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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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Bovie Resistick™ II Coated Electrosurgical Electrodes are used for cutting and coagulating soft tissues during open surgical procedures.

Bovie Resistick II Electrosurgical Electrodes ("electrodes") consist of coated blade, needle, and ball configured electrodes, sold sterile and bulk non-sterile, and are designed for single-use. These electrodes are used in conjunction with an electrosurgical handpiece and generator to deliver RF energy used to cut and coagulate soft tissues during open surgical procedures. The intended use of these electrodes is the same as that of previously cleared Resistick II electrodes. The coating is designed to reduce friction and to minimize the buildup of burned tissue. Although the coating is chemically different from that of predicate devices, biocompatibility analyses are being performed to demonstrate safety.

Each electrode consists of a stainless steel shaft and tip, a coating, and an insulation on the electrode meets the requirements for electrical safety testing of electrosurgical accessories.

Bovie Resistick II Electrosurgical Electrodes include three tip configurations; blade, needle, and ball. Within each configuration there are models that differ by length of the electrode shaft and whether the tips are partially exposed ("modified"). Eleven electrode configurations are the same shape and size as predicate devices cleared in premarket notification number K974735. There are an additional nine electrode configurations, each comprised of the same materials and having the same intended use. All electrodes are also to be available for sale as non-sterile components for subsequent placement into kits and trays.

This 510(k) summary (K093025) describes Bovie Medical's Resistick™ II Coated Electrosurgical Electrodes. The submission outlines the device's intended use for cutting and coagulating soft tissues during open surgical procedures, its components, and its operation. It also clarifies that the device includes various tip configurations and is made of the same materials as the predicate device (Resistick™ II Electrosurgical Electrode, K974735), with the key difference being a new coating designed to reduce friction and tissue buildup. The FDA's letter of December 22, 2009, indicates that the device has been found substantially equivalent to the predicate device.

Based on the provided information, the following can be extracted:

1. Acceptance Criteria and Reported Device Performance

The submission does not explicitly state specific quantitative acceptance criteria for performance metrics such as coating effectiveness, tissue adhesion reduction, or electrical safety in a tabular format. The general acceptance appears to be based on demonstrating substantial equivalence to the predicate device, Resistick™ II Electrosurgical Electrode (K974735), and meeting general safety requirements through biocompatibility analyses and electrical safety testing.

The "reported device performance" is primarily qualitative, focusing on the claims that the new coating is "designed to reduce friction and to minimize the buildup of burned tissue." The submission states, "Although the coating is chemically different from that of predicate devices, biocompatibility analyses are being performed to demonstrate safety." And, "an insulation on the electrode meets the requirements for electrical safety testing of electrosurgical accessories."

Given the provided text, a table of acceptance criteria and reported device performance cannot be generated with specific quantitative metrics.

2. Sample Size and Data Provenance

The document does not provide information on sample sizes for any specific tests or studies. It also does not specify the country of origin of data or whether it was retrospective or prospective.

3. Number and Qualifications of Experts

The document does not mention the use of experts to establish ground truth or for any other aspect related to the performance evaluation in this 510(k) summary.

4. Adjudication Method

The document does not specify any adjudication method for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study in the provided text. The device is an electrosurgical electrode, and such studies are typically not relevant for this type of medical device.

6. Standalone (Algorithm Only) Performance Study

This is not applicable as the device is an electrosurgical electrode, not an algorithm or AI-driven system. Therefore, no standalone algorithm performance study would have been conducted.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied in AI/image analysis studies is not relevant to this device submission. The evaluation of this device focuses on demonstrating substantial equivalence to a predicate device and meeting safety and performance standards relevant to electrosurgical electrodes (e.g., biocompatibility, electrical safety, coating effectiveness).

8. Sample Size for Training Set

This is not applicable as the device is an electrosurgical electrode, not an AI/machine learning system that requires a training set.

9. How Ground Truth for Training Set was Established

This is not applicable for the same reasons mentioned above.

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E-Z Clean electrosurgical electrodes are intended to conduct radio frequency (RF) current for cutting and coagulation from the RF electrosurgical generator to target soft tissue in a broad range of surgical procedures requiring the use of electrosurgery for cutting and cauterization.

Some tip configurations have a specific geometry that minimizes blanching and thermal damage in skin incisions when used in conjunction with the generator's Advanced Cutting Effect (ACE) mode.

The Megadyne E-Z Clean electrosurgical electrode is a monopolar electrosurgical electrode that is coated with polytetrafluoroethylene (PTFE). It is insulated over the majority of its exposed length. It is intended for general electrosurgical use, and is designed to fit into and work in conjunction with an industry standard hand- or footactivated electrosurgical pencil which is connected to an electrosurgical unit or ESU. This device is supplied sterile and is not intended to be reused.

The E-Z Clean electrosurgical electrodes are available in a number of tip configurations and lengths. Tips such as standard blades, modified blades, needles, blunt needles, ball-ends, and others are typical.

Some tip configurations (ACE blades) contain a slightly different geometry that will enhance the affects of the generator's Advanced Cutting Effect (ACE) Mode. In this mode, the blade will make skin incisions without the blanching or thermal damage commonly seen with standard electrosurgery. The new E-Z Clean ACE Blade provides a wound site that will heal similar to a scalpel wound (comparable Histopathology) when used in conjunction with the ACE mode. When not being used to perform skin incisions the ACE Blade functions as a standard E-Z Clean blade in all cutting and coagulating modes.

This submission also includes the option of a guard or nosecone on some configurations of electrodes. This nose cone provides additional dielectric protection at the junction where the E-Z Clean electrosurgical electrode is connected to an electrosurgical pencil.

The provided text is a 510(k) summary for the Megadyne E-Z Clean electrosurgical electrodes. It describes the device, its intended use, and its technological characteristics. However, it does not contain any information about a clinical study with acceptance criteria and reported device performance.

The document states that "Questions of safety and effectiveness are the same for this device as they are for the predicate devices and other electrosurgical electrodes on the market. There are no new technologies incorporated into the device." This implies that the device's safety and effectiveness are established through substantial equivalence to existing predicate devices, rather than a new clinical study.

Furthermore, it mentions extensive testing for conformance to voluntary standards (ISO 60601-2-2:2006 and ANSI / AAMI HF 18-2001), which are primarily engineering and safety standards, not clinical performance studies with specific patient outcomes or effect sizes.

Therefore, I cannot provide the requested information because it is not present in the provided text.

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The Rubicor Flexible Loop Electrosurgical Electrode is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses. It is also intended to be used to cut soft tissue.

The Rubicor Flexible Loop Electrosurgical Electrode is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

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The provided text describes a 510(k) premarket notification for the Rubicor Flexible Loop Electrosurgical Electrode. It details the device's intended use and claims substantial equivalence to predicate devices based on in-vitro testing. However, it does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and study specifics.

Here's a breakdown of what can and cannot be extracted from the provided text:

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

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

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified (other than "in-vitro testing"). The document does not mention country of origin, nor whether the data was retrospective or prospective.

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 specified. The document only mentions "in-vitro testing," which typically doesn't involve human experts establishing ground truth in the same way clinical imaging studies do.

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

• Not applicable/Not specified as it was in-vitro 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

• No. This document describes an electrosurgical electrode and its safety/effectiveness for tissue sampling. It is not an AI-assisted diagnostic device, and therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant or mentioned.

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

• No. This device is a surgical instrument, not a standalone diagnostic algorithm. Its performance is tied to its physical function in tissue sampling.

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

• For "in-vitro testing," ground truth would typically refer to established physical or chemical properties, measurements, or the ability to perform the intended function (e.g., cut soft tissue, collect samples for subsequent histologic examination). The document implies the ability to provide tissue samples for histologic examination, but the specific "ground truth" for the in-vitro performance itself is not detailed.

8. The sample size for the training set

• Not applicable/Not specified. This is a conventional medical device, not an AI/machine learning model that would require a "training set."

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

• Not applicable, as there is no "training set" for this type of device.

Summary of Study:

The document states that "Results of in-vitro testing demonstrate that the Flexible Loop Electrosurgical Electrode is safe and effective for its intended function." This indicates a study was conducted in a laboratory setting, likely involving tests to assess the device's ability to cut soft tissue and collect samples, as per its intended use for diagnostic sampling of breast tissue. The study aimed to show substantial equivalence to predicate devices like the Rubicor EnCapsule™ Breast Biopsy Device, SenoRx Shape Select Scalpel, Wallach LOOP Electrodes, and Megadyne Electrosurgical Electrode. However, no specific details about the methods, sample sizes, or precise outcomes of this in-vitro testing are provided beyond the general statement of safety and effectiveness.

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SureTek Reprocessed Electrosurgical Electrodes are intended for use during general, arthroscopic and endoscopic surgery for RF ablation, resection or coagulation of soft tissue and hemostasis of blood vessels.

Devices are monopolar and bipolar electrosurgical electrodes designed for ablation, resection and coagulation of soft tissue. Instruments consist of one or more distal electrodes, an insulated shaft, and a proximal handle with electrical connections to a compatible electrosurgical unit. Monopolar instruments require concurrent use of a compatible return electrode. Models have varying electrode configurations and tip angles. Some models are equipped with suction tubing for continuous cooling of the ablation site and aspiration of fluids/debris during use. Reprocessed electrodes have equivalent technological characteristics as the predicate devices, i.e. device design, dimensions, energy delivery and system compatibility are unchanged during reprocessing. Device materials are identical with the exception of shaft insulation, which may be replaced with a comparable heat shrink material.

The SureTek Medical 510(k) summary provided does not contain the specific type of acceptance criteria and associated study details that would typically be found for a medical imaging AI device. Instead, this document describes the reprocessed electrosurgical electrodes and focuses on demonstrating substantial equivalence to predicate devices for safety and performance in a manufacturing context.

Therefore, I cannot extract the information required concerning an AI device study. The provided text outlines:

1. Acceptance Criteria & Device Performance: The document states that "Simulated-use testing of instruments following maximum number of use and reprocessing cycles found their performance to be substantially equivalent to new, unused devices." This is a broad statement regarding functional equivalence but lacks specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) that would be expected for an AI device. The other listed testing (insulation, cleaning, packaging, sterility, biocompatibility) are related to manufacturing and safety standards, not AI performance.

2. Sample Size, Data Provenance: Not applicable in this context as no AI study is described. The "sample" here refers to reprocessed medical devices, not patient data.

3. Number of Experts, Qualifications: Not applicable.

4. Adjudication Method: Not applicable.

5. MRMC Comparative Effectiveness Study: Not applicable.

6. Standalone Performance: The closest analogous information is the "Simulated-use testing" which compares the reprocessed devices directly to new, unused devices. This is a standalone comparison for the physical device's function.

7. Type of Ground Truth: For the reprocessed electrosurgical electrodes, the "ground truth" seems to be the performance of new, unused devices as the benchmark for "substantial equivalence."

8. Sample Size for Training Set: Not applicable, as this is not an AI model.

9. How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided SureTek Medical 510(k) summary is for reprocessed electrosurgical electrodes and details performance testing related to manufacturing, safety, and functional equivalence to predicate devices, rather than an AI device's clinical performance study.

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Reprocessed electrosurgical electrodes are intended to remove tissue and control bleeding during surgery by use of electrical current.

The devices that are the subject of this submission are used to remove tissue and control bleeding during surgery. They are made of a variety of materials and come in different shapes. They come from several different original equipment manufacturers as single use devices. Reprocessing includes cleaning. refurbishing, testing, packaging, and sterilization. It allows the electrodes to be used several times rather than just once.

The provided text is a 510(k) summary for reprocessed electrosurgical electrodes and an FDA clearance letter. It does not contain information regarding acceptance criteria, study performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, or MRMC studies.

The document explicitly states: "Comparative performance testing and clinical evaluations were not included as part of this 510(k)." This indicates that a study demonstrating performance against acceptance criteria, as requested in the prompt, was not performed for this submission.

Therefore, I cannot provide the requested information from the given text.

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Aaron Reusable Electrosurgical Electrodes are non-sterile, reusable electrosurgical electrodes, used in conjunction with an electrosurgical handpiece and generator to deliver RF energy used to cut and excise tissue or to coagulate blood vessels during surgery.

Aaron Reusable Electrosurgical Electrodes are non-sterile, reusable electrosurgical electrodes are used in conjunction with an electrosurgical handpiece and generator to deliver RF energy used to cut and excise tissue or to coagulate blood vessels during surgery.

The provided text describes a 510(k) premarket notification for Aaron Reusable Electrosurgical Electrodes. The submission focuses on demonstrating substantial equivalence to predicate devices and validating cleaning and resterilization processes for reuse.

Based on the provided information, the device is an electrosurgical electrode, not an AI or imaging device, and therefore the standard AI/Imaging study characteristics are not applicable. The provided text addresses traditional medical device performance and safety.

Here's an interpretation of the "acceptance criteria" and "study" based on the context of a 510(k) submission for this type of device:

Acceptance Criteria and Device Performance (Interpreted from 510(k) Summary)

The primary acceptance criteria for this 510(k) submission revolve around demonstrating substantial equivalence to predicate devices and validating the reusability claims through cleaning and sterilization processes.

Study Information (Based on a Traditional Medical Device 510(k))

1. Sample size used for the test set and the data provenance:

   • The document does not specify sample sizes for the "testing performed" to demonstrate substantial equivalence or for the cleaning/sterilization validation. This level of detail is typically found in the full 510(k) submission, not the summary.
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This would be internal testing performed by the manufacturer to support their claims.

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

   • This question is not applicable in the context of this device and submission. "Ground truth" with expert consensus is typically relevant for diagnostic devices (e.g., imaging devices) where expert interpretation is compared. For this electrosurgical electrode, "ground truth" would be established by objective measurements (e.g., material degradation tests, sterility tests, electrical performance tests) against established engineering and medical device standards.

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

   • None. Adjudication methods are relevant for subjective assessments (like image interpretation) where multiple readers disagree. This submission focuses on objective performance characteristics validated against standards.

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. This is an electrosurgical device, not an AI or diagnostic imaging device. MRMC studies are not applicable.

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

   • No. This is an electrosurgical device, not an algorithm or AI system.

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

   • For the reusability claims: The "ground truth" would be objective testing results comparing the device's performance (e.g., electrical impedance, material integrity, sterility assurance levels) against established engineering standards (e.g., ANSI/AAMI ST46:1993, AAMI TIR 12:1994) after specified numbers of sterilization cycles.
   • For substantial equivalence: Comparison against the predicate device's known performance specifications and general safety/effectiveness requirements for electrosurgical electrodes.

7. The sample size for the training set:

   • Not applicable. This device does not use machine learning or AI, so there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable. No training set exists.

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Reprocessed electrosurgical electrodes are intended for precision cutting, dissecting and cauterizing soft tissue. These devices are most commonly used in surgical procedures for which minimal tissue necrosis, bleeding, and surgical field smoke is desired.

SterilMed's reprocessed electrosurgical electrodes are a monopolar electrosurgical instruments consisting of a tungsten tip, stainless steel housing, and several layers of insulation.

The provided text is a 510(k) summary for SterilMed's Reprocessed Electrosurgical Electrodes. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study with specific acceptance criteria and performance metrics for a novel AI/software device.

Therefore, many of the requested items (e.g., AI performance metrics, sample sizes for training/test sets, expert adjudication methods, MRMC studies) are not applicable to this submission.

Here's an analysis of the available information:

Device: SterilMed Reprocessed Electrosurgical Electrodes

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this context refers to demonstrating that the reprocessed device performs comparably to new, equivalent devices and meets safety standards for reuse. The submission emphasizes substantial equivalence rather than numerical performance against specific criteria.

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

The document indicates "representative samples" were used for bench testing. It does not specify a numerical sample size for these tests. Data provenance (country of origin, retrospective/prospective) is not mentioned, as this is a reprocessed medical device submission, not a clinical study on patient data.

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

Not applicable. This submission doesn't involve establishing ground truth from expert interpretations of medical images or data. The "ground truth" here is the functional performance and safety of the reprocessed device, assessed through bench testing and process validation.

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

Not applicable, as this is not a study assessing interpretations of medical data. The evaluation is based on engineering and quality control 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 an electrosurgical electrode, not an AI-powered diagnostic tool.

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

Not applicable, as this is not an algorithm or AI device.

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

The "ground truth" for this device's performance and safety is established through:

• Bench testing: Verifying functional characteristics (e.g., cutting ability).
• Process validation: Confirming the efficacy of cleaning, sterilization, and packaging procedures.
• Comparison to predicate devices: Demonstrating consistency in design, materials, and intended use.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

Not applicable. There is no "training set" for this type of device.

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