(138 days)
The Harmonic Scallop Blade is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space), ENT (Ears, Nose, Throat), and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).
The Generator G11 provides radiofrequency power to drive EnSeal electrosurgical instruments that are used during open or laparoscopic general and gynecological surgery to cut and seal vessels and to cut, grasp, and dissect tissues. In addition, the generator provides power to drive Harmonic ultrasonic surgical instruments that are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. EnSeal and Harmonic instruments when used with the Generator G11 have not been shown to be effective for sterilization procedures or tubal coagulation. Do not use these instruments for these procedures.
The Harmonic® Scallop Blade is a sterile, single patient use device, consisting of a titanium blade with a non-removable gray sheath. The Harmonic® Scallop Blade instrument allows for the cutting of soft tissue and coagulation of vessels up to and including 2 mm in diameter. A soft grip pad on the handle housing facilitates grasping. The instrument is equipped with an integrated internal torque wrench, which is used for assembly to the Harmonic® Hand Piece.
The device system has four essential parts: the generator, the Footswitch, the Hand Piece, and the instrument. The Generator G11 supplies energy to Enseal® electrosurgical instruments and Harmonic® ultrasonic surgical instruments. The generator utilizes a touchscreen display interface and has a receptacle port that accepts either Enseal® or Harmonic® devices. Connectors (one for Harmonic® and one for Enseal® instruments) are used to enable the generator to power currently cleared surgical instruments. The Generator G11 hardware has not changed from the Predicate. The Harmonic® Scallop Blade instrument is designed for use exclusively with the Generator G11 software version 2013 1 or later, which has been updated to increase the maximum Power output to 60W required to power the Harmonic Scallop Blade.
The document describes the Harmonic® Scallop Blade and Generator G11 and their substantial equivalence to predicate devices, but it does not provide a table of acceptance criteria or explicitly reported device performance metrics against specific criteria.
Instead, it relies on demonstrating comparable performance to existing, legally marketed predicate devices through various tests.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the document in a tabular format with specific acceptance criteria values and corresponding device performance values. The document states that "Device performance was assessed against design requirements, including bench and preclinical testing." and that "These testing criteria demonstrate that the Harmonic® Scallop Blade performs as intended and is substantially equivalent to the Predicate Devices."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: The document does not specify the exact sample sizes used for the ex-vivo or in-vivo tests. It generally refers to "preclinical studies" and "bench testing" without providing numerical details for the test sets.
- Data Provenance: The document does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not provided. The document describes "preclinical studies" which typically involve animal models or cadaveric tissue, and "bench testing." There is no mention of experts establishing a "ground truth" in the context of human data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided. As there's no mention of human experts establishing ground truth from test sets and no clinical trial data, adjudication methods are not discussed.
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:
Not applicable. The device is an electrosurgical/ultrasonic surgical instrument (Harmonic Scallop Blade) and its associated generator (Generator G11). This is not an AI-powered diagnostic or interpretive device, and therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a surgical instrument and generator system, not an algorithm. Performance is assessed on the physical device's function, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Given the nature of the device (a surgical instrument for cutting and coagulation), the "ground truth" implicitly refers to objective measurements of performance characteristics in ex-vivo and in-vivo (preclinical) settings. These would include:
- Device durability: Ability to withstand repeated use or specific stresses.
- Acoustics: Noise levels.
- Reliability: Consistency of performance.
- Spot coagulation: Effectiveness in stopping bleeding at a specific point.
- General procedure capability: Overall functionality during simulated surgical tasks.
- Hemostasis following muscle transection: Effectiveness in controlling bleeding after cutting muscle tissue.
- Tissue effects and healing response: Microscopic and macroscopic changes in tissue after device application, and how it heals. This would likely involve pathology and histology in preclinical studies.
- Blade strength to access orthopedic procedures: Mechanical strength and effectiveness in interacting with bone.
8. The sample size for the training set:
Not applicable. This device is not an AI/machine learning model that requires a training set. The "training" for such devices typically involves design iterations, bench testing, and preclinical studies to refine the device's physical and functional characteristics.
9. How the ground truth for the training set was established:
Not applicable. As explained above, this is not an AI/machine learning device.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.