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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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BINGO PRO is an electronic device used for precise apex localization and working length determination during root canal treatment. The device enables to obtain correct results in canals with different conditions - dry or wet.

BINGO PRO is a modern apex locator intended for precise localization of root canal apex. The measurements in BINGO PRO are performed utilizing AC signals at two frequencies -500 Hz and 8 kHz. The frequencies are alternated and not mixed, eliminating the need for signal mixing and frequency discrimination electronic circuits. The patented signal measuring method utilized in BINGO PRO is based on measurements of RMS (Root Mean Square) level of the signal. Advanced 3D user interface implemented in BINGO PRO is based on high resolution TFT color graphic display. "Live" real time presentation of endodontic file movement inside the canal is designed to make dentist's work easier and to increase his confidence. Display indicators are carefully designed to be intuitively understood and to serve for instant troubleshooting during device usage. BINGO PRO shows the movement of the file inside the canal from the beginning of the measurements to the end, providing uninterrupted feedback to the dentist. ROOT WIZARD file tracking algorithm enables full-scale display of the file movement during the treatment while APICAL ZOOM feature enables high-resolution display of the file advance in preapical and apical zones. Large, clearly recognizable graphical and numerical readings in the APICAL ZOOM are designed to enable precise control over the file advance matching the individual technique of the dentist. Visual information is accompanied by optional audio signals. Numerical values and the numerical scale shown in the APICAL ZOOM do not represent actual distance from the apex in mm; they serve as a convenient reference to judge the file tip position in relation to the apex. Operation of BINGO PRO is fully automatic, no manual calibrations or adjustments are required. The measured signal is analyzed and automatic adjustments are made if required. The device may operate within different conditions in the root canal: dry or wet. BINGO PRO may only be used with stainless steel or nickel titanium endodontic files. According to the modern approach, the final distance of the probe tip from the apex should vary in different cases: for example, in non-contaminated root canal the tip should be about 0.5 mm before the minor apical foramen; in case of bacterial contamination the canal should be cleaned to the apex. Such cases may occur in different teeth of the same patient or even in the different canals of the same root. VIRTUAL APEX feature implemented in BINGO PRO enables to mark a predetermined indication position on the display in the APICAL ZOOM area. When VIRTUAL APEX feature is enabled, the dentist gets clear visual and audio feedback that the color bar indicating file tip position has reached the pre-selected point in the apical zone. If the virtual apex is set at the fifth bar, for example, the visual mark appears at 0.5 position. Additionally, special easily recognizable "VIRTUAL APEX" audio signal is activated when the color bar indicator reaches the virtual apex mark. Utilizing the VIRTUAL APEX feature, the dentist may choose to proceed either to the VIRTUAL APEX mark in non-contaminated canals or to the APEX indication in contaminated canals using visual or audio feedback. Numerical value of virtual apex mark does not represent actual distance from the apex in mm. Built-in Demo mode of BINGO PRO enables easy simulation of all stages of the treatment and is designed to simplify familiarization of the user with the device.

Here's a breakdown of the acceptance criteria and the study details for the BINGO PRO electronic apex locator, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly define acceptance criteria in terms of specific performance metrics or thresholds (e.g., "accuracy must be X% within Y mm"). Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device (Bingo-1020) and showing that the BINGO PRO provides "clinically acceptable results" through comparison with another established device, the Dentaport ZX.

Therefore, the "acceptance criteria" can be inferred as:

• Equivalence to Predicate Device: The BINGO PRO should have the same intended use and fundamental scientific technology as the Bingo-1020.
• Clinically Acceptable Performance: The BINGO PRO's apex localization results should be equivalent to those of a recognized and cleared reference device (Dentaport ZX) in ex-vivo testing.

Here's a table based on this interpretation:

• Same fundamental scientific technology (electronic apex locator, RMS signal measurement at two frequencies: 500 Hz and 8 kHz).
• Differences in design features (e.g., display type, battery, weight) were deemed not to raise new questions of safety or effectiveness. |
  | Clinically Acceptable Apex Localization: Performance equivalent to a recognized reference device. | - Ex-vivo test compared BINGO PRO results to Dentaport ZX apex locator results.
• Conclusion: "the apex localization obtained with both devices is essentially equivalent and that BINGO PRO provides clinically acceptable results." |

Study Details:

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

• Sample Size: The document only states "ex-vivo test was performed on extracted teeth." It does not specify the number of extracted teeth used in the test set.
• Data Provenance:
  • Country of Origin: Not explicitly stated for the extracted teeth. The manufacturer is Forum Engineering Technologies (96) Ltd., located in Rishon Lezion, Israel. The predicate device's original manufacturer is also listed as Forum Engineering Technologies (96) Ltd., (Israel).
  • Retrospective or Prospective: Not specified, but "ex-vivo test" implies a prospective collection of extracted teeth for the specific purpose of this evaluation.

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 of experts or their qualifications for establishing ground truth in the ex-vivo test. It only mentions that the results from BINGO PRO were compared to a "reference device - Dentaport ZX apex locator." For ex-vivo studies involving extracted teeth, ground truth is typically established by direct visual measurement or microscopy after sectioning the tooth, rather than by human experts interpreting images from the device. However, the exact method for ground truth establishment for this study is not detailed.

4. Adjudication Method for the Test Set

• The document does not describe an adjudication method. This type of study (comparing a new device's measurements to a reference device or objective physical measurements) typically doesn't involve expert adjudication in the same way an image interpretation study would.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• No, an MRMC comparative effectiveness study was not done. The study described is a direct comparison of a new device (BINGO PRO) against a cleared reference device (Dentaport ZX) in an ex-vivo setting to assess measurement equivalence, not a study evaluating human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, a standalone performance study was done. The BINGO PRO is an electronic apex locator that provides a measurement directly. The ex-vivo test compares the measurements produced by the device itself (BINGO PRO) to measurements generated by another device (Dentaport ZX). There is no mention of a human-in-the-loop component for the device's operation or measurement interpretation in this performance evaluation.

7. The Type of Ground Truth Used

• The document states that the results from BINGO PRO were compared to the results of the "reference device - Dentaport ZX apex locator." This implies that the ground truth for the performance claim was established by the measurements from the predicate/reference device (Dentaport ZX). For apex locators, the ultimate ground truth typically involves physical measurement of the tooth, often by sectioning, but here the equivalence is drawn to another device.

8. The Sample Size for the Training Set

• Not applicable. The BINGO PRO is an electronic apex locator that uses AC signals and RMS level measurements. Its operation is "fully automatic" and does not appear to involve machine learning or AI models that require a separate training set. The device operates based on fixed algorithms and electrical principles, not pattern recognition learned from data.

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

• Not applicable. As the device does not appear to utilize a training set in the machine learning sense, there is no ground truth establishment for a training set.

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