Search Results

McPherson Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps are intended for use by a physician familiar with electrosurgery for bipolar coagulation and irrigation of tissue for general open surgery where coagulation of soft tissue is needed. Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps must be operated within the following parameters:

-Frequency range between 300 kHz-1,000 kHZ;

-Maximum generator operating voltage 600Vp.

Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures. The types of surgery intended include:

-ENT

-Gynecology

• -Urology
• -General Surgery
• -Neurosurgery
• -Laryngeal Surgery
• -Orthopedic Surgery
• -Thoracic Surgery

Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Single-use non-stick bipolar forceps and single-use non-stick irrigating bipolar forceps must only be used with a bipolar coagulation current.

HG Innovations, as a manufacturer, does not recommend a specific procedure.

Use of bipolar techniques may be desirable in order to avoid unwanted tissue damage for surgical procedures where HF current could flow through relatively small cross-sectional area of body.

The single-use, non-stick bipolar forceps and single-use, non-stick irrigating bipolar forceps (various sizes, designs and tip configurations), with preattached cables are designed to grasp, manipulate, coagulate and irrigate soft tissues and are intended for use by a physician familiar with electrosurgery in bipolar coagulation for general open surgery where coagulation of soft tissue is needed. The blood vessel or tissue is grasped between the forceps tines, each of which acts as an electrode, and current passes to desiccate and coagulate the tissue. Bipolar forceps are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coaqulation current. The bipolar forceps must be operated with the following parameters:

-Frequency range between 300 kHz-1,000 kHZ: -Maximum generator operating voltage 600Vp.

The provided document describes the FDA's "Substantial Equivalence" determination for a device, not a study to prove acceptance criteria for a new AI/software medical device.

The document discusses various performance tests and comparisons to predicate devices for Single Use Non-Stick Bipolar Forceps and Single Use Non-Stick Irrigating Bipolar Forceps, which are mechanical electrosurgical accessories.

Therefore, the requested information about acceptance criteria, study design (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone), and training set details for an AI/software device cannot be extracted from this document, as it pertains to a different type of medical device and a different regulatory review process.

The document consistently states "N/A" for "Software Verification and Validation Testing," "Animal Study," and "Human Clinical Performance Testing," further confirming that this is not an AI/software medical device submission requiring such studies.

However, I can provide a summary of the performance criteria and reported performance for the mechanical device as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria (General):

The document indicates that the device's performance was evaluated through various bench performance tests. These tests covered biocompatibility, electrical safety and electromagnetic compatibility (EMC), mechanical testing, sterility testing, and shelf-life testing. The report concludes that "HG Innovation's bipolar forceps are identical to the predicate device in their intended use/indications for use and materials used for the arms, and tips. No further testing necessary," implying that the performance data from these bench tests demonstrated substantial equivalence to the predicate devices. The details of these studies are not provided in this summary, but the results are reported as "Pass" for the relevant tests.

Information NOT Applicable/Available (as per the document's content for AI/Software specific questions):

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/software device. The document mentions "bench performance testing" which are laboratory-based physical tests, not data-driven tests on patient sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth and expert review are irrelevant for this type of mechanical device testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable. This is not an AI/software device.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device