Search Results

Apex Locator is used to detect the apex of root canal. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

Apex Locator is an oral equipment used for root canal measurements. It features an LCD color display with functional buttons, enabling users to conveniently view parameters such as battery status, test wire connection status, and apex position etc. Users can easily adjust sound level, brightness, and reference settings using intuitive buttons, and perform functional checks of both the device and cable. The device is intended to be sterilized prior to use.

The provided text is a 510(k) summary for a medical device called "Apex Locator". It details a comparison to a predicate device and states that non-clinical tests were performed. However, it explicitly states that no clinical test data was used to support the decision of substantial equivalence. This means that a study proving the device meets acceptance criteria, as typically understood in the context of clinical trials or performance evaluations with human subjects/data, was not conducted or reported in this submission. The "acceptance criteria" and "device performance" mentioned here refer to specifications confirmed through non-clinical testing and comparison to the predicate.

Given this, I cannot provide information on:

• The study that "proves the device meets the acceptance criteria" in a clinical sense.
• Sample size used for the test set and data provenance (as no clinical test data was used).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance.
• Type of ground truth (as no clinical data).
• Sample size for the training set (as no clinical data).
• How ground truth for the training set was established (as no clinical data).

I can, however, provide the acceptance criteria based on the non-clinical tests and the device performance as reported in the comparison table and discussion of differences.

Non-Clinical Acceptance Criteria and Reported Device Performance

The provided document describes acceptance criteria and reported "performance" based on non-clinical tests and comparison to a predicate device. The primary method for demonstrating performance and safety was through compliance with recognized standards and verification that design differences do not affect safety and effectiveness.

Key takeaway: This submission focuses on engineering, safety, and functional conformance rather than clinical performance data.

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation of "Study that proves the device meets the acceptance criteria":

The "study" referenced in the document is a series of non-clinical tests and a detailed comparison to a legally marketed predicate device. The conclusion of substantial equivalence is based on demonstrating that the proposed device:

1. Complies with relevant recognized safety and performance standards: These include IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 62366-1 (usability), IEC 62304 (software), ISO 10993-1 and ISO 10993-11 (biocompatibility), and IEC 62133-2 (battery safety).
2. Performs the same intended function as the predicate device.
3. Has fundamental technological characteristics that are substantially equivalent to the predicate device.
4. Any differences in technological characteristics (e.g., dimensions, weight, battery capacity, means of input) do not raise new questions of safety or effectiveness. For each noted difference, the submitter provided a justification that it "would not affect its safety and effectiveness" or "could not effects the performance and safety."
5. Achieves the same specified performance metric as the predicate device where applicable (e.g., Measurement Accuracy: ±0.5mm).

The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." Therefore, there is no clinical study that "proves the device meets the acceptance criteria" in terms of patient outcomes or comparative clinical performance. The acceptance is based on engineering principles, compliance with standards, and a robust non-clinical comparison to a predicate device.

Ask a specific question about this device

APEX LOCATOR is a device intended for locating the apex of the root canal during endodontic treatments.

APEX LOCATOR is a device used in dentistry to estimate the position of the root apex of teeth during root canal preparation. It is used connected with the Cefla dental units. Its principle of operation relies on measuring the electrical impedance of dental tissue, which varies according to tissue density and composition. The APEX LOCATOR is an accessory device for the Cefla dental units used to estimate the position of the root apex of teeth during root canal preparation. The kit is composed of the following elements: file clip (2 pieces), lip hook (4 piece), external wiring (1 piece).

The provided text is a 510(k) summary for an "Apex Locator" device. It outlines the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include information about AI/ML models, clinical studies for AI device performance, or acceptance criteria and proven performance related to such models.

The document explicitly states: "Clinical performance testing was not conducted." This directly indicates that there is no data to address the points in your request that pertain to acceptance criteria and study proving performance for an AI/ML device.

Therefore, I cannot provide the requested information because the document describes a traditional medical device (an Apex Locator based on electrical impedance measurement) and not an AI/ML-driven device. The review focuses on substantial equivalence based on technological characteristics and non-clinical performance (electrical safety, EMC, usability, biocompatibility, reprocessing validation), not on AI/ML model performance.

Ask a specific question about this device

support the dentist in the determination of the working the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.

Apex locators are equipment used for working length measurement during root canal treatment. The devices are powered by a built-in lithium battery, can be charged by a USB adaptor. The devices employ a LCD screen to display the status of file in the root canal and the relative distance between file tip and reference point.

The devices are reusable medical devices initially supplied as non-sterile to the user and requiring the user to clean and disinfect the surface of device. And their accessory, Dental root canal file clip, Dental lip hook and probe are reusable, initially supplied as non-sterile to the user, and requiring the user to sterile for initial use, as well as to reprocess after each use.

The devices include a main unit, a measurement wire A, a measurement wire B, a dental root canal file clip, a dental lip hook, a probe and an adaptor.

Main unit: measure and display working length.

Measurement wire A: connect file clip and lip hook with main unit.

Measurement wire B: connect lip hook and main unit with EM-Motor root canal preparation device.(The EM-Motor root canal preparation device is not included with the subject device and is sold separately.)

File clip: Connect to file.

Lip hook: hook patient's lip.

Touch Probe: promote to measure molar.

Power Adapter: use for charging.

Tester: use for checking whether the device is normal.

The provided document is a 510(k) summary for the Apex Locator (Model: AL-Pex, AL-Pex+). It outlines why the device is considered substantially equivalent to a predicate device, but it does not contain the specific details of a study with acceptance criteria and reported device performance in the format requested.

The document states:

• "Clinical testing is not required." This means there isn't a clinical study with real patient data to generate the performance metrics typically seen in such tables (sensitivity, specificity, accuracy, etc.) against a human or definitive ground truth.
• The performance data section primarily lists compliance with standards (electrical safety, EMC, biocompatibility) and "Accuracy verification: Internal method." This suggests the accuracy was verified through internal, non-clinical means.

Therefore, I cannot extract the information required for:

1. A table of acceptance criteria and the reported device performance: No such table is in the document for the device's main function (determining working length). The "Accuracy: ±0.5mm" mentioned in the comparison table is likely the design specification and presumed achieved, but no study results are provided to explicitly "prove" it meets this with a test set.
2. Sample size used for the test set and data provenance: No information on a test set (e.g., number of roots/teeth tested) or its provenance (country, retrospective/prospective) is provided, as clinical testing was not required.
3. Number of experts used to establish ground truth and qualifications: Not applicable as no clinical study leveraging human expert ground truth is described.
4. Adjudication method: Not applicable.
5. MRMC comparative effectiveness study: Not applicable, as no human reader study is described.
6. Standalone performance: No detailed standalone performance metrics (like accuracy with a confidence interval) are presented from a formal study. The "±0.5mm" is a general specification.
7. Type of ground truth used: Not explicitly stated for accuracy verification beyond "Internal method." For devices like apex locators, the ground truth is typically a known or precisely measured length, often in experimental setups or ex-vivo teeth, rather than clinical outcomes or pathology.
8. Sample size for the training set: Not applicable, as this is a traditional medical device, not an AI/ML-driven software device that would have a "training set" in the context of machine learning.
9. How ground truth for training set was established: Not applicable.

In summary, the provided FDA document focuses on confirming substantial equivalence through device design, intended use, and compliance with general medical device safety and performance standards (electrical safety, EMC, biocompatibility, reprocessing validation), rather than presenting specific quantitative performance data from a clinical or extensive non-clinical study that would fit the requested criteria for acceptance and proof of performance. The "Accuracy: ±0.5mm" found in the comparison table is a functional specification, not a reported result from a study described in the document.

Ask a specific question about this device

Apex Locator, DPEX III is a microprocessor controlled device intended for locating the apex of root canal.

Apex Locator, DPEX III is an apex locator intended for precise localization of root canal apex. Operation of Apex Locator, DPEX III is fully automatic, no manual calibrations or adjustments are required. The measuring signal is analyzed, and automatic adjustments are made if needed. The device may operate within different conditions in the root canal. Apex Locator, DPEX III may only be used with stainless steel or nickel titanium endodontic files. The scale indication on the apex locator screen does not represent a distinct length or distance in mm or other linear units. It merely indicates the file progression towards the apex.

The provided text describes a 510(k) premarket notification for the Apex Locator, DPEX III. It aims to demonstrate substantial equivalence to a predicate device, the RAYPEX 6.

Here's an analysis of the acceptance criteria and study information based solely on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the acceptance criteria for performance were met by demonstrating equivalence to the predicate device through performance comparison testing.

Note: The document does not provide quantitative specific acceptance criteria (e.g., "accuracy must be within X mm") or numerical performance data for the device. Instead, it relies on demonstrating equivalence to a legally marketed predicate device.

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

• Sample Size: The document mentions "using extracted tooth" for the performance comparison test, but it does not specify the sample size (i.e., number of extracted teeth) used for this test set.
• Data Provenance: The data provenance is retrospective, as it involves testing performed by the manufacturer to demonstrate equivalence. The country of origin of the data is not explicitly stated, but the manufacturer is "Guilin Woodpecker Medical Instrument Co., Ltd." in P.R. China.

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

This information is not provided in the document. The performance comparison test relies on a comparison against the predicate device, and the method for establishing "ground truth" for the apex location is not described beyond "using extracted tooth." There is no mention of human experts defining ground truth for the device's accuracy.

4. Adjudication Method for the Test Set

No adjudication method is described. Given the type of device (apex locator) and the testing described (comparison using extracted teeth), a human adjudication process by multiple experts is not indicated as part of the performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission." This indicates that there was no human-in-the-loop study comparing human readers with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The performance comparison test "using extracted tooth" functions as a standalone performance test for the device's ability to locate the apex. It evaluates the device's accuracy against the predicate without direct human interaction influencing the measurement outcome during the test itself. However, it's not an "algorithm" in the sense of a software AI model; it's a physical device measurement.

7. The Type of Ground Truth Used

The "ground truth" for the performance comparison test appears to be established by the measurement of the predicate device (RAYPEX 6). The aim was to show the new device's measurements were equivalent. For an apex locator, the true anatomical apex location in an extracted tooth would be the actual ground truth, but the document frames the comparison against the predicate as the basis for performance acceptance. It's essentially "predicate device performance" as the de facto standard for this submission.

8. The Sample Size for the Training Set

Not applicable/Not provided. This device is an electrical impedance-based apex locator, not an AI/ML device that requires a training set in the conventional sense. Its "knowledge" is embedded in its electrical design and algorithms, which are determined during engineering and design, not through a data-driven training process.

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

Not applicable/Not provided. As stated above, this is not an AI/ML device that uses a "training set" with established ground truth.

Ask a specific question about this device

BINGO-1020 is a modern device for precise apex localization during root channel treatment.

BINGO-1020 is distinguished by increasing precision at 0.1mm on wet/dry, large graphic display where current position of endo file is reflected and other essential information is displayed.

I'm sorry, but the provided text from the FDA 510(k) clearance letter for the Apex Locator Bingo-1020 does not contain information about acceptance criteria or a study proving the device meets those criteria.

The letter focuses on the FDA's determination of substantial equivalence to a predicate device, which allows the device to be marketed. It does not include details about device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request for the specific information outlined in points 1 through 9 based on the provided document.

Ask a specific question about this device