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The DENTSPLY® PRECISION TORQUE SYSTEM is used for tightening of prosthetic implant components to their recommended torque levels to deliver an accurate torque application. The SYSTEM can also be used to unthread prosthetic screws.

The DENTSPLY® PRECISION TORQUE SYSTEM utilizes a ratchet mechanism and a pre-calibrated disposable insert. Each time the wrench is used, a new breakaway insert provides for a 100% of re-calibration. Two different insert sizes are provided.

Here's an analysis of the provided 510(k) summary, aiming to extract the requested information about acceptance criteria and the supporting study:

Analysis of K964046: DENTSPLY® PRECISION TORQUE SYSTEM

The provided 510(k) summary primarily focuses on the accuracy and reliability of the DENTSPLY® PRECISION TORQUE SYSTEM in delivering a specified torque for tightening prosthetic implant components.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "well within the functional acceptance level that allowed for a maximum variance of ± 15%." for torque application. The calibration reliability acceptance criterion is inferred from the statement "The DENTSPLY® PRECISION TORQUE SYSTEM maintained its precision calibration over time," contrasting with competitors whose variance increased with repeated use.

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

• Sample Size: The study used 30 samples (5 inserts). This sample size is for the assessment of torque application accuracy.
• Data Provenance: Not explicitly stated. Given it's a device pre-market submission, it's highly likely to be prospective data generated during product development and testing in a controlled laboratory setting. Country of origin is not mentioned but would presumably be where DENTSPLY International conducts its R&D and manufacturing, likely in the US (York, PA).

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

• Not Applicable. This device is a mechanical tool. "Ground truth" in this context is established by precise mechanical measurements (e.g., using a calibrated torque sensor/transducer), not by expert human interpretation or diagnosis. Therefore, no human experts were involved in establishing the ground truth for the performance testing.

4. Adjudication Method for the Test Set

• Not Applicable. As the ground truth is established by mechanical measurement, there is no need for human adjudication of results.

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 is a mechanical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.

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

• Yes, by nature of the device. The performance study described evaluates the device itself (the DENTSPLY® PRECISION TORQUE SYSTEM) in delivering specific torque values, independent of any human variable other than operating the tool as intended. It's an "algorithm only" in the sense of the device's mechanical function, not a software algorithm.

7. The Type of Ground Truth Used

• Accurate Mechanical Measurement: The ground truth for torque application accuracy would have been established using a highly precise and calibrated torque measurement device (e.g., a torque transducer/sensor) to determine the actual torque applied by the system.

8. The Sample Size for the Training Set

• Not Applicable. This device is a mechanical tool, not a machine learning model. There is no concept of a "training set" for its development or evaluation. Its design and calibration would be based on engineering principles and iterative testing, not data-driven machine learning training.

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

• Not Applicable. (As explained in point 8, there is no training set for this type of device.)

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