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510(k) Data Aggregation
(72 days)
The intended use of the IS40 Micromotor is in general dentistry for cutting, shaping, drilling, cleaning, prophylaxis and polishing of teeth by dental professionals.
The IS 40 Micromotor with internal spray is compatible with all types of contra-angles that have an E-type connection and internal spray. The IS 40 Micromotor is used with Satelec Cocoon® Hygienist (K040529) which incorporates the M6 module with automatic servo control for motor power and speed control. IS 40 Micromotor operates at a speed from 1,600 to 40,000 rpm and provides a torque of 1.6 Newton/cm at 3 A.
This document, K042787, is a 510(k) premarket notification for a dental micromotor and does not contain the detailed study information typically found for devices that rely on clinical performance data for clearance. Instead, it relies on substantial equivalence to a predicate device. Therefore, many of the requested categories will not be applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) does not present a formal table of acceptance criteria and reported device performance in the way one would expect for a comparative study with specific endpoints (e.g., sensitivity, specificity, accuracy). Instead, substantial equivalence is claimed based on similar intended use and technical specifications.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (as described in 510(k)) |
|---|---|
| Intended Use: Used in general dentistry for cutting, shaping, drilling, cleaning, prophylaxis and polishing of teeth by dental professionals. | The IS 40 Micromotor's intended use is in general dentistry for cutting, shaping, drilling, cleaning, prophylaxis and polishing of teeth by dental professionals. (Matches predicate) |
| Compatibility: Compatible with E-type contra-angles and internal spray. | The IS 40 Micromotor is compatible with all types of contra-angles that have an E-type connection and internal spray. |
| Speed Range: (Predicate device's speed range) | Operates at a speed from 1,600 to 40,000 rpm. |
| Torque: (Predicate device's torque) | Provides a torque of 1.6 Newton/cm at 3 A. |
| Safety and Effectiveness: Differences in technical specifications, performances, and intended use are minor and do not affect the safety and effectiveness compared to the predicate device. | The submitter claims "Differences that exist between the devices relating to technical specifications, performances and intended use are minor and do not affect the safety and effectiveness of the IS 40 Micromotor." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is not a study that involved a test set of data for performance evaluation in the usual sense. Substantial equivalence is declared based on comparison of technical specifications and intended use to a legally marketed predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. There was no "test set" requiring expert-established ground truth for a performance evaluation study.
4. Adjudication Method for the Test Set
Not applicable. There was no "test set" and thus no adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document is for a 510(k) clearance based on substantial equivalence, not a clinical effectiveness trial for an AI-powered device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a dental micromotor, not an algorithm or AI-powered system.
7. The Type of Ground Truth Used
Not applicable. The clearance is based on substantial equivalence to a predicate device, not on independently validated ground truth from a clinical study. The "ground truth" for substantial equivalence is the already legally marketed and established safety and effectiveness of the predicate device.
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical dental instrument. It does not involve a training set as it is not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this device does not involve a training set.
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