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BOMEDENT Apex locator and WISMY Apex locator support 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 BOMEDENT Apex locator and WISMY Apex locator are microprocessor-controlled devices can support the dentist during endodontic treatments for the proximity of the file to the reference point for endodontic working length determination. To do so, the proposed BOMEDENT Apex locator and WISMY Apex locator assess the electrical resistance of the tooth and surrounding tissues while the file is inserted and moving along the root canal. The proposed BOMEDENT Apex locator and WISMY Apex locator products configuration consist of the following components: (1) Power Adapter (2) USB cable (3) Measuring cable A (4) File clip (5) Lip hook (6) Measuring cable C (Optional)

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: BOMEDENT Apex locator, WISMY Apex locator

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The document states that multiple tests were conducted to demonstrate the device meets the acceptance criteria. These include:

• Internal test method for Accuracy Testing: This test shown that the performance of the proposed BOMEDENT Apex locator and WISMY Apex locator are equivalent to that of primary predicate device Propex IQ® Apex Locator (K191806).
• Compliance with International Standards:
  • IEC 60601-1:2005+A1:2012 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance)
  • IEC 80601-2-60:2012 (Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment)
  • IEC 60601-1-2:2014 (Electromagnetic Compatibility)
  • IEC 62133:2012 (Secondary cells and batteries safety requirements)
  • ISO 10993-10:2010 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
  • ISO 10993-5:2009 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity)
• Compliance with FDA Software Guidance: "General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on: January 11, 2002" and "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
• Cleaning, Low Level Disinfection, and Sterilization validation: Per FDA Guidance Document, AAMI TIR 30, AAMI TIR 12, ISO 17665-1, and ISO17665-2.

Detailed Information about the Study:

• The document mentions "Internal test method" for accuracy testing, but provides no specific details such as test parameters, methodology, or results beyond the claim of equivalence.

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

• Sample Size: Not specified in the provided text for the accuracy testing.
• Data Provenance: Not specified. It only states "Internal test method." No information on country of origin or whether it was retrospective/prospective.

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

• Not applicable/Not specified. The accuracy testing seems to be a technical performance comparison against a predicate device, not involving expert-established ground truth in a clinical setting.

4. Adjudication Method for the Test Set:

• Not applicable/Not specified. This information is not relevant for the type of technical performance testing described.

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

• No, a MRMC comparative effectiveness study was not done. The document states, "Clinical testing is not required."
• Effect Size: Not applicable.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

• Yes, a standalone performance test was done in the form of "Accuracy Testing" using an "Internal test method" which evaluated the device's ability to determine working length. The device itself (an apex locator) is a standalone measurement tool, indicating its performance without human intervention (beyond operating it).

7. Type of Ground Truth Used:

• Not explicitly stated as a "ground truth" in clinical terms. For the accuracy testing, the performance of the predicate device (Propex IQ® Apex Locator, K191806) serves as the benchmark against which the subject device's performance is compared for demonstrating equivalence. This implies a technical or simulated ground truth established by comparing measurement outputs, rather than a clinical outcome or pathology.

8. Sample Size for the Training Set:

• Not applicable/Not specified. The device is a measurement tool, not an AI/machine learning algorithm requiring a "training set" in the traditional sense.

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, this information is not relevant.

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The Dental Electrical Motor iRoot Pro is a cordless endodontic treatment motorized handpiece with root canal measurement 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.

The Dental Electrical Motor iRoot 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 USB interface. 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 and calibration. The product also provides a complete rotation mode and root canal measurement mode, which can be stored in memory, and provides a key functional mode for users to use quickly.

The Dental Electrical Motor iRoot Pro is a cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge 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.

The Dental Electrical Motor iRoot Pro is intended to be sterilized prior to use.

There are four working modes as:

Mode: Only endo motor function enabled;

Mode: Endo motor and apex locator work independently, when the file reaching theapical, the apex locator only plays the role of warning and display, will not interfere with the rotation of endo motor, the motor will not stop and reverse when the file reach the apical.

Mode: In this mode, the motor will automatically rotate, stop, reverse depends on the length of the root canal measured by the apex locator.

The provided document is an FDA 510(k) clearance letter for the "Dental Electrical Motor iRoot Pro." This type of document is for market clearance based on substantial equivalence to a predicate device, and it does not typically contain detailed information about acceptance criteria and specific study results in the same way a clinical trial report or a performance study for a novel device would.

However, it does mention non-clinical tests performed and some performance claims. Based on the provided text, here's an attempt to extract and infer information about acceptance criteria and proofs, acknowledging the limitations of a 510(k) summary for this level of detail:

General Conclusion from the Document:

The device "Dental Electrical Motor iRoot Pro" was found to be Substantially Equivalent (SE) to its predicate device, Tri Auto ZX2 (K170275), based on non-clinical testing and comparison of technical specifications. No clinical studies were included in this submission (Section 7).

Specific Information Regarding Acceptance Criteria and Proof:

Since this is a 510(k) summary, the "acceptance criteria" are primarily framed around demonstrating substantial equivalence to a predicate device, rather than meeting novel performance thresholds established through extensive clinical trials. The "proof" relies heavily on non-clinical testing and comparison.

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

The document doesn't explicitly state "acceptance criteria" in a quantitative, test-result-oriented table. Instead, it compares the proposed device's specifications to those of the predicate device, implying that equivalence in these specifications serves as the "acceptance." The key performance metric mentioned is the accuracy of the root apex locator function.

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

• Sample Size: Not explicitly stated for specific tests. "Non clinical tests were conducted to verify that the proposed device met all design specifications." The document mentions "apex locator measuring accuracy performance" testing but does not provide details on the sample size (e.g., number of measurements, number of simulated canals).
• Data Provenance: The document does not specify the country of origin for the non-clinical test data. It's likely from the manufacturer's testing facilities in China (ChangZhou BoMedent Medical Technology Co., Ltd., China). The data is retrospective as it was conducted prior to the 510(k) submission.

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

• Not Applicable / Not Provided: For non-clinical performance tests (like apex locator accuracy on a test setup or engineering standards compliance), human expert consensus in the traditional sense (e.g., for image interpretation) is not typically used to establish ground truth. The ground truth for such tests is based on established metrology and engineering principles. The document does not mention any expert involvement in establishing ground truth for these non-clinical tests.

4. Adjudication method for the test set

• Not Applicable / Not Provided: As no human expert readers or reviewers are mentioned for assessing performance, no adjudication method would be relevant or provided.

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 study is included in this submission" (Section 7). Therefore, no MRMC study or AI assistance evaluation was performed or submitted.

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

• Yes (for the Apex Locator Function): The "Apex Locator Performance Testing to verify the apex locator measuring accuracy performance" (Section 6.i) is a standalone performance test of the device's accuracy in measuring root canal length. While not an "algorithm" in the sense of AI, it represents the device's intrinsic function without human interpretation. The reported performance is -1.5mm to +0.5mm for Apex position.

7. The type of ground truth used

• Engineering/Metrological Ground Truth: For the "Apex Locator Performance Testing," the ground truth would have been established through precise measurements on a phantom or cadaveric teeth model using established methods, often involving micrometers, radiovisiography, or direct visualization after sectioning, to determine the actual apical foramen position. For other non-clinical tests (e.g., electrical safety, EMC), the ground truth is defined by compliance with the referenced international standards (e.g., IEC 60601-1, IEC 60601-1-2).

8. The sample size for the training set

• Not Applicable / Not Provided: This device is a traditional electro-mechanical dental instrument, not an AI/ML-based device. Therefore, there is no "training set" in the context of machine learning.

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

• Not Applicable / No Training Set: As it's not an AI/ML device, there is no training set and therefore no ground truth established for it.

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