Search Results

The gi2000 electrosurgery unit (ESU) is intended to deliver electrosurgical outputs to perform cutting and/or coagulation, in flexible endoscopic applications.

The gi2000 is an electrosurgical generator for use in flexible endoscopic clinical settings, employing high-frequency energies to carry out cutting and coagulation of tissue during gastrointestinal surgical procedures. This isolated output electrosurgical unit (ESU) includes all standard features commonly utilized in a broad spectrum of gastrointestinal surgical procedures, encompassing monopolar cutting, monopolar coagulation, and monopolar spray coagulation, along with bipolar coagulation.

The gi2000 consists of the high-frequency electrosurgical unit with control panel and an operating foot switch. The handpiece (electrodes) and dispersive pad (return electrode) are not included with the gi2000. Instead, device labeling lists optional pieces that have been validated with the device.

The provided text is a 510(k) clearance letter for an electrosurgical generator (gi2000). While it describes the device, its intended use, and generally mentions that performance testing was completed, it does not contain the specific acceptance criteria or detailed study results as typically found in a clinical study report or a more comprehensive summary of safety and effectiveness data.

The 510(k) summary states, "Performance testing on the gi2000 was completed by three methods," and then lists the types of studies: ex-vivo comparative study, accessory compatibility study, and in-vivo preclinical test. However, it only references internal document IDs (e.g., "40-0036-11 DS, Predicate Device Comparative Study Report, gi2000") rather than providing the data itself.

Therefore, I cannot extract the detailed information requested regarding acceptance criteria and device performance, sample sizes, expert qualifications, or multi-reader multi-case studies from the provided text. The document confirms that performance testing was done and demonstrated substantial equivalence, but it does not present the specific data points to fill out your requested table and study details.

To address your request, I would need a document that contains the actual results of these performance tests, including the quantitative acceptance criteria and the values measured for the gi2000.

Ask a specific question about this device

The smoke evacuation rocker switch pencil and telescoping smoker switch pencil are intended for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.

The Valleylab™ Smoke Evacuation Rocker Switch Pencil family consists of sterile, single-use, hand-held monopolar electrosurgical instruments designed for use with compatible Covidien generators that include monopolar capabilities to cut and coagulate through tissue. They have a standard three-prong monopolar plug. The devices have an integrated smoke capture capability and are included with a default adapter that can aid in the connection to a smoke evacuation system. The adapter can be removed or replaced as needed to fit a variety of smoke evacuation systems. The proposed device family will be provided gamma sterilized. The proposed devices do not contain software.

The pencil family consists of standard and telescoping pencil models and associated accessories. The standard model is designed with a fixed smoke nozzle and electrode length, with the option for use with extender accessories (Valleylab™ Smoke Evacuation Extension Tube) and longer electrodes to access deeper spaces while maintaining smoke evacuation capabilities. The telescoping model has an independently telescoping smoke nozzle and electrode, allowing for a customizable configuration.

The provided text describes a 510(k) premarket notification for electrosurgical devices, not an AI/ML device. Therefore, the questions related to AI/ML specific acceptance criteria, study design, and performance metrics cannot be answered from the given document.

The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data, primarily related to safety and effectiveness of electrosurgical cutting, coagulation, and smoke evacuation.

However, I can extract information relevant to general device evaluation as presented:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence determination for a medical device (electrosurgical pencil) and not an AI/ML diagnostic tool, the acceptance criteria are not in terms of traditional metrics like sensitivity, specificity, or AUC. Instead, they relate to established medical device standards and functional performance in comparison to a predicate device.

The following questions are not applicable or cannot be answered from the provided text as it pertains to a traditional medical device submission, not an AI/ML device.

2. Sample size used for the test set and the data provenance: Not applicable for an AI/ML model. The "test set" here refers to physical testing of prototypes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for an AI/ML model. Ground truth in this context would be physical measurements or standardized test results.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for an AI/ML model.
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 tool, not an AI diagnostic assistant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device has no standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance data mentioned (biocompatibility, electrical safety, mechanical/functional, thermal effect), the "ground truth" would be objective measurements against established engineering standards and physical properties, not clinical diagnostic ground truth.
8. The sample size for the training set: Not applicable. There is no AI/ML model training set.
9. How the ground truth for the training set was established: Not applicable. There is no AI/ML model training set.

Summary of the study/performance evaluation presented:

The submission aimed to demonstrate substantial equivalence of the Valleylab™ Smoke Evacuation Rocker Switch Pencil family to its predicate device (Valleylab™ Smoke Evacuation Pencil, K103375). This was achieved through a series of non-clinical performance tests:

• Biocompatibility testing according to ISO 10993-1.
• Electrical safety and EMC testing complying with relevant IEC 60601 standards.
• Mechanical and functional testing to confirm performance against design requirements.
• Ex-vivo Monopolar Thermal Effect testing comparing the proposed device's thermal performance to the predicate device across various tissue types, power settings, and modes, using different electrosurgical generators.
• Human Factors and Usability testing in compliance with IEC 62366 to ensure safe and correct use.

No pre-clinical or clinical studies relying on "assessment of performance data" for substantial equivalence were conducted, as stated in the document. The overall conclusion was that the device is as safe and effective as the predicate based on the non-clinical performance documentation.

Ask a specific question about this device

The Valleylab FX8 FX Series Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.

Valleylab FX8 FX Series Energy Platform is a radio-frequency (RF) electrosurgical generator that delivers energy to compatible surgical instruments. The concentration of energy at the tip of the instrument in conjunction with tissue characteristics produces heat. The heating of tissue provides the desired surgical effect (cutting, coagulation, sealing). Variations in the waveform result in the different surgical effects achieved by different modes.

The provided text describes a 510(k) premarket notification for the Valleylab FX8 FX Series Energy Platform, an electrosurgical generator. The submission aims to demonstrate substantial equivalence to a predicate device, the Valleylab FT10 Energy Platform.

However, the documentation does not include a study proving the device meets specific performance acceptance criteria in the way one might expect for an AI/ML medical device, which would typically involve metrics like sensitivity, specificity, or AUC against a ground truth.

Instead, the provided text describes the verification and validation activities performed to demonstrate that the Valleylab FX8 FX Series Energy Platform performs as intended and is substantially equivalent to its predicate. These activities focus on safety, functionality, and performance equivalence, rather than a clinical effectiveness study with human readers or a standalone algorithm.

Here's a breakdown based on the information available, addressing the requested points:

Acceptance Criteria and Device Performance Study (as described in the document)

The document primarily focuses on demonstrating substantial equivalence through engineering and laboratory testing, rather than a clinical performance study with defined "acceptance criteria" and "reported device performance" in terms of classification metrics (e.g., sensitivity, specificity) against a clinical ground truth.

The "acceptance criteria" for this device are implicitly tied to:

• Compliance with specific electrical safety and EMC standards.
• Comparable performance to the predicate device in ex vivo tissue testing.
• Meeting system specifications.
• Successful software verification and validation.

1. Table of acceptance criteria and reported device performance:

Based on the provided text, a table like this would represent the types of tests done and the general outcomes, rather than quantitative performance metrics against a clinical outcome.

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

• Test Set Sample Size: Not specified quantitatively. The ex vivo testing mentions "porcine tissue" but does not give a sample size (e.g., number of tissue samples, number of tests performed).
• Data Provenance: The ex vivo testing was performed using "porcine tissue," implying a laboratory setting. The country of origin and whether it was retrospective or prospective is not stated, but it's clearly a controlled, pre-market lab-based testing scenario, not a retrospective analysis of clinical patient data.

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

• Not Applicable. For this type of electrosurgical generator, "ground truth" concerning thermal effects or system functionality would be established through physical measurements, engineering specifications, and validated test methods, not by expert consensus on clinical images or diagnoses.

4. Adjudication method for the test set:

• Not Applicable. As there are no human experts classifying outcomes on a test set, no adjudication method (like 2+1 or 3+1) was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. An MRMC study was explicitly not performed. The document states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." This type of study is typically done for diagnostic AI devices, not electrosurgical generators.

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

• No, not in the context of an AI algorithm. This device is an electrosurgical generator, not a diagnostic algorithm. Its "performance" is evaluated based on its physical characteristics, energy delivery, safety, and functionality, not its ability to interpret data independently.

7. The type of ground truth used:

• For electrical safety and EMC: Engineering standards and measured electrical characteristics.
• For ex vivo testing: Physical measurements of thermal effects on porcine tissue.
• For system verification: Engineering specifications and functional tests.
• For software: Software requirements, design specifications, and standard software quality assurance testing.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device that uses a "training set" in the conventional sense. The device's "training" is its design, engineering, and manufacturing process.

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

• Not Applicable. As this is not an AI/ML device, there is no "training set" or ground truth for it. Its operational parameters are determined by electrosurgical principles and engineering design.

In summary: The provided document is a 510(k) summary for an electrosurgical generator, which is a physical medical device, not a software algorithm or AI-powered diagnostic tool. Therefore, the "study that proves the device meets the acceptance criteria" is fundamentally different from what would be expected for an AI/ML product. The "acceptance criteria" discussed are related to engineering and safety standards, and performance equivalence to a predicate device, rather than diagnostic accuracy metrics.

Ask a specific question about this device

The Olympus ESG-400 electrosurgical unit is intended for cutting and coagulation of tissue in open, laparoscopic and endoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment.

The ESG-400 is a reusable, non-sterile electrosurgical generator that features different mono- and bipolar cutting and coagulation modes. The maximum output power is 320 W. It is intended for cutting and coagulation of tissue in open, laparoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment.

The updated ESG-400 allows Olympus Plasma Kinetic (PK) instruments to be connected at the device.

The provided document is a 510(k) premarket notification for an electrosurgical generator, the Olympus ESG-400, detailing its comparison to a predicate device and safety information. It focuses on demonstrating substantial equivalence rather than presenting a clinical study with detailed acceptance criteria and performance metrics for a device to "meet" those criteria in the way a diagnostic or AI-driven device would.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission for an electrosurgical generator.

However, I can extract information related to general performance testing and compliance with standards.

Here's the information that can be extracted, and where applicable, a note that the requested information is not available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Electrosurgical generators are assessed for safety and performance against recognized standards, rather than specific diagnostic accuracy metrics. The "acceptance criteria" here relate to meeting the specifications and safety requirements outlined in the standards and showing equivalence to a predicate device.

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

• Sample Size: Not explicitly stated as a number of "cases" or "patients" in the context of a typical clinical study. Performance testing involved bench tests and validation with representative HF instruments.
• Data Provenance: Not applicable in the sense of patient data. The testing was conducted internally by the manufacturer (Olympus Winter & Ibe GmbH) as bench validation.

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

• This information is not applicable and not provided in the document. The testing involved comparing device outputs and functionality against a predicate device and industry standards, not against human expert diagnoses or interpretations.

4. Adjudication Method for the Test Set

• Not applicable. The "test set" here refers to bench testing and comparison against a predicate device, not diagnostic interpretations requiring adjudication.

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 MRMC comparative effectiveness study was done. This type of study is not relevant for an electrosurgical generator, which is a therapeutic device, not an AI-driven diagnostic tool.

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

• Not applicable. This is an electrosurgical generator, not an algorithm that performs without human involvement. The device itself is the "standalone" component in its intended function.

7. The Type of Ground Truth Used

• Ground Truth: The "ground truth" for this device's performance is defined by:
  • Compliance with recognized international standards (e.g., IEC, ISO for safety, performance, EMC, software, risk management).
  • Direct comparison of waveform output and power levels to legally marketed predicate devices (Gyrus G400, K081954).
  • Internal engineering specifications and risk analysis based on ISO-14971.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device that requires a "training set" in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

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

Ask a specific question about this device

The EC 2.7 Endoscopic Cutter is a single use electrosurgical instrument designed to be used with flexible bronchoscopes and qualified electrosurgical units. It is indicated for cutting of soft tissue obstructions in upper airways and tracheobronchial tree, and provision of electrosurgical hemostasis during such procedures.

The EC 2.7 Endoscopic Cutter is a disposable, single-patient-use monopolar RF (radio-frequency) surgical endotherapy device intended to be inserted through the working channel of a flexible bronchoscope. The EC 2.7 Endoscopic Cutter is terminally sterilized via ETO. It is comprised of a separately packaged, cylindrically shaped, disposable monopolar cutting and coagulation electrode affixed to the distal end of a polymeric, flexible multi lumen shaft , and a separately packaged, single-patient-use, electrical adaptor with cabling, intended for connection to the monopolar output port of a Covidien® Corporation, ValleyLab™ Force FX™ or FX-C Electrosurgical Generator. The ValleyLab™ Force FX™ was cleared to market via 510(k) K944602.

The provided text describes a 510(k) premarket notification for the Medtronic Advanced Energy LLC EC 2.7 Endoscopic Cutter. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the typical format of a performance study with specific metrics.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data and adherence to recognized standards.

Here's an analysis based on the provided text, addressing the points where information is available:

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

The document does not present a table of specific quantitative acceptance criteria or reported device performance in the manner requested (e.g., sensitivity, specificity, accuracy).

Instead, it lists performance testing methods as evidence of compliance and substantial equivalence:

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

The document mentions "bench testing, human cadaveric studies and in vivo animal data collection." However, specific sample sizes for these tests are not provided. The provenance (country of origin, retrospective/prospective) of these studies is also not specified.

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)

This device is an electrosurgical cutting tool, not an AI/imaging device requiring expert ground truth for classification. Therefore, this information is not applicable and not present in the document.

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

Not applicable to this type of device and submission. The performance testing focuses on functional parameters, material compatibility, and adherence to standards, rather than diagnostic accuracy requiring adjudication.

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 MRMC study was conducted or is relevant to this electrosurgical device. This type of study is specific to AI-powered diagnostic tools.

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.

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

For the non-clinical performance data (bench, cadaveric, animal studies), the "ground truth" would be related to the observed physical effects and measurements, such as:

• Bench Testing: Direct physical measurements (e.g., cutting depth, coagulation area, power output, electrode integrity), functional evaluations (e.g., ability to cut specific tissue analogs), and material science tests.
• Human Cadaveric Studies: Observation of tissue cutting and coagulation characteristics on post-mortem human tissue.
• In Vivo Animal Studies: Direct observation of the device's effects on live animal tissue (e.g., cutting, coagulation, hemostasis, tissue response) under simulated surgical conditions.

These "ground truths" are based on direct physical and biological interaction observations and measurements, often compared to the known effects of the predicate device.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI/machine learning algorithm.

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

Not applicable for the same reason as point 8.

Ask a specific question about this device

The SenoRx ES 300 is an electrosurgical generator which is intended for general surgical procedures where electrosurgical cutting or coagulation of soft tissues is required.

The ES 300 Electrosurgical Generator is designed to cut and coagulate soft tissue. The ES 300 uses radio frequency (RF) energy to perform both cutting and coagulation, using RF handpieces.

The provided text describes a 510(k) summary for the SenoRx ES 300 Generator, an electrosurgical device. It outlines the device's intended use and compares it to predicate devices. However, the document does not contain information related to acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The provided text is a regulatory submission for a medical device that aims to demonstrate substantial equivalence to existing devices, not a study report detailing performance metrics against specific acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document primarily focuses on regulatory compliance and comparison to predicate devices, rather than detailed performance study results.

Ask a specific question about this device

Aesculap's Nelson delix® Electrosurgical is intended to be used in surgery to generate electrical power for both Monopolar and Bipolar cutting and coagulating in microsurgery and macrosurgery.

Aesculab's Nelson dollar Electrosurgical Unit is an Electrosurgical unit (ESU) capable of generating high frequency electrical current, driven through a software based program, for use in monopolar and bipolar electrosurgery. The Nelson asunt Electrosurgical Unit is equipped with two monopolar and two biopolar outlets. All software and electrical components are housed within a combination metallic and thermoplastic enclosure and the product is provided with a universal power cord, which automatically adapts to voltages ranging from 100-240 volts. A monopolar or bipolar cord connects the instruments to the coagulator. The unit is activated by means of a foot control or hand piece.

This document, a 510(k) Summary for the Nelson deluxe Electrosurgical Unit, does not contain information about specific acceptance criteria or a study proving the device meets those criteria.

Instead, it's a premarket notification to the FDA, demonstrating substantial equivalence to previously cleared devices. It focuses on the device's intended use, description, and comparison to predicate devices, rather than detailed performance study results against specific acceptance criteria.

Here's what can be extracted based on the provided text, and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in terms of measurable performance metrics (e.g., power output accuracy within a certain percentage, impedance range a device can handle). The document mentions conformance to "applicable IEC standards and the requirements of the Canadian Standards Association (CSA) for medical electrical equipment," but it doesn't list the specific criteria from these standards.
• Reported Device Performance: No specific performance data (e.g., measured power outputs, waveform characteristics, safety features efficacy) is reported in the text.

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

• Sample Size: Not applicable as no specific performance test set is described.
• Data Provenance: Not applicable.

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

• Not applicable as no specific performance test set with expert-established ground truth is described.

4. Adjudication Method for the Test Set

• Not applicable as no specific performance test set is described.

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

• No MRMC comparative effectiveness study is mentioned. This type of study is more common for diagnostic imaging AI, not electrosurgical units.

6. Standalone Performance Study

• No standalone (algorithm only) performance study is mentioned. The device is hardware-based with a software-driven component for generating electrical current, but it's not a standalone diagnostic algorithm.

7. Type of Ground Truth Used

• Not applicable as no specific performance test with ground truth is described.

8. Sample Size for the Training Set

• Not applicable as this document predates and doesn't involve AI/ML device training sets in the modern sense. The "software-based program" mentioned likely refers to control logic, not a machine learning model.

9. How Ground Truth for the Training Set Was Established

• Not applicable.

Summary of what the document does provide:

• Intended Use: Used in surgery to generate electrical power for both Monopolar and Bipolar cutting and coagulating in microsurgery and macrosurgery.
• Device Description:
  • Generates high-frequency electrical current.
  • Software-based program drives the current.
  • Equipped with two monopolar and two bipolar outlets.
  • Universal power cord (100-240 volts).
  • Activates via foot control or handpiece.
• Substantial Equivalence: Claimed based on similar features, functions, intended use, labeling, and basic operating principles to predicate devices:
  • Conmed / Aspen Laboratories' System 7500 ABC Electrosurgical Unit (#K981220)
  • Erbe's Erbotom ICC 300 & 350 (#K953738 & #K933002)
  • ValleyLab's Force FX (#K944602)
• Regulatory Compliance: Conforms to "applicable IEC standards and the requirements of the Canadian Standards Association (CSA), for medical electrical equipment." This implies that the device was tested against these standards, but the specific acceptance criteria and results are not detailed in this summary.

Conclusion:

This 510(k) summary is a regulatory filing focused on establishing substantial equivalence for market clearance. It explicitly states, "No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices." Therefore, it does not describe a performance study against specific, pre-defined acceptance criteria in the way a modern AI/ML device submission would. The "performance data" section only states compliance with international safety and electrical standards, without detailing the clinical or technical performance metrics and results a device like this might otherwise have.

Ask a specific question about this device