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The EMS Piezon® Master 600 is an ultrasonic scaler intended for use in the following dental and periodontal applications:

• Removing supra and subgingival calculus deposits and stains from teeth .
• Periodontal pocket lavage with simultaneous ultrasonic tip movement .
• Scaling and root planing .
• Releasing crowns, bridges, inlays, and posts as well as condensing gutta ● percha
• Plugging for amalgam condensation .
• Amalgam burnishing ●
• Preparing, cleaning and irrigating root canals .
• Cavity preparation .
• . Cementing inlays and onlays
• Retrograde preparation of root canals ●

The proposed Piezon® Master 600 is a modification of the Piezon® Master 400. The modified Piezon® Master 600 consists of the main scaler unit (including a peristaltic pump for irrigant delivery), hoses and connectors for two handpieces, a foot control containing a four-position switch, and two bottles for holding irrigation liquids. The Piezon® Master 600 is supplied with one of a number of optional Instrument Systems (containing a Universal handpiece and scaling instruments), a flat key, and a torque tool (CombiTorque) for attaching instruments to the handpiece.

This document is a 510(k) summary for a medical device (EMS Piezon® Master 600) and does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a specific study proving device performance. This type of submission is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than a full clinical trial report with detailed performance metrics.

However, I can extract the information that is present and highlight what is missing based on your request.

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific quantitative acceptance criteria (e.g., maximum leakage current, specific EMC levels).
• Detailed quantitative performance data (e.g., cleaning efficiency, scaling precision, time to complete tasks for new applications, vibration characteristics, efficacy rates for specific procedures). The document mentions "enhanced ultrasonic performance" but doesn't provide metrics.

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

This document does not provide a sample size for a test set in the context of clinical or performance data. The "performance testing" referred to (electrical safety, EMC, design control) are engineering and regulatory compliance tests, not typically clinical studies involving patient data.

Missing Information:

• Sample size for any test set involving performance on human or animal subjects.
• Data provenance (country of origin, retrospective/prospective).

3. Number of Experts and their Qualifications for Ground Truth

This document does not describe the establishment of a ground truth by experts in the way you've outlined for clinical studies. The performance testing mentioned refers to engineering and design verification.

Missing Information:

• Number and qualifications of experts for ground truth.

4. Adjudication Method for the Test Set

This document does not describe any adjudication method for a clinical test set, as no such test set is detailed.

Missing Information:

• Adjudication method.

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

This document does not mention or describe a MRMC comparative effectiveness study. The device is an ultrasonic scaler, suggesting a focus on mechanical performance rather than image interpretation by human readers.

Missing Information:

• Information on MRMC study or AI-assisted improvement for human readers.

6. Standalone (Algorithm Only) Performance Study

The device is a physical ultrasonic scaler, not an AI algorithm. Therefore, a "standalone algorithm only" performance study is not applicable in this context.

7. Type of Ground Truth Used

For the engineering and design verification tests mentioned, the "ground truth" would be established by engineering standards, regulatory requirements, and internal design specifications. For example, electrical safety is judged against a standard like IEC 60601-1, and EMC against relevant IEC or national standards. These are not "expert consensus, pathology, or outcomes data" in the typical clinical sense.

8. Sample Size for the Training Set

This document does not refer to a training set as would be used for an AI/machine learning algorithm. The development of this physical medical device would involve design, prototyping, and iterative testing, but not a "training set" in that context.

Missing Information:

• Sample size for a training set.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a training set for an AI algorithm, this information is not applicable.

Summary of what the document does provide regarding performance and acceptance:

The document describes the device as a modification of a predicate device (Piezon® Master 400). The modifications aimed to enhance procedural flexibility and ease of use, and included "enhanced ultrasonic performance." The basis for substantial equivalence is that these modifications do not alter the general intended use or fundamental scientific technology. New applications (cavity preparation, cementation, retrograde root canal preparation) are covered by equivalence to another predicate device (EMS KERMIT®) which was previously cleared for those uses.

Performance testing was conducted as part of design verification and validation activities. These included:

• Electrical safety testing
• Electromagnetic compatibility testing (EMC)
• Completion of Design Control Checklists to ensure all design requirements were fulfilled.

The results of these engineering/regulatory compliance tests "confirm that the modified EMS Piezon® Master 600 is safe and effective for the indicated dental and periodontal cleaning, preparatory, and restorative procedures." The FDA's substantial equivalence determination implies these tests met the necessary acceptance criteria for the device to be marketed.

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