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Laparoscopic surgical manual instruments are designed to be used endoscopically through cannula to perform cutting, grasping, dissecting, retracting, and manipulating functions. The Ergonomic handle is intended to be used with 5mm inserts available from K&W and previously cleared under K973259.

Symmetry® laparoscopic surgical manual instruments consist of a handle and a 5mm shaft, which hold various 5 mm inserts cleared under K973259. The shaft comes in two lengths: 33 cm and 45 cm. One handle can be used in combination with a variety of different 5 mm inserts. The handles have monopolar posts which allow them to be used for electrosurgery.

The ergonomic laparoscopic handles have an adjustable grip. They may be used in one of the three handle positions: pistol grip, hybrid, and inline. To change the handle position, retract the position adjustment button and lock the grip in the chosen position. The handle comes in two sizes.

This document describes the Ergonomic Handle (K173272), which is an accessory to laparoscopic surgical manual instruments. The device allows for adjustable grip angles to improve surgeon comfort. The information provided is for regulatory clearance (510(k)) and focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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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 Shear with Ergonomic Handle (ACE45E), Hand Control is a sterile, single patient use, ultrasonic surgical instrument 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 instrument is designed for use in open or laparoscopic procedures and is available in the 45 centimeter shaft length. The Harmonic ACE instrument is used for the coagulation of vessels up to and including 5 mm in diameter.

This submission describes a medical device, the HARMONIC ACE Curved Shears with Ergonomic Handle, which is an ultrasonic surgical instrument. The submission is for a 510(k) premarket notification, indicating that the manufacturer is demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" and "study" described are focused on showing that the modified device performs equivalently to the existing predicate device, not necessarily against a specific clinical performance metric for a novel AI system.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated. The text mentions "Preclinical porcine vessel sealing validation studies," implying animal testing. No specific number of animals or vessels is provided.
• Data Provenance: Preclinical studies, specifically "porcine vessel sealing validation studies." This indicates animal (swine) data. The studies were conducted by Ethicon Endo-Surgery, LLC. There is no mention of country of origin for the data other than the company's location in Cincinnati, OH. The studies are by nature prospective as they are validation studies for a modified device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable as this describes a physical surgical instrument, not an AI/ML device that requires expert ground truth for image or data interpretation. The performance assessment would typically be based on objective physiological measurements (e.g., burst pressure, thermal damage area) and direct observation of surgical outcomes in the animal model by research personnel, not expert panel consensus as would be used for diagnostic AI.

4. Adjudication method for the test set

This section is not applicable for the same reason as point 3. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert labeling or interpretation, which is not relevant for the performance testing of this physical surgical instrument.

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

This section is not applicable. The device is a surgical instrument, not an AI diagnostic or assistive tool for human readers. No MRMC study was conducted.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done

This section is not applicable. This is a physical surgical instrument, not an AI algorithm. Its performance is inherent to the device itself, operated by a surgeon.

7. The type of ground truth used

The "ground truth" for the device's performance was established through objective physiological measurements and direct observation in preclinical porcine vessel sealing validation studies. This includes measurements for transection times, hemostasis, thermal spread, and the ability of sealed vessels to withstand blood pressure challenges.

8. The sample size for the training set

This section is not applicable. This is a physical surgical instrument, not an AI/ML device that requires a training set. The device was developed and then tested against its design criteria.

9. How the ground truth for the training set was established

This section is not applicable for the same reason as point 8.

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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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