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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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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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C-SMART-I PRO, C-SMART-I PILOT, C-SMART-MINI AP:
The Endo Motor device is an endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge the canals while monitoring the position of the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

C-Smart-mini:
The Endo Motor device is an endodontic treatment motorized handpiece. It can be used to enlarge canals. It can be used as a low-speed motorized handpiece. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

C-SMART-I PRO: The Endo Motor device C-SMART-I PRO is a low-speed rotating oral equipment mainly used for root canal preparation and root canal measurement. The product is a portable device powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, working mode, apex position, etc. Users can also set and modify by keys, and provide design of factory initialization, calibration and functional check of the apex locator. The Endo Motor device is an endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge the canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel. The Endo Motor device C-SMART-I PRO is intended to be sterilized prior to use. The material composition of root canal files that can be used with the Endo Motor device C-SMART-I PRO is Nickel titanium (NiTi). These files are not included in the submission. There are three working modes as: M1: Apex locator only. M2: Motor only. M3: (Dual mode) Motor with apex location function.

C-SMART-I PILOT: The Endo Motor device C-SMART-I PILOT is a low-speed rotating oral equipment mainly used for root canal preparation and root canal measurement. The product is a portable device powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, working mode, apex position, etc. Users can also set and modify by keys, and provide design of function check, calibration, factory reset and can connect handpiece to control unit via Bluetooth. The Endo Motor device is an endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge the canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel. The Endo Motor device C-SMART-I PILOT is intended to be sterilized prior to use. The material composition of root canal files that can be used with the Endo Motor device C-SMART-I PILOT is Nickel titanium (NiTi). These files are not included in the submission. There are three working modes as: Endo motor mode: root canal preparation. Apex locator mode: root canal length measurement. Multi-function mode: undertake root canal measurement and preparation.

C-SMART-MINI AP: The Endo Moto device C-SMART-MINI AP is a low-speed rotating oral equipment mainly used for root canal preparation and root canal measurement. The product is a portable device powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, apex position, etc. Users can also set and modify by keys, and provide design of functional check, calibration, set dominant hand and factory reset. The Endo Motor device is an endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge the canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel. The Endo Motor device C-SMART-MINI AP is intended to be sterilized prior to use. The material composition of root canal files that can be used with the Endo Motor device C-SMART-MINI AP is Nickel titanium (NiTi). These files are not included in the submission. There are three working modes as: Endo motor: Prepare the root canal, without apex locator function. Apex Locator: Measure the length of the root canal, without motor function. Multi-function: Measuring the length while root canal preparation.

C-Smart-mini: The Endo Motors device C-Smart-mini is a low-speed rotating oral equipment mainly used for root canal preparation. The product is a portable device powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, rotary files program, etc. Users can also set and modify by keys, and provide design of calibration and screen display for right- or left-handed user. The Endo Motor device is an endodontic treatment motorized handpiece. It can be used to enlarge the canals. It can be used as a low-speed motorized handpiece. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel. The Endo Motor device C-Smart-mini is intended to be sterilized prior to use. The material composition of root canal files that can be used with the Endo Motor device C-Smart-mini is Nickel titanium (NiTi). These files are not included in the submission.

The provided text does not describe the acceptance criteria and the study that proves the device meets the acceptance criteria. Instead, it is a 510(k) premarket notification for an "Endo Motor" device, outlining its features and comparing it to a predicate device to claim substantial equivalence.

While the document references "Accuracy Testing (Internal test methods to demonstrate the apex position measurement accuracy of ±0.5mm)" among its non-clinical tests, and explicitly states "No clinical study is included in this submission," it does not provide the detailed information requested regarding acceptance criteria and a study proving those criteria are met for the device's performance.

Therefore, I cannot extract the requested information from the provided text.

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The Endo Motor, model: ZR-Rap, is a cordless endodontic treatment motorized handpiece with root canal measuring capability. It can be used to enlarge canals while monitoring the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length.

This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

The Endo Motor, model: ZR-Rap, is a battery-driven handpiece with a motor, equipped with a chuck for holding rotary instruments such as a dental file. The Endo Motor can be used for enlargement and preparation of root canals and can also be used as an apex locator.

The provided text describes an FDA 510(k) premarket notification for an "Endo Motor" device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a full clinical efficacy study with specific performance acceptance criteria against a defined ground truth.

Therefore, the document does not contain a detailed study proving the device meets specific acceptance criteria in the way you've outlined for diagnostic AI/ML devices. Instead, it focuses on non-clinical tests to show conformity to standards and comparability to a predicate device.

However, I can extract the relevant information regarding performance claims and testing as best as possible from the provided text, especially concerning the "apex locator" function.

Here's an attempt to answer your questions based on the provided document, acknowledging the limitations for a device of this type:

Acceptance Criteria and Device Performance Study (Based on 510(k) Submission)

The Endo Motor (Model: ZR-Rap) is a cordless endodontic treatment motorized handpiece with root canal measuring capability. The 510(k) submission aims to demonstrate substantial equivalence to a predicate device (Changzhou Sifary Medical Technology Co., Ltd. E-Connect S Endo Motor, K201993). The primary "acceptance criteria" in this context are conformity to relevant standards and comparable performance to the predicate, especially regarding the apex locator function.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states "A Comparative Root Canal Measurement Performance Test to evaluate the root canal length" was performed. However, it does not specify the sample size (e.g., number of teeth, number of root canals, number of measurements) used for this test set nor the data provenance (e.g., country of origin, retrospective or prospective nature). Given the nature of a 510(k) for an existing technology, such tests are often conducted in-house on extracted teeth or phantoms.

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

The document does not specify the number of experts used, their qualifications, or if external experts were involved in establishing ground truth for the "Comparative Root Canal Measurement Performance Test." It implies that the test was conducted to compare its performance with existing methods or the predicate, but details on ground truth establishment are absent.

4. Adjudication Method

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for any test sets.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with AI/ML diagnostic aids that assist human readers. The Endo Motor is a handpiece with an integrated apex locator, not a diagnostic AI/ML device that interacts with human readers for interpretation.

6. Standalone Performance Study

Yes, a standalone performance study was done for the apex locator function, as indicated by "A Comparative Root Canal Measurement Performance Test to evaluate the root canal length." The stated performance for this function is an accuracy of "-0.5mm to +0.5mm for Apex position." The study directly assessed the device's ability to measure root canal length.
The other "standalone" performance studies were non-clinical tests demonstrating conformity to various safety and performance standards (e.g., ISO, IEC).

7. Type of Ground Truth Used

For the "Comparative Root Canal Measurement Performance Test," the document does not explicitly state the type of ground truth used. For an apex locator, common ground truths involve physical measurements taken after canal preparation (e.g., direct measurement with a caliper after sectioning a tooth or using a known reference point). It's likely an objective, physical measurement rather than expert consensus, pathology, or outcomes data, but this is an inference.

8. Sample Size for the Training Set

The concept of a "training set" is typically applicable to AI/ML models. Since this device is a traditional electromechanical medical instrument with integrated measurement capabilities rather than an AI/ML diagnostic tool, there is no mention or indication of a "training set" in the provided document.

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

As there is no mention of a "training set," this question is not applicable to the information provided in the document.

In summary: The submission relies on demonstrating conformity to international standards, comparing specifications and indications for use with a legally marketed predicate, and conducting specific non-clinical performance tests (like the root canal measurement performance test) to show substantial equivalence. It does not provide the detailed study design, sample sizes, expert qualifications, or ground truth establishment methods typically found in clinical trials for novel diagnostic devices, especially those incorporating AI/ML.

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Endo Motor, Ai-Motor and Endo Radar Plus are 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 file tip inside the canal.

The Endo Motor Series includes a cordless hand-piece with charging adapter. The device has a chuck for holding rotary instruments such as dental files, and is mainly used in Endodontic surgeries. The device can enlarge the root canal by filing the dentin and measuring the root canal length, and may also be used for cutting and grinding for the preparation of root canal surgery. The rotary speed and the torque range can also be adjusted.

The provided document, K203320, is a 510(k) premarket notification for an "Endo Motor" device. This device is a dental handpiece with root canal measurement capability. The 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device through non-clinical testing and comparison of technical specifications. It does not present a study proving the device meets specific acceptance criteria based on clinical performance metrics (e.g., accuracy, sensitivity, specificity) of an AI/algorithm-driven device.

The document states that "Performance Comparison Testing of Root Canal Measurement Passed," but it does not provide details on the acceptance criteria or how this testing was conducted (e.g., sample size, ground truth, expert involvement).

Therefore, I cannot fully answer your request for information regarding acceptance criteria and the study proving the device meets them, as the provided document lacks the empirical data and methodology typically found in studies for AI/algorithm-driven devices concerning clinical performance.

However, I can extract the information provided about the non-clinical testing performed to support substantial equivalence:

Acceptance Criteria & Device Performance (Based on Non-Clinical Testing for Substantial Equivalence)

The document primarily relies on non-clinical testing and comparison to a predicate device to demonstrate substantial equivalence, rather than a clinical performance study with explicit acceptance criteria for an AI/algorithm.

Detailed Answers to Specific Questions:

1. A table of acceptance criteria and the reported device performance
See table above. Note that for "Performance Comparison Testing of Root Canal Measurement," while it states "Passed," no quantitative acceptance criteria or specific performance metrics are provided in the document.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable / Not provided. The document primarily reports non-clinical engineering and biological tests, and a comparison of technical specifications to a predicate device. There is no mention of a clinical "test set" with a specified sample size or data provenance in the context of root canal measurement performance.

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)
Not applicable / Not provided. There is no mention of expert involvement for establishing ground truth for any performance study in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable / Not provided. No test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. The device is an "Endo Motor," a physical dental handpiece. It is not an AI/software device that would involve "human readers" or AI assistance in the way described for an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The description implies that the device's "root canal measurement capability" is integral to the motor's function. While there's a "Performance Comparison Testing of Root Canal Measurement Passed," the document does not provide details on whether this was a true "standalone" algorithm performance evaluation with explicit metrics, or simply a functional test. Given the regulatory class (Class I, reserved) and the nature of the device (a physical handpiece), it is highly unlikely that a rigorous clinical standalone performance study, as typically seen for AI/ML devices, was conducted or required.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not provided. For the "Performance Comparison Testing of Root Canal Measurement," the document does not specify how the "ground truth" for root canal length was established.

8. The sample size for the training set
Not applicable / Not provided. This device is not described as an AI/ML device that requires a training set.

9. How the ground truth for the training set was established
Not applicable / Not provided. This device is not described as an AI/ML device that requires a training set.

In summary, the provided FDA 510(k) document (K203320) focuses on demonstrating "substantial equivalence" of a physical dental device (Endo Motor) through a comparison of design, intended use, and non-clinical testing results against a predicate device. It does not contain the kind of clinical performance study details (e.g., acceptance criteria for diagnostic accuracy, sample sizes of test/training sets, ground truth establishment by experts, MRMC studies) typically associated with AI/algorithm-driven medical devices. The "Performance Comparison Testing of Root Canal Measurement" is mentioned as "Passed," but without any specifics provided in this document regarding its methodology or quantitative results.

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Endo Motor T-Fine-II is indicated for use in standard endodontic procedures using rotary endodontic files for mechanical and rotary preparation of the root canal.

Cordless endo motor is a professional equipment for root canal preparation. It is a drive for contra angle headpiece which is designed to assist dentists and dental surgeons perform standard endodontic procedures. The endo motor consists of Cordless main unit, Charger station and Adapter. It is intended to use with FDA cleared contra-angle handpiece (transmission ratio of contra angle handpiece: 16:1) which would hold the drill bit or file. However the device do not included the contra angle handpiece and files. The Endo smart is equipped with rechargeable Li-ion battery, which can be recharged using the provided charge station. By means of the different buttons on the main unit, the user could control various functions in the device, such as On/off, Speed, Torque and auto-reverse/auto forward mode. The Endo motor is not sterile and cannot be autoclaved.

The provided document is a 510(k) summary for the Endo Motor Model: T-Fine-II. This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and efficacy through extensive clinical studies and setting specific acceptance criteria commonly seen for novel devices or highly complex AI/ML devices.

Therefore, the document does not contain the detailed information typically associated with acceptance criteria and a study proving a device meets these criteria for an AI/ML-based medical device. Specifically, it lacks information on:

• A table of acceptance criteria and reported device performance for an AI/ML system (as this is a mechanical dental device).
• Sample sizes for test sets, data provenance, expert ground truth establishment, or adjudication methods (as no clinical or AI-specific validation studies were conducted for this device beyond bench testing for electrical safety and EMC, and software verification/validation).
• MRMC studies, standalone algorithm performance, or specific ground truth types (pathology, outcomes data) relevant to AI/ML.
• Training set details for an AI/ML model.

What the document does provide in terms of "acceptance criteria" and "proof":

For this specific device, the "acceptance criteria" are compliance with relevant safety and performance standards for dental electrical equipment and demonstrating substantial equivalence to a predicate device. The "proof" involves a combination of bench testing and comparison.

Here's an interpretation based on the provided text, focusing on the available information:

1. Acceptance Criteria and Reported Device Performance (as inferred from the document's purpose):

2. Sample Sizes and Data Provenance:

• No specific sample sizes for test sets (patients/images) are mentioned because this device's validation is primarily through bench testing against engineering standards and comparison to a predicate, not clinical trials or AI/ML model validation with patient data.
• The document implies manufacturing is in Foshan, Guangdong, China (manufacturer location).
• The testing appears to be bench testing for engineering compliance, not retrospective or prospective clinical data collection.

3. Number of Experts and Qualifications:

• Not applicable. This information is relevant for studies establishing ground truth for AI/ML or clinical interpretation, which were not conducted or required for this device's 510(k) submission.

4. Adjudication Method:

• Not applicable. No clinical data interpretation requiring adjudication was performed or described.

5. MRMC Comparative Effectiveness Study:

• No. This type of study is for evaluating human reader performance with and without AI assistance, which is not relevant to this mechanical dental device.

6. Standalone (Algorithm Only) Performance:

• Not applicable. This device is a mechanical Endo Motor, not an AI algorithm. Its software is for controlling the device's functions, not for diagnostic or predictive tasks that would have standalone performance metrics.

7. Type of Ground Truth Used:

• No "ground truth" in the AI/ML sense (e.g., pathology, outcomes data, expert consensus) was used. The validation relies on:
  • Engineering Standards Compliance: The standards (IEC 60601 series, AAMI TIRs) themselves define the "ground truth" for safety and performance (e.g., passing electrical leakage tests, demonstrating specific torque output).
  • Predicate Device Comparison: The predicate device (K090931) serves as a benchmark for "equivalent" safety and effectiveness.

8. Sample Size for Training Set:

• Not applicable. There is no AI/ML model being trained with patient data for this device.

9. How Ground Truth for Training Set Was Established:

• Not applicable. As there is no AI/ML model training, this step is irrelevant.

In summary, the provided document is a 510(k) summary for a Class I mechanical dental device. The "acceptance criteria" and "proof" presented align with the regulatory pathway for such devices, focusing on compliance with recognized electrical and mechanical safety standards and demonstrating substantial equivalence to a predicate device, rather than detailed clinical performance studies or AI/ML validation.

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E-connect S is a cordless endodontic treatment motorized handpiece with root canal measuring capability. It can be used to enlarge canals while monitoring the position of the tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length.

This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

The E-connect S is a battery-driven handpiece with a motor, equipped with a chuck for holding rotary instruments such as a dental file. The E-connect S can be used for enlargement and preparation of root canals and can also be used as an apex locator.

The motor drives the file to rotate at a certain speed and torque through the contra angle gearing. The rotating file will cut the root canal wall along the direction of the root canal. The speed and torque of the motor are controlled by the central processor and are configurable to accommodate different files. With built-in apex locator, this device monitors the file tip position in the root canal during root canal treatment.

The components of the E-connect S include a charge base, handpiece, contra angle, insulating sleeve, file clip, lip hook, measuring wire, adapter, and spray nozzle. The contra angle is compatible with files shafts conforming to ISO 1971-1, Type 1. The key panel on the handpiece is used to control/adjust the power, memory settings, operation modes (motor/apex,) and adjust the parameters. The body of the handpiece is to be covered with a FDA cleared barrier sleeve.

The provided document is a 510(k) summary for the E-connect S Endo Motor with built-in Apex Locator. It details the device's performance data and comparison to a predicate device, but it does not contain information about an AI/algorithm-only study, a multi-reader multi-case (MRMC) comparative effectiveness study, or details on ground truth establishment for a training set. The study described focuses on non-clinical performance evaluations and comparative testing against a predicate device.

Here's the information extracted and organized, with an emphasis on what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a table format with pass/fail metrics. Instead, the document describes performance tests against recognized standards and a comparative test against a predicate device. The most relevant performance criterion discussed is the accuracy of the root apex locator function.

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Modular electrical system for mechanical preparation of the root canal, using a special root canal instrument (>>ENDO file

The cordless ENDO-handpiece EB-300 (EB-300 S) consists of the cordless drive EB-3 H (EB-3 SH) and the special contra-angle attachment EB-16 (EB-16 S), intended for mechanical rotating root canal preparation. The drive is fitted out with a 3.7 V Li-Ion battery, which can be re-charged using the provided charging station. By means of the different buttons on this drive, the user controls the various functions, such as on / off, speed, torque and auto-reverse / auto-forward mode. The drive and the contra-angle attachment are connected via a special coupling, based on ISO 3964. The handpiece's application is intended in dentistry.

The provided 510(k) summary for the W&H Cordless ENDO-Handpieces "ENTRAN" and "S5 ENDO Motor" states that clinical data were not needed and that bench testing results demonstrate substantial equivalence. This indicates that the device's acceptance criteria were based on functional performance and comparison to a predicate device, rather than patient-level outcomes.

Here's a breakdown based on your requested information, with specific notes where information is explicitly not provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for test set: Not specified. The document only mentions "Bench testing results."
• Data provenance: Not specified. As it's bench testing, it would be laboratory-generated data rather than patient data from a specific country.
• Retrospective or prospective: Not applicable for bench testing.

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

• Number of experts: Not applicable. Ground truth for most bench tests relies on engineering specifications, physical measurements, and adherence to standards rather than expert clinical consensus.
• Qualifications of experts: Not applicable.

4. Adjudication method for the test set

• Adjudication method: Not applicable. Bench tests typically involve direct measurement against specifications or comparison to a predicate device's performance under controlled conditions.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• MRMC study: No, an MRMC study was not done. The document explicitly states: "Clinical data were not needed for these new products." This type of study would involve human readers and clinical cases.

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

• Standalone study: Yes, implicitly. The "Bench testing results" without clinical data indicate that the device's technical performance was evaluated independently, without requiring human-in-the-loop performance evaluation in a clinical setting for regulatory purposes. The device itself is an "algorithm" only in the sense of its mechanical and electrical function, not in the AI/software sense often associated with "standalone" studies in medical imaging.

7. The type of ground truth used

• Type of ground truth: The ground truth for this type of device (dental handpiece) would be based on engineering specifications, performance metrics (e.g., speed, torque, battery life, mechanical integrity), and direct comparison against the predicate device's documented performance. There's no indication of pathology, expert consensus, or outcomes data being used as ground truth for this 510(k).

8. The sample size for the training set

• Sample size for training set: Not applicable. This device is a mechanical/electrical handpiece, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Any development data used by the manufacturer would be internal design and testing data.

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

• How ground truth was established for training set: Not applicable, as there is no "training set" for this type of device. The ground truth for design and development would be established through engineering principles, material science, and performance targets set by W&H Dentalwerk Buermoos GmbH.

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