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The Meddusa Bipolar System is a single-use product designed for and intended to be used exclusively with Surgi-Max® RF Generators (510(k) K100390). For optimal performance the Surgi-Max® Plus generator (510(k) K100390) is recommended.

The Meddusa™ Bipolar System is intended for use by a physician familiar with bipolar coagulation with electrosurgery where coagulation/contraction of soft tissue is needed. The types of surgery intended are: General surgery, Laparoscopic procedures, Endoscopic procedures, Laryngeal coagulation, Open abdominal, Orthopedic coagulation, Thorascopic coagulation, Neurosurgical coagulation, Gynecological coagulation, (except for use in female sterilization), Ear, Nose, Throat coagulation.

The Meddusa Bipolar System is a disposable device manufacturer of medical grade Stainless Steel, ABS plastic and TEFLON heat shrink tubing. The category of contact as classified by ISO 10993-1:2003 are that the device is an (1) External Communicating Device, (2) Contact Area: Tissue, Bone, Dentin, (3) Contact Duration

The Meddusa Bipolar System is an electrosurgical device. The provided text, a 510(k) summary, outlines its substantial equivalence to predicate devices, rather than detailing specific acceptance criteria and a study proving the device meets them in the traditional sense of a clinical trial with predefined performance metrics. The submission focuses on demonstrating safety and effectiveness through comparisons of physical and performance characteristics with existing devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Specific numerical acceptance criteria are not explicitly stated in the document, as this is a 510(k) summary focused on substantial equivalence. Instead, the performance is evaluated by demonstrating similarity to predicate devices in terms of thermal effects and safety.

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

• Sample Size for Test Set: Not explicitly stated as a numerical value for a "test set" in the context of a clinical trial. The testing was done on ex vivo tissue, specifically liver, kidney, and muscle tissue. The quantity or number of samples of these tissues is not quantified.
• Data Provenance: The data is from bench tests using ex vivo tissue. The country of origin of this tissue or the testing location is not specified, but it can be inferred to be part of the manufacturer's testing process. The study is retrospective in the sense that it's laboratory testing on prepared samples, not observations from a live patient study.

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

There is no mention of "experts" establishing ground truth in the context of radiologists or similar medical professionals for image interpretation. This device is not an imaging device that requires interpretation. The "ground truth" for the thermal effect would have been established through direct measurement and observation by the engineering or scientific personnel conducting the bench tests. No specific number or qualifications of these individuals are provided.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical trial with human observers or an "adjudication method" in the traditional sense. The performance data comes from direct measurements and observations during bench testing.

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 Meddusa Bipolar System is an electrosurgical device, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not relevant or performed.

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

Not applicable. This is a hardware medical device used by a physician, not an algorithm. The "standalone performance" is essentially the device's physical and functional performance during the bench tests, which were conducted without direct human control of the outcome metrics, but rather under controlled experimental conditions.

7. The Type of Ground Truth Used

The "ground truth" for the bench tests would be:

• Direct Physical Measurements/Observations: For thermal damage (width and depth of thermally damaged zones), temperature profiles, and peak temperatures. These are objective measurements rather than subjective interpretations or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device, so there is no concept of a "training set."

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

Not applicable, as there is no training set for this device.

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