(86 days)
Engine, power supply and controller for dental handpiece
This submission covers the BELL INTERNATIONAL, INC. series of electric dental hand-engines. BELL INTERNATIONAL. INC. offers a complete line of electric motor drive hand-engines for dental restoration and surgical applications. The handengines accept various available "E-type connector" angled and straight front-handpieces produced by many different manufacturers. The different E-type front-handpieces are designed to do different types of dental work or surgical procedures. This includes those front-handpieces that multiply or reduce terminal shaft speed.
This looks like a 510(k) premarket notification for dental hand-engines and controllers. This type of submission is for medical devices, but it's not an AI/ML device, so many of the requested fields are not applicable.
Here's the information extracted and organized to the best of what's provided for a traditional medical device submission for this product:
Acceptance Criteria and Device Performance (Dental Hand-engines and Controllers)
The acceptance criteria for these dental hand-engines and controllers are implicitly tied to their "substantial equivalence" to a predicate device (the 25-D hand engine and C-310 Console), particularly in terms of intended use, operating characteristics, and safety standards. The study proving this typically takes the form of a comparison to the predicate device, demonstrating that the new devices perform as intended and do not raise new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device, the "acceptance criteria" are generally that the devices perform comparably to or within acceptable limits of the predicate device for their stated specifications and intended use, and meet relevant safety standards.
| Feature | Acceptance Criteria (Implied by Predicate Device (25-D handengine w/C-310 Console) and Safety Standards) | Reported Device Performance (New Devices) |
|---|---|---|
| Intended Use | Engine, power supply and controller for dental handpiece | All New Models: Engine, power supply and controller for dental handpiece (Substantially Equivalent) |
| Forward & Reverse Switch | Yes | All New Models: Yes (Substantially Equivalent) |
| Engine Torque | 320 gram centimeters | Etelna II & Bravo G-7: 270 ma/cm max. (Slightly Lower than 25D, but considered "bare bones unit that offered essentially the same level of performance as the 25D and 45E") |
| RX-100 & 45EH: 400 gram centimeters (Higher than 25D, considered minor variant) | ||
| 45E: 320 gram centimeters (Substantially Equivalent) | ||
| Automatic Torque Limiting | No | All New Models: No (Substantially Equivalent) |
| Direct - Remote Selector Switch | Yes | Etelna II: No (Difference noted, but implied to be acceptable for "bare bones" functionality) |
| Other New Models (Bravo G-7, RX-100, 45EH, 45E): Yes (Substantially Equivalent) | ||
| Speed Control | Yes | All New Models: Yes (Substantially Equivalent) |
| Power Supply | 110-115 VAC, 50/60 Hz | Etelna II: 12 VDC via Battery & AC Charger (Portable, different from predicate but indicated as acceptable) |
| Bravo G-7: 12 VDC via 110-115 VAC, 50/60 Hz Transformer ("bare bones," different from predicate but indicated as acceptable) | ||
| RX-100: 110-115 / 220-230 VAC, 50/60 Hz (Broader range, functionally equivalent) | ||
| 45EH, 45E: 110-115 VAC, 50/60 Hz (Substantially Equivalent) | ||
| UL/ETL Compliant | Yes - UL-544 | All New Models: Yes - UL-544 (Meets safety standard, crucial for acceptance) |
| Console Model Compatible | C-310 | Etelna II: Etelna II |
| Bravo G-7: Bravo G-7 | ||
| RX-100: C-361, Mark VIII & RX-100 Bat. Pack | ||
| 45EH: C-361, Mark VIII, Mark IX & Mark X | ||
| 45E: C-361 (Specific console pairings are new but are deemed equivalent in functionality and safety with the overall system) | ||
| Can be used with Irrigation | Yes | All New Models: Yes (Substantially Equivalent) |
| Digital Speed Readout | No | All New Models: No (Substantially Equivalent) |
| Voltage Output | 2 - 20 volts DC | Etelna II & Bravo G-7: 12 VDC (Lower than 25D, but indicated as acceptable for "bare bones" functionality) |
| RX-100, 45EH, 45E: 3 - 30 VDC (Higher voltage range, but stated to be "substantially equivalent" for the higher speed models and within the range of previous models for the 45E) | ||
| Maximum RPM | 20,000 RPM (for 25D) | Etelna II & Bravo G-7: To 20K RPM |
| 45E: To 20K RPM | ||
| RX-100, 45EH: To 30K RPM (Higher RPM, noted as minor variant, but not raising new safety/effectiveness concerns) | ||
| Accepts Connector Type | "D-type" front-handpiece connectors | All New Models: "E-type" connectors (This is a change but noted as an industry standard and covered by separate 510(k)s for the handpieces themselves, thus not affecting substantial equivalence of these devices as an engine/controller) |
2. Sample Size Used for the Test Set and the Data Provenance
This document describes a substantial equivalence claim for medical devices, not a clinical study with a "test set" for performance evaluation in the way an AI/ML device would. The "test set" here is implicitly the new devices being compared to the predicate.
- Sample Size: The "sample size" is the set of new devices (Model 45E, Model 45EH, Model RX-100, Model Etelna II, Model Bravo G-7 hand-engines and their associated controllers: C-361 Console, RX-100 Console, Mark VIII, Mark IX, Mark X, Etelna II Console, Bravo G-7 Console).
- Data Provenance: The data provenance is from the manufacturer's specifications and comparison to a known pre-amendment device (25-D hand engine with C-310 Console) and other previously cleared devices that represent minor modifications (e.g., 45E). This is inherently retrospective, based on existing device knowledge, design specifications, and compliance with recognized standards. The country of origin of the data is not explicitly stated, but the manufacturer is Bell International, Inc. in Burlingame, CA, USA, suggesting a U.S. context for the documentation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
There is no mention of "experts" establishing a ground truth for a test set in a clinical evaluation sense. The "ground truth" for this type of submission is established through:
- The performance and safety record of the predicate device (25-D hand engine and C-310 Console), which has been in commercial distribution since 1972.
- Engineering specifications and testing by the manufacturer to ensure the new devices meet their stated performance characteristics and safety standards (e.g., UL-544 compliance).
- Regulatory assessment by the FDA, relying on established classification regulations (§ 872.4200 for dental handpiece and accessories, Class I).
4. Adjudication Method for the Test Set
Not applicable for this type of device submission. There is no "adjudication method" in the context of clinical expert review for a test set as would be found in an AI/ML device evaluation. The assessment is regulatory by the FDA based on the provided technical documentation and comparison to the predicate.
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/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The "ground truth" used for this submission is based on:
- Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate device (Bell International, Inc.'s 25-D hand engine and C-310 Console), which is a pre-amendment device.
- Manufacturer Specifications and Engineering Data: The design specifications, physical characteristics, and measured performance (e.g., speed, torque, voltage) of the new devices, along with internal quality control and testing results (e.g., UL-544 compliance).
- Regulatory Standards: Compliance with recognized electrical safety standards like UL-544.
- Intended Use Equivalence: Demonstration that the new devices do not have different intended uses or raise different questions of safety and effectiveness compared to the predicate.
8. The sample size for the training set
Not applicable. This is not an AI/ML device and does not involve a "training set" in that context.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device and does not involve establishing ground truth for a "training set."
§ 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.