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The Valleylab FT10 Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics. When used with compatible ablation devices, it is indicated for cardiac tissue ablation. The generator can also be used with compatible resectoscopes for endoscopically controlled removal or coagulation of tissue using 0.9% NaCl solution as the irrigation medium.

The tissue fusion function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures.

The Valleylab™ FT10 Energy Platform (VLFT10GEN) provides radio frequency (RF) energy for monopolar and bipolar surgical applications, tissue-fusion and vessel-sealing applications (LigaSure vessel-sealing function), and cardiac ablation. It is a combination of a full-featured general-surgery electrosurgical unit, a bipolar vessel sealing system, and an ablation unit. The monopolar and bipolar sections, including the LigaSure section of the system, are isolated outputs that provide the appropriate power for cutting, desiccating, and fulgurating tissue during monopolar and bipolar surgery. The LigaSure vessel-sealing section of the system provides power for vessel sealing. The cardiac ablation feature of the device is only available when used with compatible Cardioblate™ instruments.

The VLFT10GEN is used in hospitals and other health care facilities where surgical procedures are carried out.

The VLFT10GEN can be used with a variety of legally marketed accessories including monopolar and bipolar instruments, footswitches, and return electrode pads. The VLFT10GEN connects to electrical mains and operates at an input line frequency of 47-63 Hz.

This FDA 510(k) summary does not contain the information requested for a detailed description of acceptance criteria and a study proving a device meets them.

The document is a regulatory approval letter for the Valleylab FT10 Energy Platform, indicating its substantial equivalence to a predicate device. It describes the device, its intended use, and general performance characteristics, but it explicitly states that no clinical performance data was relied upon for this premarket submission.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to the performance evaluation of a device through specific studies, which this summary confirms were not clinically focused.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. The document describes general performance characteristics and compliance with standards (e.g., thermal spread, system functionality, electrical safety, usability), but it does not list specific quantitative acceptance criteria or corresponding reported device performance metrics in a table format.

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 provided. The document mentions "ex vivo testing using porcine tissue" for thermal spread, but it does not specify the sample size for this testing (e.g., number of porcine tissue samples). It also does not mention the country of origin of the data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Cannot be provided. Since no clinical performance study involving human interpretation or "ground truth" establishment is detailed, this information is not available.

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

• Cannot be provided. Similar to point 3, without a clinical performance study involving multiple human readers and ground truth, there is no adjudication method described.

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 provided. The document does not mention any MRMC study, AI assistance, or human reader improvement. The device described is an electrosurgical generator, not an AI-powered diagnostic tool.

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

• Cannot be provided. The device is an electrosurgical generator; the concept of "standalone algorithm performance" is not applicable in the context presented.

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

• Cannot be provided. No clinical "ground truth" is discussed for the performance evaluation in this document. The "ground truth" for the ex vivo testing would likely relate to objective measurements of thermal spread in the tissue samples, but the methodology is not detailed.

8. The sample size for the training set

• Cannot be provided. The document discusses software verification and validation, but it does not mention a "training set" in the context of an AI/ML algorithm or a similar data-driven model. The software testing mentioned is for embedded device software, not a learning algorithm.

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

• Cannot be provided. As there is no mention of a "training set," this information is not applicable.

In summary, the provided document focuses on regulatory clearance based on substantial equivalence and non-clinical verification and validation activities (e.g., bench testing, software testing, electrical safety). It explicitly states that clinical performance data was not used for this submission, which means the detailed information about acceptance criteria, specific study designs, sample sizes, and ground truth methodologies (especially as they relate to human or AI performance) is absent.

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Valleylab FT10 Energy Platform:

The Valleylab FT10 Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics. When used with compatible ablation devices, it is indicated for cardiac tissue ablation. The generator can also be used with compatible resectoscopes for endoscopically controlled removal or coagulation of tissue using 0.9% NaCl solution as the irrigation medium.

The tissue fusion function has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use this function for these procedures.

Cardioblate BP2 49321 Surgical Ablation Device:

The Cardioblate® BP2 surgical ablation device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

Cardioblate LP 49341 Surgical Ablation Device:

The Cardioblate® LP surgical ablation device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

Valleylab FT10 Energy Platform (VLFT10GEN)

The Valleylab™ FT10 Energy Platform (VLFT10GEN) is a multifunction generator which provides radio frequency (RF) energy for monopolar and bipolar surgical applications, tissuefusion and vessel-sealing applications (LigaSure/vessel-sealing function), and cardiac tissue ablation. The Cardioblate™ instruments that allow the cardiac ablation capability (49321, 49341) are single use. The Cardioblate ablation energy delivery is only available when using compatible instruments.

The VLFT10GEN is used in hospitals and other health care facilities where surgical procedures are carried out.

The VLFT10GEN can be used with a variety of legally marketed accessories including monopolar and bipolar instruments, footswitches, and return electrode pads. The VLFT10GEN connects to electrical mains and operates at an input line frequency of 47-63 Hz.

Cardioblate BP2 (49321) and LP (49341) Surgical Ablation Devices:

The Cardioblate BP2 and LP Surgical Ablation Devices are hand held, single use, bipolar, RF ablation device for use in cardiac surgery. They have a saline irrigation system to deliver fluid at the contact point between the tissue and electrode to cool the tissue during RF energy delivery. The devices are intended for intermittent operation. The Cardioblate BP2 and LP devices are dual linear electrode devices that have integral fluid delivery to both electrodes. They rapidly create linear transmural lesions in both atria of the heart during cardiac surgical procedures.

The provided document is a 510(k) summary for the Medtronic Cardioblate Surgical Ablation System, which includes the Valleylab FT10 Energy Platform and the Cardioblate BP2 and LP Surgical Ablation Devices. This submission is for a premarket notification of intent to market, claiming substantial equivalence to predicate devices. It focuses on the device's functional and safety performance rather than AI/algorithm performance. Therefore, many of the requested categories related to AI performance, such as sample size for test/training sets, expert ground truth, adjudication methods, and MRMC studies, are not applicable or cannot be extracted from this type of document.

However, I can provide the available information about the device's acceptance criteria and the studies conducted to demonstrate substantial equivalence based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance testing used to demonstrate substantial equivalence, focusing on safety and function. The acceptance criteria are generally to meet applicable standards and test protocols.

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

• Sample Size: Not specified for any of the tests. The document only mentions "components" for mechanical/electrical tests and "a soft tissue model" for benchtop testing.
• Data Provenance: The benchtop lesion verification used a "soft tissue model," which implies an in-vitro or ex-vivo experimental setup, not human patient data. The document explicitly states, "Clinical and non-clinical animal testing was not required to establish substantial equivalence," indicating no live animal or human patient data was used for this stage of testing.

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

• Not applicable/Not specified. The studies described are engineering and benchtop performance tests, not clinical studies requiring expert interpretation of medical data to establish ground truth.

4. Adjudication method for the test set:

• Not applicable. As described above, these are technical performance tests, not studies requiring adjudication of diagnostic outcomes.

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-enabled device; it's an electrosurgical generator and ablation devices. No MRMC study was conducted.

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

• Not applicable. This is not an AI algorithm.

7. The type of ground truth used:

• The "ground truth" for the performance tests was defined by compliance with established engineering standards (e.g., IEC 60601 series) and internal Medtronic test protocols, along with demonstrating "substantially equivalent ablation performance" compared to the predicate device in a benchtop model. For the software, the ground truth was meeting the requirements outlined in the FDA guidance for software in medical devices.

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the context of machine learning.

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

• Not applicable.

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The Valleylab FT10 Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics. The generator can also be used with compatible resectoscopes for endoscopically controlled removal or coagulation of tissue using 0.9% NaCl solution as the irrigation medium.

The tissue fusion function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this function for these procedures.

The Valleylab™ FT10 Energy Platform (VLFT10) provides radio frequency (RF) energy for monopolar and bipolar surgical applications, and tissue-fusion and vessel-sealing applications (LigaSure/vesselsealing function). It is a combination of a full-featured general-surgery electrosurgical unit and a bipolar vessel sealing system. The monopolar and bipolar sections, including the LigaSure section of the system, are isolated outputs that provide the appropriate power for cutting, desiccating, and fulgurating tissue during monopolar and bipolar surgery. The LigaSure/vessel-sealing section of the system provides power for vessel sealing.

The VLFT10 is used in hospitals and other health care facilities where surgical procedures are carried out.

The VLFT10 can be used with a variety of legally marketed accessories including monopolar and bipolar instruments and a newly introduced bipolar adapter, footswitches, and return electrode pads. The VLFT10 connects to electrical mains and operates at an input line frequency of 47-63 Hz.

This document is a 510(k) premarket notification for the Valleylab FT10 Electrosurgical Platform, which is an electrosurgical generator. It describes modifications made to the device, primarily software updates, and the testing conducted to demonstrate that these changes do not affect the device's safety or performance.

However, the provided text does not contain the information requested regarding acceptance criteria and a study proving a device meets criteria, in the context of an AI/ML-driven medical device. The document is for an electrosurgical platform, not an AI/ML device. Therefore, it does not include details about:

• A table of acceptance criteria and reported device performance (for AI/ML metrics like sensitivity, specificity, etc.)
• Sample sizes for test sets (in the context of image data)
• Data provenance (country of origin, retrospective/prospective)
• Number of experts and their qualifications for ground truth establishment
• Adjudication methods
• Multi-reader multi-case (MRMC) comparative effectiveness studies
• Standalone algorithm performance
• Type of ground truth (pathology, outcomes, expert consensus for AI)
• Sample size for training sets
• How ground truth for training sets was established

Instead, the document focuses on engineering and performance characteristics of an electrosurgical device, such as:

• Safety and essential performance (IEC 60601-1, IEC 60601-2-2)
• Electromagnetic compatibility (IEC 60601-1-2)
• Ex vivo testing (using porcine tissue for thermal effects)
• System verification (non-IEC electrical, instrument compatibility, basic functionality)
• Software verification and validation (FDA guidance for software in medical devices)
• Usability testing (IEC 62366)

The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." This further confirms that the type of study and data requested (which is typical for AI/ML device submissions) was not performed or required for this particular submission.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device

The Valleylab FT10 is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles. and lymphatics. The generator can also be used with compatible resectoscopes for endoscopically controlled removal or coagulation of tissue using 0.9% NaCl solution as the irrigation medium.

The tissue fusion function has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use this function for these procedures.

The Valleylab™ FT10 Electrosurgical Platform (VLFT10) provides radio frequency (RF) energy for monopolar and bipolar surgical applications, and tissue-fusion and vessel-sealing applications (LigaSure function). It is a combination of a full-featured general-surgery electrosurgical unit and a LigaSure vessel sealing system. The monopolar and bipolar sections, including the advanced bipolar/LigaSure section of the system, are isolated outputs that provide the appropriate power for cutting, desiccating, and fulgurating tissue during monopolar and bipolar surgery. The LigaSure section of the system provides power for vessel sealing.

The VLFT10 is used in hospitals and other health care facilities where surgical procedures are carried out.

The VLFT10 can be used with a variety of legally marketed accessories including monopolar and bipolar instruments, footswitches, and return electrode pads. The VLFT10 connects to electrical mains and operates at an input line frequency of 47-63 Hz.

The provided document is a 510(k) summary for the Valleylab™ FT10 Electrosurgical Platform. It describes the device, its intended use, technological characteristics, and performance testing to demonstrate substantial equivalence to a predicate device (ForceTriad™ Energy Platform).

However, the document does not describe acceptance criteria or a specific study that proves the device meets those acceptance criteria in the format requested. Instead, it outlines a series of tests performed to establish substantial equivalence.

Here's an analysis of the provided text in relation to your request:

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

The document lists several types of testing performed, but it does not explicitly state specific quantitative acceptance criteria for each test nor present the reported device performance in a comparative table against those criteria. It generally states that tests were "successfully completed" or showed "comparable performance."

For example, for ex vivo and in vivo testing, it states "showed comparable performance with regard to thermal effects, and vessel sealing capabilities. Some incremental improvements in procedural speed were seen with the VLFT10." This is a qualitative statement rather than a quantitative comparison against defined acceptance criteria.

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

• Sample Size: The document mentions "ex vivo and in vivo testing using porcine tissue and a porcine model," but does not specify the sample size (e.g., number of tissue samples, number of animals) used for these tests.
• Data Provenance: The document does not specify the country of origin of the data. The testing appears to be prospective as it was conducted specifically for the device's validation.

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 information is not provided in the document. The tests described (e.g., thermal effects, vessel sealing capabilities, electrical safety) are typically assessed through objective measurements and engineering analysis rather than expert review to establish "ground truth" in the way it might be for a diagnostic imaging device.

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

This information is not applicable and therefore not provided, as the tests described do not involve subjective interpretation requiring adjudication among experts.

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 information is not applicable as the device is an electrosurgical generator, not a diagnostic imaging device that would involve human readers or AI assistance in interpretation.

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

The device is an electrosurgical generator. It has "tissue sensing algorithms" and a "LigaSure algorithm" that have been refined. This suggests some algorithmic control or processing. However, the document does not describe "standalone algorithm performance" in terms of clinical outcomes independent of the surgical procedure and human operator. The performance is assessed in the context of the device's function (cutting, coagulation, sealing) during surgical tasks, inherently involving human interaction.

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

For the "ex vivo and in vivo testing," the "ground truth" would likely involve direct measurements of physiological effects such as thermal spread, tissue integrity, burst pressure of sealed vessels, and potentially histological examination of tissue, rather than expert consensus on subjective assessments. The document doesn't explicitly detail the "ground truth" type but implies objective biophysical measurements.

8. The sample size for the training set:

This information is not applicable as the document describes a hardware device with embedded algorithms, not a machine learning model that undergoes a distinct "training" phase with a labeled dataset in the conventional sense. The "refinement" of algorithms (e.g., tissue sensing, LigaSure algorithm) would likely involve iterative development and testing, but not a formally defined "training set" with a specified size.

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

This information is not applicable for the same reasons as point 8.

In summary:

The document focuses on demonstrating substantial equivalence through compliance with electrical safety and EMC standards, ex vivo and in vivo testing (thermal effects, vessel sealing, procedural speed), system verification (functionality, specifications), software verification and validation, and usability testing. While these tests are designed to show the device performs as intended and is safe and effective compared to its predicate, it does not structure this information as a direct comparison against pre-defined, quantitative "acceptance criteria" for clinical performance.

For a regulatory submission of this nature, "acceptance criteria" are often embedded within the test protocols and engineering specifications, which are not fully detailed in this summary. The "reported device performance" is generally described as meeting these implicit criteria or being "comparable" to the predicate.

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