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The generator is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in surgery.

The Gyrus General Purpose Electrosurgical Generator operates only in bipolar mode. It has controls for output waveform type and power. The unit has readouts for set power and waveform. There are two custom 9-way connectors on the front panel for PlasmaCision instruments and PlasmaKinetic bipolar instruments. The foot pedal is connected on the back panel. Accessories included with the generator are the disposable instruments, footswitch and a power cable.

The provided text describes a 510(k) premarket notification for the "Gyrus General Purpose Electrosurgical Generator System." This document is for a medical device and outlines its intended use and comparison to predicate devices, ultimately leading to an FDA determination of substantial equivalence.

However, the provided text does not contain any information regarding acceptance criteria or a specific study that proves the device meets acceptance criteria in the context of performance metrics (sensitivity, specificity, accuracy, etc.) typically associated with AI/software-as-a-medical-device (SaMD).

Instead, this document focuses on regulatory approval based on substantial equivalence to predicate devices. The "performance testing" mentioned is to validate the device's functional performance in line with these predicate devices, not typically a clinical study with detailed statistical outcomes for an AI algorithm.

Therefore, many of the requested items cannot be answered from the provided text.

Here's a breakdown of what can and cannot be answered:

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

• Cannot be answered from the provided text. The document states "Performance testing has been done to validate the performance of the device," but it does not provide specific acceptance criteria (e.g., minimum output power, waveform stability within a tolerance) or the numerical results of such testing. This type of detail is usually found in a separate performance test report, not in the summary document.

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

• Cannot be answered from the provided text. The document does not describe a "test set" in the context of data for an AI algorithm, nor does it mention sample sizes, data provenance, or whether any human data was used for performance evaluation beyond general "performance testing" of the hardware.

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)

• Cannot be answered from the provided text. There is no mention of experts establishing ground truth, as this is not a study evaluating an algorithmic output that requires such annotations.

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

• Cannot be answered from the provided text. Not relevant to this type of device submission.

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

• Cannot be answered from the provided text. No MRMC study is mentioned, nor is any AI component.

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

• Cannot be answered from the provided text. This device is an electrosurgical generator, which is hardware, not a standalone algorithm.

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

• Cannot be answered from the provided text. Ground truth is not discussed in the context of an algorithmic evaluation. The ground truth for this device's performance would likely be engineering specifications and safety standards.

8. The sample size for the training set

• Cannot be answered from the provided text. There is no "training set" as this is not an AI/ML device.

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

• Cannot be answered from the provided text. Not applicable.

Summary of what is present:

• Device Name: Gyrus General Purpose Electrosurgical System (Generator & Accessories)
• Intended Use: The generator is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in surgery.
• Comparison Basis: Substantial equivalence to predicate devices: K041285 (Gyrus ENT G3 System), K031085 (Gyrus Superpulse® System), K002906 (Harmonic Scalpel®).
• Regulatory Status: 510(k) clearance, Class II medical device.
• Performance Claim: "Performance testing has been done to validate the performance of the device." (Details of this testing are absent from the provided text).

The provided text is a regulatory clearance document, not a detailed scientific study report on performance metrics for an AI/SaMD product.

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The Plasmacision and Plasmablend Electrodes are indicated for Bipolar electrosurgical resection and coagulation of soft tissue and blood vessels in laparoscopic or general surgical procedures.

The Gyrus PlasmaCision and PlasmaBlend electrodes are bipolar electrosurgical instruments with the capability to cut and coagulate soft tissue and blood vessels in laparoscopic surgery under carbon dioxide gas or air insufflation. The instrument will pass through a 5mm cannula or through an operating laparoscope working channel of 5mm or larger diameter. The PlasmaCision and PlasmaBlend electrodes may also be used in general surgical procedures. The instruments are to be used only with the Gyrus General Surgery RF Workstation. Activation of the instruments is achieved via footswitch control. The Instruments are available with and without aspiration (suction) / irrigation lines. On such equipped instruments, this provides additional functionality to the device by increasing its range of capabilities within the procedure. The suction / irrigation capable versions incorporate a lumen / Y connector and male connector with polymeric tubing for adaptation to suction / irrigation systems. The instruments are, like other Gyrus bipolar electrosurgical instruments, available in a number of different shaft lengths and diameters, chosen by the surgeon to be most appropriate for the procedure to be undertaken. The instruments have a multipole arrangement at the patient interface. The instruments consist of three individually isolated conductors that act as the tissue effectors. A PlasmaBlend output is a blended cut and coagulation output that is delivered to the L09 instrument. The ratio of cut to coagulation of this output is selectable by the user and this allows the user to select the amount of haemostasis created during cutting. This output is controlled by the Gyrus General Surgery RF Workstation.

The provided text is a 510(k) Premarket Notification for the Gyrus PlasmaCision and PlasmaBlend electrodes. This document focuses on demonstrating substantial equivalence to predicate devices, rather than detailing a specific clinical study with acceptance criteria and device performance metrics in the way a diagnostic AI device would.

Therefore, the requested information elements related to a study proving acceptance criteria (like specific performance metrics, sample size, ground truth establishment, expert qualifications, and MRMC studies) are not present in the provided document. The document describes the device, its intended use, and compares it to predicate devices, stating that "performance testing has been done to validate the performance of the device." However, it does not provide the details of this performance testing, including specific acceptance criteria or quantitative results.

Here's an attempt to address the request based only on the provided text, highlighting what is missing:

1. Table of acceptance criteria and the reported device performance

The provided document does not contain a table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or quantitative reported device performance metrics for the Gyrus PlasmaCision and PlasmaBlend electrodes. The document focuses on demonstrating substantial equivalence to predicate devices. It generically states that "performance testing has been done to validate the performance of the device."

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

The document does not specify a test set sample size or data provenance (e.g., country of origin, retrospective/prospective). This type of detail is typical for studies assessing the performance of diagnostic or prognostic devices, which is not the primary focus of this 510(k) for an electrosurgical accessory.

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

The document does not describe the use of experts to establish a "ground truth" for a test set. This concept is typically relevant for diagnostic imaging or AI-based devices where expert consensus or pathology is used as a reference standard. For an electrosurgical device, performance validation would likely involve engineering tests, bench testing, and potentially animal or cadaver studies, rather than expert interpretation of a clinical test set.

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

This information is not provided as the document does not describe a clinical test set 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

An MRMC study is not applicable to this device. The Gyrus PlasmaCision and PlasmaBlend electrodes are electrosurgical instruments, not AI-assisted diagnostic tools. Therefore, there are no "human readers" or "AI assistance" in the context of this device.

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

This concept is not applicable to this device. The Gyrus PlasmaCision and PlasmaBlend electrodes are physical surgical instruments and do not involve an algorithm or AI.

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

The document does not specify a "ground truth" in the context of a diagnostic or prognostic study. Performance validation for an electrosurgical device would typically involve demonstrating its ability to safely and effectively cut and coagulate tissue, which is often assessed through engineering specifications, bench testing, and potentially in vivo models for tissue effects.

8. The sample size for the training set

The document does not mention a training set. This concept is specific to machine learning and AI algorithms, which are not involved in this electrosurgical device.

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

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

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The Gyrus Medical PSR System is intended for treatment of the following dermatological conditions:

• Rhytides of the face
• Superficial skin lesions
• Actinic Keratosis
• Viral papillomata
• Seborrhoeic Keratosis

The system is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

The Gyrus Medical PSR System is intended for treatment of the following dermatological conditions:

• Rhytides of the face .
• Superficial skin lesions .
• . Actinic Keratosis
• . Viral papillomata
• Seborrhoeic Keratosis .

Accessories included with the generator are a cable assembly/instrument, power cable and a footswitch.

The provided document, K041999, is a 510(k) summary for the Gyrus Plasma Skin Resurfacing (PSR) System. However, it does not contain specific details about acceptance criteria, device performance metrics, or a detailed study summary that would typically prove a device meets acceptance criteria.

The document mainly focuses on:

• Identifying the device and its manufacturer.
• Stating its intended use and comparison to a predicate device.
• Confirming its substantial equivalence by the FDA.
• Listing the specific dermatological conditions it's intended to treat.

There are no tables of acceptance criteria nor detailed study results with sample sizes, expert qualifications, or ground truth methodologies. The statement mentions "clinical studies have been done to validate the performance of the device" and "The clinical data results presented in this 510(k) notification to the FDA show that the device is substantially equivalent," but these details are not provided within the given text.

Therefore, based solely on the provided text, I cannot fill in the requested table and answer the specific questions about acceptance criteria and study details. The input document is a summary statement for regulatory clearance, not a detailed scientific study report.

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The Gyrus PlasmaCision Laparoscopic Spatula is indicated for resection and Coagulation of son and blood vessels in laparoscopic and general surgical when used with the Gyrus PlasmaKinetic Generator or the Gyrus PlasmaKinetic SuperPulse Generator.

The Gyrus PlasmaCision Laparoscopic Spatula is a bipolar electrosurgical instrument with the capability to cut and coagulate soft tissue and blood vessels in laparoscopic with the saper carbon dioxide gas or air insufflation. The instrument will pass through a 5mm cannula or through an operating laparoscope's working channel of 5mm minimum diameter. The instrument is to be used only with the Gyrus PlasmaKinetic Generator, the Gyrus SuperPulse Generator and associated 5 way connector cable. The device is intended for use in a non-irrigated (dry) environment. The device has the functionality to dissect, resect or vaporise tissue with haemostasis, to coagulate tissue and blood vessels and to blunt (cold) dissect tissue.

The provided 510(k) summary for the Gyrus PlasmaCision Laparoscopic Spatula (K041633) does not contain a specific study with defined acceptance criteria and reported device performance in the format requested.

Instead, the summary acts as a notification to the FDA of the intent to market the device, asserting its substantial equivalence to predicate devices based on intended use and technological characteristics. It mentions that "performance validation" has been done to validate the performance of the device without detailing the specific study design, acceptance criteria, or results for device performance against those criteria.

Therefore, I cannot extract the information required for the table and other detailed questions about a specific study.

Information NOT present in this document:

• A table of acceptance criteria and the reported device performance: The document states that "performance validation" has been performed but does not provide specific acceptance criteria or the reported performance data.
• Sample size used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device (it's a surgical instrument, not an AI algorithm).
• The type of ground truth used: Not mentioned.
• The sample size for the training set: Not applicable for this type of device.
• How the ground truth for the training set was established: Not applicable for this type of device.

Key takeaway from the document regarding performance:

The document states, "In addition, performance validation results presented in this 510(k) notification to the FDA confirm the comparison and falls substantially equivalent to predicate devices and is safe and effective in its intended use." This is a general statement of equivalence and safety, not a detailed report of a specific study with concrete acceptance criteria and quantitative performance results.

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Electrosurgical coagulation, mechanical grasping and dissection of tissue, and sealing of vessels up to 7mm, during the performance of open general surgical procedures.

The device consists of grasping jaws connected to a handle. The handle has finger loops integrated into it to allow the physician to easily manipulate the device for electrosurgical coagulation including the sealing of vessels. The overall length of the device is nine (9) inches. The device will be available in three distinct jaw configurations. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices. The forceps jaws are electrically isolated from each other enabling one jaw to act as a return electrode, eliminating the need for a return pad.

The provided text describes the 510(k) summary for the Gyrus OPEN FORCEPS, a Class II medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed acceptance criteria and a study to prove meeting those criteria for a novel algorithm or AI device.

Therefore, most of the requested information regarding acceptance criteria, performance metrics, sample sizes, expert involvement, and ground truth establishment is not available in the provided document, as it pertains to a different type of device approval process.

Here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not mentioned. The document states "Preclinical laboratory data and bench test data," but does not provide specific sample sizes for these tests.
• Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective). These would typically be relevant for clinical data, which is not described.

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

• Number of Experts: Not applicable/not mentioned. The study referenced "Preclinical laboratory data and bench test data" for a physical device, not an AI or diagnostic algorithm requiring expert-established ground truth.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not mentioned. This is not relevant for a device demonstrating substantial equivalence through bench and preclinical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices, which the Gyrus OPEN FORCEPS is not.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Not applicable. The device is a physical electrosurgical instrument; there is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the "Preclinical laboratory data and bench test data," the ground truth would likely be established by engineering specifications, physical measurements, and performance standards for electrosurgical devices (e.g., tissue impedance, temperature profiles, vessel seal integrity). Specific details are not provided.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The device is a physical instrument, not an AI/ML model that undergoes a "training set" phase.

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

• Ground Truth for Training Set: Not applicable. (See #8)

Summary of Device and Approval Process:

The K024286 submission for the Gyrus OPEN FORCEPS is for a physical electrosurgical instrument. The approval is based on demonstrating substantial equivalence to existing predicate devices (K000496, K981916, K010010). This means the device is considered safe and effective because its design, materials, function, and indications for use are similar to devices already on the market. The "study" mentioned consists of "Preclinical laboratory data and bench test data" to verify safety and effectiveness, but it is not detailed in the provided documents. The 510(k) process for such devices typically relies heavily on engineering and performance testing against established standards, rather than large-scale clinical trials or expert-adjudicated performance metrics common for AI/diagnostic tools.

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The Gyrus PlasmaKinetic Superpulse System is intended for use for ablation, removal, resection and coagulation of soft tissue and where associated hemostasis is required in open, endoscopic and laparoscopic surgical procedures.

The Gyrus PlasmaKinetic Superpulse System Generator Description: is an Electrosuraical device with a bipolar mode of operation: The generator has controls for output waveform type and power. The unit has readouts for set power and waveform. The two physically identical connectors on the front panel support PlasmaKinetic, PlasmaKinetic Superpulse (RHS only) and 4mm bipolar instruments. The foot pedal is connected on the back panel. Accessories included with the generator are the electrodes, connector cable, footswitch and a power cable.

The provided text is a 510(k) Premarket Notification for the Gyrus PlasmaKinetic Superpulse Generator System & Accessories. This document is a regulatory submission to the FDA demonstrating substantial equivalence to a legally marketed predicate device, not a study report detailing performance against specific acceptance criteria. Therefore, the document does not contain the information required to populate the table of acceptance criteria and reported device performance or other detailed study information.

The submission focuses on comparing the new device to predicate devices (Gyrus Inc PlasmaKinetic Generator (K003060), Gyrus Medical Ltd PlasmaKinetic Endourology Generator (K003569), and Gyrus Medical Ltd Endourology Axipolar Resectoscope Electrode (K001270)) and validating its performance generally. It states: "The comparison and validation results presented in this 510(k) notification to the FDA show that the device is substantially equivalent to predicate devices and is safe and effective in its intended use." However, it does not specify what those validation results are in terms of quantifiable acceptance criteria and performance metrics.

Specifically, the following information is not present in the provided text:

• A table of acceptance criteria and the reported device performance: This document confirms that "performance testing has been done to validate the performance of the device," but it does not detail the specific acceptance criteria for that testing or the quantitative results achieved.
• Sample size used for the test set and the data provenance: No information about sample sizes or the origin of any test data (country, retrospective/prospective) is provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no expert-derived ground truth for a test set is mentioned.
• Adjudication method for the test set: Not applicable, as no test set requiring adjudication is described.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: The document describes a "comparison to predicate devices" but not an MRMC study or any human reader performance evaluation.
• If a standalone performance (algorithm only without human-in-the-loop performance) was done: This is a medical device (electrosurgical generator), not an AI algorithm; therefore, standalone algorithm performance is not applicable.
• The type of ground truth used: No mention of specific ground truth (e.g., pathology, outcomes data) for any performance evaluation.
• The sample size for the training set: Not applicable, as this is not an AI/ML device with a training set.
• How the ground truth for the training set was established: Not applicable.

In conclusion, the provided 510(k) summary asserts the device's substantial equivalence to predicate devices and states that performance testing was conducted, but it does not disclose the detailed acceptance criteria or the specific results of those performance tests.

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Mechanical cutting and electrosurgical coagulation of tissue during the performance of laparoscopic and general surgical procedures.

The device is a Class II medical device. The Everest LP Bipolar Scissors and Gyrus LP Scissors are a modification to the predicate device cleared under K904993. The Bipolar Bipolar LP Scissors are identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The scissors blades are electrically isolated from each other enabling one blade to act as a return electrode, eliminating the need for a return pad. The modification has not altered the fundamental technology of the predicate device cleared under K904993. The intended use, electrosurgical coagulation and mechanical cutting during surgical procedures is similar to the predicate device cleared under K904993. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices.

The provided text is a 510(k) summary for the Everest LP Bipolar Scissors and Gyrus LP Bipolar Scissors. It discusses the device's substantial equivalence to a predicate device and its intended use. However, it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or any of the detailed aspects like sample sizes, expert ground truth, or AI performance that your request asks for.

The document states:

"The Bipolar Bipolar LP Scissors are identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The scissors blades are electrically isolated from each other enabling one blade to act as a return electrode, eliminating the need for a return pad. The modification has not altered the fundamental technology of the predicate device cleared under K904993. The intended use, electrosurgical coagulation and mechanical cutting during surgical procedures is similar to the predicate device cleared under K904993. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices."

"In conclusion, as the design, materials of construction, function and intended use of the Modified LP Bipolar Scissors is similar to that of the predicate devices currently cleared, Gyrus Medical Inc. believes that no new issues of safety and effectiveness are raised and that the submitted device is substantially equivalent."

This indicates that the device was cleared based on substantial equivalence to an existing predicate device (K904993), rather than requiring a new clinical performance study with specific acceptance criteria as you've outlined. The FDA's 510(k) process often relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, without necessarily requiring new, extensive clinical trials for every submission, especially for modifications that don't alter fundamental technology.

Therefore, I cannot populate the table or answer the specific questions you've posed because the provided text does not contain that type of detailed study information. The clearance was based on the premise that the device is "substantially equivalent" to one already on the market, implying that its performance would be similar, and thus, specific performance metrics and studies to prove them are not detailed in this summary.

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Electrosurgical cutting and mechanical dissection of tissue, during the performance of laparoscopic and general surgical procedures.

The Bipolar Needle Electrode is a modification to the predicate device cleared under K904993. The bipolar Needle Electrodes are identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The cutting electrode is electrically isolated from the return electrode, enabling one electrode to act as a return electrode, eliminating the need for a return pad. The modification has not altered the fundamental technology of the predicate device cleared under K904993. The intended use, electrosurgical cutting, and mechanical dissection are identical to the predicate devices cleared under K904993. The energy source, bipolar electrosurgical energy, is the same energy type as used for the predicate devices.

The provided text describes a 510(k) premarket notification for a medical device, the Everest Bipolar Needle Electrode and Gyrus Bipolar Needle Electrode. This submission aims to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, most of the requested information regarding acceptance criteria and a study proving performance is not present in the provided document. The document focuses on demonstrating that the modified device is substantially equivalent to an already cleared predicate, meaning its design, materials, function, and intended use are similar enough that it raises no new issues of safety and effectiveness.

Here's a breakdown based on the information provided and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

• Not Applicable / Not Provided: The document does not specify quantitative acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, or specific performance thresholds) that the device must meet, nor does it present detailed performance results from a study against such criteria. The basis for clearance is substantial equivalence to a predicate, not meeting novel performance benchmarks.

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

• Not Applicable / Not Provided: The submission is not based on a new clinical study with a test set of data. It relies on the assertion that the modified device is identical in construction (except for shaft length) and materials, and has the same intended use and energy source as the predicate (K904993). Therefore, no "test set" in the context of performance data is mentioned.

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

• Not Applicable / Not Provided: As no new clinical study with a test set is discussed, there is no mention of experts establishing a ground truth for performance evaluation.

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

• Not Applicable / Not Provided: No test set or related adjudication method is 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

• Not Applicable / Not Provided: This device is an electrosurgical cutting and coagulation device, not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI-related effectiveness metrics are irrelevant and not part of this submission.

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

• Not Applicable / Not Provided: This device is a manual surgical instrument, not an algorithm. Standalone performance for an algorithm is not relevant here.

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

• Not Applicable / Not Provided: No ground truth in the context of performance metrics is established or discussed, as the submission focuses on substantial equivalence of design and function. The "ground truth" for the submission is the established safety and effectiveness of the predicate device.

8. The sample size for the training set

• Not Applicable / Not Provided: This device is not an AI/ML algorithm that requires a "training set."

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

• Not Applicable / Not Provided: As above, this is not an AI/ML device, so a training set and its ground truth establishment are not relevant.

Summary Explanation:

The provided document is a 510(k) summary, which is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. The core argument for the Everest Bipolar Needle Electrode and Gyrus Bipolar Needle Electrode is that it is a modification to an existing predicate device (K904993).

The key statements supporting this are:

• "The Bipolar Needle Electrode is a modification to the predicate device cleared under K904993."
• "The bipolar Needle Electrodes are identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device."
• "The modification has not altered the fundamental technology of the predicate device cleared under K904993."
• "The intended use, electrosurgical cutting, and mechanical dissection are identical to the predicate devices cleared under K904993."
• "The energy source, bipolar electrosurgical energy, is the same energy type as used for the predicate devices."

Based on these points, Gyrus Medical Inc. concludes that "no new issues of safety and effectiveness are raised and that the submitted device is substantially equivalent." This type of submission relies heavily on comparison to a predicate device and demonstration that the changes are minor and do not introduce new risks or alter fundamental performance characteristics, rather than presenting a performance study against specific, novel acceptance criteria.

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Electrosurgical coagulation, electrosurgical cutting, dissection of tissue, irrigation and aspiration during the performance of laparoscopic and general surgical procedures.

The device is a Class II medical device. The Bipolar L Hook is a modification to the predicate device cleared under K904993. The Bipolar L Hook is identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The forceps jaws are electrically isolated from each other enabling one jaw to act as a refurn electrode, eliminating the need for a return pad. The modification has not altered the fundamental technology of the predicate device cleared under K904993. The intended use, electrosurgical coagulation, grasping and dissection of the tissue during surgical procedures is similar to the predicate devices cleared under K904993. The energy source, bipolar electrosurgical energy, is the same energy type as used for the predicate devices.

This document is a 510(k) summary for a medical device called the Everest Bipolar L Hook and Gyrus Bipolar L Hook. It is a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device, rather than a clinical study establishing new acceptance criteria or performance metrics.

Therefore, the requested information regarding acceptance criteria, study data, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted from this document.

Here's why and what can be understood from the provided text:

• No new acceptance criteria or device performance: The document explicitly states: "In conclusion, as the design, materials of construction, function and intended use of the modified Bipolar L Hook is similar to that of the predicate devices currently cleared, Gyrus Medical Inc. believes that no new issues of safety and effectiveness are raised and that the submitted device is substantially equivalent." This means the device relies on the established safety and effectiveness of its predicate, not on new studies with specific acceptance criteria that need to be met.
• Substantial Equivalence: The primary objective of a 510(k) submission is to demonstrate "substantial equivalence" to a device already legally marketed. This typically involves comparing device features, intended use, technology, and performance data (if applicable) to the predicate, rather than conducting new, large-scale clinical trials that define new acceptance criteria.
• Lack of Clinical Study Details: The document does not describe any clinical study or performance testing that would generate data for an "acceptance criteria" table. It mentions "electrosurgical coagulation, grasping and dissection of the tissue" as the intended use, which is similar to the predicate.

In essence, this document is a regulatory submission for a modification of an existing device, focusing on demonstrating similarity rather than presenting new performance data against specific acceptance criteria.

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Electrosurgical coagulation, mechanical grasping and dissection of tissue during the performance of laparoscopic and general surgical procedures.

The device is a Class II medical device. The Bipolar LYONS Dissecting Forceps is a modification to the predicate device cleared under K904993. The bipolar LYONS Dissecting Forceps is identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The forceps jaws are electrically isolated from each other enabling one jaw to act as a return electrode, eliminating the need for a return pad. The modification has not altered the fundamental technology of the predicate device cleared under K904993. The intended use, electrosurgical coagulation, grasping and dissection of the tissue during surgical procedures is similar to the predicate devices cleared under K904993. The energy source, bipolar electrosurgical energy, is the same energy type as used for the predicate devices.

The provided text is a 510(k) summary for the Everest Bipolar LYONS Dissecting Forceps and Gyrus Bipolar LYONS Dissecting Forceps. This document does not describe a study involving acceptance criteria, device performance, or human readers.

Instead, it's a submission to the FDA for market clearance, asserting substantial equivalence to a predicate device (K904993). The primary argument is that the new device is a modification (shaft length change) that has not altered the fundamental technology, materials, function, or intended use.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, or study details from the provided text. The document states that "Gyrus Medical Inc. believes that no new issues of safety and effectiveness are raised and that the submitted device is substantially equivalent," implying that a new clinical study with specific acceptance criteria was not conducted for this 510(k) submission.

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