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The ultrasonic scaler tips are intended for use by dental professionals to:

1. Remove supra and sub gingival calculus deposits and stain from the teeth;
2. Clean and irrigate root canals.

Ultrasonic scaler tips are an accessory to a piezoelectric ultrasonic handpiece and scaler unit. The devices are used during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of ultrasonic vibration and in various endodontic applications to prepare the teeth and/or root of the teeth for repair.
The models are GD1, GD2, GD4, GD5, GD6, PD1, PD3, PD4, PD4D, ED1. The Ultrasonic scaler tips are made from Stainless Steel 30Cr13 and the endo files are made of Nickel Titanium Alloy. The tips will be available in M3x0.6 internal thread.
GD series and PD series(except for PD4D) are used to remove calculus deposits from teeth; PD4D and ED1 are used for root canal indication.

The provided text is a 510(k) summary for "Ultrasonic Scaler Tips" and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a clinical or algorithmic study with a defined test set, ground truth experts, and statistical outcomes.

The document discusses:

• Device Description and Intended Use: The device is an accessory for professional dental use to remove calculus and stain, and to clean/irrigate root canals.
• Comparison to Predicate Devices: It details similarities and differences in product code, regulation, intended use, device description, operating principle, tip shapes, composition, coatings, interaction with other products, sterilization, and mechanism of treatment to establish substantial equivalence.
• Performance Data: It lists bench performance testing (biocompatibility, reprocessing validation, conformity to ISO standards like ISO 18397 and ISO 3630-5) conducted to support substantial equivalence.
• Absence of Clinical Data: Critically, it explicitly states, "The subject of this premarket submission, ultrasonic scaler tips, did not require clinical studies to support substantial equivalence."

Therefore, the information required to answer your detailed questions about acceptance criteria, test set, data provenance, number/qualifications of experts, adjudication, MRMC studies, standalone performance, and ground truth for training/test sets is not available in this document. This document describes a 510(k) pathway, which often relies heavily on bench testing and comparison to legally marketed predicate devices rather than novel clinical performance studies, especially for devices like scaler tips.

To directly answer your request based on the provided text:

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

The document doesn't provide specific numerical acceptance criteria or clinical performance metrics for the device itself (e.g., how effectively it removes calculus). Instead, it states that tests were conducted to demonstrate conformity to applicable clauses of ISO standards and that biocompatibility and reprocessing validation were performed. The "performance" is implicitly deemed acceptable if it meets these bench test standards and allows for substantial equivalence to predicates.

• ISO 18397 Dentistry Powered scaler
• ISO 3630-5 Dentistry Endodontic instruments Part 5: Shaping and cleaning instruments (Implicitly passed) |
  | Clinical Performance | Not Applicable / Not Required. "did not require clinical studies to support substantial equivalence." |

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified for any "test set" in the context of clinical performance data, as clinical studies were not required. For bench testing (biocompatibility, reprocessing, ISO conformity), sample sizes would be determined by the specific test protocols and standards, but are not detailed here.
• Data Provenance: Not specified, as clinical data was not used. The document pertains to a Chinese manufacturer (Guilin Refine Medical Instrument Co., Ltd.) seeking FDA clearance in the US, so any bench testing would likely have been conducted by or for the manufacturer.

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. No clinical test set requiring expert ground truth was performed or required for this 510(k) submission.

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

• Not applicable. No clinical test set requiring adjudication was performed or required.

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 device is an ultrasonic scaler tip, not an AI-powered diagnostic or assistive tool. No MRMC study or AI assistance is mentioned or relevant to its function.

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

• Not applicable. This device is an ultrasonic scaler tip, not an algorithm.

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

• Not applicable. No clinical ground truth was established or used, as no clinical studies were performed. Ground truth for the bench tests would refer to the validated methods and accepted reference standards of the specific physical, chemical, and mechanical tests conducted.

8. The sample size for the training set

• Not applicable. No training set for an algorithm was used or mentioned.

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

• Not applicable. No training set for an algorithm was used or mentioned.

In summary: The provided document is a 510(k) clearance letter and summary for an ultrasonic scaler tip, which falls under Class II medical devices. For such devices, particularly accessories, the FDA often relies on bench testing and substantial equivalence to existing predicate devices rather than requiring extensive clinical trials or AI-specific performance studies. The questions you've asked are highly relevant for AI/software as a medical device (SaMD) clearances, but not for this specific type of physical device and its associated 510(k) pathway.

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This product is intended for use by dental professionals only. This device generates ultrasonic vibrations intended for use in dental applications such as scaling, periodontal therapy, root canal treatment and cavity preparation.

The Hu-Friedy® brand Symmetry IQ Ultrasonic Scalers are similar to the Ultrasonic Scalers of the predicate device listed above. These devices are intended for use by dental professionals only. These devices generate ultrasonic vibrations intended for use in dental applications such as scaling, periodontal therapy, root canal treatment and cavity preparation. Hu-Friedy will purchase the generators from NSK, Inc. (Nakanishi) and own brand private label the device. The modifications to the Hu-Friedy product are cosmetic in nature and consist mainly of new shape and design to the housing of the control unit. All of the internal electrical and technical specifications are identical to the marketed NSK units. Hu-Friedy currently has a 510k (K053178) approval for the Symmetry line of piezoelectric tips that are compatible with Satelec and NSK piezoelectric ultrasonic scalers. The addition of the Symmetry IQ generators and handpiece will complete our ultrasonic piezo scaling product line. The Symmetry IQ Ultrasonic Scalers have essentially the same design as the predicate device's ultrasonic generators. The Symmetry IQ 2000 series is equivalent to the Varios 150 Lux (Optic), which is an integrated version of the Varios 350 Lux (Optic) to be used in the delivery tray table as a built in system. The Symmetry IO 3000 series is equivalent to the combination of the Varios 550 control unit with the handpiece used in the Varios 350 Lux (Optic). The Symmetry IQ 3000 unit is based on the NSK Varios 560 which is currently pending FDA 510k approval. The addition of a silicone grip to the ultrasonic generator handpiece used in both models is the only significant change and the reason for the new 510k application.

This submission describes the Symmetry IQ Dental Ultrasonic Scaler, a dental device used for various dental applications. The basis of the 510(k) clearance is substantial equivalence to a predicate device, as opposed to a new algorithm-based device requiring extensive performance testing against acceptance criteria.

Therefore, the requested information regarding acceptance criteria, performance studies, expert involvement, and ground truth for an AI/algorithm-based device is not applicable to this 510(k) submission.

The document states that:

• "The modifications to the Hu-Friedy product are cosmetic in nature and consist mainly of new shape and design to the housing of the control unit. All of the internal electrical and technical specifications are identical to the marketed NSK units."
• "The Symmetry IQ Ultrasonic Scalers have essentially the same design as the predicate device's ultrasonic generators."
• The "addition of a silicone grip to the ultrasonic generator handpiece used in both models is the only significant change and the reason for the new 510k application."

The studies mentioned (sterilization study, biocompatibility testing, ISO 22374 life testing) are safety and performance verification tests for the modified components and overall device, rather than comparative effectiveness studies for an AI-driven diagnostic or therapeutic tool.

As such, I cannot populate the table and answer the specific detailed questions as they are designed for performance evaluation of AI/ML software or algorithms, which is not the nature of this device's submission.

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