(184 days)
The A-dec NLZ electric motor system is control unit that drives a direct current (DC) electric micromotor that is activated by means of a foot control. It is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, prophylaxis and endodontic treatment, with use of a straight, right-angle ISO E-tvpe handpiece attachment of equal, gear-reducing, or gear-increasing speed.
The A-dec NLZ electric motor system is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment, with use of a straight, right-angle or contra-angle ISO E-type handpiece attachment of equal, gear-reducing, or gear-increasing speed.
Control Unit, Motor and Motor Tubing are constituents of the A-dec NLZ electric motor system under this 510(k) application. The A-dec NLZ electric motor system is intended for use only with the A-dec 300 (K082985) or A-dec 500 (K032756) delivery system. The A-dec 300 (K082985) or A-dec 500 (K032756) delivery system offers operation modes for use with the A-dec NLZ electric motor system.
The Control Unit of the A-dec NLZ electric motor system is contained within the control head of the A-dec 300 (K082985) or A-dec 500 (K032756). The subject device acquires +24 VAC electrical power from the delivery system to the Control Unit. User can control the motor system through Touch Pad and Foot Controller of the delivery system. The control unit receives instructions such as motor rotation/stop, speed setting value, torque setting value, and LED turning ON/OFF from Touch Pad and Foot Controller. The Control Unit drives the Motor using instructed rotation speed and torque via Motor Tubing. The delivery system provides standard mode (range of rotation speed is 1,000 - 40,000 rpm) and endo mode (range of rotation speed is 100 - 5,000 rpm).
The Motor Tubing is connected to the Control Unit via a lead wire and air/water supply via tubing inside the control head of the delivery system. The other side of the Motor Tubing is attached to the Motor.
The provided document is a 510(k) summary for the A-dec NLZ Electric Motor System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the level of detail typically required to answer your specific questions regarding acceptance criteria and a detailed study proving performance, especially in the context of AI/ML devices or studies involving human readers and ground truth.
This document describes a traditional dental device (electric motor system), not an AI/ML device. Therefore, many of your questions, particularly those about AI/ML specific details like training sets, ground truth establishment for training data, MRMC studies, or standalone algorithm performance, are not applicable to the information provided.
Based on the available information, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document states that the device was compliant with ISO 14457 and met the requirements of other standards. However, it does not provide a table with specific acceptance criteria (e.g., numerical thresholds for different performance metrics) and corresponding reported performance values for those criteria. It only provides a comparison table of features and ranges with the predicate device.
| Feature | Acceptance Criteria (Implied by standard compliance) | Reported Device Performance (A-dec NLZ Electric Motor System) |
|---|---|---|
| Bench Testing | Conformity to ISO 14457 | All samples compliant with ISO 14457 |
| Electrical Safety | Conformity to IEC 60601-1 | Test results indicate no concern |
| EMC | Conformity to IEC 60601-1-2 | Test results indicate no concern |
| Biocompatibility | Conformity to ISO 10993-5, -10 | No biocompatibility concern raised |
| Sterilization | Conformity to FDA guidance | Performed in accordance with FDA guidance |
| Software Validation | Conformity to FDA guidance | Conducted in accordance with FDA guidance |
| Backflow (Motor Tubing) | No backflow into Motor/Motor tubing | No backflow detected |
| Extractables (Water Circuit) | No extractables/leachables detected | Extractables/leachables not detected |
| Ranges (compared to predicate, not acceptance criteria) | ||
| Standard Mode Rotation Speed | 1,000 - 40,000 rpm (Predicate: 1,000 - 40,000 rpm) | 1,000 - 40,000 rpm |
| Endo Mode Rotation Speed | 100 - 5,000 rpm (Predicate: 100 - 5,000 rpm) | 100 - 5,000 rpm |
| Standard Mode Max Torque | - (Predicate: 4.10 Ncm) | 4.00 Ncm (Measured value) |
| Endo Mode Torque Range | 0.30 - 3.00 Ncm (Predicate: 0.30 - 3.00 Ncm) | 0.30 - 3.00 Ncm |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "All A-dec NLZ electric motor system samples" for bench testing but does not specify a numerical sample size. It refers to "samples" being compliant, but no specific count is provided. There is no information about data provenance as this is a device performance test, not a data-driven clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is not an AI/ML product that would require expert-established ground truth for a test set in the same way. The "ground truth" for this device's performance would be objective measurements against engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept applies to human expert review for establishing ground truth, which is not relevant here.
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 not an AI-assisted device. No MRMC study was mentioned or implied.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm, but a physical electric motor system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance tests mentioned (bench testing, electrical safety, EMC, biocompatibility, backflow, extractables), the "ground truth" is established by the specified international and national standards (e.g., ISO 14457, IEC 60601-1, IEC 60601-1-2, ISO 10993 series) and FDA guidance documents. Compliance is determined by objective measurements meeting the criteria set forth in these standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that uses a "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.