Search Results
Found 1 results
510(k) Data Aggregation
(15 days)
The Optima MX is intended for use in dentistry for restoration, phophylaxis and endodontic procedures. It provides control for motorized dental handpieces by converting pneumatic output from a dental treatment center.
The Optima MX dental unit for use in dental restoration, phophylaxis and endodontic procedures. The Optima MX is composed of a power supply, control unit, hose and a brushless micromotor. The control unit is a programmable unit that controls the torque, speed and clockwise or counterclockwise rotation of the motor. The inputs to the control unit are supplied by a color touchscreen on the Optima MX. Inputs can also be made by the foot pedal of the treatment center through the pneumatic outlet. The micromotor is a brushless motor with 4 quadrant speed control. The micromotor has a rotation speed of 100 - 40,000 rpm and can be rotated in a clockwise or counterclockwise direction.
The Bien Air OPTIMA MX is an operative dental unit intended for use in dental restoration, prophylaxis, and endodontic procedures. It provides control for motorized dental handpieces by converting pneumatic output from a dental treatment center.
Here's an analysis of its acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The submission doesn't explicitly state "acceptance criteria" but rather presents a comparison to a predicate device (SiroTorque L) to demonstrate substantial equivalence. The implication is that meeting or performing comparably to the predicate device in key performance aspects constitutes acceptance.
| Feature / Performance Metric | Acceptance Criteria (Implied - Comparable to Predicate Device) | Reported Device Performance (OPTIMA MX) |
|---|---|---|
| Intended Use | For dentistry for restoration, prophylaxis, and endodontic procedures, converting pneumatic output to electrical energy for electrically-driven dental handpieces. | The Optima MX is intended for use in dentistry for restoration, phophylaxis and endodontic procedures. It provides control for motorized dental handpieces by converting pneumatic output from a dental treatment center. (Identical in essence, slightly different wording for conversion mechanism - motorized vs. electrical energy for handpieces). |
| Speed Range | 2,000 - 40,000 rpm | 100 - 40,000 rpm |
| Torque | 2.4 Ncm maximum | 3 Ncm maximum |
| Rotation | Clockwise, counterclockwise | Clockwise, counterclockwise |
| Light | Variable intensity | Variable intensity |
| Cooling Air Requirements | 30 NI/min | 25 NI/min |
| Spray Air Pressure | 39 psi (2.7 bar) | 36 psi (2.5 bar) |
| Spray Water Pressure | 29 psi (2 bar) | 29 psi (2 bar) |
| Motor Length | 60 mm | 69 mm |
| Motor Diameter | 21 mm | 21.2 mm |
| Rotational Speed Control | Good control of speed across the range. | Good control of speed, "slightly better at lower speeds" than the predicate. |
| Torque Curve Trend | Similar torque curve trend to predicate and theoretical. | Torque curves developed for both devices shared a "similar trend." Compared to theoretical, both showed slightly lower torque in the upper range and slightly more in the lower range. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "Performance testing of the OPTIMA MX was conducted to evaluate the rotational speed and torque measurements of the device." This implies a series of measurements, but the number of individual units tested, or the number of measurements taken, is not specified.
- Data Provenance: The testing was conducted internally by Bien Air, Switzerland ("Bien Air SA Switzerland"). The testing appears to be prospective as it was conducted specifically to evaluate the OPTIMA MX against the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a mechanical/electrical unit, and its performance is evaluated against engineering specifications and comparison to a predicate device, not against expert human interpretation or "ground truth" derived from clinical experts in the same way an AI diagnostic tool would be.
4. Adjudication Method for the Test Set
Not applicable. As described above, the performance was measured objectively based on rotational speed and torque, not on subjective assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is not a diagnostic imaging device or an AI assistant for human readers. Therefore, an MRMC study is not relevant to its evaluation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in a sense. The performance testing described (rotational speed and torque measurements) represents the standalone performance of the device itself. There isn't a "human-in-the-loop" component in the direct performance evaluation of the motor's speed and torque.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is based on:
- Physical Measurements: Objective measurements of rotational speed and torque.
- Engineering Specifications: Comparison against theoretical curves and the specifications of the predicate device.
- Substantial Equivalence: The ultimate "ground truth" for regulatory clearance is demonstrating substantial equivalence to a legally marketed predicate device.
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning or AI algorithms that require a "training set" in the conventional sense. Its functionality is based on direct engineering design and control systems.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
Ask a specific question about this device
Page 1 of 1