(146 days)
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
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance | Met? |
|---|---|---|---|
| Torque Application Accuracy | Maximum variance of ± 15% from the claimed 30 Ncm value. | Mean torque delivered: 99.8% of 30 Ncm. | Yes |
| Torque Calibration Reliability | Maintain precision calibration over time. | Maintained its precision calibration over time. | Yes |
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.)
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.