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This device is designed to be used whenever monopolar electrosurgery is indicated. The intended use of this device is to conduct monopolar electrosurgical energy from target tissue of a patient back to one or two electrosurgical units (ESU), or generators.

Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators. The device is not intended for RF ablation.

The device is intended to be used as a 24-month reusable patient return electrode for patients age 12 years and older. The Universal (model 0845) and Universal Plus (model 0847) have a single cord that connects to one generator. The Universal Dual (model 0846) and Universal Plus Dual (model 0848) have two cords that can connect to one or two generators.

The Mega Soft Universal Patient Return Electrodes (ie. Mega Soft) are constructed of a layer of conductive material strain-relieved between an insulative polymer gel, and sealed between two layers of a thermal polyurethane plastic film. The thermal polyurethane plastic film and the contained polymer gel enveloping the conductive material is compressable but does not laterally move under pressure. The polymer acts as a dielectric protection and is encapsulated by a layer of urethane film. The dielectric protection remains between the thermal polyurethane plastic film and the conductive layer irrespective of pressure.

A two-conductor cable connects the conductive layer of the device to a two-conductor DetachaCable™. The DetachaCable is connected to a standard monopolar ESU. The DetachaCable is available in a variety of configurations and lengths, designed to be compatible with the various compatible generators available on the market and was cleared under K080741 on 16 December 2008.

The provided document is a 510(k) summary for the Megadyne Patient Return Electrode Pads (models 0845, 0846, 0847, 0848). This document describes the device, its intended use, comparison to predicate devices, and performance testing. However, it does not contain information about acceptance criteria, detailed study designs, sample sizes for test or training sets, ground truth establishment, or expert involvement as typically required for AI/ML device evaluations.

The reason for this is that the Megadyne Patient Return Electrode Pad is a physical medical device (an electrosurgical accessory), not a software or AI/ML algorithm. The performance data provided is related to electrical and mechanical properties, not diagnostic accuracy or AI performance metrics.

Therefore, I cannot fulfill your request for detailed information regarding acceptance criteria, study details, sample sizes, ground truth, expert qualifications, or MRMC studies for an AI device. This information is not relevant to the described device.

Instead, I can extract the acceptance criteria and study information that is applicable to this physical medical device:

Acceptance Criteria and Reported Device Performance (Physical Device)

Study Information (Physical Device Testing):

1. Sample size used for the test set and the data provenance: Not explicitly stated regarding specific numerical samples for each test parameter. The studies were bench performance testing and acute animal studies. Provenance typically refers to the origin of data; for bench testing, it's specific laboratory conditions, and for animal studies, it's a controlled animal model.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are engineering and animal model tests, not clinical evaluations requiring expert interpretation for ground truth. Compliance standards (IEC 60601 series) define the "ground truth" for success.
3. Adjudication method: Not applicable. This is not a clinical study involving human readers or AI output requiring adjudication.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not applicable for this physical device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, not applicable for this physical device.
6. The type of ground truth used: For bench performance, the ground truth is defined by the technical specifications and safety standards (e.g., IEC 60601 series) that dictate acceptable electrical resistance, mechanical integrity, and cleaning effectiveness. For animal studies, the ground truth is the physiological response and absence of adverse events in the animal model, as per the standard (IEC 60601-2-2).
7. The sample size for the training set: Not applicable; there is no training set as this is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable.

Summary from the document for this device:

The document primarily focuses on demonstrating substantial equivalence of the new Megadyne Patient Return Electrode Pads to a predicate device (Mega Soft Universal Patient Return Electrode, K133726 model 0845) based on identical technological characteristics (indications, materials, operational principles, packaging, shelf-life) and performance data from bench and acute animal studies. The differences identified (intended population, pad thickness, dual cord option, model number) were assessed through these tests to ensure they do not raise new questions of safety and effectiveness. The performance testing confirmed compliance with relevant IEC standards.

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The Ethicon Megadyne Electrosurgical Generator (ESU) is intended as a general-purpose electrosurgical generator designed to produce radio frequency (RF) current for cutting and coagulation to be delivered to target tissue through an accessory electrode during open and laparoscopic surgical procedures.

The Ethicon Megadyne TM Electrosurgical Generator is a microprocessor controlled, isolated output, high frequency generator designed for use in cutting and coagulation of tissue. The generator has the ability to perform both monopolar cutting and coagulation and bipolar coagulation of tissue in a wide range of surgical applications.

The Megadyne Electrosurgical Generator, a general-purpose electrosurgical generator designed to produce radio frequency (RF) current for cutting and coagulation of tissue during surgical procedures, underwent various performance tests to ensure its safety and effectiveness following design changes.

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K193145) rather than explicitly stating acceptance criteria and reporting performance for each individual criterion in a pass/fail format. However, based on the provided "Performance Data" and the "Comparison of Technological Characteristics" tables, the acceptance criteria implicitly involve demonstrating that the device's technical specifications and performance are either identical to the predicate or that any differences do not adversely affect safety and effectiveness.

Here's a summary of the implied acceptance criteria and the device's reported performance:

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

• Sample Size: For "Bench Testing (Thermal Effects on Tissue)," testing was performed "in triplicate at minimum". This indicates at least three repetitions for each combination of Generator mode and power setting. The document does not specify a total number of tissue samples or test runs beyond this.
• Data Provenance: The data appears to be prospective bench testing conducted specifically for the purpose of this 510(k) submission to demonstrate the performance of the modified device. The document does not mention the country of origin of the data, but it is implied to be generated by the manufacturer or its contracted laboratories for the FDA submission.

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

• The document does not mention the use of experts to establish ground truth for the bench testing. The evaluation of thermal effects was done through "image analysis using open source image processing software." This suggests an objective, quantitative measurement rather than expert interpretation for the thermal effects study. For other tests like electrical safety and EMC, ground truth is established by adherence to specified standards.

4. Adjudication method for the test set:

• None specified. Given the nature of the tests (compliance with standards, objective thermal measurement via software), an adjudication method in the context of expert consensus or disagreement is not applicable or explicitly mentioned.

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 done. This device is an electrosurgical generator, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and analysis of AI-assisted human performance are not relevant to this submission.

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

• Not applicable directly as an "algorithm only" study. The device itself is electro-mechanical, with embedded software. Software verification and validation (V&V) was performed to ensure the software functions correctly independently, but this is not a "standalone algorithm" performance in the sense of a diagnostic or predictive AI. The entire device's performance, including its software, was assessed.

7. The type of ground truth used:

• Compliance with International Standards: For electrical safety and EMC, the ground truth is defined by the requirements and test methods specified in the relevant IEC 60601 series standards.
• Objective Measurement: For thermal effects on tissue, the ground truth was based on quantitative measurements of thermal damage obtained through image analysis software.
• Manufacturer's Specifications/Design Intent: For other characteristics like operating parameters and device features, the ground truth is established by the device's design specifications and comparison to the predicate device's known characteristics.

8. The sample size for the training set:

• Not applicable. This submission is for an electrosurgical generator, which is not an AI/ML-based device that would typically involve a "training set" for model development. The software V&V confirms the performance of the embedded software, but it's not a machine learning model that learns from a training dataset.

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

• Not applicable. As a training set is not relevant for this type of device, this question is not pertinent.

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The Megadyne Smoke Evacuator with accessories is intended to remove smoke created in surgical procedures at the surgical site.

The Megadyne Smoke Evacuator is designed to provide smoke evacuation in open and Laparoscopic procedures for the removal of surgical smoke. Using a scroll pump and 4 stages of filtration, the Megadyne Smoke Evacuator is designed to evacuate surgical smoke both quietly and effectively. An intuitive front panel design allows users to customize both the rate of suction FLOW and the length of RUN TIME after the active electrode is deactivated. Push button selections for OPEN, LAP (laparoscopic), and MANUAL modes are also clearly marked and easily accessible. The Megadyne smoke evacuator provides evacuation of smoke plume via a smoke evacuation device and tubing (e.g. E-Z Clear Smoke Evacuation Electrosurgical Pencil under K141587 on February 18, 2015) connected to the face of the Filter.

The Megadyne Smoke Evacuator has undergone non-clinical testing to demonstrate its safety and effectiveness. The acceptance criteria and reported device performance are summarized below:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document provided does not specify the sample sizes used for each individual test set. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. The tests listed are non-clinical, implying laboratory-based testing rather than patient data.

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

For the non-clinical tests described, the concept of "ground truth" established by human experts, as typically seen in AI/ML performance studies for medical image analysis, does not directly apply. The acceptance criteria for these tests are based on established engineering standards (e.g., IEC standards) and design requirements. Therefore, the "ground truth" is defined by these objective measures rather than expert consensus on medical diagnoses.

4. Adjudication method for the test set:

Not applicable in the context of these non-clinical engineering and performance tests. The results are adjudicated against predefined, objective technical criteria.

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 a medical device (smoke evacuator), not a diagnostic AI device that assists human readers.

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

The device described is a physical medical device (smoke evacuator) with embedded software for control and monitoring. The "software validation" test evaluates the performance of this embedded software, which would be considered a standalone assessment of the algorithm's functionality within the device.

7. The type of ground truth used:

• Electrical Safety, Electromagnetic Compatibility, Mechanical Safety, Thermal Safety: Ground truth is established by the requirements of international standards (e.g., IEC 60601-1, IEC 60601-1-2).
• Software Validation: Ground truth is established by the functional design specifications and expected behavior of the software, with test cases designed to verify these.
• Flow Rate Testing, Filter Life Testing: Ground truth is established by internal design requirements and specifications for these performance metrics.
• Design Validation: Ground truth involves meeting user needs and avoiding use errors, likely assessed through usability testing and adherence to design specifications.
• Tissue Effects in Laparoscopic procedures: Ground truth would be based on scientific and medical understanding of minimal tissue effects during surgical procedures, likely observed and documented in a controlled setting.

8. The sample size for the training set:

Not applicable. This is a physical medical device, and the testing described is not for an AI/ML algorithm that requires a training set in the conventional sense. The "software validation" refers to verifying the embedded software, not training a machine learning model.

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

Not applicable, as there is no training set for an AI/ML model in this context.

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The Ethicon Megadyne® Electrosurgical Generator is intended as a general-purpose electrosurgical generator designed to produce radio frequency (RF) current for cutting and coagulation to target tissue through an accessory electrode during open and laparoscopic surgical procedures.

The Ethicon Megadyne Electrosurgical Generator is a microprocessor controlled, isolated output, high frequency generator designed for use in cutting and coagulation of tissue. The generator has the ability to perform both monopolar cutting and coagulation and bipolar coagulation of tissue in a wide range of surgical applications.

This document is a 510(k) premarket notification for an electrosurgical generator. It does not pertain to an AI/ML powered device, therefore, the requested information regarding acceptance criteria, study design for AI/ML performance, sample sizes for training/test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth type is not applicable.

The document discusses the substantial equivalence of the Ethicon Megadyne Electrosurgical Generator to a predicate device (Mega Power Electrosurgical Generator). The acceptance criteria and the study proving the device meets these criteria are described in terms of safety and performance bench testing, rather than AI/ML performance metrics.

Here's a breakdown of the relevant information provided, adapted to the context of this traditional medical device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of "acceptance criteria" and "reported device performance" in the way one would for an AI/ML model with metrics like sensitivity/specificity. Instead, it describes compliance with recognized electrical safety and electromagnetic compatibility standards and comparative bench testing.

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

• Sample Size: For the thermal effects on tissue, testing was performed in triplicate at minimum, default and maximum power settings for each tissue type (skeletal muscle, liver, kidney) and each generator mode. The exact number of tissue samples is not explicitly stated beyond "triplicate" per condition.
• Data Provenance: The thermal effects testing used ex-vivo harvested animal tissue (skeletal muscle, liver, and kidney). The country of origin is not specified, but it's presumed to be associated with the manufacturer's testing facilities. The nature of the study is bench testing rather than retrospective or prospective clinical data.

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

• Not Applicable in the traditional AI/ML sense. For this device, "ground truth" for thermal effects would be the measurable thermal change on the tissue. The measurement was done through "image analysis using open source image processing software." It does not involve human expert consensus or labeling of images for diagnostic purposes. The expertise would lie in the design and execution of the bench tests and the interpretation of the physical measurements, not in expert clinical review for ground truth.

4. Adjudication Method for the Test Set:

• Not Applicable. As this is not an AI/ML diagnostic device with expert annotation, there is no need for an adjudication method for labeling a test set. The data comes from physical measurements in a controlled bench setting.

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/ML diagnostic device that assists human readers. Therefore, 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 an electrosurgical generator, a hardware device, not a standalone AI/ML algorithm. Its performance is evaluated through bench testing of its physical output and safety features.

7. The Type of Ground Truth Used:

• For thermal effects on tissue, the "ground truth" was established by direct measurement of thermal damage through image analysis of ex-vivo animal tissue, compared to the performance of the predicate device.
• For electrical safety, EMC, and software validation, the ground truth is compliance with relevant recognized consensus standards (IEC standards) and FDA guidance documents.

8. The Sample Size for the Training Set:

• Not Applicable. This device does not use an AI/ML algorithm that requires a training set. The "training" in this context refers to engineering design and development, not machine learning.

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

• Not Applicable. No training set or associated ground truth for machine learning was established for this device.

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The Megadyne Foot Switch is an accessory that is interface with compatible smoke evacuation systems to control on/off inputs for manual operation.

The Megadyne Foot Switch is used with a compatible smoke evaluation system to control on/off inputs for manual operation.

This document describes a 510(k) premarket notification for a medical device called the "Megadyne Foot Switch." This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a comprehensive clinical study as one might see for an AI/ML device.

Therefore, many of the typical acceptance criteria and study elements you've asked for (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable to this specific submission. This is a hardware device (a foot switch), not an AI/ML diagnostic or therapeutic device.

Here's how to interpret the provided document in the context of your questions:

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

For a hardware device seeking 510(k) clearance, the "acceptance criteria" are typically demonstrating compliance with relevant industry standards and showing that the new device is as safe and effective as a predicate device. Performance is shown through non-clinical testing.

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

• Sample Size: Not applicable in the context of a "test set" for a clinical study. The device itself (Megadyne Foot Switch) was tested. The "sample size" would refer to the number of units tested during the engineering validation and verification processes (e.g., how many foot switches were subjected to durability testing), but this detail isn't provided in the summary.
• Data Provenance: Not applicable. This involves non-clinical engineering and laboratory testing, not human patient data.

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

• Not applicable. There's no "ground truth" established by experts in the sense of clinical annotations (e.g., for images or patient outcomes). Ground truth for a foot switch relates to its functional performance (e.g., does it turn on/off when pressed, does it resist water intrusion as specified). This is verified through engineering tests against predefined specifications.

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

• Not applicable. This is a method used for reconciling discrepant expert opinions in clinical studies; it is not relevant for hardware performance 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

• Not applicable. An MRMC study is relevant for evaluating the impact of a diagnostic tool (often AI) on human reader performance. This is a simple hardware accessory (a foot switch for a smoke evacuation system).

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

• Not applicable. This is a hardware device; there is no algorithm or AI component to evaluate in a standalone manner. Its "standalone performance" would be its ability to pass the electrical, mechanical, and durability tests, which was summarized as "compliant with" relevant standards.

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

• The "ground truth" for this device's performance is objective engineering and electrical/mechanical standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60529). The device's performance is measured directly against these quantifiable standards (e.g., Does it meet the IPX8 rating? Does it pass defined electrical safety tests?).

8. The sample size for the training set

• Not applicable. This is a hardware device, not an AI/ML model that requires a training set.

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

• Not applicable. No training set for an AI/ML model was used.

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The ZIP PEN Smoke Evacuation Electrosurgical Pencil is a monopolar device designed 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. This device conducts an electrosurgical current from an electrosurgical generator and delivers it to the target tissue to achieve the desired surgical effect.

The ZIP Pen Smoke Evacuation Electrosurgical Pencil is a sterile, single use hand held electrosurgical pencil and smoke evacuation handpiece. It is a monopolar device designed 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 device consists of a printed circuit board, flexible electrical cable, dome switches, button switch mechanisms and sealing materials. The circuit board and electrical cable provide the means for powering the device. The dome switches operate the Cut and Coag functions. These components are enclosed within an upper housing and lower molded carriage and nozzle. which snap together. The buttons sit on top of the dome switches and extend through the upper housing and facilitate activation of the device. The button proximal to the electrode is yellow and controls the cut function of the device. The button distal to the electrode is blue and controls the coagulate function of the device. Within the nozzle, there is a metal collett that holds the electrode in place. The housing and other components are designed and assembled to prevent liquid from entering the electrical connections (preventing an electrical short). This is accomplished by over molding the circuit board with nonconductive materials. Clear tubing connects to the nozzle and provides a path for capturing electrosuraical smoke. The electro-surgical cable leaves the tubing through an open port and terminates at a 3-prong electro-surgical plug. The remaining portion of the tubing (without cable inside) terminates at a connector that attaches to the smoke evacuation filter. The connector is attached to the tubing and is included as part of the smoke evacuation pencil for connection to the filter. The ZIP Pen Smoke Evacuation Electrosurgical Pencil is available with 10 ft. and 15 ft. cord/tubing (catalog numbers 2525-10 and 2525-15, respectively) and is supplied with two additional items: A holster, which is used to hold the device when it is not in use during the procedure. The holster is a component of the device and will not be sold separately. A 2.5 inch Megadyne E-Z Clean electrode. The electrode is a separate, currently marketed device that received clearance in 2008 via K081791. The associated accessories include: Nozzle Extension can be used in electrosurgery procedures where a longer electrode is required to extend the smoke capture nozzle to the surgical site. Filter -- the ULPA and charcoal filters can be used with smoke evacuation units. They filter surgical smoke and odors removed from the surgical site. Adapter can be used to facilitate the tubing connection to a variety of smoke evacuation filter/units on the market.

The provided text describes the 510(k) summary for the ZIP Pen Smoke Evacuation Electrosurgical Pencil and does not pertain to an AI/ML medical device. Therefore, a table of acceptance criteria and reported device performance as typically expected for such a device, and information regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance, are not available in this document.

Instead, the document details the safety and performance testing conducted to demonstrate substantial equivalence to a predicate device. Here's a summary of the performance data presented:

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI device context):

Specifics not applicable to AI/ML context:

• Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of medical device's performance testing. The description refers to physical tests on the device itself.
• 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. This device does not have a "ground truth" derived from expert interpretation.
• 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, 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/ML device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable. This is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable.

Further details from the provided text (beyond typical AI/ML criteria):

• Software Verification and Validation Testing: "Not applicable. The ZIP Pen Smoke Evacuation Electrosurgical Pencil does not contain software."
• Animal Study: "Not applicable. Animal studies were not performed on the device."
• Clinical Studies: "Clinical studies were not performed as the indications for use are equivalent to the predicate device, and clinical testing is not required by applicable regulations."

The study described here focuses on demonstrating the physical, electrical, and biological safety and performance of the device through bench testing and compliance with relevant international standards, rather than evaluating an algorithm's diagnostic or predictive performance.

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This device is designed to be used whenever monopolar electrosurgery is indicated. The intended use of this device is to conduct monopolar electrosurgical energy from target tissue of a patient back to one or two electrosurgical units (ESU), or generators.

Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators. The device is not intended for RF ablation.

The MegaSoft Universal Patient Return Electrode is constructed of a layer of conductive material strain-relieved with two sheets of urethane material, and sealed between two symmetric layers of a viscoelastic polymer called Akton® The Akton polymer is encapsulated by a layer of urethane film. One twoconductor cable connects the conductive layer of the device to a two conductor DetachaCable . The DetachaCable is connected to a standard monopolar electrosurgical unit (ESU). The device cable is insulated, strain-relieved, and connected well inside the device to prevent patient or user burns. In use, this device will lay on the operating surface with the patient lying on either side of the pad.

The pad size is approximately 36" x 20" x 0.135" and is intended for patients weighing ≥ 0.8 lb (350 grams).

The provided text is related to a 510(k) submission for a medical device called the "MegaSoft Universal Patient Return Electrode." It describes the device, its intended use, and its technological characteristics, and references adherence to voluntary safety standards (IEC 60601-1:2005 and IEC 60601-2-2:2009).

However, the document does not contain information about:

• Specific acceptance criteria with numerical targets.
• A detailed study proving the device meets acceptance criteria, including sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
• Standalone algorithm performance or comparative effectiveness studies (MRMC study) for an AI device. The described device is a physical electrode, not an AI/software device.
• Training set details for an AI model.

Therefore, many of the requested fields cannot be populated from the provided text. The device is a physical electrosurgical accessory, and the regulatory submission heavily relies on demonstrating equivalence to a predicate device and adherence to industry safety standards through testing, rather than a clinical effectiveness study with AI-specific metrics.

Here is what can be extracted based on the provided text, and noted where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

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This device is designed to be used whenever monopolar electrosurgy is indicated. The intended use of this device is to conduct monopolar electrosurgical energy from target tissue of a patient back to one or two electrosurgical units (ESU), or generators. At the same time the product reduces the risk of pressure related injury due to immobility during surgery.

Electrosurgical use is restricted to use with isolated monopolar electrosurgical generators. The device is not intended for RF ablation.

The Mega Soft Patient Return Electrode is constructed of a layer of conductive material strain-relieved with two sheets of urethane material, and sealed between two asymmetric lavers of a viscoelastic polymer called Akton . (The top layer of polymer is thinner than the bottom layer.) The Akton polymer is encapsulated by a layer of urethane film. One or two two-conductor cables connects the conductive layer of the device to a two conductor DetachaCable". The DetachaCable is connected to a standard monopolar electrosurgical unit (ESU). The device cable is insulated, strain-relieved, and connected well inside the device to prevent patient or user burns. In use, this device will lay on the operating surface with the patient lying on top, on the side labeled "patient side".

The adult-size device is large enough to extend at least the length and width of a typical patient torso. Pad size is approximately 20" x 46" x 1/2". The pediatricsize device is approximately 12" x 26" x 1/2" and is intended for pediatric patients weighing between 0.8 and 50 lbs.

This is a 510(k) summary for a medical device that received clearance, not a study report. Therefore, it primarily focuses on establishing substantial equivalence to existing devices rather than presenting the results of a detailed clinical efficacy or performance study with specific acceptance criteria and ground truth validation.

Based on the provided information, I can answer some of your questions but others are not applicable as this document is not a study report.

1. Table of Acceptance Criteria and Reported Device Performance
This document, a 510(k) summary, does not specify quantitative acceptance criteria for device performance in the way a clinical study would. It focuses on demonstrating substantial equivalence to predicate devices, primarily through adherence to recognized safety standards. The performance is implied to be equivalent to the predicate devices.

2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of a clinical study assessing a new algorithm or diagnostic performance. The testing mentioned is safety and performance compliance to standards for the electrosurgical device itself. Therefore, sample size and data provenance in this context are not applicable in the way you might expect for an AI/algorithm study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. Ground truth, in the sense of expert consensus for diagnostic accuracy, is not relevant for this type of device submission. The device is an electrosurgical patient return electrode, and its evaluation focuses on electrical safety and performance, not diagnostic accuracy.

4. Adjudication method for the test set
This is not applicable for the reasons stated above.

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
This is not applicable. The device is an electrosurgical patient return electrode, not an AI or imaging diagnostic tool that would involve human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This is not applicable. The "ground truth" for an electrosurgical return electrode is its ability to safely and effectively conduct electrosurgical energy and reduce the risk of pressure-related injury. This is assessed through engineering testing and adherence to recognized standards, not by expert consensus on clinical findings or pathological diagnoses.

8. The sample size for the training set
This is not applicable. There is no AI algorithm being developed or trained for this device.

9. How the ground truth for the training set was established
This is not applicable. There is no AI algorithm being developed or trained for this device.

Study Description (based on the provided 510(k) Summary):

The document describes a device safety and performance validation rather than a typical clinical study. The "study" (or validation process) performed by Megadyne Medical Products, Inc. for the Mega Soft Patient Return Electrode primarily focused on demonstrating:

• Technological Equivalence: The device shares the same technological characteristics as predicate devices.
• Safety and Effectiveness Equivalence: The safety and effectiveness questions are considered the same as for predicate devices, with no new technologies incorporated.
• Conformance to Standards: "Megadyne has conducted extensive testing to ensure conformance to the voluntary standard ISO 60601-2-2:2006, Medical electrical equipment, Part 2: Particular requirements for the safety of high frequency surgical equipment, and ANSI / AAMI HF 18-2001, Electrosurgical Devices."

This type of submission relies on demonstrating that the new device meets established industry safety and performance standards equivalent to legally marketed predicate devices, rather than performing a de novo clinical trial with specific diagnostic accuracy metrics.

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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 intended use of this device is to conduct monopolar electrosugical energy from an electrosugical generator (ESU) to target tissue during ENT and general surgical procedures. It is also a suction apparatus and is intended to be used to remove surgical smoke and fluids from the site. This device is intended to be used whenever monopolar electrosurgical coagulation and fluid aspiration are indicated.

The suction coagulator is a hand held electrosurgical device used for coagulation and aspiration during electrosurgical procedures. The device is available in two different configurations: hand controlled and foot controlled models. Both models are supplied with holsters.

The provided 510(k) submission (K072559) for the Megadyne Suction Coagulator does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

This submission is a 510(k) Premarket Notification, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical efficacy or performance studies with specific acceptance criteria as you might find for novel or higher-risk devices.

Here's a breakdown based on the provided text, indicating what information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Not present in the document. The submission discusses conformance to voluntary standards but does not list specific acceptance criteria or quantitative performance results from a device-specific study compared against those criteria.

2. Sample Size for Test Set and Data Provenance

Not present in the document. There is no mention of a test set, its sample size, or any data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Not present in the document. No information about experts, ground truth establishment, or their qualifications is provided as there is no specific performance study detailed.

4. Adjudication Method for the Test Set

Not present in the document. Since no test set or expert evaluation is described, no adjudication method is mentioned.

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

Not present in the document. No MRMC study or any comparison of human readers with/without AI assistance is mentioned. This device is a surgical instrument, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not present in the document. This device is a physical electrosurgical instrument; there is no "algorithm only" performance to evaluate.

7. Type of Ground Truth Used

Not present in the document. No ground truth establishment is described.

8. Sample Size for the Training Set

Not present in the document. As an electrosurgical device, it would not have a "training set" in the context of an algorithm or diagnostic model.

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

Not present in the document. No ground truth for training is relevant or mentioned.

Summary of what is present and relevant to safety/performance, though not matching the requested structure:

• Conformance to Standards: "Megadyne has conducted extensive testing to ensure conformance to the voluntary standard ISO 60601-2-2:2006, Medical electrical equipment, Part 2: Particular requirements for the safety of high frequency surgical equipment, and ANSI / AAMI HF 18-2001, Electrosurgical Devices." This indicates safety and basic performance testing was done against recognized industry standards, which is a common way to demonstrate safety and effectiveness for predicate-based devices.
• Substantial Equivalence: The primary "proof" in this 510(k) is the demonstration of substantial equivalence to predicate devices (MegaDyne Suction Coagulator K946327 and Valleylab's Lectrovac K791752) based on shared technological characteristics and intended use. The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...".

In essence, for this type of device and submission, the "acceptance criteria" are generally met by demonstrating compliance with established voluntary consensus standards and showing that the device is technologically similar and has the same intended use as a legally marketed predicate. Specific numerical performance metrics against detailed acceptance criteria from a dedicated clinical study are typically not required or provided in a 510(k) for such a device.

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