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The SenoRx ES-2000 electrosurgical generator and accessories are intended for general surgical procedures where electrosurgical cutting or coagulation of soft tissues is required. It is not intended for use on the skin or where electrosurgery is contraindicated.

The ES-2000 Electrosurgical Generator and Shape Select Electrosurgical Scalpel are designed to cut and coagulate soft tissue. The ES-2000 uses radio frequency (RF) energy to perform both cutting and coagulation, using SenoRx compatible disposable handpieces.

I am sorry, but the provided text does not contain the specific information required to answer your request regarding acceptance criteria, study details, and sample sizes for the SenoRx Inc. ES-2000 Generator System and Shape Select Electrosurgical Scalpel.

The document is a 510(k) summary for a medical device and primarily focuses on:

• Submitter and Device Information: Company name, address, contact, device name, and classification.
• Predicate Device Identification: Listing similar devices already on the market.
• Device Description: A brief overview of how the device works.
• Intended Use: What the device is designed for.
• Comparison with Predicate Devices: Stating that the new device is comparable to existing ones.
• FDA Correspondence: The FDA's letter granting clearance, confirming substantial equivalence to predicate devices, and outlining regulatory requirements.
• Indications for Use: The FDA-approved indications for what the device should be used for.

Missing from this document are details about:

• Acceptance Criteria and Reported Device Performance: This would typically involve specific metrics (e.g., power output accuracy, impedance range, tissue effect consistency) and the results achieved.
• Study Details: There is no mention of a specific study, its design, sample sizes (test or training), data provenance, expert involvement, adjudication methods, MRMC studies, or standalone performance.
• Ground Truth Establishment: How any "ground truth" was determined is not discussed.

For a 510(k) submission, the primary requirement is to demonstrate substantial equivalence to a predicate device, rather than to conduct de novo clinical trials with detailed performance metrics and extensive study designs often seen with novel high-risk devices or PMA applications. The comparison with predicate devices and regulatory compliance is typically sufficient for 510(k) clearance.

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