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The Piezoelectric System, distributed by Synthes, is an ultrasonic surgical system consisting of handpieces and associated tips, for cutting bone substitutes and metal. The system can be used for osteotomy, osteoplasty, decorticating, drilling, shaping, and smoothing of bones and teeth, in a variety of surgical procedures, including general orthopaedic, otolaryngological, maxillofacial, oral, hand, foot, neurosurgical spine, and plastic/reconstructive surgery.

The Satelec PIEZOELECTRIC SYSTEM is an operative unit that consists of a console, a power cord, a foot pedal, a wrench and a handpiece. The PIEZOELECTRIC SYSTEM device uses piezoelectric ultrasound technology to generate mechanical microvibrations for bone cutting, with minimal trauma to soft tissue. A variety of attachments will be available for the Piezoelectric System for cutting bone, bone substitutes, osteotomy, osteoplasty, decorticating, drilling, shaping and smoothing of bones and teeth in a variety of surgical procedures. These attachments will be available "Sterile" -Single Use only (do not re-use).

This document is a 510(k) premarket notification for a medical device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The information provided is primarily for classifying the device and establishing substantial equivalence to previously marketed devices.

Therefore, I cannot fulfill your request as the necessary information is not present in the provided text.

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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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The Synthes Electric Pen Drive (EPD) System is indicated for screw insertion, pin and wire placement, cutting of bone and metal, drilling, reaming, decorticating, shaping and smoothing of bones and teeth in a wide variety of surgical procedures, including but not limited to general orthopedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngological, reconstructive and spine surgery.

The Synthes Electric Pen Drive System consists of a console, handpieces, attachments, footswitch, and cutting tools. The console is connected to the mains by an electric cord, and includes connectors for the handpieces and the footswitch, as well as speed controls, torque limiting feature, and irrigation pump. The handpieces are pen-shaped, and will be available in two versions: 60,000 rpm and 90,000 rpm. The handpieces are connected to the console via a sterilizeable cord. The rotation speed of the motor can be controlled via the footswitch or a removable handswitch. Multiple attachments are available that have a quick-connect into the handpieces; these attachments accept various cutting tools, including drill bits, burrs and saw blades.

I apologize, but the provided text from the 510(k) summary for the "Synthes Electric Pen Drive (EPD) System" (K043310) does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a standard 510(k) summary, which focuses on demonstrating "substantial equivalence" to a predicate device. It includes:

• Sponsor and Device Name
• Classification and Predicate Device
• Device Description
• Intended Use Statement
• A general statement about comparative information supporting substantial equivalence.

Without specific performance data, statistical metrics, or details of a study, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Training set sample size.
9. How training set ground truth was established.

This type of information is typically found in detailed validation reports or clinical study summaries, which are not part of the publicly available 510(k) summary document provided.

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