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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.

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."

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