison was the performance characteristics of the predicate device (Hu-Friedy Composite Instrument) or the inherent physical properties of the device itself (e.g., its designed vibration frequency of 140 Hz). This involved direct measurement and comparison.

8. The Sample Size for the Training Set

• Not applicable as this is a physical medical device, 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 this is a physical medical device, not an AI/machine learning model.

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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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