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The Fiber Optic Brushless Electric Micromotor Set (iM100) is a brushless DC electric micromotor controlled by a control unit. It is intended to be connected with an ISO-type handpiece attachment: straight or contra-angle of equal, gear reducing, or gear increasing speed. It is indicated for use in the field of preventive applications including cavity preparation and endodontic therapy, prosthodontics applications such as crown preparations.

The Fiber Optics Brushless Electric Micromotor Set, which model is iM100, is an electric device system comprised of brushless electric motor, control box, motor cord, and AC adapter. The Fiber Optics Brushless Electric Micromotor Set is designed to accommodate equal speed, gear-reduction speed, or gear-increasing speed handpiece attachment for the purpose of performing dental restoration procedures. Brushless electric motor utilize Permanent Magnet Synchronous Motor (PMSM) to offer stable torque, control box adjust the maximum speed and direction of brushless electric motor and show actual speed rate simultaneously, motor cord connect electric motor, control box and dental unit to offer handpiece water, air coolant and electricity. When equipped with the electric micromotor, the handpiece attachments provide the same effective drive force as would be provided by existing air motors. With motor control technology allows handpieces regardless of the front-end dental treatment operations or exposure to different functional groups or dental restorative material, and the speed of the drill can be kept within a certain extent but not easily change the load that make brushless electric motor operation is more easily and efficiently, unlike the operation of the air motor handpiece need to keep relied dentist technical experience. The Fiber Optics Brushless Electric Micromotor Set could control the speed range from 2,000 to 40,000 rpm.

The provided text is a 510(k) summary for a dental micromotor, not an AI/ML medical device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, expert involvement, or MRMC studies relevant to AI/ML device performance.

This document focuses on establishing substantial equivalence to a predicate device through non-clinical testing of safety and performance for a physical medical device. It does not involve AI algorithms, image analysis, or ground truth establishment in the context of diagnostic or prognostic tasks.

To answer your prompt, I would need a document related to an AI/ML medical device.

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High Speed 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.

High Speed Handpieces and Accessories include 45° High Speed Handpieces, 90° High Speed Handpieces and Couplings. The models of 45° High Speed Handpieces are A45series (A45L, A45, A45M4) and 90° High Speed Handpieces are A6series (A6KL, A6L, A6, A6M4, A6B2), A5series (A5KL, A5K, A5L, A5, A5M4, A5B2), A4series (A4, A4M4, A4B2), A3series (A3, A3M4, A3B2), E-6510series (E-6510K, E-6510N), E-6500series (E-6500K, E-6500N), E-6110series (E-6110K, E-6110N), E-6100series (E-6100K, E-6100N), HPXseries (HPX4CML-Ti, HPX4CQ, HPX4CQ-Ti), HPMseries (HPM1CML, HPM1CQ, HPM1C4, HPM1C2, HPM1S4, HPM1S2) and HPKseries (HPK1C2, HPK1S4, HPK1S2). And the accessories of High Speed Handpiece are Couplings, the models of Accessories are Q6series (Q6M, Q6M-LED, Q6K, Q6K-LED, Q6KW), Q5series (Q5K), Q4series (Q4K, Q4M, Q4Q), Q2series (Q2Q), CKseries (CK4010, CK4000) and CNseries (CN4010, CN4000).

This looks like a 510(k) premarket notification for a dental device, specifically "High Speed Handpieces and Accessories." The document demonstrates substantial equivalence to existing predicate devices, rather than establishing de novo acceptance criteria and proving performance through a standalone study with ground truth.

Therefore, many of the requested categories in your prompt are not applicable to the information provided in this 510(k) summary. I cannot extract information related to:

• Sample size used for the test set and data provenance: This is not a study proving a diagnostic or AI device's performance against a ground truth. The tests are for engineering specifications.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as there's no diagnostic ground truth being established.
• Adjudication method: Not applicable.
• Multi reader multi case (MRMC) comparative effectiveness study: Not applicable, as this is a physical dental device, not an AI or diagnostic tool.
• Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

However, I can extract the acceptance criteria and reported device performance from the "Non-clinical Testing" section and the "Comparison of Technical Features" table, as these relate to the device's engineering specifications.

Here's a summary of the available information:

1. Table of Acceptance Criteria and the Reported Device Performance

The document states: "All the test results demonstrate the performance of High Speed Handpieces and Accessories meets the requirements of its pre-defined acceptance criteria and intended uses." While specific numerical "acceptance criteria" and "reported performance" are not presented side-by-side in a table in the exact format you requested for each test, the document implies that the device passed the tests outlined by the referenced standards.

From the "Comparison of Technical Features" section, we can infer performance characteristics based on comparison to predicate devices, which serve as a benchmark for "acceptance" in a 510(k) context.

In addition, the device successfully completed non-clinical testing according to the following standards, indicating it met the acceptance criteria defined within those standards:

• 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
• AAMI/ANSI/ISO 17665-1:2006/(R)2013 – Sterilization of health care products – moist heat - part 1: requirements for the development, validation, and routine control of a sterilization process for medical devices.
• ISO 11138-3:2006 - Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat
• ISO 14457:2012 Dentistry - Handpieces and Motors
• ISO 10993-1:2009 - Biological Evaluation of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process
• ISO10993-5:2009 – Biological evaluation of medical devices – tests for in vitro cytotoxicity
• ISO 10993-10:2010 - Biological evaluation of medical devices - tests for intracutaneous irritation and skin sensitization
• Guidance for Industry and FDA Staff-Dental Handpieces-Premarket Notification[510(k)] Submissions

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 in the summary. The document focuses on demonstrating substantial equivalence through comparison to predicate devices and adherence to recognized standards, rather than detailing a specific experimental test set. The manufacturer is based in Taiwan.

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)

Not applicable. This is a physical dental instrument, not a diagnostic device requiring expert interpretation of results to establish ground truth.

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

Not applicable.

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

Not applicable. This is a physical dental instrument.

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

Not applicable. This is a physical dental instrument.

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

Not applicable. For a physical device like this, "ground truth" would relate to its manufacturing specifications and performance against engineering standards, not diagnostic accuracy.

8. The sample size for the training set

Not applicable. This is a traditional device submission, not an AI/machine learning device that involves training sets.

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

Not applicable.

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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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CODENT Dental Air-Powered Handpiece, model HPS is intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.

Dental Air-Powered Handpiece

The provided text is for a 510(k) premarket notification for a dental air-powered handpiece. This type of document is concerned with demonstrating substantial equivalence to a predicate device, not with proving performance against specific acceptance criteria in a study format typically seen for advanced diagnostic devices or AI algorithms.

Therefore, many of the requested elements (like acceptance criteria tables, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth definitions) are not applicable or extractable from this document.

Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:

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

• Acceptance Criteria: Not explicitly stated in terms of measurable performance metrics (e.g., accuracy, sensitivity, specificity). The acceptance criterion for a 510(k) submission like this is "substantial equivalence" to a predicate device.
• Reported Device Performance: The document states: "The claim of substantial equivalence is based on comparisons of formulations and intended uses of the HPS Dental Air-Powered Handpiece and its claimed predicate." No specific performance data (e.g., rotational speed, torque, vibration levels) or clinical outcomes are provided for the CODENT device or its predicate.

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

• Not applicable/available. This document does not detail a study involving test sets of data. It's a review of device design and intended use for substantial equivalence.

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)

• Not applicable/available. No such ground truth establishment is described for this type of device submission.

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

• Not applicable/available.

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

• Not applicable/available. This device is a dental handpiece, not an AI-powered diagnostic device.

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

• Not applicable/available. This is not an algorithm.

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

• Not applicable/available. The "ground truth" for this submission is whether the device's design, materials, and intended use are comparable to a legally marketed predicate device.

8. The sample size for the training set

• Not applicable/available.

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

• Not applicable/available.

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