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ELEC Master & ELEC Master Dual are intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment.

Device Description

This product consists of a micro motor controller and display panel. Receiving rated input of AC 24V, this device controls motor speed, and rotation direction through the motor control circuit inside the controller. Motor speed, light and rotation direction functions can be set on the display panel.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA for a dental handpiece and accessories called "ELEC Master" and "ELEC Master Dual" by MGNEWTON Ltd. It's a regulatory document demonstrating substantial equivalence to a predicate device, not a detailed study report. Therefore, most of the requested information regarding acceptance criteria and performance studies is not explicitly provided in the typical format of a medical device performance study report.

Here's an analysis based on the provided text, addressing your questions to the extent possible:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria and reported device performance in the sense of accuracy, sensitivity, specificity, or other clinical performance metrics that would be associated with a diagnostic or treatment guidance AI device.

Instead, the "acceptance criteria" here relate to conformity with established standards for dental handpieces and electrical safety, and substantial equivalence to a predicate device. The "reported device performance" is essentially that the device complies with these standards and has equivalent specifications to the predicate.

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance (Compliance/Equivalence)
Indications for Use (Substantial Equivalence)	Matches the indications for use of the predicate device (A-dec NLZ electric motor system).	"ELEC Master & ELEC Master Dual are intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis and endodontic treatment." This is reported as "Substantially Equivalent" to the predicate's indications.
Technological Characteristics (Substantial Equivalence)	Similar drive, device components, light, range of rotation speed, rotation direction, and max torque as the predicate device. Differences in spray air/water pressure are deemed not to raise new questions of safety/effectiveness.	The device's drive, components, light, rotation speed, rotation direction, and max torque are all listed as "Substantially Equivalent." Differences in spray air pressure (44 psi vs 29 psi) and spray water pressure (22 psi vs 29 psi) were identified but deemed acceptable as "optional features" not affecting substantial equivalence.
Standards Conformance	Compliance with specific ISO and IEC standards for dental handpiece coupling, general dental unit requirements, handpieces and motors, electrical safety, EMC, basic safety and essential performance of dental equipment, and usability engineering.	Non-clinical bench tests were performed to ISO 3964, ISO 7494-1, ISO 14457, IEC 60601-1, IEC 60601-1-2, IEC 80601-2-60, and IEC 62366. It's stated that "None of the testing demonstrated any design characteristics that violated the requirements of the standards or resulted in any safety hazard."
Sterilization Validation	Validation of the sterilization method.	"sterilization validation... were also conducted." (No specific details of the validation or specific acceptance criteria provided here, but it implies successful validation.)
Software Validation	Validation of the device's software.	"...software validation were also conducted." (No specific details of the validation or specific acceptance criteria provided here, but it implies successful validation.)

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

This document describes non-clinical bench tests (performance tests, electrical safety, EMC, sterilization validation, software validation) against recognized standards and a comparison of technical specifications to a predicate device. It does not involve a study with a test set of human subjects or patient data in the way an AI diagnostic device would. Therefore, sample size for a test set and data provenance (country of origin, retrospective/prospective) are not applicable in this context. The "test set" here refers to the actual device prototypes undergoing the specified bench tests.

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)

This section is not applicable. The "ground truth" for this type of device is established by adherence to engineering specifications and international standards (e.g., maximum torque defined by a standard, electrical safety requirements). These are objective measurements against predefined criteria, not subjective interpretations requiring expert consensus.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth from expert interpretations (e.g., radiologists reading images) where disagreement might occur. For objective bench tests and compliance with engineering standards, no such adjudication is needed.

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

This section is not applicable. This device is a dental handpiece motor system, not an AI-powered diagnostic or treatment assistance tool. Therefore, MRMC studies and the concept of "human readers improving with AI assistance" are irrelevant to this submission.

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

This section is not applicable. The device is not an algorithm or AI system. Its performance is evaluated through its physical and electrical characteristics as determined by bench testing against established standards.

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

The "ground truth" in this context is the compliance with predefined technical specifications and international consensus standards. For example, the "ground truth" for torque is the specified 3Ncm, and the test verifies that the device meets this. The "ground truth" for electrical safety is its conformity to IEC 60601-1.

8. The sample size for the training set

This section is not applicable. This is not an AI/machine learning device, so there is no training set.

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

This section is not applicable. As there is no training set, the establishment of ground truth for it is irrelevant.

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K Number

K202965

Device Name

CURA-Temp

Manufacturer

Mgnewton LTD.

Date Cleared

2022-12-21

(812 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K073296

Intended Use

Fabrication of temporary crowns, bridges, inlays and veneers. Fabrication of long-lasting temporary restorations. Lining material for prefabricated temporary crowns made of composite and metal.

Device Description

This product is ISO10477 Type 2 & Class 2, a light cured resin that forms the shape of a resin to make a temporary crown to protect the tooth for crown treatment for a certain period until the prosthesis is made. It is packaged in an impermeable syringe which is polymerized by light-cured energy and composed of base and photocatalytic agent.

AI/ML Overview

The provided document is a 510(k) Pre-Market Notification for a dental device called CURA-Temp. It focuses on demonstrating substantial equivalence to a predicate device, not on proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the information requested in your prompt is not available in this document.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a comparison table between the subject device (CURA-Temp) and its predicate device (TempXN28, currently marketed as Protemp Plus). This table implicitly shows the acceptance criteria by listing the predicate device's performance thresholds, largely based on ISO 10477 standards.

Item	Acceptance Criteria (based on Predicate/ISO 10477)	Reported Device Performance (CURA-Temp)
Depth of cure	$\geq$ 70% of top surface	99 %
Flexural Strength	$\geq$ 50 MPa	Avg. 83.5 MPa
Water Sorption	$\leq$ 40 µg/mm³	Avg. 19.4 µg/mm³
Solubility	$\leq$ 7.5 µg/mm³	Avg. 2.72 µg/mm³
Color Stability	No more than a slight change	No a slight change in colour
Shade Consistency	No more than a slight difference	No a slight change in colour
Surface Finish	A glossy surface	A glossy surface
Biocompatibility	Compliance with EN ISO 10993-1	Compliance with EN ISO 10993-1

Note: The "acceptance criteria" here are inferred from the predicate device's performance and the ISO 10477 standards that both devices are tested against. The CURA-Temp's performance clearly meets or exceeds these criteria.

2. Sample sized used for the test set and the data provenance
This information is not provided in the document. The document refers to "non-clinical performance tests" and "biocompatibility tests" but does not specify sample sizes for these tests or the data provenance. Since it's a 510(k) submission, the data is likely from laboratory bench tests conducted by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The document describes bench testing and biocompatibility testing, which typically do not involve human experts establishing ground truth in the way a clinical study or image interpretation study would.

4. Adjudication method for the test set
This information is not provided. As above, adjudication methods are typically relevant for human-involved evaluations (e.g., clinical trials, image interpretations), which are not detailed 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
This information is not applicable/provided. The CURA-Temp is a dental resin for temporary crowns, not an AI or imaging device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The CURA-Temp is a physical medical device (dental resin) and does not involve algorithms or AI performance.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical performance tests (e.g., flexural strength, water sorption), the "ground truth" is established by physical measurements and adherence to international standards (ISO 10477). For biocompatibility, the "ground truth" is established by laboratory tests following ISO 10993 standards. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense of a clinical diagnostic study.

8. The sample size for the training set
This information is not applicable/provided. This device is a physical product and does not involve AI or machine learning algorithms that require a training set.

9. How the ground truth for the training set was established
This information is not applicable/provided. As above, there is no "training set" for this type of device.

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