Search Results

The HARMONIC Hook instrument is 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, gynecologic, exposure to orthopedic structures (such as spine and joint space), and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).

The HARMONIC Hook instrument is a sterile, single patient use instrument, consisting of a 5 mm titanium blade. The instrument allows for the cutting of soft tissue and coagulation of vessels up to and including 2 mm in diameter. The working length of the HARMONIC Hook instrument is 32 cm.

The HARMONIC Hook instrument works with the Generator G11 as part of a system. The device system has four essential parts: the Generator G11 (GEN11), the footswitch (FSW11), the handpiece (HPBLUE), and the HARMONIC Hook (HARBH32). The HARMONIC Hook has an internal torque wrench for assembly to the HPBLUE handpiece. The HPBLUE handpiece connects the HARMONIC Hook device to the Generator G11, and converts electrical energy into mechanical motion (ultrasonic energy). The high-frequency mechanical vibration at 55.5 kHz of the HARMONIC Hook blade transects, dissects, and coagulates tissue, sealing vessels up to 2 mm. This ultrasonic vibration, a form of mechanical energy, does not allow electricity to pass to or through the patient.

The HARMONIC Hook can be operated using the 360° circumferential activation switch on the handle housing or the right footswitch pedal (MAX) of the footswitch (FSW11). Only the right footswitch pedal is active when using the device; the left footswitch pedal (MIN) is not active when using HARMONIC Hook.

The provided text describes a medical device called the HARMONIC Hook and its premarket notification to the FDA. The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and performance data for an AI/algorithm-based device.

Therefore, many of the requested details, such as those pertaining to AI/algorithm performance, ground truth establishment, expert adjudication, and multi-reader multi-case studies, are not applicable and not found in the provided text, as the HARMONIC Hook is a physical surgical instrument, not an AI or software-based device.

However, based on the non-AI related performance data mentioned, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions "predetermined acceptance criteria" for blade amplitude and frequency during bench testing, and that the data "met" these criteria. However, the specific numerical values for these criteria and the reported performance are not provided.

2. Sample Size Used for the Test Set and Data Provenance:

• Bench Testing (Blade Amplitude/Frequency): The sample size is not specified. The provenance is laboratory evaluations.
• Acute Animal Testing: The sample size (number of animals) is not specified. It was an acute study (implying prospective). The country of origin is not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable in the context of an AI device. For the physical device testing, the "ground truth" was likely established by direct measurement during bench testing and observation/histology in animal studies by qualified personnel, but the number and qualifications of these individuals are not specified.

4. Adjudication Method for the Test Set:

• Not applicable as there's no mention of subjective interpretation of results requiring adjudication in the context of AI. For the physical device, results were likely directly measured or observed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. Not applicable to this type of device. The study described was an animal model comparison to a predicate device, focusing on physical tissue effects. The document explicitly states: "This premarket notification does not rely on human clinical trial data to demonstrate substantial equivalence."

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

• Not applicable. This is a physical surgical instrument, not an algorithm.

7. The Type of Ground Truth Used:

• Bench Test: Direct physical measurements (e.g., of blade amplitude and frequency).
• Acute Animal Testing: Direct observation of tissue effects (creation of tissue planes, dissection, hemostasis) and sealing of vessels up to 2mm. This could have been confirmed by gross observation and potentially histology, though not explicitly stated for the animal study.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/machine learning device that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

• Not applicable. (See point 8).

Ask a specific question about this device