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The 430 SWL 45 and 430 SW 45 air-powered high speed handpieces are used by trained dental professionals for the removal of impacted third molars as well as endodontic and periodontal procedures for which a conventional handpiece would be used.

The 430 SWL 45 and 430 SW 45 air-powered high speed handpieces are used by trained dental professionals for the removal of impacted third molars as well as endodontic and periodontal procedures for which a conventional handpiece would be used.

The 430 SWL 45 and 430 SW 45 High-Speed Handpieces are designed with a 45 degree back angled head to facilitate access to the back of the oral cavity. They are designed so that air that expelled from the head of the handpiece is directed out the side of the handpiece head and not directed onto the work area of the bur. The handpieces are intended for use with a friction grip bur that conforms to ISO 1797-1 standards. Recommended air pressure is 30-34 PSI which results in a bur rotation of approximately 400,000 RPM.

The 430 SWL 45 High-Speed Handpiece is a fiber optic, swivel connector type handpiece with a lubefree, ceramic bearing, push button autochuck turbine. The 430 SW 45 High-Speed Handpiece is a non-fiber optic version of the 430 SWL 45 Handpiece.

The DentalEZ Inc., StarDental Division 430 SWL 45 and 430 SW 45 High-Speed Handpieces are dental devices, not an AI or imaging device. Therefore, much of the requested information, such as sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable.

Here's the available information based on the provided text, focusing on the acceptance criteria and the studies performed to demonstrate equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not list specific numerical acceptance criteria for performance metrics in a table format. Instead, it states that the devices were developed considering applicable technical standards and internal specifications, and their conformance was verified through bench testing. The comparison to predicate devices focuses on similarity in characteristics rather than meeting defined performance thresholds.

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

Not applicable in the context of this device and study type. Clinical data or test sets as typically understood for AI algorithms are not mentioned. The "tests" referenced are bench tests of the device itself.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The "ground truth" for this device's performance is established by industrial standards, internal specifications, and physical measurements during bench testing, not expert consensus on medical images or patient outcomes.

4. Adjudication Method

Not applicable. This is not a study requiring adjudication of expert opinions.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. This type of study is relevant for AI-assisted diagnostic tools. The provided document describes a dental handpiece, not an AI device.

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

No. This describes a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is established by:

• International Standards: e.g., ISO 7785-1, ANSI/AAMI ST79:2010 & A1:2010 & A2:2011, AAMI/ANSI/ISO 14937:2009, ISO14971:2009.
• StarDental Internal Specifications: Used in the development and testing documentation (TR 468, TR 470).
• Physical Measurements and Bench Testing Results: Directly observed performance characteristics during testing.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI or machine learning device.

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

Not applicable, as there is no training set mentioned.

Studies that Prove the Device Meets Acceptance Criteria:

The acceptance criteria are implicitly met through the following non-clinical studies and comparisons:

• Bench Testing (TR 468): This internal test was developed to determine the performance characteristics of the handpieces, considering StarDental internal specifications and ISO 7785-1, 1997-08-01. This demonstrates the device's mechanical and operational performance against established standards.
• Bench Testing (TR 470): This internal test focused on the effectiveness of housing pressure relief slots and the vortex washer, and quantified the air bleed of the handpiece head. It also compared these characteristics with predicate devices. This shows functional design and safety aspects.
• Sterilization Validation Studies: Performed by HIGHPOWER Validation Testing & Lab Services, these studies confirmed the effectiveness of sterilization and dry times. They followed ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 and AAMI/ANSI/ISO 14937:2009, ensuring the device meets critical infection control requirements.
• Risk Analysis (ISO14971:2009): A risk analysis was conducted according to this standard, indicating that potential risks were identified and mitigated, contributing to the device's safety.
• Substantial Equivalence Argument: The core of the 510(k) submission is the argument that the proposed devices are "substantially equivalent" to predicate devices based on similarities in intended use, principles of operation, and functional design. This implies that the performance and safety are comparable to already approved devices. The FDA concurred with this assessment in their letter.

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The NuTorque Programmable Electric System is used by trained dental professionals to perform general dental procedures including crown preparation, cavity preparation, crown finishing, inlay and the filling, polishing, prophylaxis and endodontic treatment.

The NuTorque Programmable Electric System is an electric handpiece system for use in performing various dental procedures including grinding and trimming. post and pin drilling, pin setting, finishing, polishing, endodontic, caries removal and prophylaxis.

The NuTorque Programmable Electric System is composed of a power supply. control unit, cable and brushless micromotor. The control unit controls the torque, speed and directional rotation of the motor. The system is programmed through the use of a color touch screen on the control unit. The motor has a rotational speed of 100- 40,000 rpm's and can be operated in a clockwise or counterclockwise direction. The system also provides variable light intensity to the handpiece.

The provided text is a 510(k) summary for the NuTorque Programmable Electric System, a dental handpiece system. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain information regarding detailed acceptance criteria for the device's performance, nor does it describe specific studies with sample sizes, expert involvement, or ground truth establishment relevant to the request.

The text mentions:

• "Performance testing was conducted to validate the safety and effectiveness of the NuTorque Programmable Electric System."
• "This testing included the electrical safety, electromagnetic compatibility and validation and verification of the software."
• "Testing was completed in accordance with recognized consensus standards."

Based on the provided text, I cannot complete the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth, or MRMC studies, as this information is not present in the given document.

The document focuses on demonstrating substantial equivalence to a predicate device (Ti-Max NL400), which is a regulatory pathway that often relies on comparing technical characteristics and intended use rather than requiring extensive clinical performance studies with specific acceptance criteria and validation metrics as might be found for novel diagnostic AI devices.

Therefore, the table below will reflect the absence of the requested information from the provided document.

Acceptance Criteria and Device Performance

Study Details (Based on provided text)

1. Sample size used for the test set and the data provenance: Not specified in the provided document.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided document.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified in the provided document.
4. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance: Not applicable/Not specified in the provided document. This device is a dental handpiece system, not an AI diagnostic tool that would typically involve human reader performance studies.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable/Not specified in the provided document. This device is a physical dental instrument system, not a standalone algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified in the provided document for performance testing. The document states "Performance testing was conducted to validate the safety and effectiveness" but does not detail the methodology for establishing ground truth for mechanical/electrical performance.
7. The sample size for the training set: Not applicable/Not specified in the provided document. This is not an AI/machine learning device that would have a training set in the typical sense.
8. How the ground truth for the training set was established: Not applicable/Not specified in the provided document.

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