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The Hawkeye™ Introducer Systems, and accessories, are intended for use in minimally invasive surgery allowing access for delivery and placement of surgical instruments (e.g., ESTECH COBRA Adhere XL, AFfirm Pacing Probe). They are indicated for patients requiring blunt dissection of tissue including structures in the thoracic space.

The Hawkeye family consists of two products; the ESTECH Hawkeye Magnetic Introducer System and the ESTECH Hawkeye Scope System.

The Hawkeye Magnetic Introducer System is comprised of three main components:

• 1. Hawkeye Magnetic Cannula Assembly
• 2. Magnetic Introducer
• 3. Malleable Stylet

Both Systems allow for endoscopic visualization within the thoracic cavity, blunt dissection, and facilitate the placement of surgical equipment. These pieces may be packaged, sterilized and sold separately. They are single-use only.

Please provide the acceptance criteria and the study that proves the device meets the acceptance criteria. The requested information is specific to clinical performance, interpretability, or diagnostic accuracy studies.

The provided document describes the Hawkeye™ Introducer Systems, a device intended for minimally invasive surgery to allow access for delivery and placement of surgical instruments and for blunt dissection of tissue.

However, the document does not contain information regarding:

• Any specific acceptance criteria related to the device's clinical performance, interpretability, or diagnostic accuracy (e.g., sensitivity, specificity, accuracy thresholds).
• Details of a study that tested the device against such criteria. The "Summary of Supporting Data" only mentions:
  • Biocompatibility analysis (compliance with ISO 10993)
  • Bench testing (met proposed product specifications)
  • Animal testing
  • Cadaver testing

Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance for a clinical or diagnostic accuracy study. The document focuses on establishing substantial equivalence based on material properties, design, and intended use compared to a predicate device, rather than providing clinical performance data.

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