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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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