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Whip Mix Preppies Plus ® is a device used as part of a professionally administered prophylaxis treatment. It is used on the tooth surface prior to;

• . Restoration cementation.
• Acid etching procedures: .
  • o Sealants
  • Orthodontic brackets o
  • 0 Composite restorations

Whip Mix Preppies Plus is an innovative blend of polishing and cleaning agents including 2% Chlorhexidine Gluconate (CHG) relative to liquid component and is in a paste form. Each cup provides enough flour of pumice paste for a single use. Preppies Plus has no fluoride, oils, or added flavoring agents.

The provided text is a 510(k) summary for a dental abrasive polishing agent, Preppies Plus®. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through quantitative metrics.

The document primarily focuses on demonstrating substantial equivalence to predicate devices, particularly regarding safety and intended use, rather than presenting a performance study with specific acceptance criteria and outcome metrics.

Here's a breakdown of what can be extracted from the text in relation to your request, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Cannot be provided: The document does not define specific quantitative acceptance criteria (e.g., minimum abrasive effectiveness, maximum sensitivity reduction, etc.) or report detailed performance metrics against such criteria. The "Substantial Equivalence" table compares device characteristics and intended uses, but not performance against pre-defined success/acceptance criteria.

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

• Cannot be provided: There is no mention of a "test set" in the context of a performance study. The document refers to "non-clinical tests for bio-compatibility performed," but no details on sample size, methodology, or data provenance (country of origin, retrospective/prospective) are given for these tests.

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

• Cannot be provided: Since no performance study utilizing a "test set" with ground truth is described, information about experts or their qualifications is absent.

4. Adjudication Method for the Test Set:

• Cannot be provided: As no performance study with a test set is detailed, there's no mention of an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No: The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it refer to AI assistance or human reader improvement with AI. This is a medical device, not an AI/software device in the context of diagnostic imaging.

6. Standalone (Algorithm Only) Performance Study:

• No: This is a physical dental product, not an algorithm. Therefore, a standalone algorithm-only performance study is not applicable and not mentioned.

7. Type of Ground Truth Used:

• Cannot be provided: No performance study establishing ground truth (e.g., pathology, outcomes data, expert consensus) is described for this device. The closest concept is the "known risks associated with chlorhexidine in the FDA database," used as input for a risk management process, but this is not establishing ground truth for device performance.

8. Sample Size for the Training Set:

• Not Applicable/Cannot be provided: This is a physical dental product, not a machine learning model, so there is no "training set" in that context.

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

• Not Applicable/Cannot be provided: As there's no training set, there's no method for establishing its ground truth.

Summary of Device Safety and Effectiveness provided in the document:

The document states that the safety and effectiveness are established through:

• The established use of chlorhexidine in medical device applications since the 1970s and in many dental applications.
• A thorough search of the FDA database for known risks associated with chlorhexidine, which informed their risk management process.
• Adherence to ISO 14971 for risk management, identifying and mitigating known hazards to an acceptable level.
• Comparison to their existing 510(k) exempt device (Preppies Flour of Pumice), with the only difference being the addition of 2% Chlorhexidine Gluconate (CHG).
• "Acceptable results of the non-clinical tests for bio-compatibility performed." (No details on what these tests were, their methodology, or results are provided).
• The conclusion that the new device "introduces no new risks and is considered substantially equivalent" to predicate devices.

In essence, this 510(k) summary primarily asserts substantial equivalence based on material composition (addition of CHG), intended use, and a risk management process, rather than presenting a detailed performance study with quantitative acceptance criteria.

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