(171 days)
The DENTA PORT is a dental root canal measurement and treatment device that can measure the length of the root canal and enlarge the canal while monitoring the position of the file tip inside the canal.
The DENTA PORT is composed of a canal measurement base module (the DP-RCM module) and a canal enlargement module (the DP-TR module). The DP-RCM module can be used alone and has a root canal measurement capability. The DP-TR module can be used only when it is connected to the DP-RCM module. When connected, it can be used to enlarge canals while monitoring the position of the file tip inside the canal. It can be used to measure the length of the canal, and it can be used as a low speed motorized handpiece. The device measures electrical impedance (400, 8000 Hz) between the electrode (root canal file) located inside of the opened root canal and an oral mucous electrode, calculating the ratio of two impedance values, and thereby indicating the position of the file tip inside the root canal.
This 510(k) summary for the J. Morita Manufacturing Corporation's DENTA PORT Dental Device does not contain the kind of detailed information typically found in a study proving a device meets acceptance criteria. It primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and intended use, rather than presenting performance data from a specific study against predefined acceptance criteria.
Therefore, many of the requested sections will state that the information is "Not provided in the document."
Here's an attempt to extract the available information and note the missing data:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated as criteria in the document) | Reported Device Performance (as described for the DENTA PORT) |
|---|---|
| (Implicit: Accurate root canal length measurement) | "The root canal length can be measured in a simple and safe way by measuring electrical impedance (400, 8000 Hz) between the electrode (root canal file) located inside of the opened root canal and an oral mucous electrode, calculating the ratio of two impedance values, and thereby indicating the position of the file tip inside the root canal." |
| (Implicit: Effectiveness in various canal conditions) | "The DENTA PORT requires no adjustments or calibrations and can be used whether the canal is dry or filled with strong electrolytes such as blood, hydraulic saline, etc. The size of the file has almost no effect on the measurement." |
| (Implicit: Continuous monitoring during enlargement) | "Since the position of the file tip and the meter reading are directly related, root canal enlargement can easily be performed while continuously monitoring the length of the canal electrically." |
| (Implicit: Effectiveness of motor/enlargement features) | DP-TR module features: Auto Start/Stop, Auto Apical Reverse, Auto Torque Reverse, Auto slow down. Measures electrical impedance to indicate file tip position and uses this for motor movement. Enables mechanical preparation and removal of gutta-percha. |
| (Implicit: Safety) | "This allows the dentist to safely and efficiently perform canal enlargements of root canals." (for DP-RCM) and "This allows the dentist to safely and efficiently perform the mechanical preparation of root canals and the mechanical removal of gutta-percha points." (for DP-TR) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not provided in the document.
- Data Provenance (country of origin, retrospective/prospective): Not provided in the document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not provided in the document. This document does not describe a clinical study with expert-established ground truth.
4. Adjudication Method for the Test Set
- Not provided in the document. No test set or adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was one done? No. The document does not describe an MRMC study.
- Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as no such study is presented.
6. Standalone (Algorithm Only) Performance Study
- Was one done? No. The document describes the device's operational principles and features, but not a standalone performance study with quantitative results.
7. Type of Ground Truth Used
- Not provided in the document. The document relies on technological characteristics and intended use for substantial equivalence, not a specific ground truth type from a performance study.
8. Sample Size for the Training Set
- Not applicable. This device is described as operating based on electrical impedance measurements and not as an AI/machine learning algorithm that requires a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no mention of a training set or its associated ground truth establishment.
Summary of what the document does provide in relation to criteria/performance:
The 510(k) summary focuses on describing the technological characteristics and intended use of the DENTA PORT device and comparing them to a predicate device (Tri Auto ZX). The acceptance "criteria" are implicitly met by the device's design and functionality, which are presented as similar to the legally marketed predicate device. The document asserts that these similarities mean the DENTA PORT raises no new issues of safety or effectiveness. It details how the device measures root canal length using electrical impedance and its features for canal enlargement and monitoring. However, it does not contain specific quantitative performance metrics from a dedicated clinical study or validation against pre-defined numerical acceptance criteria for accuracy, precision, or diagnostic performance.
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