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The A-dec/W&H Electric Motor kit is a device system comprised of a control unit that drives a DC electric micromotor that is activated by means of a footswitch. It is intended for use in general dental applications such as: cutting a tooth for cavity preparation, crown preparation, crown finishing, inlay, filing, polishing, prophylaxis, and endodontic treatment, with use of a straight, right-angle, or contra-angle ISO E-type handpiece attachment of equal speed, gear-reduction speed, or gear-increasing speed.

The A-dec/W&H Electric Motel EA-53 is designed to accommodate existing and new Alegra, Proxeo, Endea, and Synea handpiece attachments for the purpose of performing dental restoration procedures. When equipped with the electric micromotor, the handpiece attachments provide the same effective drive force as would be provided by existing air motors. The significant advantage to driving a handpiece with the electric micromotor is the near-constant torque applied by the electric brushless micromotor. With air motor drive, the handpiece will tend to stall in extreme torque situations. The near-constant torque applied by the electric micromotor results in a more uniform and efficient dental reduction of the operatory site. The electric micromotor is autoclavable. This 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 300W power supply secondary voltage output. The handpiece tubing extends from the control head to the ISO-E coupler. The micromotor is attached to the coupler on one end and attached on the other (output) end to a handpiece attachment suitable for the intended dental procedure. This system will include: Motor Controller, Electric Micromotor, Handpiece tubing with E-connector.

The provided text describes a 510(k) premarket notification for the A-dec/W&H Electric Motor, Model EA-53. However, it explicitly states that clinical testing has not been conducted for this product. Therefore, no studies proving the device meets acceptance criteria via clinical performance data are available in this document.

The submission focuses on demonstrating substantial equivalence to a predicate device (A-dec/W&H Electric Motor, Model EA-50LT) based on technological characteristics and non-clinical test data.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

No specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy) are reported for clinical performance, as clinical testing was not performed. The non-clinical tests focused on functional and safety parameters.

The document states, "The A-dec/W&H Electric Motor, Model EA-53 has been successfully validated to confirm the performance of the device," for all listed non-clinical tests. However, the exact pass/fail criteria or quantitative results for these validations are not detailed in this summary.

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

• Sample Size for Test Set: Not applicable for clinical performance, as no clinical testing was conducted. For non-clinical tests (e.g., EMC, electrical safety), the sample size of tested devices is not specified, but typically involves a limited number of production units.
• Data Provenance: Not applicable for clinical performance. For non-clinical tests, the data would be generated internally by the manufacturer or by a contracted testing facility.

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

Not applicable, as no clinical ground truth was established due to the absence of clinical testing.

4. Adjudication Method for the Test Set

Not applicable, as no clinical adjudication was performed.

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

No MRMC study was conducted or reported, as there was no clinical testing involving human readers or AI assistance.

6. Standalone Performance Study

No standalone performance study (algorithm only) was conducted or reported, as the device is a mechanical/electrical dental motor, not an AI algorithm.

7. Type of Ground Truth Used

• Clinical Ground Truth: Not applicable, as no clinical testing was performed.
• Non-Clinical Ground Truth: For the non-clinical tests, the "ground truth" would be defined by the relevant consensus standards (e.g., for electrical safety, EMC) against which the device's performance was measured. In essence, the standard is the ground truth.

8. Sample Size for the Training Set

Not applicable. The device is a physical product (electric motor) and does not involve AI or machine learning that requires a "training set" of data in the conventional sense. Its functionality is based on established engineering principles and mechanical/electrical design.

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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The A-dec/W&H ZA-55 Synea Sonic Scaler Handpiece Attachment is intended for use in dental treatment procedures. The pneumatically operated sonic device can be used, in conjunction with the appropriate tips, for the removal of supra and subgingival calculus, and teeth cleaning procedures.

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This document is a 510(k) premarket notification from the FDA regarding a dental device. It does not contain information about acceptance criteria or a study proving device performance in the way a clinical trial or AI/ML performance study would.

The document is a regulatory approval letter based on "substantial equivalence" to legally marketed predicate devices, not on specific performance metrics or a detailed clinical study demonstrating new or improved efficacy against defined acceptance criteria.

Therefore, I cannot provide the requested information from this document:

1. A table of acceptance criteria and the reported device performance: Not present. This document is about regulatory clearance based on substantial equivalence, not performance against specific criteria.
2. Sample size used for the test set and the data provenance: Not present. No clinical or performance study with a test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method for the test set: Not present.
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 present. This device is a sonic scaler handpiece, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. This is a physical dental instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

The document's purpose is to confirm that the A-dec/W&H ZA-55 Synea Sonic Scaler Handpiece Attachment is "substantially equivalent" to existing devices, allowing it to be marketed. It refers to general controls, registration, labeling, and good manufacturing practices but does not include data from a performance study.

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The A-dec/W&H Alegra Air-Driven Highspeed Handpiece is an air-powered dental device. This device is designed for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth.

The A-dec/W&H Alegra Handpiece Attachment is powered by either an air-motor or electric motor and is intended for use in general dentistry. This device is designed for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth.

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I am sorry, but based on the provided text, there is no information available about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a 510(k) clearance letter from the FDA for a dental handpiece, indicating that the device has been found substantially equivalent to a legally marketed predicate device. This type of clearance focuses on demonstrating equivalence rather than presenting specific performance study results against predefined acceptance criteria.

The document contains:

• Device Information: Trade/Device Name, Regulation Number, Regulation Name, Regulatory Class, Product Code.
• FDA Clearance Details: Confirmation of substantial equivalence, general controls provisions, and contact information for various FDA departments.
• Indications For Use: A description of how the dental handpiece is intended to be used (e.g., removing carious material, cavity and crown preparation).

Therefore, I cannot provide the requested table or answer the other questions because the necessary information is not present in the provided text.

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The A-dec/W&H Synea Profin reciprocating contra-angle handpiece attachment is intended for use in removing protrusions or excess of filling materials and cements, preparation, finishing and polishing in the interdental and subgingival regions, stripping, vibrating of inlays using Dentatus tips and root canal preparations using endodontic files.

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I am sorry, but the provided text does not contain any information about acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or specific study designs (like MRMC or standalone performance).

The document is a 510(k) premarket notification letter from the FDA to A-dec, Incorporated, regarding a dental handpiece attachment. It primarily confirms the substantial equivalence of the device to legally marketed predicate devices and outlines regulatory compliance requirements.

Therefore, I cannot fulfill your request for the detailed study information as it is not present in the given text.

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The A-dec/W&H Synea Air-Driven Highspeed Handpiece is an air-powered dental handpiece for use in general dentistry. This device is designed for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth.

The A-dec/W&H Synea Handpiece Attachment is powered by either an air-motor or electric micromotor for use in general dentistry. This device is designed for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth.

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I apologize, but the provided text from the FDA 510(k) clearance letter for the A-dec/W&H Synea dental handpieces does not contain any information regarding acceptance criteria, device performance studies, or the methodologies typically associated with evaluating AI/ML-based medical devices.

This document is a standard clearance letter for a conventional medical device (dental handpieces) and primarily focuses on:

• Substantial Equivalence Determination: Confirming that the device is substantially equivalent to a legally marketed predicate device.
• Regulatory Classification: Stating the regulation number, name, and regulatory class.
• Indications for Use: Describing how the device is intended to be used.
• Compliance Guidance: Reminding the applicant of general controls and other FDA regulations.

Therefore, I cannot extract the information required by your request, such as a table of acceptance criteria, sample sizes, expert qualifications, or details about AI/ML study methodologies, because that information is not present in this document.

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The A-dec/W&H Electric Motor kit is a device system comprised of a control unit that drives a D.C. brushless micromotor that is activated by means of a footswitch. It is intended for use in general dental applications such as: cutting a tooth for cavity preparation, finishing, inlay, filing, polishing, prophylaxis and endodontic treatment, with use of a straight, right-angle, or contra-angle ISO E-type handpiece attachment of equal speed, gear-reduction speed, or gear-increasing speed.

The A-dec/W&H Electric Motor kit is a device system comprised of a control unit that drives a D.C. brushless micromotor that is activated by means of a footswitch.

I'm sorry, but without further context, the provided text does not contain the specific information required to answer your request regarding acceptance criteria and a study proving device performance. The document appears to be a 510(k) clearance letter for a dental motor, indicating that the device has been found substantially equivalent to a predicate device. However, it does not include details about:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number/qualifications of experts, or adjudication methods for any test set.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used.
• Sample size or ground truth establishment for a training set.

Therefore, I cannot fulfill your request based on the provided input.

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