Search Results

The Disposable Monopolar Laparoscopic Tips and Reusable Handles are designed to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/laparoscopic, general surgical procedures.

The Disposable Monopolar Laparoscopic Tips and Reusable Handles are sterile packaged single use monopolar attachments intended for use in combination with the Reusable Handle. It is designed to include graspers, dissectors, forceps, and scissors, intended to grasp, manipulate, cut, and cauterize soft tissue.

The Disposable Monopolar Laparoscopic Tips are offered in a working diameter of 5 mm with various jaw patterns including scissors, graspers, forceps and dissectors.

The Reusable Handle is supplied non-sterile and in intended to be sterilized by the user using an autoclave process. The shaft of the handle is 34 cm in length and is made from stainless steel covered with an external insulation. Handles are offered in ratcheting configurations and are intended to be connected to the sterile disposable tips. Once connected the rotation knob provides 360 degrees of rotation for the instrument shaft and jaws. The handle includes an RF Post for electrosurgery when attached to an approved electrosurgical generator to provide coagulation of tissue when used with an appropriate ground (neutral) electrode.

The provided document is a 510(k) premarket notification for a medical device (Disposable Monopolar Laparoscopic Tips and Reusable Handles). It describes the device, its intended use, and substantial equivalence to a predicate device.

However, the document does not contain information about:

• Acceptance criteria for a study, beyond the general statement that nonclinical testing "met all design specifications and are substantially equivalent to the predicate device."
• A study proving the device meets acceptance criteria in the format typically seen for algorithm performance (e.g., sensitivity, specificity, AUC). The "study" mentioned here is nonclinical testing to ensure electrical performance and thermal spread are comparable to the predicate device, not a diagnostic accuracy study.
• Sample sizes for test sets (in the context of algorithm evaluation).
• Data provenance, number of experts, adjudication methods, MRMC comparative effectiveness studies, standalone performance, type of ground truth, training set sample size, or how training ground truth was established. These questions are highly relevant to the evaluation of AI/ML-based medical devices, which this product is not.

The document describes a traditional medical device (electrosurgical instruments) and demonstrates substantial equivalence through nonclinical testing, primarily focused on electrical safety, biocompatibility, sterilization, and basic performance parameters like thermal spread in tissue. It explicitly states, "There were no clinical trials performed on these devices."

Therefore, I cannot provide a table of acceptance criteria and reported device performance for an AI/ML device, nor can I answer the specific questions related to the study design for such a device, as this information is not present in the provided text.

The information that is provided regarding "tests" can be summarized as:

Nonclinical Tests Performed:

• Biocompatibility Testing: Conforms to ISO 10993 standards (Parts 1, 5, 7, 10, 11).
• Medical Electrical Equipment Safety Testing: Conforms to IEC 60601 series standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18).
• Aging Study
• Autoclave Sterilization Validation
• Ethylene Oxide Sterilization: Per ISO 11135:2014.
• Performance Studies: Designed to test appearance, dimensions, corrosion resistance, operational forces, cutting efficacy, and thermal effects on tissue.
• Electrical Performance: Followed FDA guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery," requiring testing on three different tissue types (e.g., Kidney, Muscle as shown in tables) at minimum, default, and maximum generator power to simulate thermal spread.

Table 1 & 3: Thermal Damage Results (Example provided for Kidney and Muscle Tissue)

Summary and Limitations based on the provided text:

1. Acceptance Criteria and Reported Device Performance: General statement that "Results showed an equivalent thermal spread under the same conditions across the different tissue types and power settings" compared to the predicate. The thermal damage tables provide measured performance for the subject device. Specific numerical acceptance criteria (e.g., "thermal spread must be

Ask a specific question about this device