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The Midwest Motor Control Module includes a control unit, ports for three motors, an apex location port, and a peristaltic pump port. The motor ports are compatible with the Midwest Power Lux and Midwest Power Lux Implant.

The Midwest Power Lux electric micromotor is intended for use as a drive for rotating and oscillating straight and contra-angle hand pieces for endodontic and general dental purposes.

The Midwest Power Lux Implant motor is intended for use in implant placement and includes a closed system for delivery of sterile solution via peristaltic pump operation.

The apex locator supports the dentist in the determination of the working length during the endodontic treatment.

These motors are to be driven by the control unit. The control unit is an internal component of a dental delivery system.

The use of this product is intended exclusively for duly qualified dental practitioners.

This device is a system that includes a control module (internal component of a dental delivery system) that can operate up to three dental motors, an apex locator, and a peristaltic pump. The motors do not operate concurrently. The motors that can be attached include dental motors and dental implant motors. The motors included with this module in this subject system are the Midwest Power Lux and Midwest Power Lux Implant. Also included is the cable, file, and tip required for the operation of the apex location technology. The programming supports manual use of the apex locator as well as combined use of the locator with a motor. The included peristaltic pump and control allows for sterile solution irrigation when required.

The provided FDA 510(k) Clearance Letter for the "Motor and Apex Module (MaAM)" (K251811) does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria related to the apex locator's accuracy or the motors' performance in a clinical setting.

The document primarily focuses on regulatory approval, substantial equivalence to predicate devices, and general safety and performance testing. While it mentions the device supports "determination of the working length during the endodontic treatment" (for the apex locator) and drives "rotating and oscillating straight and contra-angle hand pieces for endodontic and general dental purposes" (for the motors), it does not provide the specific performance metrics (e.g., accuracy, precision, torque output, speed stability) for these functions, nor the studies that verified them.

The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states: "Not applicable (no clinical data necessary)." This indicates that the FDA clearance was based on non-clinical testing, primarily focused on safety, electrical compatibility, and adherence to established industry standards (ISO 14457 for dental motors, IEC 62471 for photobiological safety, and ISO 3964 for dental coupling dimensions).

Therefore, based solely on the provided document, I cannot generate the requested table and study details. The information about performance acceptance criteria, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment for clinical effectiveness is absent.

However, I can extract and present the information that is available in the document regarding testing:

Summary of Device Performance and Testing (Based on Available Information in K251811)

The provided 510(k) clearance letter for the Motor and Apex Module (MaAM) establishes substantial equivalence to predicate devices based on non-clinical testing. The document explicitly states "Not applicable (no clinical data necessary)", indicating that the clearance did not involve clinical studies assessing the device's functional performance in a patient setting, such as the accuracy of the apex locator or the clinical efficacy of the motors.

The testing highlighted in the document focuses on compliance with international standards and mechanical/electrical safety.

1. Table of Acceptance Criteria and Reported Device Performance

Given that clinical performance acceptance criteria and respective reported device performance data are not detailed in the provided document, the table below reflects the types of non-clinical testing mentioned and the general conclusion of meeting specifications.

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

• Sample Size: Not specified in the document. Testing was non-clinical (bench/laboratory).
• Data Provenance: Non-clinical (bench testing in a laboratory). Country of origin is not specified for the test data itself, but the applicant (Dentsply Sirona Inc.) is located in the United States. The testing was retrospective in the sense that it was conducted prior to the submission for clearance.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. The clearance was based on non-clinical, standard-driven testing. There was no clinical ground truth established by experts for performance assessment in a patient setting.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set or subjective assessment requiring adjudication (like image interpretation) was mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study was done. The document explicitly states "Not applicable (no clinical data necessary)". Therefore, no effect size of human readers improving with AI vs. without AI assistance can be reported. The device is not an AI-assisted diagnostic tool in the sense of image interpretation.

6. Standalone Performance (Algorithm Only)

• Not applicable. The device is a physical medical device (motors, control module, apex locator) and not an algorithm or AI software for standalone performance evaluation in a diagnostic context. Its "performance" refers to its physical and electrical operation within specified limits, not its diagnostic accuracy.

7. Type of Ground Truth Used

• Not applicable, for clinical performance. For the non-clinical tests, the "ground truth" was established by the specifications defined in the referenced ISO and IEC standards (e.g., a motor must achieve a certain speed, a coupling must fit, light emission must be within safety limits). There was no "expert consensus, pathology, or outcomes data" ground truth as would be used for diagnostic accuracy studies.

8. Sample Size for the Training Set

• Not applicable. This device is hardware with embedded control software; it is not a machine learning or AI model that requires a training set in the typical sense of algorithm training on data.

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

• Not applicable. As above, this device does not utilize a "training set" in a machine learning context.

In conclusion, the FDA 510(k) clearance for the MaAM (K251811) was granted based on non-clinical testing demonstrating conformance to relevant safety and performance standards for dental motors, photobiological safety, and dental coupling dimensions. The document explicitly states that no clinical data was necessary for this clearance, meaning functional performance (e.g., apex locator accuracy, motor clinical efficacy) in a patient setting was not assessed as part of this submission.

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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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Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.

The Dental Implant Unit is intended for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue. The device is composed of main unit, motor with tube, handpiece, foot pedal and holder. Eight different programs can be selected by the user. Switching between these programs is performed by foot control or via touch display. The programs include Positioning, Hole-drilling, Hole-Broadening, Tapping, Implanting, Lock the Abutment Screw, User Defined Mode and Cleaning. The control unit is intended to be used with the motor.

The provided FDA 510(k) clearance letter and associated summary pertain to a Dental Implant Unit, which is a Class I medical device (a "Dental Handpiece and Accessories"). Class I devices are generally subject to general controls and are considered low-risk.

The documentation does not detail performance testing results for the device against specific, quantitative acceptance criteria for a clinical or software-based performance study as would be expected for a higher-risk Class II or Class III device, particularly those involving AI or diagnostic capabilities.

Instead, the submission focuses on demonstrating substantial equivalence ("SE") to a predicate device (K231845, also a dental implant unit) primarily through:

• Engineering and design comparisons: Showing similar indications for use, fundamental operating principles, and safety features.
• Compliance with recognized electrical safety and biocompatibility standards: This is the primary form of "performance testing" described.

Therefore, the following information will reflect what is discernible from the provided document, highlighting the absence of typical AI/diagnostic device study elements.

Acceptance Criteria and Device Performance (Based on Provided Document)

Study Information (Where applicable, based on provided text)

1. Sample sized used for the test set and the data provenance:
* Test Set Sample Size: Not specified in terms of patient data or typical "test set" for AI/diagnostic algorithms. The "test set" here refers to the device units themselves undergoing engineering and safety tests. The specific number of units tested is not provided, but implies typical engineering validation.
* Data Provenance: Not applicable in the context of patient data. The tests are laboratory/benchtop tests conducted to verify compliance with engineering standards.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* This is not applicable as the "ground truth" for a dental implant unit (a mechanical drive) is established by engineering specifications, calibration, and standardized testing procedures, not by expert human interpretation of medical images or clinical data. Experts involved would be engineers or technicians with relevant expertise in electrical safety, mechanical testing, and quality assurance.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable for this type of device and testing. Engineering tests rely on quantitative measurements against defined thresholds—there's no "adjudication" in the sense of resolving conflicting human interpretations.

4. 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:
* No MRMC study was done. This device is a mechanical drive unit for dental surgery, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there is no "human reader" component or effect size to report.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This device is not an algorithm or AI system. It is a piece of hardware. While it has software ("Compliance with IEC 62304"), this software controls the mechanical functions of the unit (e.g., motor speed, irrigation), not performs diagnostic or interpretive tasks.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Engineering Specifications and International Standards: The "ground truth" for this device's performance is compliance with established international standards for electrical safety (IEC 60601-1, IEC 60601-1-2), software (IEC 62304), and biocompatibility (ISO 10993-1), as well as verification against its own design specifications (e.g., speed range, output power). There is no "pathology" or "outcomes data" ground truth in this context.

7. The sample size for the training set:
* Not applicable. This is a hardware device; it does not have a "training set" in the machine learning sense. The software it contains likely undergoes traditional software development and validation, but not machine learning training.

8. How the ground truth for the training set was established:
* Not applicable. See point 7.

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The NLZ Built-in Motor System is indicated for use in the field of prophylaxis dentistry, restorative applications including cavity preparation and endodontic therapy, prosthodontics applications such as crown preparations.

The NLZ Built-in Motor System is a dental treatment system that is integrated and used in conjunction with dental chair units. It is composed of a motor system, a Multi-Pad, as well as a handpiece (optional) and cord that are compatible with different electric attachments The motor system has a control unit that works as an electric micromotor which can turn on or off and regulates the speed of the electric motor by the foot pedal of the dental unit. This product can be connected to dental units currently in use to add on a brushless electric micromotor with an LED light. Depending on the specifications of each chair unit manufacturers, the combination and operation method of the NLZ Built-in Motor System board, harness, and operation method will change.

This is a 510(k) summary for a dental handpiece and accessories, the NLZ Built-In Motor System. It outlines the regulatory process for marketing the device and demonstrates substantial equivalence to predicate devices, but does not describe or include details of an acceptance criteria table or specific studies that show the device meets acceptance criteria related to an AI device's performance.

Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets them, as the provided text pertains to a traditional medical device (a dental handpiece motor system) and its regulatory clearance process, not an AI/ML-enabled device. The document focuses on demonstrating the device's substantial equivalence through non-clinical performance and biocompatibility testing against established standards for dental medical devices.

Specifically, the document does not contain any of the following information relevant to an AI/ML device performance study:

• A table of acceptance criteria and reported device performance: No such table exists for AI performance metrics.
• Sample size for the test set and data provenance: No test set of data for an algorithm is mentioned.
• Number of experts used to establish ground truth and their qualifications: No expert review for ground truth is discussed.
• Adjudication method for the test set: Not applicable in this context.
• Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
• Standalone algorithm performance: The device is a physical dental motor system, not a standalone algorithm.
• Type of ground truth used: Not applicable for this type of device.
• Sample size for the training set: There is no AI model to train.
• How ground truth for the training set was established: Not applicable.

The performance testing listed focuses on:

• Motor performance
• Reprocessing (sterilization)
• Software (life cycle processes, which is about development and maintenance, not AI performance)
• Electrical safety
• Electromagnetic compatibility (EMC)
• Biocompatibility

These are standard non-clinical tests for physical medical devices to ensure safety and functionality, not AI performance.

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The Surgic Pro2 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.

The Surgic Pro2 consists of the Control Unit, the Foot Control, Motor and accessories. The Control Unit drives the Motors during procedures and is used to control the functions related to the Motor such as rotational direction. The Foot Control provides the user with "hands-free" control of the coolant flow, program selection, forward/reverse rotational direction, and speed during operation. Two models of the Motor with Motor cord are available, SGL80M Optic Motor. The SGL80M Optic Motor contains LED illumination of over 32,000 LUX. Each Motor is included with each series set in accordance to the client's specific needs and requirements.

The Surgic Pro2 is intended for use in 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.

Features of this product are Bluetooth connectivity with a Foot Control, "Osseo 100+" ISQ measurement device *, and other company's products "iPad". The ISQ values measured by the "can be displayed on the Surgic Pro2 control unit. The "iPad" can display information on the control unit including ISQ values on the dedicated application for Surgic Pro2. The displayed information can be stored in the iPad.

• The ISQ value is measured by the Osseo100+ and the ISQ value displayed on the display of the SurgicPro2 connected via Bluetooth.

The product is provided unsterilized, and the motors are washed and sterilized at a medical institution, and used repeatedly. The product has no bio-contact components.

The provided text is an FDA 510(k) summary for a dental device called "Surgic Pro2." It outlines the device's technical specifications, intended use, and the non-clinical tests performed to demonstrate substantial equivalence to predicate devices. However, this document does not contain information about studies proving the device meets acceptance criteria related to AI/algorithm performance, multi-reader multi-case studies, or detailed ground truth establishment.

The non-clinical tests mentioned are primarily related to general device performance, reprocessing, software life cycle (general, not AI-specific), electrical safety, EMC, and cybersecurity. There is no mention of an AI/ML component or any performance metrics like sensitivity, specificity, or AUC that would typically be associated with AI application acceptance criteria for diagnostic or assistive devices.

Therefore, I cannot fulfill your request for information regarding AI acceptance criteria and a study proving the device meets these criteria based on the provided text. The text does not describe such a study or an AI component.

To directly address your request given the provided text's limitations, here's what I can extract and what I cannot:

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

The document mentions validation and verification testing against various standards and guidance documents. These are the "acceptance criteria" for the general device performance and safety. The "reported device performance" is simply that the "results of the exit [sic] the requirements of the following standards and guidance."

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

• Not specified. The document does not provide details on the sample sizes for the performance tests, only lists the standards against which they were tested. Data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned for these non-clinical tests.

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

• Not applicable/Not specified. For the non-clinical tests mentioned (e.g., electrical safety, sterilization), "ground truth" as it applies to clinical data review by experts is not relevant. The conformity to standards would be assessed through engineering and quality testing, not expert clinical review.

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

• Not applicable/Not specified. This is relevant for clinical studies with expert reviewers, not for the type of non-clinical device performance and safety testing described.

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:

• No evidence of an MRMC study. The document describes a traditional 510(k) pathway for a dental handpiece system, focusing on substantial equivalence based on technical characteristics and non-clinical performance (safety, reprocessing, software lifecycle, etc.), not a comparative effectiveness study involving human readers or AI assistance.

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

• Not applicable. The device described (Surgic Pro2) is a dental surgical system with a micromotor, handpieces, and control unit. While it has software and Bluetooth connectivity (e.g., to display ISQ values from another device), it is not an AI/algorithm-only device for diagnosis or image analysis. Its software controls mechanical functions, not an independent interpretive algorithm.

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

• Not applicable/Compliance with standards. For the non-clinical tests performed, the "ground truth" is typically defined by the specified parameters and limits within the engineering standards (e.g., specific electrical leakage limits, torque values, sterilization parameters).

8. The sample size for the training set:

• Not applicable. This device is not described as having an AI/ML component that would require a training set.

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

• Not applicable. As above, no AI/ML training set is indicated.

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The CEFLA Dental Micromotors are brushless electric micromotors control unit inside CEFLA Dental Units. They are intended to be connected with an ISO-type handpiece attachment: straight or contra-angle of equal, gear reducing, or gear increasing speed.

They are intended for professional use in dental surgery such as: preventive applications, endodontic treatment, prosthetic applications and implantology practices.

The CEFLA Dental Micromotors are brushless electric micromotors controlled by a control unit inside CEFLA Dental Units.
The dental electric micro-motor is a dental tool, which allows performing the rotation, at a variable speed, of a drill (or another tool) supported by a handpiece connected to the micromotor. It is used for dental procedures concerning restorative and prosthetic dentistry, implant surgery, endodontic (including the reciprocating function). This device is included in the Instrument Boards of the Dental Units.
The CEFLA Dental Micromotors family presents two versions:

1. long version (long) available in two variants: with white Led light, or with white and UV LED light; the long version is especially suitable for implant & endodontic procedures:
2. short version (short) available in three variants: without any incorporated LED, with optional white Led light, or with white and UV LEDs; the short version is especially suitable for prosthetic & restorative procedures.
   Both versions are manufactured with the same essential technical specifications and mechanical performances; the only difference is related to the different lengths and the maximum available torques.
   Furthermore, both versions of micro-motors are intended to be connect with the following two parts:
3. CEFLA Dental Unit, legally marketed in USA, through a cord for connection between micromotor and the dental unit system including electronic board;
4. handpieces which transmit movement to their tips or other instrument, legally marketed in USA.
   The near-UV LED light is limited to visualization of dental composites with limited exposure time (i.e., observation of the margin of the composite and tooth structure). The near-UV LED light is not intended for use during rotation of the handpiece.

The provided text is a 510(k) Summary for a dental device (micromotors). It describes the device, its intended use, and compares it to predicate and reference devices to demonstrate substantial equivalence.

However, the document does not contain any information about acceptance criteria or a study that proves the device meets those criteria in the context of AI/ML performance evaluation. It focuses on non-clinical performance testing (electrical safety, EMC, photobiological safety) and states that clinical performance testing was not conducted.

Therefore, I cannot provide the requested information regarding AI/ML performance acceptance criteria, study details, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided text.

The closest relevant sections in the document discuss:

• Non-clinical Performance Testing (Page 18): This section lists various safety and compatibility tests carried out (Electrical safety, Electromagnetic compatibility, Photobiological safety). It states that other non-clinical performance tests were not repeated as the tests performed for the predicate device (K213022) are considered valid for the proposed variants.
• Clinical Testing (Page 18): Explicitly states, "Clinical performance testing was not conducted."
• Conclusion (Page 18): Asserts substantial equivalence based on similarities in intended use, principle of operation, functional design, and established medical use, with differences deemed minor and not negatively affecting substantial equivalence.

In summary, the provided document does not describe the kind of AI/ML performance study, acceptance criteria, or related details that your request asks for. This device is a dental micromotor, not an AI/ML-driven diagnostic or therapeutic device.

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The Fiber Optic Brushless Electric Micromotor Set (iM100) is a brushless DC electric micromotor controlled by a control unit. It is intended to be connected with an ISO-type handpiece attachment: straight or contra-angle of equal, gear reducing, or gear increasing speed. It is indicated for use in the field of preventive applications including cavity preparation and endodontic therapy, prosthodontics applications such as crown preparations.

The Fiber Optics Brushless Electric Micromotor Set, which model is iM100, is an electric device system comprised of brushless electric motor, control box, motor cord, and AC adapter. The Fiber Optics Brushless Electric Micromotor Set is designed to accommodate equal speed, gear-reduction speed, or gear-increasing speed handpiece attachment for the purpose of performing dental restoration procedures. Brushless electric motor utilize Permanent Magnet Synchronous Motor (PMSM) to offer stable torque, control box adjust the maximum speed and direction of brushless electric motor and show actual speed rate simultaneously, motor cord connect electric motor, control box and dental unit to offer handpiece water, air coolant and electricity. When equipped with the electric micromotor, the handpiece attachments provide the same effective drive force as would be provided by existing air motors. With motor control technology allows handpieces regardless of the front-end dental treatment operations or exposure to different functional groups or dental restorative material, and the speed of the drill can be kept within a certain extent but not easily change the load that make brushless electric motor operation is more easily and efficiently, unlike the operation of the air motor handpiece need to keep relied dentist technical experience. The Fiber Optics Brushless Electric Micromotor Set could control the speed range from 2,000 to 40,000 rpm.

The provided text is a 510(k) summary for a dental micromotor, not an AI/ML medical device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, expert involvement, or MRMC studies relevant to AI/ML device performance.

This document focuses on establishing substantial equivalence to a predicate device through non-clinical testing of safety and performance for a physical medical device. It does not involve AI algorithms, image analysis, or ground truth establishment in the context of diagnostic or prognostic tasks.

To answer your prompt, I would need a document related to an AI/ML medical device.

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Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.

The Implanter is intended for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue. The submission consists of: - the control unit - a motor with cable with light (sterilizable: SPM58L) - a wired foot control (MF4) - and as an attachment the surgical contra-angle handpieces (with LED:WP-1L/without LED:WP-1). Eight different programs can be selected by the user. Switching between these programs is performed by foot control or via touch display. The programs include Positioning, Hole-drilling, Hole-Broadening, Tapping, Implanting, Lock the Abutment Screw, User Defined Mode and Cleaning. The control unit is intended to be used with the motor SPM58L. To run the Implanter according to its intended use, Guilin Woodpecker provides two different surgical handpieces.

The provided text is a 510(k) Summary for a medical device called "Implanter incl. Accessories." It details the device's indications for use, comparisons to a predicate device, and non-clinical testing performed to demonstrate substantial equivalence.

However, the document states, "No clinical data is needed to demonstrate substantial equivalence." This means there was no study conducted to prove the device meets acceptance criteria using performance metrics like sensitivity, specificity, or reader improvement with AI assistance.

Therefore, I cannot provide information on acceptance criteria and a study that proves the device meets them in the format requested, as that type of study was explicitly not conducted or deemed necessary for this 510(k) submission.

The document focuses on demonstrating substantial equivalence to an already legally marketed device (the predicate device) through non-clinical testing, rather than proving a specific performance level of a novel AI algorithm.

Below is a breakdown of the information that is available in the provided text, focusing on the nearest equivalents to your requested points:

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

Since this is a 510(k) submission focused on substantial equivalence through non-clinical testing, there are no specific performance acceptance criteria like sensitivity/specificity or reader improvement from an AI study. Instead, the acceptance criteria are implicit in the conformity to established medical device standards and FDA guidance documents and the demonstration that technological differences do not impact safety or effectiveness compared to the predicate device.

The "reported device performance" is demonstrated through the satisfactory completion of these non-clinical tests.

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

This information is not provided in the document. The testing described is non-clinical, likely bench testing performed by the manufacturer (Guilin Woodpecker Medical Instrument Co., Ltd. in China) or a contracted lab. Details on specific sample sizes for each non-clinical test (e.g., how many handpieces were tested for lifecycle, how many components for biocompatibility) are not included in this summary.

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 information is not applicable/not provided. The device is an "Implanter incl. Accessories" (a dental handpiece and motor system), not an AI diagnostic imaging device. Therefore, there is no "ground truth" established by clinical experts in the context of diagnostic interpretation. The "ground truth" for non-clinical testing refers to established engineering standards, physical measurements, and chemical analyses.

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

This information is not applicable/not provided. Adjudication methods like "2+1" typically refer to the process of resolving discrepancies among multiple human readers in a clinical study involving subjective interpretation. Since this is non-clinical testing of a physical medical device, such an adjudication method is not relevant.

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

No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical data is needed to demonstrate substantial equivalence." This type of study is relevant for AI-powered diagnostic aids, which this device is not. It is a mechanical dental instrument.

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

Not Applicable. This device is a mechanical dental instrument, not an AI algorithm. Its performance is inherent in its physical and functional specifications.

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

As explained in point 3, the concept of "ground truth" in the clinical diagnostic sense (like expert consensus or pathology for imaging) is not applicable here. The "ground truth" for this device's non-clinical testing refers to:

• Established national and international engineering standards (e.g., IEC 60601-1, ISO 14457, IEC 62304, ISO 10993 series, IEC 62471).
• FDA guidance documents specific to medical electrical equipment, software, biocompatibility, reprocessing, and dental handpieces.
• Objective physical and chemical measurements (e.g., power output, torque, speed range, material composition analysis, sterilization efficacy, electromagnetic compatibility).

8. The sample size for the training set

This information is not applicable/not provided. This device is a mechanical medical instrument, not an AI model that requires a training set.

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

This question is not applicable. Since there is no AI model or training set, there is no ground truth established for a training set.

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C-Sailor Pro: This device 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. It must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

C-PUMA MASTER: The Dental Electrical Motor is intented for use in dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to the mouth. This device is designed for use by a trained professional in the filed of general dentistry.

The proposed device is used to provide the driving force of dental mobile phone for dental surgery. The functions corresponding to the dental operation steps are preset through the host or foot switch, and the electric energy and signal are transmitted to the motor through the motor cable. The motor drives the mobile phone, and the mobile phone drives the dental operation instruments to perform the operation.

The Dental Implantation Systems(C-Sailor Pro) consists of the Foot Control, AC Electrical Cord, Motor (With Cable), Handpiece Stand, Tube Holder, Spare Fuse, Handle (Foot control), and Stand for use with specific Motors. The Dental Electrical Motors(C-PUMA MASTER) consists of the Control Unit, Electrical Motor, Adaptor, Power Cord, Handpiece Stand and Motor Shaft Plug for use with specific Motors.

The provided text describes a 510(k) premarket notification for "Dental Implantation Systems, Dental Electrical Motors." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical testing and comparison of technical specifications.

It's crucial to understand that this document does not describe a study involving an AI/ML algorithm or its performance criteria. The device in question is a dental electromechanical system, not a software-as-a-medical-device (SaMD) or an AI-enabled device that would require the types of acceptance criteria and performance studies detailed in the prompt's request.

Therefore, many of the requested points, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)," "number of experts used to establish ground truth," and "sample size for training set," are not applicable to this submission.

However, I can extract information related to the closest concept of "acceptance criteria" and "study" as presented for this type of medical device submission.

Acceptance Criteria and Device Performance (as inferred from a 510(k) for an electromechanical device)

For this type of device, "acceptance criteria" are typically the standards compliance and functional equivalence to the predicate device. The "study" proving this involves non-clinical bench testing to demonstrate adherence to specific performance and safety standards, and a comparison of key technical specifications with the predicate device.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify a "sample size" in terms of patient data or clinical cases, as no clinical study was conducted. For non-clinical bench testing, the "sample size" would refer to the number of devices or components tested. This is typically determined by the testing standard requirements but is not explicitly stated here (e.g., "1 device tested for electrical safety," etc.).
• Data Provenance: The data comes from non-clinical bench testing performed by the manufacturer (Foshan COXO Medical Instrument Co., Ltd.) in China. The testing validates compliance with international standards (e.g., ANSI, IEC, ISO). The tests were conducted to verify that the device "met all design specifications" and was "Substantially Equivalent (SE) to the predicate device." It is retrospective in the sense that it's a report of completed tests, not prospective patient enrollment.

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

• Not Applicable. For this type of electromechanical device and 510(k) submission, "ground truth" as established by medical experts for diagnostic accuracy is not relevant. The "ground truth" in this context is the compliance with engineering and safety standards, verified through objective laboratory measurements and tests, and the functional specifications of the predicate device.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert readings for diagnostic accuracy studies. This submission relies on objective engineering and performance conformity with standards and the predicate device.

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

• No. No clinical study, and therefore no MRMC study, was conducted or submitted. The document explicitly states: "No clinical study is included in this submission."

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

• Not Applicable. This is an electromechanical dental device, not an algorithm. Therefore, "standalone algorithm performance" is not a concept relevant to this submission.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is based on:
  • Compliance with recognized international standards (e.g., ANSI, IEC, ISO) for medical device safety, electrical performance, EMC, biocompatibility, and specific dental equipment requirements.
  • Technical specifications and performance data of the legally marketed predicate device (NAKANISHI INC.'s Surgic Pro, Surgic Pro+ K173905).
  • Bench test results demonstrating the proposed device's adherence to its design specifications and functional equivalence.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of an AI/ML algorithm. This is an electromechanical device.

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

• Not Applicable. As there is no training set, there is no ground truth establishment for one.

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The CEFLA Dental Micromotors are brushless electric micromotors control unit inside CEFLA Dental Units.
They are intended to be connected with an ISO-type handpiece attachment: straight or contra-angle of equal, gear reducing, or gear increasing speed.
They are intended for professional use in dental surgery such as: preventive applications, endodontic treatment, prosthetic applications and implantology practices.

The CEFLA Dental Micromotors are brushless electric micromotors controlled by a control unit inside CEFLA Dental Units.
The dental electric micro-motor is a dental tool, which allows performing the rotation, at a variable speed, of a drill (or another tool) supported by a handpiece connected to the micromotor. It is used for dental procedures concerning restorative and prosthetic dentistry, implant surgery, endodontic (including the reciprocating function). This device is included in the Instrument Boards of the Dental Units.
The CEFLA Dental Micromotors family presents two versions:

1. long version (long) with Led light, especially suitable for implant & endodontic procedures;
2. short version (short) with optional Led light, especially suitable for prosthetic & restorative procedures.
   Both versions are manufactured with the same essential technical specifications and mechanical performances; the only difference is related to the different lengths and the maximum available torques.
   Furthermore, both versions of micro-motors are intended to be connect with the following two parts:
3. CEFLA Dental Unit, legally marketed in USA, thought a cord for connection between micromotor and the dental unit system including electronic board;
4. handpieces which transmit movement to their tips or other instrument, legally marketed in USA.

This document is for Premarket Notification (510(k)) and pertains to dental micromotors, not an AI/ML powered medical device. Therefore, the information requested in points 1-9 regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device is not explicitly available in this submission.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance testing relevant to the physical device.

However, I can extract information regarding non-clinical performance testing that serves as "acceptance criteria" for this specific medical device, as well as the types of studies conducted to show it meets those criteria:

Non-Clinical Performance Testing (Acceptance Criteria & Reported Performance):

The submission states that various non-clinical tests were conducted and proved the device met the relevant standards. While specific numerical acceptance criteria values are not provided, the "Meets" status implies successful completion against the requirements of the listed standards.

Study Details (based on the provided document):

1. Sample size used for the test set and the data provenance: Not applicable. These are non-clinical hardware performance tests, not AI/ML model evaluations requiring test sets of patient data.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are engineering and performance tests against established standards.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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 a physical device, not an AI-powered diagnostic tool. The document explicitly states: "Clinical Testing: Clinical performance testing was not conducted."
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for these tests are the established, quantifiable requirements and limits set forth in the referenced international standards (e.g., IEC 60601-1, ISO 14457).
7. The sample size for the training set: Not applicable. This is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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