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.

AI/ML Overview

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.

Feature / Acceptance Criteria (based on Predicate)	Predicate Device (25-D hand engine w/ C-310 Console)	Mark 20 Controller (Reported Performance)	Mark 25 Controller (Reported Performance)	Meets Acceptance (Substantially Equivalent)
Intended Use	Engine, power supply and controller for dental handpiece	Engine, power supply and controller for dental handpiece	Engine, power supply and controller for dental handpiece	Yes
Forward & Reverse Switch	Yes	Yes	Yes	Yes
Engine Torque	320 gram centimeters	400 gram centimeters	400 gram centimeters	No (Exceeds predicate)
Automatic Torque Limiting	No	No	Yes	No (Mark 25 has new feature)
Direct - remote selector switch	Yes	Yes	Yes	Yes
Speed Control	Yes	Yes	Yes	Yes
Power Supply	AC - 110-115 VAC, 50/60 Hz	AC - 110-115 VAC, 50/60 Hz	AC - 110-115 VAC, 50/60 Hz	Yes
UL/ETL Compliant	Yes - UL-544	Yes - UL-544	Yes - UL-544	Yes
Engine Models	25D hand engine	45E hand engine - RX-100	45E hand engine - RX-100	Yes (Accommodates equivalent functionality)
Irrigation Support	None	Yes - Constant speed	Yes - Variable speed	No (New feature)
Digital speed readout	No	Yes	Yes	No (New feature)
Voltage output	2 - 20 volts DC	3 - 30 volts DC	3 - 30 volts DC	Yes (Equivalent or exceeds, deemed substantially equivalent)

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.

Summary

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ction 510(k) Premarket Notification Summary of Safety and Effectiveness Information

Mark 20 and Mark 25 Irrigating Handengine Controller

Requlatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

1. Device Trade Name: Mark 20 and Mark 25 Hand Engine Controller
  Dental handpiece controller Common Name:

Classification Name: Dental handpiece and accessories

2. Establishment Name & Registration Number:

Name: BELL INTERNATIONAL

Number: 2921268

3. Classification:

§ 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 contraangle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth. (b) Classification. Class I. [55 FR 48439, Nov. 20, 1990].

Product Code(s): 76EBW

Device Class: Class I

Classification Panel: Dental

4. Equivalent / Predicate Device(s):

The 25-D hand engine and C-310 Console (Controller) 1.

5. Description of the Device:

The 45E and the RX-100 produce more torque than the original 25D handengine. The 25D offered 320 gram centimeters and the 45EH and RX-100 offer 400 gram centimeters torque.

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

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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.

6. Comparison to Predicate Device(s):

The new controllers and handengines are substantially equivalent to the parent model 25-D hand engine with C-310 Console. The model 25D is a pre-amendment device, having been in commercial distribution since 1972. The model 25D along with it's minor modification model, the Mark VI-0 controller has operating speeds of approximately 400 rpm to 20,000 rpm.

The 25D handengine produces torque values of 320 grams centimeters, it is powered by direct current from 3 to 20 volts and it accommodates a ISO chuck of 2.35mm.

The 45EH handengine has a operating range from 1500 to 30,000 rpm and produces torque values of 400 grams centimeters, it operates from 3 to 30 volts direct current and takes a ISO chuck of 2.35mm.

The RX-100 handengine has a operating range from 1500 to 30,000 rpm and produces torque values of 400 grams centimeters, it operates from 3 to 30 volts direct current and takes a ISO chuck of 2.35mm.

The Mark 20 and Mark 25 Controllers are substantially equivalent to the C-310 Console Controller supplied with the predicate device sold by Bell International as the 25-D hand engine with C-310 Console. The important difference between the C-310 Console Controller and the Mark 20 and Mark 25 Controllers is the modest difference in control features and the availability of surgical irrigation.

7. Modified Device Data:

Not applicable to this device. This submission covers a new device not a modified device.

8. Applicant / Sponsor Name / Address:

BELL INTERNATIONAL, INC. 31 Edwards Court Burlingame, CA 94010

9. Contact Person:

Mr. Dewey Bell Bell International, Inc. 31 Edwards Court Burlingame, CA 94010 (415) 348-2055 (415) 348-3937

10. Manufacturing Facility:

At the present time, the Mark 20 and Mark 25 Controller are manufactured in-house by BELL International, Inc.

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11. Comparison Table:

FEATURE	Mark 20 Controller	Mark 25 Controller	25-D hand engine w/C-310 Console	SE?
Intended Use	Engine, power supply andcontroller for dental handpiece	Engine, power supply andcontroller for dental handpiece	Engine, power supply andcontroller for dental handpiece	Yes
Forward &reverse switch	Yes	Yes	Yes	Yes
Engine torque	400 gram centimeters	400 gram centimeters	320 gram centimeters	no
AutomaticTorque Limiting	No	Yes	No	No
Direct - remoteselector switch	Yes	Yes	Yes	Yes
Speed Control	Yes	Yes	Yes	Yes
Power Supply	AC - 110-115 VAC, 50/60 Hz	AC - 110-115 VAC, 50/60 Hz	AC - 110-115 VAC, 50/60 Hz	Yes
UL/ETLCompliant	Yes - UL-544	Yes - UL-544	Yes - UL-544	Yes
Engine Models	45E hand engine - RX-100	45E hand engine - RX-100	25D hand engine	Yes
IrrigationSupport	Yes - Constant speed	Yes - Variable speed	None	No
Digital speedreadout	Yes	Yes	No	No
Voltage output	3 - 30 volts DC	3 - 30 volts DC	2 - 20 volts DC	Yes

12. Safety Standards:

The Mark 20 and Mark 25 Controller are designed to meets UL-544 (medical device) requirements for electrical safety.

13. Sterilization Information:

The device may not be sterilized. Surface disinfecting of the console, cords, foot switch and hand engine and tubing may be accomplished using a number of available non-solvent based commercial germicidal or surface disinfectant preparations. Only the front handpiece of the dental drill may be sterilized.

Regulation Number and Section

§ 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.