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Single-use, bipolar forceps are intended for bipolar coagulation to remove tissue and control bleeding by use of high frequency electrical current.

The bipolar forceps must be operated with the following parameters:

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

HG Innovations Ltd.'s Electrical Surqical Instruments encompass a wide variety of instruments that are widely used in the medical industry. Electrosurgical forceps and electrodes have been used in surgery for many years. The single-use, bipolar forceps (various lengths and designs), with preattached cables are designed to grasp, manipulate and coagulate 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 coagulation current.

This FDA 510(k) summary provides information for a Single Use Bipolar Forceps (K230432).

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

Important Note: This document is a 510(k) Summary for a medical device (bipolar forceps), not a diagnostic AI software. Therefore, many of the typical AI/ML study components like multi-reader multi-case (MRMC) studies, expert ground truth adjudication for complex interpretations, and training set details are not applicable here. The "acceptance criteria" discussed are largely related to engineering performance and biological safety, not diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• For a medical device like this, the "test set" refers to the physical units of the device that underwent various engineering, electrical, and biological safety tests.
• The exact sample sizes for each specific test (e.g., how many devices were subjected to the drop test, how many samples for cytotoxicity) are not explicitly stated in this 510(k) summary. These details would typically be found in the full test reports referenced in the submission.
• Data Provenance: The tests are standard performance and safety tests for medical devices, performed by the manufacturer (HG Innovations Ltd.) or contracted testing facilities. The provenance is internal to the manufacturer's quality system and likely conducted in the UK where the manufacturer is located, or by certified labs. These are prospective tests performed on newly manufactured devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

• This question is not applicable to this type of device and submission. "Ground truth" in the context of diagnostic AI typically refers to an expert interpretation of medical images or data.
• For the performance tests described, "ground truth" is established by standard engineering principles, calibrated instruments, and internationally recognized test methods. The "experts" involved are likely engineers, quality assurance personnel, and certified lab technicians who conduct and interpret the results of these physical and chemical tests, rather than clinical experts establishing a diagnostic ground truth.

4. Adjudication Method for the Test Set:

• This question is not applicable. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among multiple human readers when establishing a "ground truth" for diagnostic studies.
• For engineering and safety tests, the outcome is typically objective (e.g., pass/fail based on a measurement against a defined tolerance).

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 question is not applicable. This device is a surgical instrument, not an AI diagnostic tool. No human reader involvement or AI assistance is relevant to its direct function, nor were MRMC studies performed.

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

• This question is not applicable. This device is a physical surgical instrument and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For this device, the "ground truth" for its performance and safety is derived from:
  • International Standards: e.g., ISO 10993 series for biocompatibility, IEC 60601-2-2 for electrical safety.
  • Engineering Specifications: The device's design specifications (e.g., tip sizes, lengths, materials) are compared against functional requirements and predicate device characteristics.
  • Regulatory Requirements: Adherence to FDA regulations and guidance.
• There's no "expert consensus" on diagnostic findings, pathology, or outcomes data in the context of this device's performance demonstration.

8. The sample size for the training set:

• This question is not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

• This question is not applicable for the same reason as above; there is no training set for a physical medical device.

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