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The PIEZON 250 is a device for delivering ultrasonic movement and irrigant 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 planing
• Removal of supra and subgingival calculus and stains from teeth

The proposed PIEZON 250 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. In the proposed PIEZON 250, irrigating liguid is pumped to the handpiece from a 350ml (or 500ml) irrigating bottle by a peristaltic pump rather than from an external water supply. The flow rate of the irrigating liquid is adjusted via a rotating knob located on the side of the control unit. The PIEZON 250 is supplied with two handpieces - the Piezon handpiece LED (lightemitting diode) and 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 250 have been previously cleared (see 510(k) numbers referenced in Section 3).

The provided document describes a 510(k) submission for a device modification of the PIEZON 250 ultrasonic scaler. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than proving efficacy through clinical studies and acceptance criteria as would be the case for novel devices. Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically understood for new device validation, is largely not applicable in this context.

However, I can extract information related to the "non-clinical performance testing" which serves a similar function for device modifications.

Here's a breakdown of the available information:

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

The document does not explicitly state "acceptance criteria" in a quantitative table format with corresponding "reported device performance" as would be seen for a clinical trial or algorithm validation study. Instead, it refers to fulfilling "design inputs" and meeting "functional and performance requirements" through non-clinical testing.

The basis for substantial equivalence is listed as:

• Intended Use: Identical to predicate (dental and periodontal applications, scaling, root planing, removal of calculus and stains).
• Treatment Site: Identical to predicate (subgingival and supragingival).
• Function: Identical to predicate (ultrasonic scaling).
• Mechanism of Action: Identical to predicate (ultrasonic energy).
• Components: Mostly identical, with modifications in the control unit, handpieces, and irrigation system being the primary differences.

Implicit Acceptance Criteria (derived from the substantial equivalence claim and non-clinical testing summary):

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable. The document states "No clinical testing was conducted for this submission." The evaluation relied on non-clinical performance testing and comparison to predicate devices, not a clinical test set.
• Data Provenance: Not applicable for a clinical test set. The non-clinical testing would typically be performed in a lab setting by the manufacturer (E.M.S. ELECTRO MEDICAL SYSTEMS S.A. in Switzerland).

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 as no clinical test set was used and no ground truth was established by experts in the context of a clinical study. The "ground truth" here is the established safety and effectiveness of the legally marketed predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable as no clinical test set was used.

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 is not an AI device, and no MRMC comparative effectiveness study was conducted.

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

• Not applicable. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" in this context is the regulatory determination of safety and effectiveness for the predicate devices (miniPiezon and Piezon Master 700). The PIEZON 250 demonstrates substantial equivalence to these already cleared devices through non-clinical testing and comparison of technological characteristics.

8. The sample size for the training set

• Not applicable. This is not a machine learning/AI device, so there is no "training set."

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

• Not applicable. There is no training set for this type of device submission.

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