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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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EnDrive is a battery-operated electronic medical device used for the treatment of root pulp infection, which allows root canal preparation by means of continuously or alternately rotating endodontic instruments with torque control, or retreatment of an already treated tooth, with integrated apex locator.

EnDrive is a battery-operated electronic medical device used for the treatment of root pulp infection, which allows root canal preparation by means of continuously or alternately rotating endodontic instruments with torque control, or retreatment of an already treated tooth, with integrated apex locator. We can identify two different functional principles: one is the motor function which serves to shape the root canal the other is the apex locator function to determine the apex approach when the file is in the root canal. The motor function, when the file has a movement transmitted from the motor through the contra-angle, allows the proper shaping of a root canal with infected pulp through rotary or reciprocating movement, helping to remove debris and infected tissue from the canal.

The motor, controlled in speed and torque, uses brush less DC technology with 3 phases and 3 Hall sensors, driven by an embedded software. The apex locator function allows to determine when, during an endodontic treatment, the tip of an endodontic instrument, in steel or nickel-titanium, inserted by the dentist inside the root canal, is at the apex of the canal.

Two electrodes are applied to the patient, a lip clip on the lip and a file clamp to the endodontic instrument positioned inside the canal. When the device signals the apex has been reached, the dentist positions the instrument stopper on the dental crown and indirectly goes to measure the working length of the canal using a ruler for endodontic: instruments, so the length from which the dentist must remove the infected pulp.

The provided FDA 510(k) Clearance Letter for EnDrive (EnDriveUS) outlines the device's technical specifications and a summary of non-clinical tests conducted to demonstrate substantial equivalence to a predicate device. However, the document does not contain a detailed study proving the device meets specific acceptance criteria in the manner requested (i.e., a clinical study with a detailed test set, ground truth, expert adjudication, or MRMC study).

The document primarily focuses on demonstrating substantial equivalence through bench testing of key performance characteristics and compliance with various standards.

Here's a breakdown of the information available and what is not disclosed in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the "Non-Clinical and/or Clinical Tests Summary & Conclusions" section (Page 7), here's the information that can be extracted:

Note: The "acceptance criteria" for EnDrive are largely implicitly defined by its substantial equivalence to the predicate device (Endo Motor, K220829). The document states that EnDrive's performance is either within or acceptably comparable to the predicate's ranges.

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

• Sample Size for Test Set: Not specified. The document mentions "bench test reports" but does not provide details on the number of samples, root canals, or measurements included in these tests for speed, torque, or apex locator accuracy.
• Data Provenance: Not explicitly stated as "country of origin." However, the applicant is "Advanced Technology Research (A.T.R.) s.r.l." located in Pistoia, Italy. The testing described appears to be a non-clinical, bench-top study rather than a human clinical trial, making "retrospective or prospective" less applicable in the typical sense. It implies prospective testing conducted on the device itself.

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

• Number of Experts: Not applicable/Not specified. For the bench tests described (motor speed, torque, apex locator accuracy), the "ground truth" would typically be established by calibrated measurement instruments, not human experts. Human experts are generally relevant for interpreting images, diagnosing conditions, or performing clinical assessments, none of which are described in the performance tests here.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are used in studies where multiple human readers assess data, and disagreements need to be resolved. Since the reported performance tests are bench-top measurements against instrument-derived "ground truth," such a method is not relevant.

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

• Was an MRMC study done? No. The document does not describe any study involving human readers assessing cases with or without AI assistance. The device is a "motorized handpiece with integrated apex locator," not an AI diagnostic/interpretive tool in the context of MRMC studies.
• Effect size of improvement with AI vs without AI assistance: Not applicable, as no MRMC study was conducted or described.

6. Standalone Performance Study (Algorithm only without Human-in-the-loop)

• Was a standalone study done? Yes, in essence. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section describes performance characteristics (motor speed, apex locator accuracy, torque) of the device itself, implying standalone performance. The device's "integrated apex locator" function is a component of the device's overall functionality, and its accuracy (±0.5mm) is reported as a standalone metric for that function.
  • However, it's crucial to distinguish this from AI/software-only standalone performance. This is about the electromechanical performance of the hardware and its integrated functions, not a purely software-based diagnostic algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: For the reported performance metrics (motor speed, torque, apex locator accuracy), the ground truth would be established by calibrated reference instruments or precise physical measurements. For example:
  • Motor Speed: A calibrated tachometer or speed sensor.
  • Torque: A calibrated torque sensor.
  • Apex Locator Accuracy: Physical measurement of root canal length (e.g., using a micrometer or precise ruler) in a controlled phantom/model alongside electronic readings.
  • General compliance with standards implies that the tests performed to meet those standards would use appropriately robust and validated ground truth methodologies.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not specified/Not applicable in the AI/ML sense. The EnDrive is described as an electronic medical device with embedded software controlling motor functions and an apex locator. While "embedded software" runs the device, the document does not suggest the use of machine learning or AI models that would require a distinct "training set" in the context of typical AI/ML submissions to the FDA (e.g., for diagnostic image analysis). The software likely relies on algorithms and control logic rather than learned patterns from a training dataset.

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

• How Ground Truth for Training Set Was Established: Not applicable/Not specified. As there's no mention of a machine learning "training set," there's no information on how its ground truth would be established. The device's functionality is based on established engineering principles for electromechanical control and impedance-based apex localization, not typically on a data-driven training paradigm requiring labeled ground truth in the way a diagnostic AI does.

In summary: The provided FDA clearance letter focuses on establishing substantial equivalence for a medical device (a dental handpiece with an integrated apex locator) primarily through bench testing against performance specifications and compliance with relevant industry standards. It does not detail a clinical study with elements like a human-adjudicated test set, MRMC comparisons, or specific AI/ML training data that your request implies. The performance claims are limited to the mechanical and electronic accuracy of the device's core functions.

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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 intended use of DPA is for polishing and cleaning teeth.

Plastic one-piece housing (external casing) with 1 internal drive shaft and a spindle installed and aligned at right angle (90 degree) with each other. The tip of spindle is fitted with rubber prophy cup for cleaning and polishing teeth. A small amount of food-grade grease is added between the drive shaft and the spindle as lubrication. The disposable prophylaxis angle is available in a soft cup and firm cup format, which differ in the material used to form the cup. The Medicom and Practicon brands differ in logo and packaging, but utilize the same design.

This FDA 510(k) clearance letter pertains to a Disposable Prophy Angle, a dental device, not an AI/ML medical device. Therefore, much of the requested information regarding AI/ML device testing (e.g., sample size for test set, data provenance, expert ground truth, MRMC study, training set details) is not applicable to this document.

However, I can extract the relevant information regarding performance criteria and testing for this device.

Acceptance Criteria and Study for Disposable Prophy Angle (K240950)

This document describes the 510(k) clearance for a Disposable Prophy Angle, a dental handpiece accessory used for polishing and cleaning teeth. The device is not an AI/ML medical device, and thus, many of the typical AI/ML study parameters are not applicable.

The submission demonstrates substantial equivalence to predicate devices by meeting recognized performance requirements through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

The documentation references compliance with a specific industry standard for performance.

Note: The specific numerical values or thresholds for "temperature rise" and "vibration" are not provided in this summary but would be detailed in the full test reports submitted to the FDA.

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

Not Applicable (N/A). This is a hardware dental device. The testing described is non-clinical performance testing (temperature rise, vibration) based on engineering specification compliance, not an AI/ML model evaluated on a test set of data. The "test set" would refer to the physical samples of the device and its components. The document doesn't specify the number of units tested, only that "all models of the device (soft cup and firm cup)" were tested.

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

Not Applicable (N/A). Ground truth based on expert review is specific to AI/ML or diagnostic image analysis. For this device, "ground truth" refers to established engineering standards (ANSI ADA Specification No. 85) and comparative performance against a predicate device.

4. Adjudication method for the test set

Not Applicable (N/A). Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human readers in AI/ML or diagnostic studies. This is a non-clinical, hardware performance test.

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 (N/A). This is not an AI/ML device; therefore, an MRMC study and analysis of human reader improvement with AI assistance are irrelevant.

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

Not Applicable (N/A). This is not an algorithm or software device.

7. The type of ground truth used

The "ground truth" (or basis for acceptance) for this device's performance testing is:

• Established engineering standards: Specifically, "ANSI ADA Specification No. 85, Part I: Disposable Prophy Angles, section 5.5."
• Comparative equivalence: Demonstration of "equivalent performance to the predicate device" for temperature rise and vibration.

8. The sample size for the training set

Not Applicable (N/A). This is a hardware device; there is no training set for an AI/ML model.

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

Not Applicable (N/A). There is no training set for an AI/ML model.

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Endo Motor with E-LITE MAX, E-LITE PRO and ELITE-INO is cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used for preparation and enlargement of root canals, or measuring the canal length. And it can be used to enlarge the canals while monitoring the position of the file tip inside the canal.

E-LITE MAX & ELITE-INO:

The Endo Motor with E-LITE MAX and ELITE-INO is a low-speed rotating oral equipment mainly used for root canal preparation and root canal measurement. It is designed to enlarge the root canal, facilitate dentin filling, or measuring the root canal length. The product is a portable device consist of a cordless hand-piece and a charge base, it is powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, file system, Apex etc. Users can also set and modify by keys, and provide design of factory initialization, and calibration of the apex location. It can be used as a low-speed motorized handpiece and device for measuring canal length. The rotary speed and torque range are adjustable.

There are three function features for E-LIT MAX and ELITE-INO:

• Root Canal enlargement: Prepare the root canal with apex locator function.
• Apex Location: Measure the length of the root canal.
• Multi-function: Measuring the length while root canal preparation.

The device can save 9 programs, each program can set different parameters according to the user.

E-LITE PRO:

The Endo Motor with E-LITE PRO is a low-speed rotating oral equipment mainly used for root canal preparation. It is designed to enlarge the root canal or facilitate dentin filling. The product is a portable device having a cordless hand-piece with a charging adapter, it is powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, file system, Apex etc. Users can also set and modify by keys, and provide design of factory initialization, and calibration of the apex location. It can be used as a low-speed motorized handpiece and device for measuring canal length. The rotary speed and torque range are adjustable.

There is only one function features for E-LITE PRO:

• Root Canal enlargement: Prepare the root canal, without apex locator function.

The device can save 9 programs, each program can set different parameters according to the user.

The Endo Motor must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

The Endo Motor is intended to be sterilized prior to use.

The compatible device can be used with Endo Motor is rotary instruments such as rotary root canal files, the working part of rotary instruments normally made of Nickel titanium (NiTi). These files are not included in the submission.

The provided FDA 510(k) clearance letter and summary for the "Endo Motor" (K242514) indicate that this is a dental handpiece and accessories, specifically an endodontic motor with root canal measurement capabilities. This type of device is not an AI/ML-enabled medical device and therefore the provided document does not contain the information typically found in an FDA submission for AI/ML devices regarding acceptance criteria, training data, ground truth establishment, or clinical study design (e.g., MRMC studies).

The document states: "No clinical test data was used to support the decision of substantial equivalence." This further confirms that a study validating an AI/ML component was not part of this clearance.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance of a traditional medical device (an endomotor) against established electrical safety, EMC, usability, and functional standards, as opposed to the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information related to AI/ML device validation because it is not present in the provided document. The document describes compliance with recognized standards for traditional medical devices (e.g., IEC 60601-1 for electrical safety, ISO 10993-1 for biocompatibility).

However, I can extract the general "acceptance criteria" and "device performance" as understood for this type of non-AI device from the provided tables, focusing on the comparative aspects:

Acceptance Criteria and Device Performance (Based on traditional device comparison):

The acceptance criteria for the Endo Motor (E-LITE MAX, E-LITE PRO, ELITE-INO) are primarily established through a direct comparison to a predicate device (Guilin Woodpecker Medical Instrument Co., Ltd.'s Endo Motor, K203320) and compliance with relevant international standards for medical devices. The objective is to demonstrate that the proposed device is "substantially equivalent" in terms of safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

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

This document does not describe a "test set" in the context of an AI/ML model's performance on a dataset of patient cases. Instead, "tests" refer to engineering and biocompatibility validations of the physical device. Therefore, typical sample size metrics for AI/ML validation are not applicable here. The data provenance is implied by the testing standards (e.g., in-house testing by the manufacturer based on international standards). The nature of this submission indicates a retrospective comparison to an already cleared predicate device, rather than a prospective clinical trial.

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

Not applicable. This is not an AI/ML device and does not involve human expert adjudication of medical image data for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable for the reasons stated above.

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. The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." This type of study is specifically relevant to AI/ML devices where the goal is to show the impact of the AI on human reviewer performance.

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

Not applicable. This is a physical endodontic handpiece, not a software algorithm.

7. The type of ground truth used

For this conventional medical device, "ground truth" refers to the established performance requirements defined by recognized standards (e.g., IEC, ISO) and the functional specifications of the predicate device. Compliance is demonstrated through laboratory testing of the physical device, rather than through expert consensus on medical data or pathology results.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML 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 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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ChecQ is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.

The ChecQ is a dental implant stability analyzer comprising a main unit and a charging cradle that uses Resonance Frequency Analysis (RFA) to measure implant stability non-invasively. It works with the ChecQPEG, which attaches to the dental implant, and measures stability by analyzing resonant frequencies generated by magnetic field stimulation from the probe tip. The stability result is displayed on the main unit's screen as an Implant Stability Quotient (ISQ), ranging from 1 to 99. The RFA method evaluates by applying transverse force to the implant using magnetism, measuring movement, and analyzing the resulting resonance frequency. The resonance frequency depends on the bone-implant gap and is calculated using a formula, with values expressed as ISQ scores (1-99) for clinical interpretation. The ChecQ mechanism converts voltage pulses generated by the DAC of the MCU into magnetic pulses, which induce vibrations in the ChecQPEG magnets. The device captures the free vibrations as magnetic pulses, processes them through an FFT to extract the natural frequency, and calculates the ISQ value based on this frequency.

The provided text relates to the FDA 510(k) clearance for the ChecQ (AC100) device, a dental implant stability analyzer. However, the document outlines the equivalence to predicate devices based on non-clinical testing rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria through a multi-reader multi-case (MRMC) study or a standalone algorithm performance study.

The document emphasizes "technological comparison" and "non-clinical testing" for substantial equivalence. It does not describe a clinical study in the format typically used to assess the performance of an AI/ML medical device, which would involve a test set, ground truth experts, adjudication, and performance metrics like sensitivity, specificity, or AUC.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated based on the given information:

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

The document does not specify quantitative acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) for the device. Instead, it focuses on demonstrating equivalence to a predicate device through non-clinical testing.

The reported device performance is described qualitatively:

• "The results confirmed that ChecQ exhibited equivalent performance, establishing its functional equivalence with the predicate device."
• "Additional testing was conducted to evaluate the potential effects of the barrier sleeve on ISQ measurements, confirming that the presence of the barrier sleeve did not impact measurement accuracy."

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

The document mentions "multiple measurements using standardized test jigs" for comparative testing against the predicate device (Osstell Beacon). This indicates an in-vitro, non-clinical test using artificial setups rather than a test set derived from patient data. Therefore, there's no information on:

• Sample size: Not applicable in the context of patient data; the "test set" consists of measurements on test jigs.
• Data provenance: Not applicable as it's not human patient data. The testing appears to be conducted by the manufacturer, presumably in South Korea given the applicant's origin.
• Retrospective or Prospective: Not applicable as it's not a clinical study.

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

Not applicable. The "ground truth" for the non-clinical comparison was established by the measurements from the predicate device (Osstell Beacon) and potentially engineering specifications for dimensional tests. There were no human experts involved in establishing ground truth for a clinical test set.

4. Adjudication method for the test set

Not applicable, as there was no clinical test set requiring expert adjudication.

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. The document explicitly states that the "ChecQ dental implant stability analyzer underwent comparative testing against the predicate device, Osstell Beacon, to assess its accuracy. The self-test methodology involved multiple measurements using standardized test jigs..." This is a non-clinical comparison of the device's output to a known standard (the predicate device) or engineering specifications, not an MRMC study with human readers.

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

Yes, in a sense, a "standalone" performance comparison was done, but it was comparing the device's measurement (ISQ score) against the measurement of another device (Osstell Beacon) on artificial test jigs, not against a clinical ground truth for diagnostic accuracy. The device (ChecQ) measures "Implant Stability Quotient (ISQ), ranging from 1 to 99," directly.

7. The type of ground truth used

The "ground truth" for the non-clinical comparison was the output of the predicate device (Osstell Beacon) under the same test conditions, and engineering specifications for mechanical properties and dimensions. It was not expert consensus, pathology, or outcomes data from patients.

8. The sample size for the training set

Not applicable. This device is an electro-mechanical measurement device, not an AI/ML algorithm that requires a "training set" in the context of machine learning. The device determines ISQ values based on resonance frequency analysis and established formulas, not through learned patterns from a training dataset.

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

Not applicable, for the same reason as point 8.

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The reciprocating/oscillating contra-angle handpieces are for the following applications: Preparation, removing protrusions or excess of filling materials and cements, finishing and polishing in the interdental, supragingival and subgingival regions, plaque removal and IPR (interproximal reduction) in orthodontics.

W&H's reciprocating/oscillating handpieces were developed as dental contra-angle handpieces that are powered by either an air motor or an electric micromotor. The internally mounted gearing elements transmit the supplied rotational movement up to the head-side assembly holding the clamped tool and generating its reciprocal movement. Because of being designed for two different manufacturers´ files/tips (tools), the following types have been developed: the Synea Profin handpieces WG-67 LT and WG-67 A, intended to be provided with tips/files offered by the Swedish company Dentatus AB (Establishment Reg. No. 8030870) and the Synea Intensiv handpieces WG-68 A, WG-69 LT and WG-69 A (incl. Swiss Edition for WG-69 A and WG-69 LT), intended to be provided with tips/files offered by the Swiss manufacturer Intensiv SA (Establishment Reg. No. 8030958). All these devices´ application is intended in dentistry.

The provided text is a 510(k) Premarket Notification summary for dental handpieces. It does not describe an AI/ML medical device or a study involving human readers and AI assistance for diagnostic purposes. Therefore, most of the requested information regarding acceptance criteria, study design (sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), and training set details for an AI/ML device cannot be extracted from this document.

The document focuses on demonstrating substantial equivalence of the new Synea Fusion Handpieces to a legally marketed predicate device (K082827) based on non-clinical testing for mechanical, material, and reprocessing characteristics, as well as biocompatibility.

Here's what can be extracted based on the provided text, and what cannot:

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

The document does not provide a specific table of acceptance criteria with reported performance values in the way one would for an AI/ML diagnostic device with performance metrics like sensitivity, specificity, or AUC. Instead, it states that "Non-clinical testing has been performed showing that the device performs as intended and are substantially equivalent to the predicate device (K082827)."

The acceptance criteria are implied by the standards applied and the successful completion of the tests:

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

This information is not applicable and therefore not provided in the document, as the testing was non-clinical (laboratory/bench testing) of physical devices, not data from patients for an AI/ML diagnostic system. There were no "test sets" of patient data.

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. Ground truth as typically understood for AI/ML diagnostic devices (e.g., radiologist reads, pathology) was not established for this type of device (dental handpieces). The "truth" for the performance criteria established was based on engineering specifications and adherence to international standards.

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

Not applicable, as this was not a human-reader based study for diagnostic accuracy.

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. No MRMC study was conducted, as this is not an AI-assisted diagnostic device. The document explicitly states "Clinical performance testing was not conducted."

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

Not applicable. This is not an AI algorithm.

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

For this device, "ground truth" refers to the established engineering specifications and validated test methods defined by the applied ISO standards and internal procedures. For example:

• Mechanical/Functional: Compliance with force, speed, and dimensional tolerances as defined by ISO 14457.
• Biocompatibility: Absence of toxic or adverse biological reactions based on validated assays defined by ISO 10993-1 and ISO 7405.
• Reprocessing: Successful elimination of microbial load and retention of functional integrity after reprocessing cycles, validated according to ISO 17664, ANSI/AAMI ST79, and ISO 17665-1.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable.

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The Integrated Endo System is dental device which combine in a single main control unit an endo motor to clean the root canal, a dental obturator to fill and pressurize, an electronic apex locator to assist the operator to locate the file tip in the root canal and an ultrasonic-handpiece for root-canal cleaning and preparation.

The Integrated Endo System is intended solely for use by trained dental professionals in professional health care facilities on patients that need root-canal-treatment.

The Integrated Endo System Meet Endo-II is composed of Main Unit, Adapter, MeetMotor, MeetFill, MeetActivator. It is standalone AC-powered dental control units with a touch display screen to which multiple hand-held dental handpieces for root canal therapy procedure (MeetMotor is for root canal preparation, MeetFill is for root canal backfilling, MeetPex is for working length measurement of root canal, MeetActivator is for root canal irrigation).

These multifunctional devices are intended for use by professionals in the dental clinic use environment. Based on the modular concept of the Integrated Endo System different handpieces can be combined with the control unit. The key hand-held components like handpieces or endodontic tools of the Integrated Endo System are medical devices commercially available by themselves and have separate FDA registration or clearance for marketing in the US.

The provided document describes a 510(k) premarket notification for the "Integrated Endo System (Meet Endo-II)". This submission is for a dental device, not an AI/ML medical device, and therefore, the information typically found in an AI/ML acceptance criteria and study report (e.g., specific metrics like sensitivity/specificity, sample sizes for test/training sets, expert adjudication, MRMC studies) is not present.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (EndoPilot2 K202906) through non-clinical performance testing, electrical safety, biocompatibility, and software validation for a "Moderate Level of Concern" software. It is a comparison of technological characteristics and safety standards rather than a performance study on a diagnostic or pattern-recognition AI/ML algorithm.

Therefore, I cannot extract the requested information regarding AI/ML acceptance criteria and study details from this document. The document confirms that the device meets various electrical, safety, and performance standards relevant to general medical devices and integrates several dental functions, but it does not describe a study involving an AI/ML algorithm's diagnostic performance.

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The HPR Cordless Hygiene Handpiece is a cordless prophylaxis handpiece featuring control buttons and equipped with a battery pack and a wireless foot control. It is designed for use with disposable prophylaxis angles in hygiene operatory to perform cleaning and polishing procedures on teeth surface and fillings.

The HPR Cordless Hygiene Handpiece is a cordless prophylaxis handpiece featuring control buttons and equipped with a battery pack and a wireless foot control.

The provided text is a 510(k) clearance letter from the FDA for a dental handpiece. It does not contain information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment for a medical device. These details are typically found in the 510(k) submission itself or in a summary of safety and effectiveness, which is not included in this document.

Therefore, I cannot extract the requested information from the given input.

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