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The MALIS 2000 Bipolar Electrosurgical system is indicated for use in micro, macro and endoscopic bipolar cutting and coagulation of tissue and sealing of blood vessels in all types of surgery.

The Malis 2000 Bipolar Electrosurgical System includes the generator, a Bipedal footswitch for operating the cutting and coagulation functions, a connecting cable to allow the use of a MALIS irrigator with the MALIS 2000 generator. The unit incorporates the use of a LCD panel to make it easier for the surgeon to see the setting.

The provided submission does not contain information about acceptance criteria or a study proving the device meets said criteria.

The document is a 510(k) Summary of Safety & Effectiveness for the Malis Bipolar 2000 Electrosurgical System, dated March 7, 2005. It focuses on demonstrating substantial equivalence to a predicate device (VFS 300) rather than presenting performance acceptance criteria or study results against such criteria.

The submission includes:

• General Information: Date prepared, submittor, contact.
• General Provisions: Trade name, classification, predicate device, intended use.
• Device Description: Details of the Malis 2000 Bipolar Electrosurgical System components and features.
• Substantial Equivalence Table: Compares the new device (Malis 2000) to the predicate device (VFS 300) across various attributes like intended use, control circuitry, method of operation, RF output range, blend cut/coag, activation, output power controls, power display, and sterilization. This table indicates that the new device has largely similar specifications to the predicate, with minor modifications in activation (additional finger-operated instruments) and user interface (rotary switches and LED display).
• FDA Letter: A letter from the FDA (dated March 9, 2005) indicating that the device has been found substantially equivalent to legally marketed predicate devices.
• Indications for Use: Page outlining the intended uses of the device.

None of these sections discuss predefined acceptance criteria or present data from a study designed to evaluate the device's performance against such criteria. The focus is entirely on comparing the new device's specifications and intended use to an existing, legally marketed device to establish substantial equivalence for regulatory clearance.

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Electro-Surgical accessories: Hand-Switching Pen for the removal of tissue and Electro-Surgical accessories: Hand Officening vising high frequency (RF) current.

Plastic disposable finger operated bipolar electro-surgical instruments with either blade, ball or loop tips.

This document is a 510(k) summary for a medical device called the "Valley Forge Scientific Malis™ Bipolar Disposable Electro-Surgical Pens". It describes the device, its intended use, and its substantial equivalence to predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the way that would be expected for a diagnostic AI device.

Therefore, many of the requested categories are not applicable to the provided text.

Here's an analysis based on the provided document:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as quantifiable performance metrics from a study. The document focuses on substantial equivalence to predicate devices and adherence to general controls for medical devices.
• Reported Device Performance: Not reported in terms of specific performance metrics from a study as this is not a diagnostic device with performance claims like sensitivity or specificity. The key performance aspect highlighted is the bipolar technology, which "eliminates the electrical current being passed through the patient and the use of grounding pads and their inherent safety hazards" and "permits the surgeon to work in a wet or irrigated surgical field without current shunting." These are functional benefits rather than quantitative "performance" in the context of device accuracy.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. This submission is for an electro-surgical instrument, which is typically cleared through substantial equivalence based on engineering specifications, biocompatibility, electrical safety testing (ISO standards), and comparison to existing predicate devices, rather than a clinical trial with a "test set" in the context of diagnostic performance. There is no mention of a clinical study or a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. As there is no clinical "test set" or diagnostic ground truth to be established, no experts were utilized in this manner for this type of device submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No clinical test set or adjudication process is described.

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. This is not an AI-assisted diagnostic device, so an MRMC study is irrelevant to this submission.

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

• Not Applicable. This is a hardware electro-surgical device, not an algorithm.

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

• Not Applicable. Given the nature of the device (electro-surgical instrument), the "ground truth" for its safety and effectiveness would come from engineering testing, adherence to recognized standards (though none are mandated for this specific device per the document), and demonstration of substantial equivalence in form and function to legally marketed predicate devices. No formal "ground truth" as you'd find in a diagnostic study is mentioned.

8. The sample size for the training set

• Not Applicable. There is no mention of a training set as this is not a learning algorithm or a device requiring data training.

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

• Not Applicable. No training set is mentioned.

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The Stryker Interventional Pain RF Generator, in combination with the Stryker RF Electrodes and Cannulae, is intended for coagulation of soft tissues in orthopedic, arthroscopic, spinal, and neurosurgical applications. Examples include, but are not limited to, Facette Denervation, Percutaneous Chordotomy/Dorsal Root Entry Zone (DREZ) Lesion, Trigeminus Neuralgia, Peripheral Neuralgia, and Rhizotomy.

The Stryker Interventional Pain RF Generator, in combination with the Stryker RF Electrodes and Cannulae, is intended for coagulation of soft tissues in orthroscopic, spinal, and neurosurgical applications.

This document, K032601, is a 510(k) premarket notification for the Stryker Interventional Pain RF Generator. It states that the device is substantially equivalent to existing marketed devices and does not contain information regarding acceptance criteria or a study proving the device meets specific acceptance criteria in the manner requested.

Specifically, the document focuses on:

• Establishing substantial equivalence to predicate devices (Oratec, Radionics, Baylis, NeuroTherm, and Arthrocare) based on intended use, safety, and effectiveness.
• Indications for Use: coagulation of soft tissues in orthopedic, arthroscopic, spinal, and neurosurgical applications (e.g., Facet Denervation, Percutaneous Chordotomy/Dorsal Root Entry Zone (DREZ) Lesion, Trigeminal Neuralgia, Peripheral Neuralgia, and Rhizotomy).
• Regulatory Classification: Class II, Product Code GXD (Generator, Lesion, RF).

There is no detailed information in this document about:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance. This document uses a "substantial equivalence" argument, not data from a specific study to prove performance against criteria.
3. Number or qualifications of experts used to establish ground truth.
4. Adjudication method.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study, including effect size.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document's purpose is to seek FDA clearance for market entry by demonstrating substantial equivalence to already legally marketed devices, implying that if the predicate devices met safety and effectiveness standards, this new device, being "equivalent," also meets them without needing new, extensive performance studies as might be seen for novel devices.

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The MALIS™ Irrigation Module 1000 is indicated for use with irrigating bipolar forceps with the CODMAN® / MALIS™ generators.

The MALIS™ Irrigation Module 1000 is an irrigation control system for use with the MALIS™ CMC-III Bipolar Electrosurgical Systems and the Synergy MALIS™ Precision System. This system provides controlled flow of irrigating fluid across the tips of bipolar irrigating forceps.

The provided document is a 510(k) summary for the MALIS™ Irrigation Module 1000. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results. Therefore, much of the requested information regarding detailed acceptance criteria, sample sizes, expert involvement, and ground truth establishment is not available in this document.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information:

• No specific, quantifiable acceptance criteria (e.g., specific flow rates, pressure ranges, electrical parameters, software response times) are provided. The "acceptance criteria" are broadly defined by substantial equivalence to the predicate device and general statements of "all testing passed."
• No quantitative device performance metrics are reported.

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "Verification and validation tests" and "Electrical safety testing" but does not detail the number of units tested or the duration/extent of testing.
• Data Provenance: Not applicable in the context of clinical data for AI models. The testing described is for device functionality and safety, not performance on patient data.

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

• Not applicable. This document describes a medical device for irrigation, not an AI or diagnostic imaging device that uses expert-established ground truth from medical images/cases. The "ground truth" here is implied by engineering specifications and safety standards.

4. Adjudication Method for the Test Set:

• Not applicable. There is no mention of human-in-the-loop assessment or expert adjudication for the device's technical performance tests.

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. This device is not an AI-powered diagnostic tool, and no MRMC study was performed or is relevant to this type of device.

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

• Not applicable. This is a physical medical device, not an algorithm. The "software" component mentioned would likely refer to embedded control software, for which standalone performance testing (i.e., verifying the software correctly controls the device) would have been part of the verification and validation, but this is not an AI algorithm in the common sense.

7. The Type of Ground Truth Used:

• For device functionality and safety: The "ground truth" would be established engineering specifications, performance standards (e.g., related to flow, pressure, electrical safety), and regulatory compliance requirements. These are typically defined internally by the manufacturer and by relevant industry standards (e.g., IEC standards for electrical safety).

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" in the context of this device. The device design and verification adhere to engineering principles and established performance specifications, not machine learning training.

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

• Not applicable. See point 8.

Summary of Device Acceptance and Study:

The MALIS™ Irrigation Module 1000 gained acceptance for marketing through the 510(k) pathway by demonstrating substantial equivalence to a previously cleared predicate device, the MALIS™ Irrigation System (K854413).

The "study" that proves the device meets acceptance criteria consists of:

• Verification and validation tests: These were conducted on the system and its software, and "all testing passed." The specific criteria for these tests were not detailed but would typically involve ensuring the device functions according to its design specifications regarding fluid flow, pressure, and control mechanisms.
• Electrical safety testing: Conducted to ensure compliance with relevant electrical safety standards, and "all testing passed."

The fundamental acceptance criterion for this 510(k) submission was that the new device, MALIS™ Irrigation Module 1000, is substantially equivalent to the predicate device (MALIS™ Irrigation System) in terms of its intended use, function, technical specifications, and operating principles. The safety and efficacy were substantiated by this similarity to the original device. No new clinical studies or detailed performance data comparing it to a standard of care were required or presented because the device was not deemed to represent a significant change in technological characteristics or indications for use.

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The Valley Forge Bi-Dent Electrosurgical System is intended for the Dental Practitioner for the cutting and coagulation of oral tissue.

The Valley Forge Bi-Dent Electrosurgical System is a Bipolar Surgical System. It is a Bipolar Coagulator/Cutting System with integrated irrigation. It incorporates the effectiveness and safety features of bipolar coagulation/cutting and irrigation packaged into one functional unit. Some of the effective safety features of the Bipolar Coagulator/Cutting System are: Bipolar Technology eliminates the need for grounding pads and the possibility of patient burns. Bipolar Cutting/Coagulation minimizes damage to adjacent tissue since the patient is no longer the return path for the electrical current. Bipolar Technology works at voltages approximately 1/10th the voltage required for monopolar technique. Localized Bipolar Cutting/Coagulation gives the surgeon precise control of the electric current at the tissue site. The System's patented waveform and exceedingly low Output Impedance provide superior Cutting/Coagulation and the absence of charring and sticking even in a dry field. Because of the high output impedance of monopolar and other bipolar systems, instruments short-out in an irrigated or bloody field. The Bipolar Coagulator/Cutting System offers an Irrigation Delivery System to keep tissue moist and cool during coagulation. Because of the System's ability to work in a wet field, tissue samples removed for biopsy are not charred or desiccated. Unlike monopolar systems, the Bipolar Coagulator/Cutting System provides smooth, progressive coagulation with precise flow-controlled irrigation. The System permits the physician to cut and coagulate in an Irrigated Field thereby minimizing heat build-up or thermal damage to adjacent tissues. The waveform parameters of the Bipolar Coagulator/Cutting System are programed for the smoothest, most gentle, precise and efficient coagulation and cutting of tissue during any surgical procedure.

The provided document is a 510(k) premarket notification for the Bi-Dent Bipolar Surgical System. It primarily outlines the device's substantial equivalence to a predicate device and discusses the technology and benefits of bipolar electrosurgery, particularly in the context of the Malis Bipolar Coagulator systems.

There is no specific acceptance criteria table or formal study detailed in this document that explicitly proves the device meets specific performance metrics against pre-defined acceptance criteria.

The document focsues on:

• Substantial Equivalence: The FDA's letter states the device is "substantially equivalent" to legally marketed predicate devices. This is a regulatory determination based on comparison to existing devices, not necessarily a demonstration against novel performance criteria.
• Technological Description and Advantages: The "Summary of Safety and Effective Information" (Exhibit VI) and the attached articles by Dr. Leonard Malis describe the Bi-Dent Bipolar Surgical System's technology, its evolution from earlier Malis coagulators, and the claimed advantages of bipolar coagulation with integrated irrigation (e.g., reduced tissue damage, precise control, ability to work in a wet field, elimination of grounding pads).

Given the nature of a 510(k) submission focused on substantial equivalence, the document doesn't typically provide the kind of detailed performance study and acceptance criteria you've requested. The "proof" of meeting acceptance criteria for a 510(k) is usually the demonstration that the new device performs as intended and is as safe and effective as a legally marketed predicate device, often through a comparison of technological characteristics and, if necessary, performance data that shows it is "substantially equivalent."

Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text, as the information is not present. Here's what I can synthesize from the document:

Absence of Specific Acceptance Criteria and Dedicated Study in the Provided Document

The provided document is a 510(k) premarket notification, which focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting a detailed study against specific pre-defined acceptance criteria. Therefore, the requested information regarding acceptance criteria, a comparative study proving the device meets these criteria, and detailed study parameters (like sample size, ground truth establishment, expert qualifications, etc.) is not explicitly available in the provided text.

The document discusses the benefits and technological advancements of the Bi-Dent Bipolar Surgical System (which is based on the Malis Bipolar Coagulator technology) compared to older electrosurgical methods, but this is presented as background and justification for substantial equivalence, not as the results of a formal study designed to demonstrate performance against specific, quantitative acceptance criteria.

Information that can be inferred or directly stated from the document:

• Indications for Use (Implicit Acceptance Criteria - Functional Performance): The device is intended "for the Dental Practitioner for the cutting and coagulation of oral tissue." The "acceptance criteria" in this context would be that the device effectively performs these functions safely, similarly to predicate devices.
• Reported Device Performance (Implicit):
  • "cutting and coagulation of oral tissue."
  • "Bipolar Technology eliminates the need for grounding pads and the possibility of patient burns."
  • "minimizes damage to adjacent tissue"
  • "works at voltages approximately 1/10th the voltage required for monopolar technique."
  • "gives the surgeon precise control of the electric current at the tissue site."
  • "provide superior Cutting/Coagulation and the absence of charring and sticking even in a dry field."
  • "ability to work in a wet field"
  • "tissue samples removed for biopsy are not charred or desiccated."
  • "provides smooth, progressive coagulation with precise flow-controlled irrigation."
  • "permits the physician to cut and coagulate in an Irrigated Field thereby minimizing heat build-up or thermal damage to adjacent tissues."
  • "waveform parameters...programmed for the smoothest, most gentle, precise and efficient coagulation and cutting of tissue".
• Type of Ground Truth / Justification (Implicit): The "Summary of Safety and Effective Information" and the included articles from Dr. Malis (a neurosurgeon) rely on:
  • Expert experience and clinical observations: Dr. Malis's extensive experience over "over thirty years" with bipolar coagulation.
  • Bench testing/Engineering principles: Discussions of waveform parameters, impedance, voltage, and current flow.
  • Early animal studies (Rat brain studies mentioned in general, not specific to this device's submission): Mention of rat studies to compare unipolar vs. bipolar and to assess leakage current and damage (though these are used to explain concepts and critique methodologies, not as a direct performance study of the Bi-Dent).
  • Comparison to predicate devices: The overall 510(k) process is a comparison to legally marketed devices.

Unable to Answer Based on Provided Document:

1. A table of acceptance criteria and the reported device performance: No such table or quantitative criteria are provided.
2. Sample size used for the test set and the data provenance: No specific test set or study data are provided beyond theoretical explanations and expert opinion.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific "test set" with ground truth established by experts is detailed for this 510(k). The document highlights Dr. Leonard I. Malis, a "former Chairman of the Department of Neurosurgery at Mount Sinai School of Medicine, New York, NY and Neurosurgeon-in-Chief and Director of Neurosurgery of Mount Sinai Medical Center," as the developer and primary expert associated with the technology.
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: No.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device.
7. The type of ground truth used: As mentioned above, it's largely expert clinical experience, engineering principles, and theoretical comparisons rather than directly stated "ground truth" for a specific test set.
8. The sample size for the training set: Not applicable (not an AI/ML device with training data).
9. How the ground truth for the training set was established: Not applicable.

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The bipolar ball electrodes are designed for electrosurgical coagulation of soft tissue in a bloody, irrigated or wet surgical field.

Bipolar Ball Electrodes

The provided text describes the regulatory clearance of a medical device (Bipolar Ball Electrodes) not an AI device, and therefore does not contain information about acceptance criteria, study data, or performance metrics in the way one would typically describe for a software algorithm or AI model.

The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies against pre-defined acceptance criteria, especially not in the context of an AI device.

Therefore, I cannot provide a response filling the requested table and sections as the information is not present in the provided text.

Specifically:

• Acceptance Criteria and Reported Device Performance: Not mentioned. The document relies on the opinion of an expert and general descriptions of the technology's benefits compared to monopolar electrosurgery.
• Sample Size (test set), Data Provenance: Not applicable/not mentioned. No specific test set data is presented.
• Number of Experts, Qualifications, Adjudication Method: Not applicable/not mentioned.
• MRMC Comparative Effectiveness Study: Not applicable/not mentioned.
• Standalone Performance: Not applicable/not mentioned.
• Type of Ground Truth: Not applicable/not mentioned for device performance. The "ground truth" for 510(k) historically is substantial equivalence to a predicate.
• Sample Size (training set), Ground Truth (training set): Not applicable/not mentioned.

The text primarily summarizes the safety and effectiveness features of the bipolar ball electrodes and the FDA's clearance decision.

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Valley Forge bipolar loop electrodes are designed for electrosurgical excisions in a dry, infiltrated or wet field. Gynecological indications are as follows:

• loop excisions of the cervix

• cervical conizations

• external anogenital lesions

• 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):

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.

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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Not Found

Valley Forge Scientific Corp., the manufacturer of several electrosurgical systems, now plans to introduce a new MINI-SYMM Bipolar System which enables the surgeon to coagulate while irrigating the surgical field.

The provided text describes a medical device, the MINI-SYMM Bipolar System, an electrosurgical device for coagulation during surgery. However, the document is a "Summary of Safety and Effective Information" and focuses on the underlying technology, its advantages, historical context, and the expertise of its inventor. It does not contain a specific study designed to prove the device meets acceptance criteria, nor does it present discrete acceptance criteria with reported device performance in a tabular format.

The document highlights general benefits and characteristics of bipolar electrosurgery, and specifically features of the MINI-SYMM system, but these are presented as inherent design advantages rather than outcomes of a specific performance study.

Therefore, I cannot provide the requested information in the format specified because the input text does not contain:

1. A table of acceptance criteria and reported device performance.
2. Details of a specific study to prove acceptance criteria. This includes sample size, data provenance, expert qualifications for ground truth, adjudication methods, MRMC study details, standalone performance results, or detailed training set information.

The document functions as a background and justification for the device's design based on established principles of bipolar electrosurgery, rather than a report on a new clinical or performance study of the MINI-SYMM Bipolar System itself.

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Not Found

Valley Forge Scientific Corp., the manufacturer of several Malis solid state bipolar coagulation/cutting systems, now plans to introduce a new Bipolar Loop Electrode which Dr. Malis has used to core all types of brain and spinal cord neoplasms such as meningiomas, neuromas, and gliomas bloodlessly. The loop electrodes restrict cutting current flow outside of the loops to any other tissues and no current to any ground. Accordingly, there is no heat spread.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The text describes the history and features of a bipolar electrosurgical coagulator and its accessories, but it does not present any specific performance metrics, study designs, or results that would allow me to fill in the requested table and information points.

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