(89 days)
Valley Forge bipolar loop electrodes are designed for electrosurgical excisions in a dry, infiltrated or wet field. Gynecological indications are as follows:
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loop excisions of the cervix
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cervical conizations
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external anogenital lesions
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large vaginal intraepithelial neoplastic lesions
Valley Forge Scientific Corp, the manufacturer of several Malis bipolar coagulation/cutting systems, now plans to introduce Bipolar Loop Electrodes for gynecological procedures.
The provided text does not contain detailed acceptance criteria or a study that rigorously proves the device meets specific performance metrics in the format requested. Instead, it offers a summary of safety and effectiveness information for the Bipolar Loop Electrode, focusing on its design principles, historical use in neurosurgery, and perceived advantages over monopolar systems, particularly for gynecological procedures.
The information provided is primarily qualitative and relies on expert opinions and prior clinical experience rather than a structured study with quantifiable acceptance criteria.
Here's an analysis based on the available text:
Acceptance Criteria and Device Performance (Based on provided text, these are general claims rather than specific quantitative criteria):
| Acceptance Criterion (Implicit/Claimed) | Reported Device Performance (as stated in the document) |
|---|---|
| Safety: Elimination of grounding pad requirement and associated burns. | Bipolar Technology eliminates the need for grounding pads and the possibility of patient burns. |
| Safety: Minimal damage to adjacent tissue. | Bipolar Coagulation minimizes damage to adjacent tissue since the patient is no longer the return path for the electrical current. |
| Safety: Lower operating voltage. | Bipolar Technology works at voltages approximately 1/4th the voltage required for a monopolar technique. |
| Control/Precision: Precise control of electric current at the tissue site. | Localized Bipolar Coagulation gives the surgeon precise control of the electric current at the tissue site. |
| Effectiveness: Superior coagulation and absence of charring/sticking. | The system's patented waveform and exceedingly low output impedance provide superior coagulation and the absence of charring and sticking even in a dry field. |
| Effectiveness: Functionality in irrigated/bloody fields. | Bipolar electrosurgery provides smooth, progressive coagulation with the option of precise, flow-controlled irrigation. Permits the physician to coagulate in an irrigated field thereby minimizing heat build-up or thermal damage to adjacent tissues. (Unlike monopolar systems, which short-out). |
| Pathology Quality: Production of excellent, undamaged pathology specimens. | Used to core all types of brain and spinal cord neoplasms "bloodlessly, while the contiguous tissues remain functioning normally, and the removed specimens show no damage whatsoever." "The use of these bipolar loops has produced excellent pathology specimens in a wide variety of benign and malignant tumor types, without the confusing thermal damage produced by monopolar loops." |
| Clinical Efficacy (Gynecology): Adequate specimens, minimal blood loss, short operating time for CIN. | Dr. Martin Weisberg concludes that "Bipolar loop excision allows for adequate specimens to be obtained with minimal blood loss and short operating time." |
| General Effectiveness: Smooth, gentle, precise, and efficient cutting and coagulation. | The waveform parameters... are programmed for the smoothest, most gentle, precise and efficient cutting and coagulation of tissue during any surgical procedure. |
Study Information:
The document refers to expert opinions and historical use rather than a singular, dedicated study with clear methodology for proving device performance against acceptance criteria.
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Sample size used for the test set and the data provenance:
- No specific "test set" sample size or data provenance (e.g., country of origin, retrospective/prospective) is explicitly stated for a formal study validating the device against acceptance criteria.
- The document references:
- Dr. Leonard I. Malis's extensive use in neurosurgery since 1981, stating he has used bipolar loops to "core all types of brain and spinal cord neoplasms." This implies a large, but unspecified, number of cases over years, likely retrospective clinical experience.
- Dr. Martin Weisberg's "Thomas Jefferson University Hospital Study" for gynecological procedures, reporting on "bipolar loop excision." The sample size for this specific study is not provided, nor is its retrospective or prospective nature explicitly mentioned, though it sounds like a clinical summary of cases rather than a controlled trial.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The "ground truth" seems to be established through the collective experience and opinions of leading experts in the field of electrosurgery.
- Dr. Leonard I. Malis: Described as "the world's foremost authority on bipolar electrosurgery" and a neurosurgeon who has used bipolar loops since 1981. His expertise is in neurosurgery, and he provides observations on bloodlessness, contiguous tissue function, and specimen integrity.
- Dr. Martin Weisberg: Associated with "Thomas Jefferson University Hospital" and quoted on the benefits of bipolar loop excision for gynecological procedures, specifically CIN. His specific qualifications (e.g., specialty, years of experience) are not detailed beyond his affiliation and role in the study mentioned.
- These experts are cited for their clinical observations and conclusions, rather than formally establishing "ground truth" for a predefined test set in a study.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- No formal adjudication method is described. The information presented is based on expert statements and observed clinical outcomes, not a blinded review of a dataset by multiple adjudicators.
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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:
- No MRMC or AI-assisted study is mentioned. This device is an electrosurgical tool, and the context is traditional surgical efficacy and safety, not diagnostic imaging with AI.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (electrosurgical electrode), not an algorithm or AI system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" is primarily based on:
- Expert Clinical Observation and Consensus: Dr. Malis's and Dr. Weisberg's long-term clinical experience and qualitative observations on surgical outcomes (e.g., blood loss, operating time, tissue damage, specimen quality).
- Pathology: Dr. Malis explicitly states "The use of these bipolar loops has produced excellent pathology specimens... without the confusing thermal damage produced by monopolar loops." This indicates pathology review was part of the clinical assessment.
- Outcomes Data: References to "minimal blood loss and short operating time" and "safe and complete removal of tumors" indirectly point to clinical outcomes as a measure of effectiveness.
- The "ground truth" is primarily based on:
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The sample size for the training set:
- Not applicable. This is an electrosurgical device, not a machine learning model requiring a training set. The "training" for its development comes from years of surgical practice and engineering refinement.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set in the AI/ML sense. The "ground truth" for the device's development and claimed performance is derived from the established principles of bipolar electrosurgery and the clinical experience of expert surgeons over many years.
§ 884.4120 Gynecologic electrocautery and accessories.
(a)
Identification. A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.(b)
Classification. Class II (performance standards).