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Codent Low Speed Dental Handpieces and Accessories are intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

Codent Low Speed Dental Handpieces and Accessories include low speed air motor, straight handpiece and contra-angle handpiece. The gear ratios of handpieces are 1:5 and 1:1. The handpieces have maximum speed of 200,000 rpm and minimum speed of 40,000 rpm. The air motors are capable of running up to a speed of 25,000 rpm. AI6C and AI2C air motors can be connected to LEIPB1, LEIPA1, A11, A65L, A65, A61L and A61 handpieces; LAISA1, LBIPA1, LEIPD4 and LEIPC4 of Codent's FDA 510(k) K133069. E-1110 and E-1100 air motors can be connected to E-2000. E-4010 and E-4000 handpieces.

This document is a 510(k) premarket notification for a medical device, which seeks to demonstrate substantial equivalence to a predicate device. It primarily focuses on comparing the new device, "Codent Low Speed Dental Handpieces and Accessories," to a previously cleared device (K133069) from the same manufacturer. While it describes modifications and design comparisons, it does not contain the specific information requested about acceptance criteria, detailed study results, sample sizes, ground truth establishment, or expert evaluations in the manner typically found in a clinical study report for an AI/ML powered device.

The document discusses bench testing conducted to ensure that design changes do not "cause any actual performance impact" or "additional risk" compared to the predicate device. This type of testing is often used to demonstrate that the new device maintains the safety and effectiveness characteristics of the predicate, but it is not a clinical study involving human subjects or expert readers for diagnostic/AI performance evaluation.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to the clinical validation of AI/ML devices, which is not the subject of this 510(k) submission for a non-AI/ML dental handpiece.

Here's an attempt to answer based on the provided text, highlighting what is missing:

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

The document does not explicitly state formal "acceptance criteria" in a quantitative, measurable way for clinical performance metrics often seen with AI/ML devices, nor does it provide detailed performance results in the context of a clinical study. Instead, it relies on demonstrating that the modified device's functionality and performance are the same as or equivalent to the predicate device through bench testing for various physical and functional characteristics.

The "reported device performance" is essentially that the device functions as expected and does not introduce new risks compared to the predicate, as evidenced by the bench testing. No specific numerical performance values (e.g., accuracy, sensitivity, specificity) against a clinical ground truth are reported.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The document refers to "bench testing," which implies laboratory-based evaluations rather than testing on a clinical dataset or patient information. Therefore, there is no "test set" in the context of clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. The device is a dental handpiece, not a diagnostic tool requiring expert interpretation or ground truth establishment based on clinical findings.

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

This information is not applicable and not provided for the reasons stated above.

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 such study was done or reported. This device is a mechanical dental handpiece and does not utilize AI.

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

Not applicable. This device is a mechanical product, not an algorithm.

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

Not applicable. The "ground truth" for this type of device relates to engineering specifications and safety standards, confirmed through bench testing, rather than clinical outcomes or diagnoses. The safety and basic functionality are compared to the predicate device.

8. The sample size for the training set

Not applicable. This device does not involve AI or machine learning, so there is no training set.

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

Not applicable. There is no training set for this device.

Summary of the Study and Device Meeting Acceptance Criteria (as per the document):

The "study" conducted for this 510(k) submission is primarily non-clinical bench testing. The purpose was to demonstrate that modifications to the Codent Low Speed Dental Handpieces and Accessories (K150798) do not negatively impact safety and performance, and that the device remains substantially equivalent to its predicate (K133069).

The modifications include:

• Changing shaft materials from Brass to Aluminum (Aluminum was already used in the sleeve of the predicate).
• Adding new models for market segmentation.
• Adding LED light function in some air motor models.
• Adding 2-hole air motor design to comply with 2-hole dental units.

The document claims the device meets acceptance criteria by stating:

• Risk Assessment: The material change (Aluminum shaft) poses no biocompatibility risk as Aluminum was already used in the predicate's sleeve. The low voltage/current for LED/Halogen lamps does not cause high-temperature risk. The 2-hole air motor design is just a pipeline route difference and does not change functionality, performance, or introduce additional risk.
• Functionality and Performance Test Results: Bench testing was executed covering "drop, noise, air supply, spray air supply, water supply, air and water pressure stability, temperature, vibrations, resistance to reprocessing, operating control, usability, chuck system for shanks, speed, eccentricity, torque and the experiment of illumination." The conclusion is that "the changes of design don't affect the functionality and performance test results that would not cause additional risk."

In essence, the "acceptance criteria" here implicitly refer to maintaining the safety and performance characteristics of the predicate device, as confirmed through engineering and functional bench tests rather than clinical trials with specific diagnostic or therapeutic efficacy endpoints.

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The Codent Low Speed Dental Handpieces and Accessories are intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

Codent Low Speed Dental Handpieces and Accessories include low speed air motor, straight handpiece and contra-angle handpiece. The Codent Low Speed Dental Handpieces and Accessories are intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.

The gear ratios of handpieces are 1:5 and 1:1, with the maximum speed of 200,000 rpm and 40,000 rpm. AI4C and AI2N air motors can be connected to LAISAI, LBIPA1, LEIPD4 and LEIPC4 hanpieces. AE4N and AE2N air motors can be connected to LAESA2 and LDEPA2 hanpieces. The 4 air motors are capable of running up to a speed of 25,000 rpm.

This looks like a 510(k) summary for a dental handpiece, not an AI/ML medical device. The document describes traditional medical device testing and regulatory approval processes based on substantial equivalence to predicate devices, rather than a study proving the device meets acceptance criteria for an AI/ML product.

Therefore, I cannot provide the requested information for an AI/ML device because the provided text does not describe an AI/ML device or its associated studies.

However, I can extract information related to the device's performance testing and comparison to predicates, as presented in the document, even though it doesn't align with the AI/ML specific questions.

Here's what can be extracted from the document:

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

The document does not provide a table with explicit acceptance criteria values alongside device performance values. Instead, it states that "All the test results demonstrate the performance of Codent Low Speed Dental Handpieces and Accessories meets the requirements of its pre-defined acceptance criteria and intended uses." The acceptance criteria are implicitly those established by the standards listed.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for any of the non-clinical tests. It only lists the standards in accordance with which the tests were conducted (e.g., ISO 7785-2:1995, ISO 13294:1997). There is no mention of data provenance in terms of country of origin or whether the tests were retrospective or prospective, as these concepts are not applicable to the non-clinical, bench testing described for this type of device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable to the type of testing described. The "ground truth" for a dental handpiece's performance is established by its compliance with recognized industry standards for mechanical, electrical, and biological safety, not by expert consensus on interpretations of data.

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

This is not applicable. Adjudication methods are typically used in clinical trials or studies involving human judgment, not for the non-clinical bench testing of a dental handpiece.

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

This is not applicable as the device is a dental handpiece, not an AI/ML diagnostic or assistive tool.

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

This is not applicable. The device is a physical dental handpiece, not an algorithm.

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

The "ground truth" for this device, in the context of its safety and effectiveness, is its compliance with international and national standards (e.g., ISO, ANSI/AAMI) for dental handpieces, air motors, and sterilization. These standards define the acceptable performance characteristics and safety profiles.

8. The sample size for the training set

This is not applicable. The device is a physical dental handpiece and does not utilize a training set in the AI/ML sense.

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

This is not applicable for the same reason as above.

Summary of what the document DOES discuss regarding performance and acceptance:

The document states that the Codent Low Speed Dental Handpieces and Accessories underwent "Non-clinical Testing" in accordance with several standards, including:

• ISO 7785-2:1995 Dental Handpiece Part 2: straight & Geared Angle Handpieces
• ISO 13294:1997 Dental Handpiece Dental Air Motors
• ISO 3964:1982 Dental Handpieces Coupling Dimensions
• ISO 1797-1: 2011 Dentistry Shanks for Rotary Instruments Part 1: Shanks Made of Metals
• ISO 14971:2007 Medical devices — Application of risk management to medical devices
• ISO 9168:2009 Dentistry - Hose connectors for air driven dental handpieces
• ANSI/AAMI ST79:2010/A3:2012 Comprehensive guide to steam sterilization and sterility assurance in health care facilities, Amendment 3
• ISO 14457:2012 Dentistry Handpieces and Motors
• Guidance for Industry and FDA Staff-Dental Handpieces-Premarket Notification [510(k)] Submissions
• ISO 10993-1:2009, Biological Evaluation of Medical Devices -- Part 1: Evaluation And Testing Within A Risk Management Process

The report concludes: "All the test results demonstrate the performance of Codent Low Speed Dental Handpieces and Accessories meets the requirements of its pre-defined acceptance criteria and intended uses. Conformity with the above standards also demonstrates that the Codent Low Speed Dental Handpieces and Accessories are as safe and effective as the predicate devices."

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