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Titan 3 Low Speed Angle Attachments are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings, as well as disking, cavity and crown preps, polishing, post and pin drilling and pin setting.

The proposed angles are attached to a pneumatically driven low speed motor via the use of either a motor-to-angle adaptor (K960260) or 16:1 contra angle (preamendment). Air supplied to the motor (K960260) drives a gearing system through the adaptor or contra angle to the angle attachment. A torque multiplier can be used between the motor and motor-to-angle adaptor or contra angle to reduce the rpms from the motor while increasing the torque. A dental bur is inserted into the angle to perform the procedure.

There are four different angle styles that will marketed under the names Titan 3 LubeFree Angles, Titan 3 Lubricated Angles, and Five Star Prophy Angles with some variations within each style. The main differences between the styles of the proposed angles are in the mechanical chucking mechanism of the angle and prophy, the composition of the outside plating of the angle attachment and the lubrication that may be needed to maintain the attachment.

The angles are constructed of brass, which is chrome plated The internal drive gears are constructed of stainless steel.

The lubricated angles, consisting of a ball bearing manual latch angle, ball bearing auto latch angle, ball bearing auto chuck friction grip angle and a Prophy angle require daily lubrication using the recommended lubricant, Dentalube II, which is manufactured by StarDental (K070869).

The lubefree angles, consisting of a ball bearing manual latch angle, ball bearing auto latch angle, ball bearing auto chuck friction grip angle and a Prophy angle, are lubricated during the assembly process and require no further lubrication by the user.

All proposed angles are autoclavable.

This looks like a 510(k) premarket notification for a dental device, not an AI/ML device. The document describes a traditional medical device (dental handpiece attachments) and its comparison to a predicate device for substantial equivalence. Therefore, many of the requested categories for AI/ML device studies (like sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, etc.) are not applicable and are not present in this document.

However, I can extract the relevant information regarding acceptance criteria and the studies performed for this specific device.

Acceptance Criteria and Device Performance (as applicable to a non-AI/ML device):

Study Information (as applicable to a non-AI/ML device):

1. Sample sizes used for the test set and the data provenance: Not explicitly stated in this document for individual tests, as it's a traditional device submission. The "test set" would refer to the physical devices undergoing testing. The provenance is from DentalEZ, Inc., StarDental Division, Lancaster, PA, USA. The testing is prospective for the specific devices being submitted.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For this type of device, "ground truth" refers to physical measurements and adherence to engineering and performance standards, not expert interpretations of data.

3. Adjudication method for the test set: Not applicable. Performance is measured against objective engineering and regulatory standards, not expert adjudication.

4. 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 device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.

6. The type of ground truth used:

   • Functional/Performance: Metrological measurements of RPMs and operational characteristics against established engineering specifications and the predicate device's performance.
   • Biocompatibility: Material specifications and compliance with known biocompatible materials.
   • Sterilization: Results from sterilization validation cycles against microbiology standards (e.g., achieving sterility assurance level).
   • Mechanical: Physical inspection, material analysis, and functional tests (e.g., torque, durability).
   • Risk Analysis: Compliance with the methodology outlined in ISO14971:2012.

7. The sample size for the training set: Not applicable, as this is not an AI/ML device. There is no "training set" in the context of an algorithm.

8. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

Overall Study Conclusion:

The document explicitly states: "Based upon the comparison of technological characteristics, demonstrated through bench testing and intended use, the Titan 3 Low Speed Angle Attachments are substantially equivalent to the predicate devices."

Specific Studies/Tests Mentioned:

• Performance testing: In accordance with ISO 14457:2012 Dentistry – Handpieces and motors.
• Sterilization validation: In accordance with ANSI/AAMI ST79:2010 & A4:2013, AAMI/ANSI/ISO 14937:2009, and ANSI/AAMI ST81:2004 (R2010).
• Risk analysis: Developed using ISO14971:2012.
• Bench testing: Implied for comparison of technological characteristics.

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The Concentrix High-Speed Handpieces are used by trained dental professionals for a variety of procedures including but not limited to caries and amalgam removal, restorative work and crown preparations.

The Concentrix High-Speed Handpieces are pneumatically driven, hand-held devices used by trained dental professionals to perform a variety of dental procedures.
The Concentrix MX is a non-fiber optic, 2/3 line fixed backend handpiece with a steel bearing manual chucking turbine. The Concentrix PX is a non-fiber optic, 2/3 line fixed backend handpiece with a steel bearing, push button autochuck turbine. The Concentrix FX is a non-fiber optic, 3/4 line fixed backend handpiece with a steel bearing, push button autochuck turbine. The Concentrix SX is a fiber optic, swivel handpiece with a steel bearing, push button autochuck turbine.

This document describes a 510(k) Premarket Notification for the DentalEZ, Inc. Concentrix High-Speed Handpiece Series. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics in the typical sense of a diagnostic or AI-powered device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable to this type of regulatory submission, as it is not an AI/diagnostic device.

The "acceptance criteria" here are effectively the criteria for demonstrating substantial equivalence to the predicate device.

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

For a 510(k) submission for a dental handpiece, "acceptance criteria" are implied by demonstrating that the new device has the same technological characteristics, intended use, and performance as the predicate device, or that any differences do not raise new questions of safety and effectiveness.

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. This is a 510(k) submission for a mechanical dental instrument, not a diagnostic or AI device that relies on a test set of patient data. The "study" here is a comparison to a predicate device based on engineering and design characteristics.

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. Ground truth for a diagnostic test set is not relevant to this device. The assessment is based on engineering evaluations and comparison to the predicate device characteristics.

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

Not applicable. This concept is for diagnostic studies with human readers.

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 not an AI-assisted device.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable. The "ground truth" for this submission is the performance and safety profile of the legally marketed predicate device (Star Dental 430 Series High Speed Handpiece, K960719), as established through its prior clearance and market history. The substantial equivalence relies on demonstrating that the new device is as safe and effective as this predicate.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

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