Search Results

The Tri Auto ZX2 device 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 Tri Auto ZX2 is a battery-driven handpiece with a motor, equipped with a chuck for holding rotary instruments such as a dental file and reamer. The Tri Auto ZX2 can be used for cutting and grinding teeth by transferring rotary movement to a rotary instrument attached to the head. Cutting and grinding of teeth can be done depending on the situation by switching (reversing) the rotation direction. Rotation speed is accelerated or decelerated according to the user's preference, rotation control based on torque detection, or set timing. These controls enable the cutting, grinding, enlargement, and preparation of root canals. Moreover, the Tri Auto ZX2 can be used for the removal of extraneous materials such as gutta-percha points, and for professional mechanical tooth cleaning. In addition, the Tri Auto ZX2 can be used as an apex locator, and the measured value can be used for rotation control. The Tri Auto ZX2 is intended to be sterilized prior to use.

The provided text is a 510(k) Summary for the Tri Auto ZX2, a dental device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with defined ground truth. Therefore, much of the requested information regarding acceptance criteria, sample size for test sets, expert involvement, and ground truth establishment is not directly applicable or available in this type of document.

However, I can extract the information that is present and indicate where the requested details are not provided.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for the Tri Auto ZX2 as performance metrics to be proven against in a standalone study. Instead, it compares the device's technological characteristics to predicate devices to demonstrate substantial equivalence. The "performance" section within the comparison table implicitly serves as a form of performance criteria.

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

The document states, "Performance testing was conducted to confirm that the device is capable of measuring and enlarging root canals in a manner that is substantially equivalent to the primary predicate and reference predicate devices." However, it does not specify the sample size for this performance testing, nor does it provide details on the data provenance (e.g., country of origin of the data, retrospective or prospective). This would typically be found in a detailed study report, not a 510(k) summary.

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

This information is not provided in the 510(k) summary. Given that testing was for technical functions like rotation speed, torque, and apex locator accuracy, it is likely that engineering measurements and established reference methods were used rather than expert human assessment for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided and is generally not applicable to the type of in-vitro, engineering-focused performance testing described for this device. Adjudication methods are more common in clinical studies where human interpretation of results is involved.

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

The Tri Auto ZX2 is a physical dental handpiece with an integrated apex locator, not an AI-powered diagnostic imaging device. Therefore, an MRMC comparative effectiveness study is not applicable to this device, and no such study was performed or reported.

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

The document mentions "Performance testing was conducted to confirm that the device is capable of measuring and enlarging root canals..." This implies standalone performance testing of the device's functions. However, it's not an "algorithm only" device in the context of AI, but rather a physical instrument. The "algorithm" for apex location is embedded. The results of this testing led to the claims of achieving the "Accuracy of the root apex locator function: -1.5mm to +0.5mm for Apex position" and the specified engine performance. Details of the methodology and results would be in the full test reports, not the summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The formal "ground truth" as typically defined for diagnostic AI is not explicitly stated for the performance testing. For the apex locator function, ground truth would likely be established through physical measurements against known lengths in standardized root canal models or extracted teeth, using precise tools, and for the motor, it would be direct engineering measurements of RPM and torque. This is based on the nature of the device's functions, which are quantifiable physical properties rather than subjective interpretations.

8. The sample size for the training set

The device is a physical instrument with embedded control logic (not a machine learning AI), therefore, the concept of a "training set" in the context of AI development does not apply. The device's control system and apex locator function are based on established engineering principles and algorithms, likely developed through R&D and traditional software engineering, not machine learning training.

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

As the concept of a "training set" for AI does not apply to this device artifact, the establishment of ground truth for a training set is not applicable.

Ask a specific question about this device

The TRI AUTO ZX device 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 to measure the length of the canal, and it can be used as a low speed motorized handpiece.

The TRI AUTO ZX device is a cordless endodontic treatment motorized handpiece with root canal measurement capability.

I apologize, but the provided text does not contain information about the acceptance criteria, device performance, or any studies conducted on the "TRI AUTO ZX" device. The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a legally marketed predicate device.

The letter mentions the device's indications for use:

• Cordless endodontic treatment motorized handpiece with root canal measurement capability.
• Enlarge canals while monitoring the position of the file tip inside the canal.
• Measure the length of the canal.
• Used as a low speed motorized handpiece.

However, there is no data or details regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or details of a test set.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Ask a specific question about this device