(126 days)
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
| Acceptance Criterion (Parameter for Success) | Reported Device Performance |
|---|---|
| Transection times (Preclinical) | Demonstrated equivalent performance to predicate. |
| Hemostasis (Preclinical) | Demonstrated equivalent performance to predicate. Specifically, "seals vessels up to and including 5 mm". |
| Thermal spread measurements (Preclinical) | Demonstrated equivalent performance to predicate. |
| Blood pressure challenges on sealed vessels (Preclinical) | Demonstrated equivalent performance to predicate. |
| Functionality and reliability (Testing) | Meets design requirements following device modifications. |
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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