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The ELEC ENGINE (Model: ISE-170L) is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.

As an engine to operate and control handpiece used for dental implant surgery, this device is composed of main body, BLDC motor and foot control.

With external power supply being provided, this device operates the main body through switching AC power to DC power and it performs dental implant surgery with handpiece being connected for rotation power generated through turning BLDC motor.

The provided document is an FDA 510(k) clearance letter for a dental handpiece and accessories, the "ELEC ENGINE (Model: ISE-170L)". It focuses on establishing substantial equivalence to a predicate device, not on proving clinical performance through a comparative effectiveness study involving AI or human readers.

Therefore, the information regarding acceptance criteria, study design for proving performance, expert involvement, and specific performance metrics for AI-driven devices (like an MRMC study, effect size, standalone performance, or ground truth establishment relevant to AI/diagnostic support) is not present in this document. The document describes a traditional medical device clearance based on equivalence to an existing device, focusing on electrical, mechanical, biocompatibility, and reprocessing safety and performance standards.

Here's a breakdown of what can be extracted and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present acceptance criteria or reported performance in the context of an AI/diagnostic device's accuracy or efficacy. Instead, it lists standards the device conforms to for safety and basic mechanical performance.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. For a device like this, testing would typically involve a certain number of manufactured units or components selected to demonstrate compliance with the listed standards. It's not based on patient data sets like an AI algorithm.
• Data Provenance: Not applicable in the context of clinical data. The tests are technical/engineering verifications rather than clinical studies on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts/Qualifications: Not applicable. The "ground truth" here is compliance with engineering standards and specifications, not clinical diagnoses or interpretations. These tests would be conducted by qualified engineers and technicians.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. Performance is determined by meeting pre-defined thresholds and specifications from the relevant international standards (e.g., IEC, ISO).

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

• MRMC Study: No. This document describes a mechanical/electrical dental device, not an AI or diagnostic imaging device.

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

• Standalone Performance: Not applicable. This is not an AI algorithm. Its performance is inherent to its mechanical and electrical characteristics.

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

• Type of Ground Truth: The "ground truth" for this device is based on engineering specifications, international performance standards, and safety requirements (e.g., electrical safety, mechanical robustness, biocompatibility, reprocessing efficacy). It is not derived from clinical data, pathology, or outcomes.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This device is not an AI/machine learning model, so there is no "training set."

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

• Ground Truth for Training Set: Not applicable. As it's not an AI model, there is no training set or associated ground truth establishment.

In summary: The provided FDA 510(k) clearance letter details the regulatory approval of a traditional dental device. The "acceptance criteria" and "study" described are focused on proving the device's safety, performance characteristics, and substantial equivalence to a legally marketed predicate device through engineering and quality standard adherence, not through clinical performance studies involving AI or diagnostic accuracy metrics.

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The Dental Handpiece, Wireless Endodontic Handpiece, endoit, model no. (EH-C500) is intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth.

Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) consists of a Main Body, connectable Contra Angle, Charging Cradle, and AC/DC Adapter. The Main Body of the handpiece is used for transmitting rotational force required in general dental treatment. The torque transmitted from a wireless electric micro-motor gets further transmitted to the joint part of the device. The rotational force is then decelerated according to the speed reducer of the gear which is transmitted to the head of the dental handpiece. The rotational force is transmitted under the permitted rotation mechanism.

Based on the provided FDA 510(k) summary, the device in question is a Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500). This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a clinical study of AI performance. Therefore, many of the typical acceptance criteria and study details for AI/ML-driven medical devices (e.g., Sensitivity, Specificity, MRMC studies, ground truth establishment for images) are not applicable here.

This device is not an AI/ML-driven diagnostic or therapeutic device. It is a traditional medical device (a dental handpiece). The "acceptance criteria" and "study" described in the document relate to engineering and performance testing to ensure the device meets established safety and performance standards for dental handpieces, and demonstrates substantial equivalence to predicate devices.

Here's an attempt to answer your questions based on the provided text, while noting where AI/ML-specific criteria are not relevant:

Acceptance Criteria and Device Performance for the Dental Handpiece, Wireless Endodontic Handpiece, endoit (Model EH-C500)

This device is a dental handpiece, and its acceptance criteria are primarily related to its mechanical, electrical, and material safety and performance, rather than diagnostic accuracy as would be the case for an AI/ML algorithm. The "study" described is a series of engineering design verification and validation tests, along with biocompatibility testing.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a non-AI device, the acceptance criteria are not typically expressed as traditional metrics like sensitivity, specificity, or AUC. Instead, they are related to compliance with recognized standards and successful completion of pre-defined engineering tests. The document states that "The favorable test results of the proposed device which confirmed to meet the FDA recognized standards as well as ISO standard demonstrate that the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) retains the substantially equivalent profile in safety and essential performance of medical electrical equipment as the predicate (K220577) Dental Handpiece model CA160L and predicated (K123582) Endo A Class."

Here's a summary of the types of criteria and the general performance statement:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated as a number of "cases" or "patients" as would be for an AI study. The testing for this device involves:
  • Biocompatibility: Likely conducted on samples of device materials, not a "test set" of patients. The document references testing done on a previous predicate device (K192809) which results were applied.
  • Design Verification and Validation: This typically involves testing a certain number of manufactured units of the device (e.g., several units tested for rotational speed, noise, durability, etc.). The exact number is not specified in the summary but would be detailed in the full test reports.
  • Electrical/EMC Testing: This would be conducted on device units in specialized labs.
• Data Provenance: Not applicable in the sense of patient data origin. The testing is laboratory and bench testing of the physical device and its materials. This is effectively "prospective" testing of the new device's engineering performance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable. For this type of device, "ground truth" is established by engineering specifications, recognized industry standards (e.g., ISO, IEC), and scientific principles, not by expert interpretation of clinical data or images. The "ground truth" is that the device must meet the specified performance parameters (e.g., a certain rotational speed, torque, noise level) and safety requirements (e.g., electrical safety, material biocompatibility). These are verified through objective measurements and accepted testing methodologies.

4. Adjudication Method for the Test Set

• Not applicable. As there are no human interpretations of data (e.g., images) that require consensus, there is no need for an adjudication method. Test results are objective measurements against established engineering and safety thresholds.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

• No. This is not an AI/ML diagnostic device, so an MRMC study comparing human reader performance with and without AI assistance is not relevant or performed for this type of 510(k) submission.

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

• No. This is a hardware medical device with an electromechanical function, not a software algorithm. Therefore, "standalone algorithm-only performance" is not a relevant concept for this product. The device's "standalone performance" is its ability to meet its engineering and safety specifications on its own, which is what the various design verification tests confirm.

7. The Type of Ground Truth Used

• Engineering Specifications and Recognized Standards: The "ground truth" is defined by the requirements outlined in the relevant ISO and IEC standards (e.g., ISO 14457 for handpieces and motors, IEC 60601-1 for electrical safety, ISO 10993-1 for biocompatibility) and the manufacturer's own pre-defined design requirements for functional performance (e.g., rotational speed range, noise limits). Successful completion of tests against these standards constitutes meeting the "ground truth."

8. The Sample Size for the Training Set

• Not applicable. This device does not use an AI/ML algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established

• Not applicable. As there is no AI/ML algorithm or training set, this question is not relevant.

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Dental Handpiece with models of CA160, and CA500L are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth.

Dental Handpiece is designed for use by a trained professional in the field of general dentistry.

Dental Handpiece with the model CA160, CA160L and CA500L consists of the main body of the handpiece, which is used for transmitting rotational force for the general dental treatments. The torque transmitted from a wired electric micro-motor gets further transmitted to the joint part of Dental Handpiece. The rotational force is then decelerated according to the speed reducer of the gear which is transmitted to the head of the dental handpiece. The rotational force is transmitted under the permitted rotation mechanism.

Model CA160, CA160L and CA500L can be connected to spray adapter (accessory component) which is used for channeling water and air for further applications to the dental treatments. The only difference between model CA160 and CA160L is that the CA160L has lighting function.

The provided text is a 510(k) summary for a dental handpiece. It details the device's equivalence to a predicate device but does not describe an AI medical device or a study involving AI performance metrics like sensitivity, specificity, or reader studies. Instead, it focuses on the engineering and biocompatibility testing of a physical dental instrument.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance for an AI model, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these concepts are not applicable to the content provided.

The document discusses the following types of tests for the dental handpiece:

Design Verification & Performance Data:

• Appearance Test
• Operation Test
• Rotational Speed Test
• Noise Test
• Spray Test
• Light Test
• Serviceable Year/Shelf-Life Test

Biocompatibility Testing (applicable from the predicate device):

• ISO MEM Elution Using L-929 Mouse Fibroblast Cells (GLP)
• ISO Guinea Pig Maximization Sensitization Test (GLP 2 Extracts)
• ISO Intracutaneous Irritation Test (GLP 2 Extracts)
• ISO Materials Mediated Rabbit Pyrogen (GLP)
• ISO Acute Systemic Injection Test (GLP 2 Extracts)

The document concludes that the proposed device is substantially equivalent to the predicate device based on these tests and that no new questions of safety or effectiveness are raised.

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The ELEC-LED is intended for use in dentistry for restoration, prophylaxis and endodontic procedures. It provides control for motorized dental handpieces by converting pneumatic output from a dental treatment center.

This product consists of a micro motor controller and display panel. Receiving rated input of AC 24V, this device controls motor speed, and spinning direction through the motor control circuit inside the controller. Motor speed, motor operating mode, light and spinning direction functions can be set on the display panel. The operating mode of the motor is composed of three modes: HD (Hand control mode), PP (Press pedal mode) and EP (Electric pedal mode).

This document pertains to the 510(k) premarket notification for the "ELEC-LED" dental handpiece control unit. The purpose of this submission is to demonstrate substantial equivalence to a predicate device, not to prove clinical effectiveness or performance in an AI-assisted diagnostic context.

Therefore, none of the requested information regarding acceptance criteria, study design for AI performance, sample sizes for test/training sets, expert consensus, adjudication methods, MRMC studies, standalone AI performance, or ground truth establishment can be found in this document.

The document details the device's technical specifications, indications for use, and a comparison to a predicate device ("Optima MX INT"). It also lists performance tests conducted, which are primarily non-clinical bench tests for electrical safety, mechanical standards, and biocompatibility, as well as software documentation following FDA guidance for medical device software.

The performance tests mentioned are as follows:

• ISO 3964:2016 Dental Handpieces Coupling dimensions
• ISO 7494-1:2011 Dentistry Dental units -Part 1: General requirements and test methods
• ISO 14457:2017 Dentistry Handpieces and motors
• IEC 60601-1, IEC 62366-1, IEC 60601-1-2: Electrical safety and EMC
• IEC80601-2-60:2012: Particular Requirements For The Basic Safety And Essential Performance Of Dental Equipment
• IEC 62366: Application of usability engineering to medical devices
• ANSI AAMI ST79:2017, ISO 17665-1, and ISO TS 17665-2: Sterilization validation

These tests are standard for dental equipment to ensure safety and function, but they are not clinical studies designed to assess diagnostic accuracy or the impact of AI on human reader performance.

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The Impla-NX (Model: ISE-270M) is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.

As an engine to operate and control handpiece used for dental implant surgery, this device is composed of main body, BLDC motor and foot control.

With external power supply being provided, this device operates the main body through switching AC power to DC power and it performs dental implant surgery with handpiece being connected for rotation power generated through turning BLDC motor.

The provided text does not contain information about acceptance criteria for device performance with specific metrics like sensitivity, specificity, or AUC, nor does it detail a study proving the device meets such criteria in terms of clinical outcomes or diagnostic accuracy.

Instead, the document is a 510(k) summary for a dental handpiece and accessories, Impla-NX (Model: ISE-270M), demonstrating substantial equivalence to a predicate device (Surgic Pro by NSK Nakanishi, Inc.). The performance testing mentioned is primarily non-clinical bench testing against various ISO and IEC standards related to dental equipment, electrical safety, EMC, photobiological safety, and sterilization validation.

Therefore, most of the requested information cannot be extracted from this document as it pertains to clinical performance studies and AI/human reader assessments, which are not relevant to this device's regulatory submission as presented.

However, I can provide information based on the type of performance tests conducted and the general conclusion:

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

The document lists various international standards that the device was tested against. The "acceptance criteria" would be compliance with these standards, and the "reported device performance" is that these tests were conducted and found to be compliant. Specific numerical performance metrics for each standard are not provided in this summary.

2. Sample size used for the test set and the data provenance: Not applicable. The document describes non-clinical bench testing against standards, not a clinical study with a patient test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not a study requiring expert-established ground truth for diagnostic purposes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 device is a dental surgical engine, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical ground truth. For the non-clinical tests, the "ground truth" would be the specifications and requirements defined by the respective ISO and IEC standards.

8. The sample size for the training set: Not applicable. This is not an AI/machine learning device requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

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Dental Handpiece with models of SG200, SG200L, SA100L, SA100R, CA100L, and CA100R are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth.

In addition, Dental Handpiece with models of SG200, SG200L are also intended for implant surgery such as perforating the bone, tapping and threading procedures.

Dental Handpiece is designed for use by a trained professional in the field of general dentistry.

Dental Handpiece with models of SG200, SG200L, SA100L, SA100R, CA100L, and CA100R are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth.

In addition, Dental Handpiece with models of SG200, SG200L are also intended for implant surgery such as perforating the bone, tapping and threading procedures.

Dental Handpiece is designed for use by a trained professional in the field of general dentistry.

The proposed dental handpiece consists of the main body of a handpiece, which is used for transmitting a rotational force for the general dental treatments as well as accessory components. which are used for channeling water and air for further applications to the dental treatments. The torque transmitted from an electric micro-motor gets further transmitted to the joint part of Dental Handpiece. The rotational force is then decelerated according to the speed reducer of the gear to be transmitted to the head of the dental handpiece. The rotational force is transmitted under the permitted rotation mechanism.

The product is offered as an electrical-powered Dental Handpiece that is reusable and ergonomically shaped. The dental handpiece can be sterilized by the steam autoclave method. Through the tube and the electrical motor connected to a dental unit, the Dental Handpiece equipped with a handpiece connection according to ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) receive the energy for the gear, the cooling water and air for cutting treatment. Dental burs and other attachments will be used with the proposed Dental Handpiece per ISO 1797:2017 (Dentistry - Shanks for rotary and oscillating instruments).

Dental Handpiece has been developed with a full range of surgical contra angle intended to be used in implantology. The contra angle-design, size and performance of the proposed Dental Handpiece conform to ISO 14457 (2017) "Dentistry -Handpieces and motors"

The six (6) product codes and models of Dental Handpiece are SG200L, SG200, CA100L, CA100R. SA100L. SA100R.The component names and functional descriptions for critical components of Dental Handpiece are provided in the table below.

The provided text describes a 510(k) premarket notification for a Class I dental handpiece, meaning it is seeking to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving a specific performance metric against acceptance criteria. Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, expert involvement, etc.) is not explicitly available in the provided document in the way it would be for a novel device undergoing clinical trials.

The document focuses on demonstrating that the new dental handpiece is substantially equivalent to existing predicate devices (SMARTmatic (K163239) and ANTHOGYR Contra angles and Handpieces (K093894)). Substantial equivalence is primarily proven by showing similar indications for use and technological characteristics, and by conforming to recognized standards.

Here's an analysis of the provided information relative to your request:

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

The document does not provide a table of acceptance criteria in the sense of specific thresholds for a novel device's performance metrics (e.g., a specific accuracy or sensitivity). Instead, it lists design verification and performance data tests that were conducted to confirm the device meets pre-determined design requirements and conforms to recognized standards. The "reported device performance" is generally stated as "favorable test results" or "demonstrates conformance."

Here's a table based on the information available, interpreting "acceptance criteria" as meeting the relevant standard and "reported device performance" as the outcome of the testing:

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This product is a cordless motor handpiece system intended for tightening and loosening an abutment screw to fix and remove the abutment on a dental implant in prosthodontic treatment.

This device is a cordless torque driver used for connecting and disconnecting dental implant abutments used in dentistry. The torque driver function includes adjustment of spinning direction (forward and reverse), speed and torque. The maximum torque is 35 Ncm. The device consists of a torque driver, a charge adapter and a charge cradle.

This application describes the MEG-TORQ device, a cordless motor handpiece system for tightening and loosening abutment screws on dental implants. The FDA's 510(k) clearance (K161500) is based on the device being substantially equivalent to the predicate device, ISD900 (K110278), manufactured by NAKANISHI Co., Ltd.

Here's an analysis of the provided information concerning acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" as a set of quantified thresholds for performance metrics. Instead, "performance data" describes tests performed to affirm the device's safety and functionality in relation to established standards and its predicate device. The conclusion of these tests is that the device meets these standards and is therefore "substantially equivalent."

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a sample size for the non-clinical performance tests. The testing appears to be primarily laboratory-based engineering and performance verification against standards and the predicate device's specifications. The data provenance is implied to be from the manufacturer, MICRO-NX Co., Ltd. (REPUBLIC OF KOREA), as they conducted and submitted the tests. The tests performed are retrospective in the sense that they are conducted on the final device design to demonstrate compliance, rather than during an iterative development process.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not provided. The "ground truth" here is compliance with technical standards and the functional performance outlined in the predicate device's specifications. These are established through recognized testing methodologies rather than human expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set:

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human readers are interpreting images or data, and disagreements need to be resolved to establish ground truth. The tests described are objective engineering and performance tests against defined standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, a MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical performance testing was provided in the submission." This type of study would involve human readers (e.g., dentists) using the device and evaluating its effectiveness compared to alternatives, potentially with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. The MEG-TORQ is a physical medical device (a dental handpiece), not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not relevant.

7. Type of Ground Truth Used:

The ground truth used for demonstrating substantial equivalence is based on:

• Standards Compliance: Meeting the requirements of recognized international and national standards (ISO 14457, ANSI/AAMI ST79, ISO17665-1/2, ISO 11138-1/3, IEC 60601-1/1-6, EN 60601-1-2, EN 61000-3-2/3-3).
• Predicate Device Specifications: The functional and safety characteristics of the legally marketed predicate device (ISD900, K110278).
• Engineering Verification: Direct measurement of physical performance (e.g., torque output, speed, "abutment screw shear" test) against expected values or parameters to ensure safe and effective operation within the intended use.

8. Sample Size for the Training Set:

Not applicable/provided. As this is a mechanical device, there is no "training set" in the context of an AI algorithm or model. The device development would involve engineering design and testing prototypes, but not a data-driven training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable/provided. See point 8.

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