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The NT and Mac Series Endodontic Files are engine files and hand instruments designed for use in root canal preparation.

The NT and Mac Series Endodontic Files are a series of engine (rotary) driven and hand driven endodontic files for use in root canal preparation. The files are constructed of nickel-titanium and color coded for ease of use. The files are available in 21 and 25mm lengths and ten graduating sizes.

This 510(k) submission (K971319) for the Tycom Dental NT and Mac Series Endodontic Files primarily focuses on establishing substantial equivalence to a predicate device (Tycom Dental Quantec Series 2000, K962031). It does not contain information about a study proving the device meets specific acceptance criteria in the way a clinical performance study for an AI/CADe device would. Instead, the submission relies on demonstrating that the new devices share the same intended use and similar technological characteristics as the previously cleared predicate.

Therefore, many of the requested categories for a study proving acceptance criteria cannot be extracted from this document, as such a study was not performed or detailed within this submission for these specific devices.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not define specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) for the NT and Mac Series Endodontic Files, nor does it report device performance against such criteria. The basis for clearance is substantial equivalence.

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

Not applicable. No "test set" in the context of performance metrics for an AI/CADe device was used. The submission relies on a comparison of device characteristics to a predicate.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. No ground truth was established by experts for performance evaluation, as no such performance study was conducted or detailed in this submission.

4. Adjudication Method

Not applicable. No adjudication method was used for a test set, as no performance study was conducted.

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

Not applicable. There is no MRMC study mentioned in this document, as the device is a medical instrument (endodontic file), not an AI/CADe system designed for reader interpretation.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The device is a physical instrument, not an algorithm.

7. Type of Ground Truth Used

Not applicable. No ground truth in the context of performance evaluation was used. The ground truth for this submission is the established safety and effectiveness of the predicate device (Tycom Dental Quantec Series 2000).

8. Sample Size for the Training Set

Not applicable. The device is a physical instrument, not a machine learning model, so there is no "training set."

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

Not applicable. As there is no training set, this question is not relevant.

Summary of Acceptance Criteria and "Study" (Substantial Equivalence):

The "acceptance criteria" can be inferred from the FDA's decision to clear the device based on substantial equivalence.

Study Proving Acceptance Criteria:

The "study" in this case is the 510(k) premarket notification process, which relies on demonstrating substantial equivalence to a previously cleared predicate device rather than de novo clinical trial data for performance metrics.

• Device Name: NT and Mac Series Endodontic Files
• Predicate Device: Tycom Dental Quantec Series 2000 (K962031, cleared June 4, 1996)
• Basis for Equivalence: The submission asserts that the NT and Mac Series Endodontic Files are "substantially equivalent ... in terms of intended use and technological characteristics" to the Quantec Series 2000 hand files and engine files, respectively. No specific performance data (e.g., in vivo or in vitro studies measuring file breakage rates, cutting efficiency, etc.) is presented in this summary to support this beyond the claim of similar material (nickel-titanium) and function. The fundamental characteristics are stated to be similar according to comparison charts provided in the full 510(k) submission.

In essence, for this type of device and submission, the "proof" is the detailed comparison of features, materials, and intended use against a legally marketed predicate device, satisfying the FDA that the new device raises no new questions of safety or effectiveness.

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