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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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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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Propex IQ® Apex Locator supports the dentist in the determination of the working length during the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.

The proposed Propex IQ® Apex Locator is a microprocessor-controlled device that supports the dentist during endodontic treatments for the determination of the file to the reference point for endodontic working length determination. To do so, the proposed Propex IQ® Apex Locator assesses the electrical resistance of the tooth and surrounding tissues while the file is inserted and moving along the root canal. The proposed Propex IQ® Apex Locator product configuration consists of the following components:

• The proposed Propex IO® Apex Locator
• The proposed Propex IQ® Apex Locator Measurement cable
• The Proposed X-Smart IO® Measurement Cable
• The proposed Propex IQ® Apex Locator External Tester
• The Propex IQ® Disposable Barrier Sleeve
• The proposed Propex IQ® Lip clip
• The proposed Propex IQ® File clip
• The proposed Propex IQ® Clamp
• Propex IQ® Charger and AC Adapter Plugs

The document describes the Dentsply Sirona Propex IQ Apex Locator and its non-clinical performance data to demonstrate substantial equivalence to its predicate devices.

Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes for the "Accuracy Testing" or "Disinfectant Resistance Testing." It refers to "Internal test method" for accuracy, suggesting it was conducted in a controlled lab or in-house environment rather than a clinical setting. Given the nature of the device (apex locator), the "test set" for accuracy would likely involve extracted teeth or simulated root canals.

The data provenance is non-clinical performance data, primarily from internal testing and conformance to international standards. There is no mention of country of origin for the data; it is assumed to be performed by the manufacturer, Dentsply Sirona. The tests are retrospective in the sense that they are conducted on a developed device to prove its performance against established standards and predicates.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the non-clinical tests. For "Accuracy Testing," the "ground truth" would likely be the actual measured length of the root canal established by precise laboratory methods or a gold-standard manual measurement. This might involve trained technicians or dental professionals, but their specific roles and numbers are not detailed.

4. Adjudication Method for the Test Set

No adjudication method is mentioned as this was a non-clinical study focused on direct measurement and conformance to standards, not subjective interpretation.

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 MRMC comparative effectiveness study was mentioned. The device is not an AI-assisted diagnostic tool; it is an apex locator, a measurement device for determining root canal length. There is no "human reader" component in the context of interpretation or AI assistance.

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

The accuracy testing on the Propex IQ Apex Locator and its comparison with predicate devices served as a standalone performance assessment of the device's ability to measure root canal length. The device itself operates to provide a measurement, and its performance was evaluated independently.

7. The Type of Ground Truth Used

For the accuracy testing, the ground truth would be the actual physical measurements of root canal length, likely established by high-precision manual or digital methods that are considered the gold standard for such measurements in dental research (e.g., direct visualization after sectioning, or radiographic measurements validated post-extraction). The document states "Internal test method," implying a controlled experimental setup to determine true root canal length.

8. The Sample Size for the Training Set

The document does not mention a "training set" as this device is not described as being based on machine learning or AI that requires training data. It is a measurement device based on electrical resistance principles.

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

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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