(265 days)
This device is intended for use in general dentistry and restorative dentists and dental professionals in a dental office.
The Lares Research Perceptive electrical motor and control is an air-to-electric dental unit for use in dental restoration and prophylaxis procedures. The unit includes a power supply, control unit, user display tablet, hose and a brushless motor. The control unit is programmable to adjust motor speed, motor direction, and light intensity. The inputs to the control unit are supplied by an electronic tablet which is connected to the unit via a USB cable. The electronic tablet Perceptive application accepts both finger touch and a limited set of voice commands. The motor speed can also be controlled via the pneumatic footswitch connected to the control unit. The unit is designed to control the motor to drive ISO 3964 compatible contra angle and straight dental handpieces at an output speed of 1,000 to 40,000 rpm.
The provided text describes a 510(k) premarket notification for a dental device, focusing on its substantial equivalence to a predicate device. It includes some information about nonclinical tests but does not detail acceptance criteria or a comprehensive study design fitting all the requested information for an AI/ML medical device.
Based on the provided text, here's what can be extracted and what information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Maintain control of motor speed | Maintained control |
| Maintain control of motor direction | Maintained control |
| Maintain control of light output | Maintained control |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The text mentions "prototype Preceptive electric dental control units" but does not quantify how many unique units or test runs were involved.
- Data Provenance: Not specified, but implied to be internal testing at Lares Research ("in-house usability testing"). It is a nonclinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The text mentions "usability testing" but does not detail the involvement or qualifications of experts or a formal ground truth establishment process in the context of device performance.
4. Adjudication method for the test set
- This information is not provided.
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
- This information is not applicable/provided. The device is an electric dental motor and control unit, not an AI/ML diagnostic or assistive tool for human readers. No MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable/provided in the context of an AI/ML algorithm. The performance described relates to the electromechanical operation of the dental motor and control unit itself.
7. The type of ground truth used
- The ground truth for the performance tests appears to be direct measurement of the device's output (motor speed, direction, light output) against its intended operational parameters. It's not expert consensus, pathology, or outcomes data in the typical sense of AI/ML diagnostic devices.
8. The sample size for the training set
- This information is not applicable/provided as this is not an AI/ML device that requires a distinct training set for an algorithm. If "training set" refers to development testing, it is not specified.
9. How the ground truth for the training set was established
- This information is not applicable/provided.
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.