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Used for ultrasonic procedures:

• All general supra and subgingival scaling applications .
• Periodontal debridement for all types of periodontal diseases .

The Cavitron Touch™ Ultrasonic Scaling System is an ultrasonic scaling unit that is used in all general supra and subgingival scaling applications and periodontal debridement for all types of periodontal diseases. The Cavitron Touch™ Ultrasonic Scaling System includes a digital touch screen interface and Bluetooth technology. This device is equipped with the Tap-On™ Wireless Foot Pedal with Tap-On™ technology.

The provided text describes a medical device, the Cavitron Touch™ Ultrasonic Scaling System, and its substantial equivalence to a predicate device, the Cavitron® RF Ultrasonic Scaler System with Sterimate Handpiece (K052334). However, the document does not contain specific acceptance criteria or a study proving the device meets those criteria with quantitative performance metrics for the reasons listed below for each criterion. This is a 510(k) submission, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical trial with explicit acceptance criteria for efficacy.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

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

• The document does not specify sample sizes for any test sets related to performance characteristics (e.g., number of units tested, duration of tests).
• The data provenance is internal testing performed by DENTSPLY International Inc. (Section 7, "Internal specification and testing"). Country of origin is not specified but the company is based in York, Pennsylvania, USA. The testing would be prospective in nature for a new device design.

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. This submission focuses on engineering and performance verification against existing standards and internal specifications, not on establishing ground truth for diagnostic or clinical interpretation using expert readers.

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

• Not applicable. As the "ground truth" and "expert" roles are not relevant in this type of engineering and performance verification submission, there is no adjudication method described.

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

• No, an MRMC comparative effectiveness study was not done. This device is an ultrasonic scaler; it is a tool used by dental professionals, not an AI-powered diagnostic system that assists human readers in case interpretation. The document explicitly states "No data from human clinical studies has been included to support the substantial equivalence of the Cavitron Touch™ Ultrasonic Scaling System" (Section 9, page 9).

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

• Not applicable. This device is an ultrasonic scaler. Its function is to perform ultrasonic scaling procedures, which inherently involves a human operator (a dental professional). It is not an algorithm that functions in a standalone capacity without human intervention.

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

• Not applicable/Not explicitly defined in the clinical sense. For a device like an ultrasonic scaler, "ground truth" for non-clinical performance would relate to engineering specifications, safety standards (e.g., electrical safety, electromagnetic compatibility), and functional requirements (e.g., power output, water flow, touch screen responsiveness). The closest to "ground truth" would be the standards themselves (e.g., AAMI ANSI ES 60601-1, IEC 60601-1-2) and the internal specifications against which the device was tested.

8. The sample size for the training set

• Not applicable. This device is not an AI/machine learning system that requires a "training set" in the conventional sense. The development likely involved iterative design and testing, but not a formally defined "training set" for an algorithm.

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

• Not applicable. As there is no training set for an AI/ML algorithm, the concept of establishing ground truth for it does not apply.

Summary of Study Type:

The document describes non-clinical performance data (Section 7, page 9) which includes:

• Verification of design
• Ultrasonic scaling performance
• Function of the device
• Adherence to international standards (AAMI ANSI ES 60601-1, IEC 60601-1-2)
• Guidance for software validation (FDA - Guidelines for the Content of Premarket Submissions for Software Contained in Medical Devices- Software Validation)
• Internal specification and testing for handpiece operation, autocycle operation, touch screen/user interface, and radio frequency distance for the wireless foot pedal.

This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device through engineering and performance testing, rather than through extensive clinical trials with explicit performance metrics and acceptance criteria for patient outcomes.

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The Cavitron® Prophy-Jet® Air Polishing Prophylaxis System is designed for use in general prophylaxis and periodontal treatments and other areas of operative dentistry. It can also be used for:

• . Stain removal,
• Prophylaxis of orthodontic patients, .
• Preparing tooth surfaces prior to bonding and sealant procedures, and ●
• Implant debridement .

The Cavitron® Prophy-Jet® Air Polishing Prophylaxis System is an air polishing unit that delivers an air/water/powder mixture at the air polishing insert tip that polishes the tooth enamel without direct contact of the device. The system is used with water-soluble prophy powders such as Cavitron® PROPHY-JET® Sodium Bicarbonate Prophy Powder (K970342) or Cavitron® JET-Fresh® Aluminum Trihydroxide Prophy Powder (K014188) (for patients with low sodium requirements). Updated design features on the Cavitron® Prophy-Jet® Air Polishing Prophylaxis System include a Tap-On™ Wireless Foot Pedal, prophy mode auto cycles, an illuminated diagnostic display, automated purge function, Cavitron® JET-Mate™ detachable sterilizable handpiece (K023697), and a swivel handpiece cable with more precise lavage control. Upon installation, the Cavitron® Prophy-Jet® Air Polishing Prophylaxis System unit is connected to external air and water lines, as well as an AC power cord.

Here's a breakdown of the acceptance criteria and study information for the Cavitron® Prophy-Jet® Air Polishing Prophylaxis System, based on the provided text:

Important Note: The provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed, novel clinical trial data. Therefore, many of the requested elements (especially those related to human reader studies, specific ground truth establishment for a test set, and detailed statistical results) are not available in this type of document. The study described here is primarily non-clinical performance testing.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the compliance with regulations and successful performance in the specified tests, which aim to ensure the device is safe and effective and substantially equivalent to predicate devices. The reported device performance is that it met these criteria.

Study Details

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

• Sample Size (Test Set): Not explicitly stated for each test (e.g., number of samples for stain removal or abrasion tests). The document refers to "internal specification and testing" and "third-party testing" for these aspects. For electrical and software compliance, the "sample" is typically the device itself or its software.
• Data Provenance: The tests include "Internal specification and testing" and "third-party testing." The country of origin for the data is not specified, but the applicant is DENTSPLY International, located in York, PA, USA. The studies are prospective in the sense that they were conducted specifically for this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• This information is not provided in the document. For non-clinical performance tests like stain removal and abrasion, ground truth might be established through standardized methods, quantitative measurements, or comparison to established benchmarks, rather than expert consensus on a test set in the way it might be for an imaging AI device.

4. Adjudication Method for the Test Set:

• Not applicable/Not provided. This type of detail is typically relevant for human review of data, such as in clinical imaging studies. For the described non-clinical performance tests, adjudication methods are not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. The document explicitly states: "No human clinical data has been provided to support substantial equivalence." Therefore, an MRMC study was not performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:

• Not applicable in the AI sense. The device is a physical instrument, not an AI algorithm. The performance evaluation focuses on the device's physical capabilities (stain removal, abrasion, electrical safety, etc.) and software functionality as an integrated system, which is inherently "standalone" in its operation relative to human decision-making. No "algorithm only" performance would be separately evaluated in this context.

7. The Type of Ground Truth Used:

• Standardized Test Methods/Quantitative Measurements/Predicate Device Comparison: For non-clinical tests, ground truth is established by standardized testing protocols (e.g., for electrical safety, EMC), internal specifications, and performance against accepted benchmarks (e.g., stain removal effectiveness compared to industry standards or predicate device performance, enamel abrasion within acceptable limits). The core of this submission is showing substantial equivalence to predicate devices, implying their existing performance provides a "ground truth" for acceptable levels.

8. The Sample Size for the Training Set:

• Not applicable. This device is a physical instrument, not an AI/ML algorithm that requires a training set in the conventional sense. The "training" for such a device involves engineering design, prototyping, and iterative testing, not data-driven model training.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. As above, there's no "training set" in the context of an AI algorithm. The design and development process for a physical medical device relies on engineering principles, material science, previous device knowledge (predicates), and internal testing to ensure it meets its intended specifications and safety standards.

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