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The Piezosurgery MEDICAL is an ultrasonic surgical system consisting of handpieces and associated tips for cutting bone, osteotomy, osteoplasty and drilling in variety of surgical procedures, including but not limited to otolaryngological, oral/maxillofacial, hand, foot, neurosurgical, spine, and plastic/reconstructive surgery. It may also be used with endoscopic visual assistance to perform the above listed procedures.

The Piezosurgery® Medical device is an ultrasonic surgical system consisting of a central console with two integral peristaltic irrigation pumps, and two detachable handpieces. Each handpiece is connected to the console electrically, and each is also connected to one of the irrigation pumps via an irrigation tubing kit. The handpieces contain the ultrasonic transducers. A separate electricallyoperated footswitch is provided with the device, which also attaches to the central console. The irrigation tubing kits and insert tips are supplied sterile and are intended for single-use. A range of optionally available handpiece tips provides the surgeon with a wide variety of options for drilling, cutting and sawing.

The console has a touch-screen display and contains general control system circuits and two ultrasonic generators which drive the handpiece functions. The irrigation tubing kit is fed with physiological saline solution during the surgical procedure from saline bags (not supplied) which hang from drip stands that attach to the rear of the central console.

The user may activate either of the two handpieces by the selection from the LCD touch-screen and by pressing the footswitch.

This looks like a 510(k) premarket notification for a medical device called Piezosurgery Medical. It's a submission to show substantial equivalence to already marketed devices, not a study demonstrating performance based on acceptance criteria in the way you've described for an AI/ML device.

Therefore, many of the specific questions about acceptance criteria, study design, sample sizes, ground truth, experts, and AI performance cannot be directly answered from the provided text. This document is focused on regulatory clearance based on equivalence, not a clinical performance study with specific metrics and acceptance criteria for a new algorithmic device.

However, I can extract what is provided related to "performance data" which, in this context, refers to the device's operational characteristics rather than clinical outcomes measured against statistical targets.

Here's an attempt to address your request based only on the provided text, highlighting where information is not applicable or missing for this type of submission:

1. Table of acceptance criteria and the reported device performance

This document does not present "acceptance criteria" in the context of specific quantitative efficacy or diagnostic performance targets, nor does it provide a direct "reported device performance" against such criteria. The "Performance Data" section describes the device's operational capabilities.

2. Sample size 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. This submission is for regulatory clearance based on substantial equivalence to predicate devices, not a clinical trial with a test set of patient data.
• Data Provenance: Not applicable for a clinical test set. The manufacturer is Mectron Spa, Italy, and the 510(k) owner is Piezosurgery SRL, Italy.

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

• Not applicable. There is no mention of a test set requiring expert-established ground truth for performance evaluation in this 510(k) submission.

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

• Not applicable. No test set requiring adjudication is mentioned.

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 a surgical instrument (Piezosurgery Medical), not an AI/ML diagnostic or assistive tool for human readers (e.g., radiologists). Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this device.

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

• Not applicable. The Piezosurgery Medical is an ultrasonic surgical system, a physical instrument operated by a surgeon ("human-in-the-loop" by design), not a standalone algorithm.

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

• Not applicable. The submission focuses on the device's functional and technological characteristics and its intended use, demonstrating equivalence to predicate devices. It does not present a clinical performance study that would require a defined "ground truth" in the context of diagnostic accuracy or treatment success.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device where a "training set" would be used.

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

• Not applicable. As above, there is no training set for this type of device.

Summary of what is provided regarding performance and regulatory rationale:

The "Performance Data" section describes the device's operational flexibility (four cutting modalities, five irrigation levels, seven power levels) and its inherent technological features like ultrasonic frequency modulation and automatic tuning to achieve the desired surgical effect (a "hammering effect" for cutting action).

The conclusion of the 510(k) submission states that: "Based on the information contained within this submission, it is concluded that the Piezosurgery Medical device is substantially equivalent to the predicate devices already in interstate commerce within the USA." This statement, along with the FDA's clearance letter, indicates that the device met the regulatory standard of substantial equivalence, which is the primary "acceptance criterion" for a 510(k) submission – meaning it is as safe and effective as a legally marketed predicate device. The information supporting this includes the device description, intended use, and technological characteristics, as well as the operational "performance data" detailed above.

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