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Engine, power supply and controller for dental handpiece

The new device submission covers two handengine controllers designed to operate the 45E and RX-100 dental handengines. The 45E and the RX-100 are low-voltage DC-motors with Econnector type front ends. Both the RX-100 may be operated by the Mark 20 or Mark 25 Controller. Both engines have Off/On or variable speed footswitches. Both engines accept various and straight front handpieces on the motor to do different types of dental work or surgical procedures. The Mark 20 and Mark 25 Controllers are typical rheostat based hand engine controllers. The Mark 20 or Mark 25 Controller allows the practitioner infinite control over the speed of the engine and dental front handpiece up to the rated speed capacity of the selected engine and handpiece. Both the Mark 20 and Mark 25 Controller allow the selected hand engine and dental front hand piece to be operated in forward or reverse directions as well as by local control or remote foot switch. Dental or endodontic surgical procedures needing irrigation are supported by the integral fluid pump. The pump is constant speed in the Mark 20 and is variable speed in the Mark 25 unit.

This document is a 510(k) Premarket Notification Summary for a medical device, specifically dental handengine controllers. As such, it does not contain the kind of detailed study information (like sample sizes, expert qualifications, adjudication methods, or MRMC studies) that would typically be found in a clinical trial report or a submission for a device involving AI or complex diagnostic interpretations.

The acceptance criteria here refer to the performance characteristics of the new device (Mark 20 and Mark 25 Controllers) compared to a predicate device (25-D hand engine with C-310 Console) to establish substantial equivalence. The "study" proving this is primarily a comparison of technical specifications and features.

Here's the information broken down based on your request, with an emphasis on what's available and what's not in this type of document:

1. Table of acceptance criteria and the reported device performance

The "acceptance criteria" are implied by the features and performance metrics of the predicate device, which the new devices aim to meet or exceed while remaining substantially equivalent. The "reported device performance" is the specified performance of the Mark 20 and Mark 25 controllers.

Explanation of "SE?" column from the original document: The "SE?" column in the provided table indicates "Substantially Equivalent?". A "Yes" means that feature is considered equivalent to the predicate. A "No" means there's a difference, which then needs justification for substantial equivalence (e.g., increased torque or added features are typically considered improvements that don't raise new questions of safety or effectiveness).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not applicable. This is a comparison of device specifications and performance rather than a clinical study involving patient samples or data. The "test set" would be the devices themselves, subjected to engineering tests (not detailed in this summary).
• Data Provenance: Not applicable for clinical data. The data provenance relates to the specifications and performance characteristics of the devices, likely derived from internal engineering and manufacturing records.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. Ground truth, in the sense of expert consensus on diagnostic interpretations, is not relevant for this device (a dental handengine controller). The "ground truth" here is the measured performance and design specifications as evaluated by engineers during the device development and testing phases.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations of clinical data, which is not relevant here.

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-assisted diagnostic device, nor is it a device that involves human readers interpreting cases.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a mechanical/electrical medical device, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this type of device is based on engineering specifications, measured physical performance (e.g., torque, RPM, voltage output), and compliance with recognized safety standards (like UL-544). This is not clinical ground truth.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/machine learning device. Device development involves engineering design, prototyping, and testing, not algorithmic training.

9. How the ground truth for the training set was established

• Not applicable. See point 8.

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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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