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Air Motor is intended for the following application(s): Driving the handpiece for the tooth restoration, prophylaxis, and root canal preparation.

The air motor converts the compressed air supplied from the dental unit into rotary motion. The rotation is transmitted to instruments for tooth restoration, prophylaxis, and root canal preparation connected to straight and geared angle handpieces.

The provided document is a 510(k) premarket notification for a dental air motor. The core of this document is a comparison of the subject devices (Air Motor FX204 M4 and Air Motor M205) against predicate devices to demonstrate substantial equivalence, rather than a clinical study evaluating the device against acceptance criteria in the typical sense of AI/ML performance.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" for AI/ML devices are not applicable in this context. The document focuses on performance testing to demonstrate safety and effectiveness for a mechanical device.

However, I can extract the information relevant to how the device's technical specifications and performance were evaluated against established standards and predicate devices.

Here's a breakdown of the relevant information from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical thresholds in a table format for each specific performance metric in the way you might see for an AI algorithm (e.g., AUC > 0.90). Instead, the acceptance criterion for this 510(k) submission is to demonstrate "substantial equivalence" to legally marketed predicate devices by showing that the subject devices perform similarly and meet relevant safety and performance standards.

The closest we have to "reported device performance" and "acceptance criteria" are the comparison tables (Table 1 for FX204 M4 and Table 2 for M205) and the "Judgement" column, which indicates if the subject device is "Same," "Similar," or "Different" to the predicate. For "Different" or "Similar" aspects, further testing or justification is provided to demonstrate that the difference does not raise new questions of safety or effectiveness.

Below are tables summarizing the key performance and safety aspects evaluated and how the subject device's performance compared to the predicates, along with the implicit "acceptance criteria" through this comparison.

For Air Motor, FX204 M4 (model without spray) - (Based on "DEVICE AND PREDICATE COMPARISON TABLE-1")

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document mentions "Statistical calculation of sample size" under performance testing, but does not provide specific numbers for units tested for each type of test. The nature of these tests (e.g., drop test, reprocessing resistance, water leakage, vibration, sterilization validation) typically involves testing a representative sample of devices, but the exact number isn't quantified in the provided text.
• Data Provenance: Not explicitly stated, however, the applicant is "NAKANISHI INC." based in "700 Shimohinata Kanuma Tochigi, 322-8666, Japan". It's highly probable the testing was conducted in Japan or through certified testing facilities used by the manufacturer. The data would be prospective in the sense that these tests are performed on the manufactured devices to ensure they meet specifications.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• This concept typically applies to clinical studies or studies involving human interpretation (e.g., radiology expert review for AI algorithms). This submission is for a mechanical dental device.
• The "ground truth" here is compliance with engineering standards (e.g., ISO 14457 for dental handpieces), safety standards (e.g., ISO 10993 for biocompatibility), and the performance characteristics of the predicate devices.
• No "experts" in the sense of clinical reviewers establishing ground truth for individual cases are mentioned. Instead, the evaluations are based on technical testing by qualified personnel in accredited laboratories.

4. Adjudication Method for the Test Set

• Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or subjective assessments, often in AI/ML performance evaluation where ground truth is based on expert consensus.
• This is not applicable here as the evaluation is based on objective measurements against engineering standards and comparison with predicate device specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not applicable. This is a submission for a mechanical dental motor, not an AI/ML diagnostic or assistive device that would involve human readers interpreting cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This device does not involve a software algorithm in the context of an AI/ML device requiring this type of performance evaluation.

7. Type of Ground Truth Used

• The "ground truth" for this submission is primarily technical specifications/performance derived from engineering standards (e.g., ISO 14457, ISO 10993) and comparison to the known and established safety and effectiveness of legally marketed predicate devices.
• For example, passing ISO 14457 test methods indicates the device performs as expected for a dental handpiece. Biocompatibility is "ground-truthed" by adherence to ISO 10993.

8. Sample Size for the Training Set

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

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as there is no "training set" for this type of device.

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Low-speed (vane motor) handpiece is used for drilling of teeth in a variety of dental procedures.

The Midwest Rhino XE and Air Motor M are low speed air motors. The motors are reusable and can be sterilized in an autoclave. Air Motor M includes an external spray port whereas the Midwest Rhino XE does not have the external sprayport.

This document is a 510(k) premarket notification for the Dentsply Sirona Midwest Rhino XE and Air Motor M dental handpieces. As such, it focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing acceptance criteria and conducting a primary study to prove them.

The information provided confirms that no clinical performance data from human studies was included to support substantial equivalence. The substantial equivalence is based on:

• Identical Indications for Use with the predicate device (LS-100, K792302).
• Same fundamental technology and intended uses as the predicate and a reference device (W&H Air-Powered Handpieces and Handpiece Attachments (Air Motor AM-25 E RM), K162926).
• Non-clinical performance testing to verify conformity with various ISO standards and FDA guidance documents.

Therefore, many of the requested sections related to acceptance criteria and a primary study are not applicable to this 510(k) submission. However, I can extract the relevant information regarding the performance comparison and the non-clinical testing conducted to support substantial equivalence.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission, "acceptance criteria" in the context of a primary study proving efficacy are not explicitly stated as they would be for a novel device. Instead, the "acceptance criteria" can be inferred as demonstration of meeting relevant standards and having comparable technical specifications to predicates. The "reported device performance" are the specifications of the proposed devices.

Note: The document primarily highlights differences and how they are addressed (e.g., conformity testing to ISO 14457). The "Acceptance Criteria" for proposed devices are framed as demonstrating substantial equivalence to the predicate, often meaning being within a cleared range or addressing differences through standard conformity.

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 document as it pertains to non-clinical performance testing. The document states "Testing to verify the performance requirements of the proposed devices... was conducted." It specifies the standards to which this testing conformed but not the sample size, data provenance, or whether it was retrospective/prospective.

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 as no human clinical studies were performed, and thus no expert-established ground truth for a test set was necessary for this type of 510(k) submission.

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

This is not applicable as no human clinical studies were performed.

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. This device is a dental handpiece, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

This is not applicable, as the device is a physical dental handpiece and not an algorithm.

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

For the non-clinical performance data, the "ground truth" can be considered the established requirements and parameters defined by the various ISO standards and FDA guidance documents listed (e.g., ISO 14457 for dentistry handpieces and motors, ISO 17665-1 for moist heat sterilization, ANSI/AAMI ST79 for steam sterilization, AAMI TIR 30 and ISO 15883-5 for cleaning validation, ISO 10993-1 and ISO 7405 for biocompatibility). The devices' performance was "verified" against these technical and safety standards.

8. The sample size for the training set

This is not applicable as no algorithm or AI component is involved requiring a training set.

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

This is not applicable as no algorithm or AI component is involved.

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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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