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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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Cleaning, polishing and restoring natural esthetics of tooth enamel.

The ß-Powder system is comprised primarily of ßtricalcium phosphate. X-ray diffraction methods were used to identify the crystalline structure. These studies showed that the main constitutent of the device is ßtricalcium phosphate with a small amount of hydroxyapatite, but no other contaminants. Inductively coupled plasma/mass spectroscopy was used for cadmium (Cd) and lead (Pb) analyses, and atomic absorption spectrophotometry was used for mercury (Hg) and arsenic (As). The levels of these harmful elements were below 0.5 ppm

The provided text is a 510(k) summary for a medical device (B-Powder) and a clearance letter from the FDA. This type of documentation focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through extensive clinical studies.

Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, etc.) is not present in the provided text.

Here's why and what can be extracted:

• No Acceptance Criteria or Performance Reporting: The 510(k) process for this device (B-Powder) establishes that it is "substantially equivalent" to already marketed devices. This means the manufacturer did not have to conduct new clinical trials to prove efficacy or safety against specific performance metrics, but rather demonstrate that its characteristics and intended use are similar enough to existing, cleared devices.
• Focus on Material Composition and Intended Use: The summary focuses on the material composition (beta-tricalcium phosphate with some hydroxyapatite) and its intended use (polishing/prophy powder) being similar to predicate devices.
• Analytical Testing, Not Clinical Studies: The "studies" mentioned (X-ray diffraction, ICP/MS, atomic absorption spectrophotometry) are analytical tests to characterize the material, not clinical performance studies. These tests confirm the material content and the absence of harmful elements, but they don't assess clinical outcomes like cleaning effectiveness or polishing quality in a human population.
• MRMC, Standalone Performance, Ground Truth, Training Set: These concepts are typically relevant for AI-powered diagnostic or prognostic devices that perform classifications or measurements. The B-Powder is a physical dental material, so these types of studies are not applicable.

In summary, based only on the provided text, I cannot fill in the table or answer the specific questions about acceptance criteria, study details, expert ground truth, or AI study specifics because this information is not part of a 510(k) submission for this type of device.

The document states: "Compliance with Performance Standards: No performance standards are applicable." This directly indicates that there aren't formal quantitative acceptance criteria for this device that would be proven by a performance study.

Here's what I can extract and explain based on the provided text, addressing the spirit of your request where possible by highlighting what was not done or not required for this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
No test set or clinical study data is reported as part of this 510(k) submission. The evaluation was based on material characterization and comparison to predicate devices, not clinical performance testing.

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 ground truth establishment by experts for a test set was required or mentioned for this type of device submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication was used or mentioned.

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 a dental polishing powder, not an AI-powered diagnostic tool. MRMC studies are not relevant to its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a dental polishing powder, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The basis for clearance was "substantial equivalence" to legally marketed predicate devices, not performance against an independently established clinical ground truth. The "ground truth" implicitly relies on the established safety and effectiveness of the existing predicate devices.

8. The sample size for the training set
Not applicable. There was no "training set" for this device, as it is a material and not an algorithm.

9. How the ground truth for the training set was established
Not applicable. As above, no training set or ground truth in the context of an algorithm's development was relevant or established for this submission.

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