(146 days)
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):
| Acceptance Criteria Category | Metric | Reported Device Performance |
|---|---|---|
| Functional / Performance | Operates at variable speeds up to 20,000 rpm (matching predicate). | Variable up to 20,000 rpm. |
| Biocompatibility | Identical material composition as predicate (brass, stainless steel for drive shaft), known for corrosion resistance and biocompatibility. | Identical material composition as the predicate; construction uses chrome plated brass and 300 series stainless steel drive shaft. |
| Sterilization | Validation in accordance with ANSI/AAMI ST79:2010 & A4:2013, AAMI/ANSI/ISO 14937:2009, and ANSI/AAMI ST81:2004 (R2010) (matching predicate's previous validation, updated for current standards). | Sterilization validation performed in accordance to ANSI/AAMI ST79:2010 & A4:2013, AAMI/ANSI/ISO 14937:2009, and ANSI/AAMI ST81:2004 (R2010). |
| Mechanical/Physical | Method of operation, use of same base materials, lubrication requirements, style of angles, and autoclavability are consistent with the predicate device. Constructed of brass (chrome plated), internal drive gears of stainless steel. | Consistent with predicate, constructed of brass (chrome plated) with stainless steel internal drive gears. |
| Risk Management | Risk analysis performed per ISO14971:2012. | Risk analysis for the Angle Attachments for Low-Speed Handpieces was developed using ISO14971:2012. |
Study Information (as applicable to a non-AI/ML device):
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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.
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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.
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Adjudication method for the test set: Not applicable. Performance is measured against objective engineering and regulatory standards, not expert adjudication.
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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.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
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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.
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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.
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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.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.