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Alpha Endo Handpiece is a cordless motor handpiece with torque control used for driving files in both reciprocating and rotation mode during the preparation stage of root canal therapy.

The Alpha Endo Handpiece is a medical electrical device that provides the driving force required for surgical instruments used in root canal surgery to enlarge and shape the root canal during root canal surgery. The Alpha Endo Handpiece mainly uses a variable speed gear plate to turn the high speed of the motor into the low speed required for root canal preparation surgery, while obtaining a larger cutting torque, and then further increases or reduces the speed and torque within this range through the speed regulating circuit, making root canal preparation efficient and safe. Speed and maximum torque are selectable and are always controlled by a torque sensor with an automatic protection mode to prevent the file needle from breaking.

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The InnerView System is intended to precisely measure the damping characteristics of the periodontium and its associated fixed structures (teeth and/or implants). It can provide data to quantify tooth and/or dental implant mobility by producing two distinct outputs. InnerView's Mobility quantifies the external tooth and/or implant mobility. InnerView's NFE quantifies the internal mobility within the tooth and/or implant structure.

The InnerView System is an electromagnetically driven percussion system designed for dental professionals to collect percussion data of intraoral sites such as teeth and/or dental implants. The device utilizes non-destructive quantitative percussion diagnostics (QPD), a mechanics-based methodology to measure the damping capacity of a tooth and implant by applying light percussion to its buccal surface.

The InnerView System consists of a wireless handheld handpiece, a base station, single-use disposable tips, and software. A USB cable connects the base station to the user's PC. The handpiece and base station are automatically paired when the handpiece is placed in the base station. The base station also functions as a charger for the handpiece when docked. A fresh disposable tip must be attached to the handpiece before each new procedure and replaced after each patient use.

The percussion response captured by the handpiece is wirelessly transmitted to the base station, then forwarded to the PC via USB, and subsequently to the Cloud-based software for analysis and calculations. The percussion data is captured in an energy response graph (ERG), which depicts the mechanical response of the intraoral site as a function of time. InnerView proprietary software algorithms analyze the ERG data and, through the user interface, display two independent outputs: Mobility, which quantifies external mobility of the tooth or implant, and NFE, which quantifies internal mobility within the tooth or implant structure.

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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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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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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 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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The Trust is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region. The Trust is restricted to usage with Dentium implant system, and the angle of the abutment must be maintained at 90° when in use.

This equipment measures the time between the healing abutment and the striking rod by mechanically striking the implanted abutment and quantifies the fluctuation between the implant abutment and the alveolar bone. It is a principle to measure the contact time according to the acceleration change at the moment of being hit by using the acceleration sensor mounted on the Attack Pole. The higher the number, the better the fixation between the implant fixture and the bone.

The provided text describes a 510(k) premarket notification for a medical device called "The Trust," which measures the stability of dental implants. To answer your request about acceptance criteria and the study proving the device meets them, I need to focus on the "Performance Data" section and the "Comparison Technological Characteristics with the Predicate Devices" table, as these are the most relevant parts.

Here's a breakdown based on the information provided and common expectations for such submissions:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed in a separate table with specific pass/fail values. Instead, the document relies on demonstrating "similar performance" to a predicate device and meeting "established specifications." The key performance characteristic mentioned is the "Error of measurement value."

Table of Acceptance Criteria and Reported Device Performance:

Study Information:

Based on the provided text, the study proving the device meets the acceptance criteria is primarily an equivalence test to the predicate device (AnyCheck IMT-100), rather than an independent clinical study with human subjects.

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

   • Test Set Sample Size: The document does not explicitly state the sample size used for the performance comparison tests. It mentions "performance comparison tests with already licensed products" (refer to "002 Equivalence test to AnyCheck"). This often implies bench testing or testing on phantom models, rather than a large clinical test set with patient data.
   • Data Provenance: Not specified. Given it's a Korean manufacturer, it's likely the testing was conducted in South Korea. The type of study (retrospective or prospective) is not explicitly stated, but equivalence testing of this nature for dental handpieces typically involves prospective bench-top testing.

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

   • Not applicable/Not specified. For this type of device and performance testing, ground truth would likely be established by controlled experimental setups and direct measurement by engineers/technicians, rather than expert review of images or clinical outcomes.

3. Adjudication Method for the Test Set:

   • Not applicable/Not specified. As the "ground truth" is likely derived from calibrated measurements in a controlled environment, there wouldn't typically be a need for expert adjudication in the way it's used for AI diagnostic studies.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No. An MRMC study is typically performed for AI-driven diagnostic devices where human readers interpret medical images. This device measures implant stability mechanically. There is no indication of such a study being conducted or required.
   • Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was performed.

5. Standalone (Algorithm Only) Performance:

   • Yes, implicitly. The "Performance Data" section refers to tests to ensure the device met "established specifications" and "consistent performance for the intended use." This strongly suggests bench testing or in vitro (non-human) testing of the device's measurement capabilities, which would be considered standalone performance. The "±3 ISV" error of measurement is a standalone performance metric.

6. Type of Ground Truth Used:

   • Likely bench-top measurements / calibrated experimental setup. The device measures a physical property (time between abutment and striking rod, quantified as ISV). The "ground truth" for evaluating its accuracy would come from highly controlled conditions where the "true" stability or a reference value is known (e.g., using standardized implant models with predefined stability levels or comparing to a gold standard measurement technique). It is not pathology, expert consensus, or outcomes data.

7. Sample Size for the Training Set:

   • Not applicable/Not specified. This device is described as a mechanical measurement device using an acceleration sensor, not an AI/machine learning device that requires a "training set" in the conventional sense. The "principle to measure the contact time according to the acceleration change... by using the acceleration sensor mounted on the Attack Pole" suggests a direct physical measurement.

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

   • Not applicable, as there's no indication of a "training set" for an AI algorithm.

Summary of Device Performance Test and Conclusion:

The performance evaluation for "The Trust" appears to have focused on demonstrating its technical accuracy and equivalence to a legally marketed predicate device (AnyCheck IMT-100). The key performance metric highlighted is the "Error of measurement value" of ±3 ISV, which matches that of the predicate. The submission argues that similarities in operational principles and biological safety, despite minor design differences (e.g., how the calibrator is integrated, magnetic vs. screw connection for the attack pole), do not raise new questions of safety or effectiveness. Biocompatibility testing was also conducted according to ISO 10993 standards and found the materials to be non-toxic and non-sensitizing.

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The Endo Tabletop consists of a motorized endodontic handpiece for root canal cleaning and preparation. In addition, some models may also incorporate an electronic apex locator that assists the operator to locate the file tip in the root canal. The Endo Tabletop is intended solely for use by trained dental professionals on patients that need root canal treatment.

The Endo Tabletop is designed to drive dental endodontic instruments for a rotating treatment of root canals. Therefore, the Endo Tabletop provides different kinds of movement:

1. Continuous rotary motions (adjustable speed, torque and direction depending on the file used)
2. Reciprocating motions (speed, torque, direction, and angles depending on the file used)
   This functionality is provided by a Brushless Direct Current (BLDC) motor having speed and torque controls. The motor speed control is driven by a dedicated controller using pulse width modulation (PWM) of the excitation voltage and the motor torque control is performed by controlling and limiting the maximum current flow. The contra-angle transmits the motor movement in speed and direction to the endodontic file.
   The user can set the device by a graphical user interface on a 7" touch Thin-Film Transistor (TFT) display. The handpiece can be started/ stopped with a finger switch and foot control.
   All models can also be used for root canal length determination using the integrated apex locator functionality. This apex locator functionality is provided by evaluating the electical impedance between to the file clamp, placed into the dental root canal and the lip clip placed on the patient. The results of this estimation must be confirmed by standardized diagnostic imaging like an X-ray.
   The proposed apex locator function has two modes standalone mode. In standalone mode, the apex determination works with the lip and the endodontic file, which is connected to a file clamp. In combined mode, the apex determination works with the lip clip and the endodontic file which is connected to the contra-angle.

This is a 510(k) summary for a dental handpiece with an apex locator. The document does not contain the specific acceptance criteria and detailed study results in the format requested.

Here's an analysis based on the provided text:

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

The document does not provide a table of acceptance criteria and reported device performance with specific numerical values for metrics like accuracy, precision, or other quantitative measures typically found in performance studies. Instead, it lists various standards and guidance documents that the device's testing complied with. For example, it states:

• "All testing to the applicable elements of the standard passed." (referring to ISO 14457:2017)
• "Results confirm that the design inputs, function, and performance specifications for the proposed device are met."
• "performance data support the conclusion that the proposed device performs as well as the predicate device EndoPilot2 (K202906)."

This implies that the device met the requirements outlined in these standards, but the specific performance data against those requirements is not detailed in this summary.

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

The document does not specify the sample size used for any of the performance tests (e.g., how many devices were tested for endurance, how many measurements were taken for the apex locator accuracy). It also does not mention the data provenance in terms of country of origin or whether studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This section is not applicable as there is no mention of a human-read or expert-adjudicated test set in the document. The testing described focuses on mechanical, electrical, software, and biocompatibility performance of the device and does not involve human interpretation or classification of medical images/data.

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

This section is not applicable as there is no mention of a human-read or expert-adjudicated test set in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. The device described is a dental handpiece and electronic apex locator, which are physical tools, not AI-driven diagnostic software that would typically be involved in MRMC studies to assess human reader improvement. The document explicitly states, "There are no clinical tests submitted, referenced or relied on in the 510(k) for a determination of substantial equivalence."

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

The device is not an algorithm, so the concept of standalone algorithm performance does not directly apply. However, the performance of the apex locator functionality (e.g., its accuracy in determining file tip position) would be considered part of its standalone performance. The document states:

• "The apex location is the same, at ≤ 0.5 mm." This refers to the accuracy of the apex locator functionality compared to the predicate device.
• "File performance (speed/torque) is determined by the system consisting of contra-angle and motor together."
• Various non-clinical tests were conducted to confirm the performance, including those conforming to ISO 14457:2017.

While specific numerical results beyond "≤ 0.5 mm" for apex location are not provided in this summary, the mentioned tests represent the standalone performance evaluation of the device's functions.

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

For the apex locator, the "ground truth" would likely be established through a reference method, such as direct measurement on extracted teeth validated by X-ray or micro-CT, or comparison to a clinically accepted gold standard. The document mentions: "The results of this estimation must be confirmed by standardized diagnostic imaging like an X-ray." However, it does not explicitly state how the "≤ 0.5 mm" accuracy was determined or what the ground truth method was for the performance testing.

For other aspects like mechanical, electrical, and biocompatibility testing, the "ground truth" is defined by the requirements of the relevant international standards (e.g., ISO 14457:2017, IEC 60601 series, ISO 10993 series).

8. The sample size for the training set

This section is not applicable as the device is not an AI/ML algorithm that requires a training set.

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

This section is not applicable as the device is not an AI/ML algorithm that requires a training set.

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The EM-07 is a cordless handpiece with apex localization capability, used for driving files in both continuous rotation and reciprocating mode during an endodontic procedure for enlargement of root canals, while monitoring the position of the endodontic file tip within the canal.

The EM-07 is a cordless handpiece with apex localization capability.

This document is an FDA 510(k) clearance letter for a dental handpiece, not a study report. It states that the device, EM-07 Cordless Endo Motor, has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria. The standard content of an FDA clearance letter focuses on regulatory approval rather than detailed performance study results.

To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical study report submitted to the FDA for review.

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

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

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