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The Sirona Dental Systems PerioScan is an ultrasonic scaler that aids in the recognition of calculus and intended for use in the following dental and periodontal applications:

• . Aiding in subgingival calculus detection
• Calculus removal (subgingival and supragingival) .
• Retrograde root treatment .
• . Endodontics
• Insertion of inlays .
• . Micropreparation (cavity preparation)
• Periodontology

The Sirona PerioScan Ultrasonic Scaler consists of a table-top unit with two detachable irrigant bottles with caps (lids), a footswitch, an ultrasonic handpiece, hoses and connectors, a variety of optional tips for different dental procedures, and a tool for attaching the tips to the handpiece.

The PerioScan unit provides ultrasonic scaler therapy as described in the above indications and detection-aid-function for recognition of subgingival calculus.

The table-top unit houses the operator input and controls for the supply of irrigant, cooling liquid and light for the handpiece. The device is connected to 120V mains power supply, and it may be connected to a mains water supply. The irrigant for the handpiece is drawn from the two internal liquid containers or from the mains water supply. The handpiece is connected to the table-top unit via a hose and can be deposited in the claw. A footswitch with two single foot pedals is used to control the handpiece. The PerioScan handpiece is an electrically operated scaler driven by a piezo ceramics. The handpiece includes an illumination and two signal LEDs and a Spray water controller, all located in the hose.

PerioScan switches between detection and scaling operation mode, if selected, using the footswitch. Detection of subgingival calculus is signaled through an illuminator ring and operator display. Additionally a signal tone may be emitted if desired.

The provided text describes the Sirona Dental Systems PerioScan, an ultrasonic scaler with an added detection-aid function for recognizing subgingival calculus. However, the document does not contain specific acceptance criteria or a study detailing the device's performance against such criteria. It primarily focuses on demonstrating substantial equivalence to a predicate device.

Therefore, many of the requested information points cannot be extracted from this document, as the detailed study methodologies and results are absent.

Here's what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Clinical studies and testing have been performed that validate detection-aid-function for recognition of subgingival calculus for the proposed PerioScan device." However, it does not provide details about these studies, including specific acceptance criteria or the actual performance metrics achieved.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified in the document.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not specified in the document.
• Qualifications of Experts: Not specified in the document.

4. Adjudication method for the test set

• Adjudication Method (e.g., 2+1, 3+1, none): Not specified in the document.

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

• The document implies that the device "aids in the recognition of calculus." However, it does not describe an MRMC comparative effectiveness study or quantify any effect size of human improvement with the device vs. without it. The focus is on the device's ability to signal the presence of calculus.

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

• The device is an "ultrasonic scaler that aids in the recognition of calculus," implying a human-in-the-loop scenario where the device provides a signal to the operator. Therefore, a standalone (algorithm only) performance assessment, without human interpretation of the signal, would not be directly applicable to its stated function. The document does not describe such a standalone study.

7. The type of ground truth used

• Type of Ground Truth: Not specified in the document. While "subgingival calculus detection" is the target, the method used to definitively establish the presence or absence of calculus for ground truth generation in the "clinical studies and testing" is not described.

8. The sample size for the training set

• Sample Size for Training Set: Not specified in the document. The document mentions "clinical studies and testing," but it does not differentiate between training and test sets, nor does it provide sample sizes for either.

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

• How Ground Truth for Training Set was Established: Not specified in the document.

Summary of what is known about the study:

• Device: Sirona Dental Systems PerioScan Ultrasonic Scaler with a detection-aid function for subgingival calculus.
• Purpose of Study (Implied): To validate the detection-aid function for recognition of subgingival calculus.
• Outcome: The clinical studies and testing performed validate this function, leading to a determination of substantial equivalence to a predicate device (Sirona PerioScan Ultrasonic Scaler without the detection-aid function).
• Limitations from this document: The document is a 510(k) summary, which generally provides a high-level overview. It does not include the detailed study protocols, acceptance criteria, results, or methodologies that would be found in a full study report.

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