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The Coated Electrosurgical Electrodes are intended for the following indications: Cutting of Soft Tissue, Coagulation of Soft Tissue.

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The provided 510(k) summary for K132224 describes the Unimed Surgical Coated Electrosurgical Electrodes. This document does not detail a study involving AI performance, human readers, or image analysis, as it pertains to a physical medical device (electrosurgical electrodes) rather than an AI-powered diagnostic tool. Therefore, many of the requested categories related to AI performance, expert adjudication, MRMC studies, and ground truth for AI models are not applicable.

Here's an analysis of the provided information based on the sections that are relevant to the device:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify a distinct "test set" sample size in the way it might for an AI model. For physical testing of the electrodes, the sample sizes for each specific test (e.g., coating adhesion, pull force, electrical testing) are not provided in this summary. The data provenance is internal to Unimed Surgical Products, Inc. for the verification testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a physical device, and the ground truth for its performance is established through engineering and biological testing against predefined specifications and standards (e.g., IEC 60601-2-2, ISO 10993-1). No human experts are described as "establishing ground truth" in the context of diagnostic performance for this type of device.

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

Not applicable, as this relates to human expert review for establishing ground truth in diagnostic studies, which is not relevant here.

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 an electrosurgical electrode and does not involve AI assistance for human readers or diagnostic interpretation.

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

Not applicable. This device is an electrosurgical electrode and does not involve an algorithm.

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

The "ground truth" for the device's performance is based on established engineering specifications, international standards (e.g., IEC 60601-2-2 for electrical safety, ISO 10993-1 for biocompatibility), and regulatory requirements. For example:

• Physical Testing: Measured values (e.g., pull force, adhesion strength) compared against predefined minimums.
• Electrical Testing: Compliance with specified electrical characteristics according to industry standards.
• Biocompatibility: Adherence to the requirements of ISO 10993-1 for biological safety.

8. The sample size for the training set

Not applicable. This is a physical device, and the concept of a "training set" is not relevant.

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

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

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The Electrosurgical Pencils and Electrodes are used for the cutting and coagulation of soft tissue. The Intended Use of the modified device, as described in its labeling, has not changed as a result of the modifications and do not alter the scientific technology of the device.

The Electrosurgical Pencils are for the cutting and coagulation of soft tissue and have a 3-pin connector attached to a 10 foot conductive cable and are designed for use with standard electrosurgical generators (ESU). The connector or plug fits into the monopolar side of a standard electrosurgical unit. The handpieces are made of plastic with two buttons or a rocker switch toward the distal part of the pencil in the case of the hand-controlled pencils, while the foot-controlled pencil that is connected to the generator by means of an adapter activated by a monopolar footswitch. One button or switch is to control the CUT mode of the ESU while the other controls the COAG mode.

The Holster is intended to store the pencil while it is not actively in use that attaches to a surgical drape and avoids accidental activation when not in use

The Tip Cleaner is intended to be used for eschar removal that tends to build up on an uncoated electrode by gently scraping it along the aggressive surface. The Tip Cleaner attaches to a surgical drape by an adhesive backing.

The Coated Electrode is an electrode use to cut and coagulate soft tissue coated with a material intended to reduce the build up of eschar usually eliminating the need for a Tip Cleaner.

Pencils packaged with Coated Electrodes will not have a Tin Cleaner.

This document, K993647, is a 510(k) premarket notification for "Disposable Hand and Foot-Switching Pencils with Holster, Non-Coated Electrode and Tip Cleaner" and "Disposable Hand and Foot-Switching Pencils with Holster and Coated Electrode." The purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to present a study proving the device meets acceptance criteria through performance data.

Therefore, the requested information regarding acceptance criteria and a study proving their fulfillment cannot be extracted from the provided text. The document primarily focuses on:

• Device Classification: Class II.
• Materials: Non-toxic materials used in previously legally marketed devices.
• Description: Detailed explanation of the electrosurgical pencils, holster, tip cleaner, and coated electrode.
• Intended Use: Cutting and coagulation of soft tissue.
• Regulatory Decision: A determination of substantial equivalence to predicate devices, allowing the device to be marketed.

Key points from the document regarding the regulatory process:

• The FDA reviewed the 510(k) submission and determined the device is substantially equivalent to devices marketed prior to May 28, 1976.
• This determination is based on the comparison to predicate devices, not on a new study demonstrating performance against specific acceptance criteria.
• The letter states that the "Intended Use of the modified device, as described in its labeling, has not changed as a result of the modifications and do not alter the scientific technology of the device." This reinforces that the submission is about equivalence, not a novel performance study.

In summary, the provided text does not contain a study demonstrating the device meets acceptance criteria. It is a regulatory approval document based on substantial equivalence, which typically relies on comparisons to well-established predicate devices and adherence to general controls, rather than new clinical or performance studies with acceptance criteria as described in your request.

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These electrosurgical devices are designed for cutting of soft tissue and coagulation.

The unimed Coated Laparoscopic Electrode, unimed Coated Arthroscopy Electrode and the unimed Coated Suction-Irrigation Electrode are coated with Emralon 333 or Teflon 420-104. Both are dry lubricants which provide a low coefficient of friction and reduce eschar build-up during surgery and the need for higher power settings. Without eschar build-up that takes place with a standard stainless steel tip less scraping and inconvenience takes place resulting in greater OR efficiency. Each coating is non-toxic, corrosion resistant, and therefore safe for the patient and the OR staff. These electrosurgical devices are designed for cutting of soft tissue and coagulation. The electrodes are available in a variety of diameters, lengths and tip configurations. The electrodes are available sterile, single use only.

This abstract document is a medical device summary for an electrosurgical electrode and does not contain information about acceptance criteria or a study proving device performance in the context of AI/ML or diagnostic accuracy. The text describes the device, its materials, classification, and claims of substantial equivalence based on prior 510(k) notifications.

Therefore, I cannot provide the requested information.

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The unimed Surgical Products unimed Suction-Irrigation Electrode and unimed Sliding Sheath are electrosurgical devices designed for suction/irrigation as well as cutting and coagulating of soft tissue.

unimed Surgical Products intends to market the unimed Suction-Irrigation Electrode with five tip configurations. The tip configurations are the Spatula, J-Hook, L-Hook, Coagulator and Needle. The electrodes are available with a shaft diameter of 5mm and a working length of 28cm or 32 cm. The unimed Sliding Sheath will be marketed in one configuration in 28cm and 32cm lengths. The proximal end is designed to fit a standard monopolar cord.

This document is a Safety and Effectiveness Summary for an Electrosurgical Electrode from 1996. It describes the device, its materials, and claims substantial equivalence to existing devices.

Crucially, this document does not describe acceptance criteria or a study proving the device meets those criteria from an AI/ML or diagnostic performance perspective. Instead, it focuses on the device's physical characteristics, intended use, and substantial equivalence for regulatory approval in a pre-AI era.

Therefore, I cannot extract the requested information from the provided text as it pertains to AI/ML device performance or diagnostic accuracy studies. The concepts of "acceptance criteria" and "study proving the device meets acceptance criteria" in this context would be related to electrical safety, biocompatibility, sterilization efficacy, and functional performance (e.g., suction flow rate, irrigation efficacy, cutting/coagulation effectiveness) for a hardware medical device, not a software algorithm.

To directly address your request given the input, here's an explanation of why the information cannot be provided:

1. Table of acceptance criteria and reported device performance: Not applicable. The document discusses "safety and effectiveness" in a general sense for a medical device (electrosurgical electrode), not specific performance metrics related to diagnostic accuracy or AI output. It does not list specific numerical performance targets or results from a study measuring them.

2. Sample size, data provenance: Not applicable. This refers to data used for AI model training/testing, which is not relevant to this 1996 hardware device submission.

3. Number of experts and qualifications: Not applicable. This refers to experts used for ground truth labeling in AI studies.

4. Adjudication method: Not applicable. This refers to resolving discrepancies in ground truth labeling for AI studies.

5. MRMC comparative effectiveness study: Not applicable. This refers to studies comparing human reader performance with and without AI assistance.

6. Standalone performance: Not applicable. This refers to the performance of an AI algorithm on its own.

7. Type of ground truth: Not applicable. This refers to the reference standard for evaluating AI output.

8. Sample size for training set: Not applicable.

9. How ground truth for training set was established: Not applicable.

In summary, the provided text describes a traditional medical device (an electrosurgical electrode) and its regulatory submission details from 1996, long before the widespread use of AI in medical devices and diagnostic performance studies became a standard requirement for regulatory submissions.

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The unimed Coated Electrodes are indicated for use in the cutting and coagulation of soft tissue.

The Coated Electrodes are coated with Emralon 333 or Teflon 420-104. Both are dry lubricants which provide a low coefficient of friction and reduce eschar build-up during surgery and the need for higher power settings. Without eschar build-up that takes place with a standard stainless steel tip less scraping and inconvenience takes place resulting in greater OR efficiency. Emralon and Teflon are non-toxic, corrosion resistant, and therefore safe for the patient and the OR staff. The Coated Electrosurgical Electrodes are available in a variety of tip configurations and lengths. The tip configurations include blades, needles, and balls. The blades and needles are also available with the tips only partially exposed. These devices are designed to cut and coagulate soft tissue during surgical procedures. The entire line of electrodes will fit all button, rocker, and footcontrolled pencils. The electrodes are available sterile, single use only.

This document is a 510(k) premarket notification decision letter from the FDA regarding Unimed Surgical Products, Inc.'s Coated Needle Electrode, Coated Blade Electrode, and Coated Ball Electrode. It states that the FDA has found the device substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about acceptance criteria, a study that proves the device meets acceptance criteria, or any of the detailed study parameters requested in the prompt.

The document primarily focuses on:

• The FDA's decision of substantial equivalence.
• Classification of the device (Class II).
• General controls provisions and existing regulations.
• Indications for Use (cutting and coagulation of soft tissue).
• A brief description of the device materials (Emralon 333 or Teflon 420-104 coating) and benefits (reduced eschar build-up, lower friction, non-toxic, corrosion-resistant).
• The fact that Unimed already supplies these as components and now wants to market them under its own name.

Therefore, I cannot provide the requested information. The document is a regulatory approval letter, not a scientific study report.

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