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Electric Handpiece Motor EM-12 L is a brushless DC electric micromotor controlled by a control unit. The electrical drive, EM-12 L is indicated for use in the field of preventive applications including cavity preparation and endodontic therapy, prosthodontics applications such as crown preparations.

The W&H electric motor EM-12 L is designed to accommodate existing and new handpiece attachments (already cleared for market under K070663 and K162926) for the purpose of performing dental procedures as described above. The advantage to driving a handpiece with this electro motor is the adjustable speed and near-constant torque applied by the electric brushless micro motor. The system will be used in an integrated configuration on the dental operatory chair system. The motor controller is contained within the control head (Dental unit) and acquires +24 VAC from the chair system 300 W power supply secondary voltage output. The motor tubing extends from the motor controller inside the control head to the micro-motor with ISO-E-coupler suitable to a handpiece attachment for the intended dental procedure. The Electric Handpiece Motor is to be installed in A-dec dental operative units. The power/CAN-Bus will be provided by the dental unit controller board and connected to the controller.

The provided text describes the 510(k) premarket notification for the "Electric Handpiece Motor EM-12 L". It focuses on establishing substantial equivalence to a predicate device and details non-clinical testing. It explicitly states that clinical performance testing was NOT conducted. Therefore, there is no study described that proves the device meets acceptance criteria related to clinical performance. The acceptance criteria and "device performance" in this context refer to the successful completion of non-clinical tests and the device's adherence to relevant standards, not clinical efficacy or diagnostic accuracy.

Here's the breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated for each non-clinical test. The testing was performed on the device itself and its components.
• Data Provenance: The tests were conducted internally by the manufacturer (W&H Dentalwerk Bürmoos GmbH) or by accredited labs on their behalf, adhering to international and FDA standards. The country of origin is Austria (manufacturer location). This is retrospective data regarding the device's design and manufacturing.

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

• Not applicable. The ground truth for these non-clinical tests is established by the specified international standards (e.g., IEC 60601, ISO 14457, ISO 10993) and FDA guidance documents. Compliance with these standards indicates the "ground truth" of safety and performance for this type of device in a regulatory context. There are no "experts" in the sense of clinical reviewers establishing ground truth for individual cases.

4. Adjudication method for the test set

• Not applicable for non-clinical engineering and safety tests. The "adjudication" is whether the device's performance characteristics (e.g., electrical safety, EMC emissions, torque, temperature) meet the predefined limits and requirements set forth in the relevant standards.

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. This is a dental handpiece motor, not an AI or imaging device that would involve human readers or MRMC studies.

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

• No. This is a physical medical device (dental handpiece motor), not an algorithm. Performance assessment is based on physical and electrical characteristics against predefined engineering and safety standards.

7. The type of ground truth used

• The ground truth used for these non-clinical tests is compliance with established international and national standards, regulations, and validated test methodologies. For example, for Electrical Safety, the ground truth is defined by IEC 60601-1. For biocompatibility, it's ISO 10993.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. This is not an AI/ML device that requires a training set.

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Pneumatic drive system for dental handpieces and dental air motors, which is intended to be used in general dental applications such as: removal of decayed materials, cavities and crown preparations, removal of filings, finishing of tooth and restauration surfaces, polishing, prophylaxis and endodontics.

The Advanced Air System is intended for dental transmission instruments used in the field of preventive dentistry, restorative dentistry such as cavity preparation and prosthodontics such as crown preparation and endodontics.
The system consists of the control unit (AC-1.0), which is designed to be built in a dental chair. As an attachment the air-driven handpiece (RK-97 L, RG- 97 L, and/or RK-94 L) or the air motor (RM-25 L RM) can be used.
The air-driven handpiece is equipped with a speed sensor, which is connected to a control module that regulates the applied air pressure to the handpiece through a proportional valve in order to maintain constant speed throughout the dental treatment.

This document describes a 510(k) premarket notification for the "Advanced Air System" device. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific clinical acceptance criteria for new therapeutic or diagnostic claims. Therefore, the information typically requested in your prompt regarding acceptance criteria, study design, expert ground truth, and statistical performance metrics (like those used for AI/ML devices) is not directly applicable or available in this document.

However, I can extract information related to the device's technical specifications and the non-clinical performance testing conducted to support its substantial equivalence.

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

The document does not explicitly define "acceptance criteria" in the sense of clinical performance thresholds (e.g., sensitivity, specificity, or therapeutic efficacy rates). Instead, it establishes substantial equivalence based on a comparison of technological characteristics and adherence to recognized standards.

Technological Characteristics Comparison (Subject Device vs. Predicate Device)

The report concludes that the "differences between the devices shown in the side-by-side comparison table above are minor and do not have any negative effect on equivalence."

2. Sample sized 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 performance testing described is primarily non-clinical, involving engineering and biocompatibility evaluations, not data from a test set of clinical cases.

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 device is a dental handpiece system, and its approval relies on technical specifications and non-clinical performance, not expert-adjudicated ground truth as would be required for a diagnostic or AI/ML device.

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, as this is not an AI/ML diagnostic or assistive device.

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

Not applicable, as this is not an AI/ML device.

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

Not applicable. The "ground truth" for this device's performance is adherence to recognized engineering standards and comparison to a legally marketed predicate device's technical specifications and performance.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

Study Proving Device Meets "Acceptance Criteria" (Substantial Equivalence):

The "study" proving the device meets the "acceptance criteria" (defined here as demonstrating substantial equivalence to predicate devices and adherence to relevant safety and performance standards) consists of a series of non-clinical tests:

• Electrical Safety Tests: According to IEC 60601-1:2005.
• Electromagnetic Compatibility (EMC) Test: According to IEC 60601-1-1:2007.
• Product Testing of Handpiece Function and Life Cycle Testing: Per ISO 14457:2012 (Dentistry - Handpieces and Motors).
• Software Validation: According to IEC 62304:2006 (Medical device software).
• Usability Validation: According to IEC 62366:2007.
• Thermal Safety: According to IEC 62471:2006 (Photobiological safety of lamps and lamp systems).
• Biocompatibility Evaluation: Based on identical patient-contacting materials with previously cleared W&H handpieces (TA-97LED and AM-25L RM) and Cytotoxicity Testing per EN ISO 10993-5:2009-06. This evaluation meets ISO 7405:2008.

The document states, "The results demonstrate substantial equivalence in this regard" for the product testing. No clinical data was deemed necessary for this submission. The overall conclusion is that "The “Advanced Air System”, as designed and manufactured, is substantially equivalent to its predicate device."

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The dental contra-angle handpiece "KOMET - OS30" is intended for mechanical interproximal enamel reduction (stripping, slenderizing) in use of an oscillating movement

The dental handpiece attachment "KOMET - OS30" is a drive, in order to enable the mechanical interproximal enamel reduction by means of the oscillating movement of the attached "KOMET - OS Discs". "OS30" is provided with a coupling system according to ISO 3964, allowing the handpiece's attachment onto a corresponding dental motor. The handpiece's gearing elements transmit the motor's rotational movement up to the integrated head gear, where this movement is converted into an oscillating one. The "OS Disc", chucked in the said head gear, oscillates in an angle of 30°, depending on the motor's speed with max. 5.000 oscillations/min.

The provided document is a 510(k) Pre-market Notification for a dental contra-angle handpiece. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a formal study with detailed performance metrics.

Therefore, the document does not contain the requested information regarding acceptance criteria, a specific study proving device performance, sample sizes, expert involvement, adjudication methods, or MRMC/standalone studies as typically found for AI/imaging device submissions.

Here's why and what information can be extracted:

• Acceptance Criteria & Reported Device Performance: This document states "Bench testing results demonstrate substantially equivalence," but does not provide a table of specific acceptance criteria or quantitative performance data. The device is a mechanical contra-angle handpiece, not an AI or diagnostic imaging device that would typically have performance metrics like sensitivity, specificity, or AUC against a ground truth. Its acceptance is based on demonstrating it functions similarly to existing, cleared devices.

• Sample Size (Test Set) and Data Provenance: Not applicable. Performance testing for this device would likely involve mechanical and functional benchmarks, not a "test set" of patient data.

• Number of Experts and Qualifications: Not applicable. Ground truth for this type of mechanical device is typically established through engineering specifications and functional testing, not expert clinical interpretation.

• Adjudication Method: Not applicable.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is a mechanical device, not an AI diagnostic tool where human reader performance would be a factor.

• Standalone (Algorithm Only) Performance: Not applicable. This is a mechanical device, not an algorithm.

• Type of Ground Truth: For a dental handpiece, the "ground truth" would be engineering specifications and successful functional operation (e.g., maintaining oscillations, durability, safety parameters). The document implies that this was established through "bench testing results."

• Sample Size for Training Set: Not applicable. This is a manufactured product, not a machine learning model.

• How Ground Truth for Training Set Was Established: Not applicable.

Summary of available information related to performance/equivalence:

1. Acceptance Criteria/Reported Device Performance:

   • Acceptance Criteria (Implied): Substantial equivalence to predicate devices (Dentsply International: "Interproximal Reduction System", K053368, and A-dec Incorporated: "A-dec/W&H Synea Profin Reciprocating Contra-Angle Handpiece Attachment WA-67...", K082827). This implies meeting similar safety and performance envelopes as the predicates.
   • Reported Device Performance: "Bench testing results demonstrate substantially equivalence." The device is described to convert rotational movement into an oscillating movement, with the "OS Disc" oscillating in an angle of 30°, depending on the motor's speed, with max. 5,000 oscillations/min. This performance is consistent with its intended mechanical function and similar to predicate devices.

2. Sample Size (Test Set) and Data Provenance: Not provided/Not applicable given the device type.

3. Number of Experts and Qualifications: Not provided/Not applicable.

4. Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No.

6. Standalone Performance Study: No, as it's a mechanical device. Performance was assessed via "bench testing results."

7. Type of Ground Truth: The ground truth for proving substantial equivalence was based on engineering specifications and functional performance verified through "bench testing."

8. Sample Size for Training Set: Not applicable.

9. How Ground Truth for Training Set Was Established: Not applicable.

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The SUPERtorque High-Speed Handpieces are intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.

The GENTLEpower Handpieces and Attachments are intended for the removal of carious material, excess filling material, reducing hard tooth structure, cavity and crown preparation, root canal preparation, finishing tooth preparations, restorations and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.

The SUPERtorque High-Speed Handpieces are dental handpieces for use by a trained professional in general dentistry. The devices are air-powered handpieces that are reusable and ergonomically shaped, and are provided both with and without a fiber optic light system. The devices can be sterilized by the steam autoclave method.

The GENTLEpower Handpieces and Attachments are dental instruments for use by a trained professional in general dentistry. The handpieces and attachments are powered by either an air-motor or electric motor. The devices are re-usable and ergonomically shaped, and can be sterilized by the steam autoclave method.

The provided text is a 510(k) Summary for dental handpieces. It describes the devices, their intended use, and claims substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving that the device meets those criteria.

The document discusses:

• Device Names: SUPERtorque High-Speed Handpieces and GENTLEpower Handpieces and Attachments
• Common Name: Dental Handpiece
• Classification Name: Handpiece, Air-Powered, Dental
• Intended Use: Removal of carious material, reducing hard tooth structure, cavity/crown preparation, finishing tooth preparations, restorations, and polishing teeth.
• Predicate Devices: Siemens AG (now Sirona) T1 Control High-Speed Dental Handpieces (K965238), DEN-TAL-EZ, Inc. STAR DENTAL 430 Series High-Speed Handpieces (K960719), and A-DEC/W&H Synea Air-Driven Highspeed Handpieces and Attachments (K070663).
• Regulatory information: Product codes, regulation number, and classification.

To answer your request, a document detailing performance testing, clinical studies, or engineering studies would be required. The given text is purely for regulatory submission and substantial equivalence claims, not for scientific performance validation.

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The COMFORTdrive 200XDA Handpieces are intended for the removal of carious material, cavities and crown preparations, removal of fillings, and processing of tooth and restoration surfaces. They are designed for use by a trained professional in the field of general dentistry.

The COMFORTironic 4894 is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. They are designed for use by a trained professional in the field of general dentistry.

The COMFORTarive 200XDA Handpieces are dental instruments for use by a trained professional in general dentistry. The handpieces are powered by an integrated electric motor. The devices are re-usable and ergonomically shaped, and can be sterilized by the steam autoclave method.

The COMFORTtronic 4894 dental control unit is a stand-alone system for operating electrically-driven handpieces such as the COMFORTdrive 200XDA. External power supply provides electric power to the unit. The 4-hole tubing connected to the unit supplies chip/cooling air, water and pressure signal. The speed of the electric handpiece is controlled by air pressure. The control unit is positioned close to a treatment unit at the location preferred by the dentist.

The provided documents are 510(k) summaries for two dental devices: the COMFORTdrive 200XDA Handpieces and the COMFORTtronic 4894. These are submissions to the FDA to demonstrate substantial equivalence to existing legally marketed devices, rather than studies designed to prove a device meets specific acceptance criteria through performance metrics.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, experts, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from these documents.

The documents focus on:

• Device Name: COMFORTdrive 200XDA Handpieces and COMFORTtronic 4894
• Common Name: Dental Handpiece and Accessories, Operative Dental Unit
• Classification Name: Handpiece, AC-Powered, Dental (21 CFR § 872.4200); Operative Dental Unit and Accessories (21 CFR § 872.6640)
• Intended Use:
  • COMFORTdrive 200XDA Handpieces: For removal of carious material, cavities and crown preparations, removal of fillings, and processing of tooth and restoration surfaces by a trained professional in general dentistry.
  • COMFORTtronic 4894: To convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces by a trained professional in general dentistry.
• Predicate Devices:
  • COMFORTdrive 200XDA Handpieces: A-dec/W&H, Synea Air-Driven Highspeed Handpieces (K070663)
  • COMFORTtronic 4894: Bien Air., Optima MX (K042759) and Sirona Dental Systems GmbH. Sirotorque L (K031584)
• Substantial Equivalence: Asserted based on identical intended use and similar design, application, function, and technical characteristics to the predicate devices.

There is no data presented in these 510(k) summaries that describes: performance metrics, acceptance criteria, study sizes, ground truth establishment, expert involvement, or any form of comparative effectiveness study. These types of details are typically found in more extensive technical reports or clinical study summaries, which are not part of the provided 510(k) summary text.

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