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The PIEZON 150 is a device for delivering ultrasonic movement and water to a stainless steel tip which is used by a dentist or dental hygienist. The indications for use are:
• Periodontal pocket lavage with simultaneous ultrasonic tip movement
• Scaling and root planning
• Removal of supra and subgingival calculus and stains from teeth
• Intended for use in dental and periodontal applications performed by an ultrasonic scaler.

The proposed PIEZON 150 ultrasonic scaler is a modification of the previously cleared miniPiezon (K953026). The working instrument for the scaling function is the handpiece, which is connected to the control unit via a handpiece cord and mounted in a holder on the side of the control unit.

The PIEZON 150 connects to an external water supply and delivers water via the connected handpiece. The power of ultrasonic vibrations is adjusted via a power knob on the top of the control unit. The flow rate of the irrigating liquid is adjusted via a rotating knob located on the side of the control unit.

The PIEZON 150 is supplied with two handpieces - the Piezon Handpiece LED (lightemitting diode) or the Piezon Handpiece. The Piezon Handpiece LED is identical to the Piezon Handpiece LED described in K093000 for the Piezon Master 700 ultrasonic scaler (K093000) and contains 6 LEDs in the body of the handpiece and a light guide that is positioned under the nozzle. The Piezon Handpiece is identical to the Piezon Handpiece LED, except that the Piezon Handpiece does not have LEDs or the light guide. All instruments compatible with the PIEZON 150 have been previously cleared (see 510(k) numbers referenced in Section 3).

The modifications made to the miniPiezon to produce the PIEZON 150 include:
• Shape and contours of the control unit redesigned to accommodate the finger-tip power control, improve aesthetics, facilitate cleaning, and enhance ergonomics
• Use of a potentiometer for power regulation via the power control knob to improve ultrasonic power control.
• One operating mode with a Standard power range (0-100% power) for scaling procedures and a Perio range (0-37.5% power) for periodontal procedures
• Supported handpieces (Piezon Handpiece (FT-215#) and Piezon Handpiece LED (FT-223#)
• Ultrasonic generator upgraded to EJ-110. the Light command, Motor/Solenoid valve command and Pedal command have been added.

The provided document is a 510(k) summary for a medical device modification, specifically for the PIEZON 150 ultrasonic scaler. It states that no clinical testing was conducted for this submission. Instead, substantial equivalence was determined based on non-clinical performance testing and comparison to predicate devices.

Therefore, the requested information regarding acceptance criteria derived from a study proving the device meets those criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, cannot be extracted from this document, as these types of studies were not performed or reported for this submission.

Here's a summary of what can be gathered, addressing the relevant points from your request:

1. A table of acceptance criteria and the reported device performance

The document states: "Non-clinical performance testing demonstrates that all design inputs for the PIEZON 150 were satisfied by the design outputs, that the device meets electrical safety and electromagnetic compatibility requirements, and functional and performance requirements."

While the document generally states that "functional and performance requirements" were met, it does not explicitly list quantitative acceptance criteria for these functional performance aspects, nor does it provide specific "reported device performance" metrics against such criteria in a measurable way beyond stating they were satisfied.

The comparison table (sections 3 and 4 of the input) highlights the technological characteristics of the proposed device and predicate devices, which implicitly defines the expected performance by showing similarity. For instance:

The "reported device performance" essentially aligns with the characteristics of the predicate devices, and any noted "improvements" (like the potentiometer for power regulation) are presented as enhancing an already acceptable functionality.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical test set data was used. Non-clinical performance testing was conducted, but details on sample sizes or data provenance for these engineering tests are not provided.

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 clinical studies requiring expert ground truth were conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical studies requiring adjudication were conducted.

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 an ultrasonic scaler, not an AI-based diagnostic tool, and therefore MRMC studies are not relevant. No such study was conducted.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical studies requiring ground truth were conducted. Substantial equivalence was based on non-clinical performance and comparison to predicate devices, implying that the established safety and efficacy of the predicate devices serve as the "ground truth" for the modified device's expected performance.

8. The sample size for the training set
Not applicable. No algorithm training was performed for this hardware device.

9. How the ground truth for the training set was established
Not applicable. No algorithm training was performed and therefore no ground truth for a training set was established.

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