(90 days)
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:
- A table of acceptance criteria and the reported device performance: No such table or quantitative criteria are provided.
- 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.
- 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.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device.
- 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.
- The sample size for the training set: Not applicable (not an AI/ML device with training data).
- How the ground truth for the training set was established: Not applicable.
§ 872.4920 Dental electrosurgical unit and accessories.
(a)
Identification. A dental electrosurgical unit and accessories is an AC-powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. This device is intended to cut or remove soft tissue or to control bleeding during surgical procedures in the oral cavity. An electrical current passes through the tip of the electrode into the tissue and, depending upon the operating mode selected, cuts through soft tissue or coagulates the tissue.(b)
Classification. Class II.