K Number
K994203
Manufacturer
Date Cleared
2000-03-06

(84 days)

Product Code
Regulation Number
872.4850
Panel
DE
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The BONART CO., LTD. ART Ultrasonic Scaler is intended for use during dental cleaning and periodontal therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.

Device Description

The BONART CO., LTD. ART Ultrasonic Scaler is available in two models: a 25 kHz power output and a 30 kHz power output. The Bonart ART comes equipped with a turbo mode and can be operated in scaling or perio mode functions. The Bonart ART Scaler is equipped with water adjustment and power adjustment. The unit is operated by a footswitch and comes complete with a handpiece. The handpiece is compatible with Cavitron and Bonart tips.

AI/ML Overview

The document provided describes a 510(k) submission for the BONART CO., LTD. ART Ultrasonic Scaler. This type of submission is for a medical device that is substantially equivalent to a legally marketed predicate device, and it typically relies on bench testing and comparisons to established devices rather than extensive clinical studies with specific performance metrics like those for AI/ML devices. Therefore, a direct mapping of the requested information for acceptance criteria and a study proving it is not entirely applicable in the context of this document.

However, I can extract the relevant information and explain why certain aspects of your request cannot be fulfilled based on the provided text.

Here's the breakdown of the information that can be extracted or inferred from the document:

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

The document does not provide specific quantitative acceptance criteria or detailed performance metrics in the way one would expect for an AI/ML diagnostic device with sensitivity, specificity, etc. The "performance data" section focuses on bench testing and compliance with industry standards.

Acceptance Criteria (Implied)Reported Device Performance
Conformance to applicable industry and clinical standards"Physical performance studies were conducted to verify that the Bonart ART Scaler conformed to all emission and immunity standards in accordance with EN and IEC regulations."
Performance as intended (based on functional equivalence to predicates)"Results of the testing showed that the Bonart ART Scaler performs as intended." (Intended use: dental cleaning and periodontal therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.)
Substantial equivalence to predicate devices"The Bonart ART Ultrasonic Scaler is substantially equivalent to the Power Plus Scaler... and to the 25/30 Multi-Function Ultrasonic Scaler..." "The fundamental technical characteristics of the Bonart ART Scaler are similar to those of the predicate devices."

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

This information is not provided in the document. The performance data section refers to "performance bench testing" but does not detail sample sizes (e.g., number of devices tested, number of hours of operation, specific types of calculus removed) or the origin/nature of the data.

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)

This information is not applicable/provided. For a device like an ultrasonic scaler, "ground truth" in the context of diagnostic accuracy established by experts is not the primary assessment method. Performance is evaluated through engineering and functional tests against specified standards and comparison to predicate devices, not typically by expert consensus on diagnostic interpretations.

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

This information is not applicable/provided. Adjudication methods are relevant for studies where multiple readers interpret cases and their interpretations need to be reconciled for ground truth establishment. This is not the type of study described for an ultrasonic scaler.

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

This information is not applicable/provided. MRMC studies and the concept of "human readers improving with AI assistance" are relevant for AI/ML diagnostic devices. The BONART ART Ultrasonic Scaler is a dental instrument, not an AI/ML diagnostic system. Its performance is assessed functionally.

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

This information is not applicable/provided. This question is relevant for AI/ML algorithms. The ART Ultrasonic Scaler is a physical device operated by a human. Its performance is always "human-in-the-loop" as it's a tool for a dental professional.

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

As mentioned, "ground truth" in the diagnostic sense is not directly applicable. The "ground truth" for this device's performance is implicit in its ability to meet engineering specifications, safety standards (emission and immunity), and functional equivalence to legally marketed predicate devices for its intended use (removing calculus deposits).

8. The sample size for the training set

This information is not applicable/provided. There is no "training set" in the context of an ultrasonic scaler. This term is used for AI/ML algorithms.

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

This information is not applicable/provided. Again, there is no training set for this type of device.


Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The Bonart ART Ultrasonic Scaler underwent "performance bench testing in accordance with applicable industry and clinical standards." These physical performance studies were conducted to "verify that the Bonart ART Scaler conformed to all emission and immunity standards in accordance with EN and IEC regulations."

The results of this testing "showed that the Bonart ART Scaler performs as intended." The "intended use" is "for use during dental cleaning and periodontal therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth."

The primary method for demonstrating safety and effectiveness for this 510(k) submission was through substantial equivalence to predicate devices (TPC Advanced Technology Inc. Power Plus Scaler (K983029) and Tony Riso Co. 25/30 Multi-Function Ultrasonic Scaler (K964320)). The submission highlighted specific technical characteristics that were similar:

  • Availability of 25 kHz and 30 kHz power outputs.
  • Ability to operate in scaling and perio modes.
  • Presence of power and water adjustment features.
  • Equipped with a handpiece and compatibility with Cavitron brand inserts.
  • Inclusion of turbo functions.

Therefore, the "study" demonstrating performance was a combination of:

  • Bench testing to ensure compliance with relevant safety and performance engineering standards (EN and IEC).
  • A detailed comparison of technical and functional characteristics to legally marketed predicate devices to establish substantial equivalence for its intended use.

§ 872.4850 Ultrasonic scaler.

(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.