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The Harmonic Shears are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space), and other open and endoscopic procedures.

The Harmonic ACE Curved Shears with Scissor Handle (ACE-S) is a sterile, single patient use, ultrasonic surgical instrument consisting of a scissor handle housing assembly with hand control buttons, a rotating shaft with a curved, ultrasonic blade and a clamp arm on a 14 cm length shaft. The handle housing has an integrated audible/tactile mechanism for indicating full closure. The instrument is designed for use in open or laparoscopic procedures. The Harmonic ACE instruments are used for the coagulation of vessels up to and including 5mm in diameter. The Harmonic ACE Curved Shears with Ergonomic Handle (ACE-E), Hand Control are sterile, single patient use, ultrasonic surgical instruments consisting of an ergonomic housing assembly with hand control buttons, a rotating shaft with curved, ultrasonic blades and clamp arms. The handle housing has an integrated audible/tactile mechanism for indicating full closure. The instruments are designed for use in open or laparoscopic procedures and are available in various shaft lengths. The Harmonic ACE instruments are used for the coagulation of vessels up to and including 5mm in diameter.

This is a submission for a 510(k) premarket notification for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive de novo clinical studies with detailed acceptance criteria and expert ground truth.

Based on the provided document, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states, "The devices continue to meet predetermined acceptance criteria." The listed parameters were part of the "preclinical study criteria for success."

2. Sample Size and Data Provenance

• Sample Size: Not explicitly stated for specific tests (e.g., number of vessels, number of animals). The document refers to "Preclinical porcine vessel sealing validation studies."
• Data Provenance: Porcine (animal) model, preclinical.
• Retrospective or Prospective: Prospective (validation studies conducted for this submission).

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. This submission is for a physical surgical instrument, not an AI/software device that requires expert-established ground truth on diagnostic images or other data for its performance evaluation. The "ground truth" here is objective physiological and physical measurements.

4. Adjudication Method for the Test Set

• Not Applicable. As this is not an AI/software device involving expert consensus on interpretations, there is no adjudication method for a test set in the traditional sense. The metrics are objective physiological measurements.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• No. This is not a software/AI device, and therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or performed.

6. Standalone (Algorithm Only) Performance Study

• Not Applicable. This is a physical surgical instrument; there is no standalone algorithm to evaluate.

7. Type of Ground Truth Used

• Objective Physiological Measurements and Physical Device Performance Criteria. The ground truth for evaluating the device's performance relies on direct measurements of:
  • Transection times
  • Hemostasis (presumably evaluated visually and/or through blood loss)
  • Thermal spread (measured physically)
  • Vessel sealing integrity under blood pressure challenges
  • Functionality and reliability against design requirements.

8. Sample Size for the Training Set

• Not Applicable. This is a hardware modification submission, not an AI/machine learning model that typically requires a "training set." Device development involves iterative design, testing, and refinement, but not in the sense of an algorithm training on a dataset.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. There is no "training set" or corresponding ground truth establishment in the context of an AI/ML model for this device. The design control process involves verification and validation activities guided by engineering specifications and predicate device performance.

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