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The CrossWise™ RF Transseptal Cannula and accessories are used to create an atrial septal defect in the heart. Secondary indications include infusing solutions including heparinized saline and mixtures of 50% contrast media and 50% saline.

The CrossWise Multi-Use RF Adapter Cable (Model CW-1001) is used in Transseptal Puncture Procedures (TSP) to connect the CrossWise™ RF Transseptal Cannula (K241414) to a 3/32" electrosurgical (ES) pencil. The cable delivers radiofrequency (RF) energy to the CrossWise™ RF Transseptal Cannula to facilitate septal puncture. The CrossWise RF Transseptal Cannula is connected to a ValleyLabs Force2 ES Generator (K051644) via the CrossWise Multi-Use RF Adapter Cable (Model CW-1001) or CrossWise RF Adapter Cable (Model CW-1002 / K241414) and a commercially available 3/32" ES pencil. The CrossWise Multi-Use RF Adapter Cable has unique connectors on each end which cannot be connected to an improper device and/or accessory. The CrossWise Multi-Use RF Adapter Cable (Model CW-1001) and CrossWise RF Adapter Cable (Model CW-1002) are both compatible with all CrossWise RF Transseptal Access System models. The dimensions for the CrossWise Multi-Use RF Adapter Cable can be found on the package labels. Circa Scientific sterilized the CrossWise Multi-Use RF Adapter Cable via ethylene oxide (EO) for initial use and is intended for multiple patients use, following prescribed reprocessing instructions. The prescribed reprocessing includes cleaning and steam/autoclaye sterilization procedures that have been validated for up to10 uses when users follow the cleaning and sterilization methods described in the Cleaning and Sterilization Instructions sections of the CrossWise Multi-Use RF Adapter Cable IFU. The CrossWise Multi-Use RF Adapter Cable does not come into direct or indirect contact with the patient according to the definitions in Section 3.0 of ISO 10993-1, and Attachment G of the September 2023 FDA Guidance document.

The provided document is a 510(k) Pre-Market Notification for a medical device called the "CrossWise™ Multi-Use RF Adapter Cable." This document primarily focuses on demonstrating the substantial equivalence of the new device to a previously cleared predicate device, especially regarding its reusability and materials.

The request asks for information typically found in studies validating an AI/ML medical device, specifically regarding acceptance criteria and performance data for an algorithm. However, this 510(k) submission does not describe an AI/ML device or algorithm. Instead, it describes a physical medical device (an adapter cable) and the bench testing performed to ensure its safety and effectiveness, particularly its reprocessing capabilities.

Therefore, many of the requested points, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)," "number of experts used to establish the ground truth," and "sample size for the training set," are not applicable to this type of device and submission.

However, I can extract information related to the acceptance criteria and the study that proves the device meets those criteria, reinterpreting the request for a physical device rather than an AI/ML algorithm.

Device Description:
The CrossWise™ Multi-Use RF Adapter Cable (Model CW-1001) is used in Transseptal Puncture Procedures (TSP) to connect the CrossWise™ RF Transseptal Cannula to a 3/32" electrosurgical (ES) pencil. The cable delivers radiofrequency (RF) energy to the cannula to facilitate septal puncture. The primary difference from the predicate device is its ability to be reprocessed (cleaned and re-sterilized) for up to 10 uses, and minor material modification to the connector shroud to withstand autoclave temperatures.

1. Table of Acceptance Criteria and Reported Device Performance

For this multi-use physical device, the "acceptance criteria" revolve around its ability to maintain its functionality and safety after repeated reprocessing cycles, showing substantial equivalence to the predicate device.

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

• Test Set Sample Size: The document does not explicitly state the numerical sample size for individual tests (e.g., "n=X cables tested"). It mentions "Devices" were tested and "testing was conducted on devices at 2 aging points: after manufacturing (T=0) and after 6 months of accelerated aging (T=6M AA)." It also states that devices were "subsequently conditioned to reflect the intended reusability of the devices after reprocessing."
• Data Provenance: The data is from non-clinical bench testing performed by the manufacturer, Circa Scientific, Inc., to support the 510(k) submission. There is no indication of country of origin of the data beyond the manufacturer's location (Englewood, CO, USA). The testing is prospective as it's specifically designed to validate the new device's capabilities prior to market clearance.

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

• This concept is not applicable to this type of device validation. "Ground truth" established by experts (e.g., radiologists interpreting images) is relevant for AI/ML diagnostic tools. For this physical device, the "ground truth" is defined by established engineering and medical device standards for performance, sterilization, and material properties. The engineers and quality assurance personnel conducting and overseeing these tests are inherently acting as the "experts" whose work ensures compliance with these standards.

4. Adjudication Method for the Test Set

• This concept is not applicable. Adjudication methods (e.g., 2+1, 3+1 consensus) are used for resolving disagreements in expert interpretations, typically in diagnostic or prognostic AI/ML studies. For bench testing of a physical device, results are typically objectively measured against pre-defined engineering specifications, not subject to subjective interpretation and 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

• This is not applicable. An MRMC study is designed to evaluate the impact of an AI diagnostic tool on human reader performance. The device here is a physical adapter cable, not an AI/ML algorithm.

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

• This is not applicable. A standalone performance evaluation is performed for AI/ML algorithms. The device submitted is a physical product. Its "standalone" performance is assessed via the bench tests (e.g., electrical resistance, tensile strength) without human interaction being part of the performance metric itself, but this is a fundamentally different type of evaluation from an AI algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this physical device is based on engineering specifications, material science properties, and established medical device performance standards (e.g., ISO 11135, ISO 17665, AAMI TIR12, ANSI/AAMI ST79, ANSI/AAMI ST98, IEC 60601-2-2). The physical and functional characteristics of the cable are objectively measured and compared against these pre-defined benchmarks to ensure safety and effectiveness for its intended use. There is no "pathology" or "outcomes data" in the sense of clinical study that establishes efficacy for this specific component; rather, component performance ensures the overall system works.

8. The Sample Size for the Training Set

• This is not applicable. There is no "training set" as this is not an AI/ML device that learns from data.

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

• This is not applicable as there is no "training set."

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

Summary of the study/performance evaluation presented:

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

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

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

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The BiZact™ device is a bipolar instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired.

The tissue fusion function of the device can be used on vessels (arteries and veins) and lymphatics up to and including 3 mm diameter. The BiZact device is indicated for use in open general surgical procedures.

It is also indicated for adult ENT procedures, including tonsillectomy for the ligation and division of vessels, tissue bundles and lymphatics 2-3 mm away from unintended thermally sensitive structures.

The BiZact™ device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use for these procedures.

The BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider is a sterile, single use, hand-held electrosurgical device that incorporates RF tissue fusion technology for a desired tissue effect when used with the ForceTriad Energy Platform (K051644, K070162, K102913, and K110268), the Valleylab™ LS10 LS Series Single Channel Vessel Sealing Generator (K143654), or the Valleylab FT10 Energy Platform (K151649, K170170) for ligation and division of vessels, tissue bundles, and lymphatics during open general surgical procedures.

The BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider attaches to a compatible electrosurgical generator with a 10 foot cord containing a proprietary connector. The generator is able to identify the BiZact™ device via the RFID tag embedded in the connector (Valleylab LS10 LS Series single Channel Vessel Sealing Generator and Valleylab FT10 Electrosurgical Platform) or with a barcode on the connector (ForceTriad). The generator delivers energy to the device using a defined algorithm that adjusts the generator output as a function of the electrical resistance of the combination of the BiZact instrument and the generator algorithm achieve complete and permanent tissue fusion.

The provided document is a 510(k) premarket notification for a medical device (BiZact Tonsillectomy Device) and does not contain information about an AI/ML-based device or its performance criteria related to AI/ML tasks.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML device's performance. The document focuses on the substantial equivalence of a physical electrosurgical device to a predicate device, based on mechanical, electrical, functional, biocompatibility, sterilization, and animal (ex-vivo/in-vivo) studies.

The request asks for:

1. Table of acceptance criteria and reported device performance (for AI/ML): Not applicable, as this is not an AI/ML device. The document summarizes various engineering and biological tests, but not specific AI performance metrics like sensitivity, specificity, or AUC.
2. Sample size for test set and data provenance: The document mentions "fresh porcine renal arteries" for burst pressure, "porcine model" for lymphatic and acute hemostasis studies, and a "chronic hemostasis porcine study." It does not specify sample sizes in terms of number of cases for these animal studies beyond indicating they were sufficient for verification. Data provenance is "porcine model" (animal data), which is prospective in the context of these experiments. There is no human patient data test set for AI.
3. Number of experts and qualifications for ground truth: Not applicable for an AI/ML device. Ground truth in this context would be physical measurements, biological response, or pathological findings from the animal studies, not expert consensus on AI outputs.
4. Adjudication method: Not applicable for an AI/ML device.
5. MRMC comparative effectiveness study: Not applicable, as there's no AI component or human reader interaction with AI.
6. Standalone AI performance: Not applicable.
7. Type of ground truth: For the physical device, it's based on physiological and pathological outcomes in animal models (e.g., vessel burst pressure, acute hemostasis, lymphatic sealing, lateral thermal spread over time).
8. Sample size for training set: Not applicable, as there is no AI training set.
9. How ground truth for training set was established: Not applicable.

In summary, the provided document describes a medical device clearance for an electrosurgical tool, not an AI/ML device. Therefore, none of the requested information pertaining to AI/ML acceptance criteria and performance studies can be found or inferred from the text.

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The reprocessed Medline ReNewal LigaSure Impact LF4318 Curved Large Jaw, Open Sealer/Divider is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels is desired. The LF4318 is intended to be used with the ForceTriad energy platform to cut and seal vessels, and to cut, grasp and dissect tissue during surgery.

The indications for use include open procedures (general, urologic, vascular, thoracic, and gynecological) where ligation and division of vessels is performed. These procedures include vaginal hysterectomies, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy, etc. The LigaSure Impact 4318 can be used on vessels (arteries, veins, pulmonary vasculature, and lymph) up to and including 7 mm and tissue bundles.

The LigaSure system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

The reprocessed Medline ReNewal LigaSure Impact, Curved, Large Jaw, Open Sealer/Divider (LF4318) is a sterile, single-use, hand-held bipolar electrosurgical instrument designed exclusively for use with the ForceTriad Energy Platform (cleared under K051644, K070162) to seal and divide vessels (including pulmonary) up to and including 7 mm in diameter, tissue bundles, and lymphatics during open general surgical procedures. The ForceTriad's' tissue-fusion (LigaSure) mode is designed to deliver precise energy to tissue for a controlled time period to achieve complete and permanent tissue fusion.
The device combines the benefits of a long, curved jaw and a shaft-based jaw mechanism for improved access and visibility to critical structures. The pistol-grip-style handle was designed for improved comfort and usability, with an integrated hand switch and cutter for the subsequent sealing and dividing of tissue. Hand controls have been symmetrically placed to facilitate handling by both left- and right-handed users. The LF4318 device connects to the ForceTriad energy platform with a 10-foot cord containing a LigaSure cable connector. This connector functions as a unique product identifier for device -specific recognition by the generator. The 10-foot cord, cable connector, and ForceTriad are not reprocessed by Medline ReNewal.

The provided text describes a 510(k) premarket notification for a reprocessed medical device, the Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider (Model LF4318). This submission aims to demonstrate substantial equivalence to a legally marketed predicate device (Covidien LigaSure Impact LF4318).

Here's an analysis of the acceptance criteria and the study information, extracting what's available from the document:

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

The document does not explicitly present a table of "acceptance criteria" with specific pass/fail thresholds for each test, nor does it provide a direct numerical "reported device performance" against such criteria. Instead, it states that the functional characteristics "have been evaluated and found to be equivalent to the predicate devices based on the following tests."

However, we can infer the type of performance evaluation conducted:

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

The document does not specify the sample size for any of the tests conducted.
The document does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of the testing). The nature of the tests (e.g., simulated use, burst pressure, histopathology, cleaning, biocompatibility) suggests they are prospective bench and lab-based studies, rather than clinical data.

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)

The document does not provide information on the number of experts used or their qualifications for establishing ground truth, as this type of preclinical testing typically relies on predefined material properties and functional parameters rather than expert interpretation of complex clinical data. For histopathology, it would typically be a pathologist, but no specifics are given.

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

The document does not describe any adjudication method. This is generally not relevant for the types of bench and lab tests listed.

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 performed or described. The device is a reprocessed electrosurgical instrument, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This section is for AI/software devices. The device is a physical electrosurgical instrument.

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

The "ground truth" for the performance tests would be established through:

• Physical and electrical measurements: For electrical safety, device integrity, blade function, shaft rotation, handle locking, device recognition.
• Material and mechanical properties standards: For burst pressure, product stability.
• Microscopic evaluation/laboratory analysis: For histopathology (tissue effect), seal quality, tissue sticking, cleaning (protein, carbohydrates).
• Standardized biological assays: For biocompatibility (sensitization, irritation, pyrogenicity, acute systemic toxicity).
• Sterility testing: For sterilization validation.

These are objective measurements and standardized tests designed to demonstrate equivalence to the predicate device's established performance specifications.

8. The sample size for the training set

Not applicable. This device is a physical instrument, not a machine learning model that requires a training set. The term "training set" would not apply here.

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

Not applicable. See point 8.

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The LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels is desired. The LigaSure Impact LF4318 is intended to be used with the ForceTriad™ energy platform to cut and seal vessels, and to cut, grasp and dissect tissue during surgery.

The indications for use include open procedures (general, urologic, vascular, thoracic, and gynecological) where ligation and division of vessels is performed. These procedures include vaginal hysterectomies. Nissen fundoplication, colectorny, adhesiolysis, oophorectorny, etc. The LigaSure Impact LF4318 can be used on vessels (arteries, veins, pulmonary vasculature, and lymph) up to and including 7mm and tissue bundles.

The LigaSure™ system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

The LigaSure Impact™, Curved, Large Jaw, Open Sealer/Divider (LF4318) is a sterile, single-use, hand-held bipolar electrosurgical instrument designed exclusively for use with the ForceTriad™ Energy Platform (cleared under K051644, K070162) to seal and divide vessels (including pulmonary) up to and including 7mm in diameter, tissue bundles, and lymphatics during open general surgical procedures. The ForceTriad's tissue-fusion (LigaSure) mode is designed to deliver precise energy to tissue for a controlled time period to achieve complete and permanent tissue fusion.

The device combines the benefits of a long, curved jaw and a shaft-based jaw mechanism for improved access and visibility to critical structures. The pistol grip style handle was designed for improved comfort and usability, with an integrated hand switch and cutter for the subsequent sealing and dividing of tissue. Hand controls have been symmetrically placed to facilitate handling by both left and right-handed users. The LF4318 device connects to the ForceTriad energy platform with a 10 foot cord containing a LigaSure cable connector. This connector functions as a unique product identifier for device-specific recognition by the generator.

The provided text is a 510(k) summary for a medical device (LigaSure Impact™ Curved, Large Jaw, Open Sealer/Divider) and does not describe the acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner typically assessed for AI/software devices.

Instead, it describes the performance testing undertaken to demonstrate substantial equivalence to predicate devices, which is the regulatory pathway for this type of medical device. Therefore, I cannot extract the information required by your prompt as it pertains to AI/software acceptance criteria and studies (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size).

However, I can extract the information provided about the device's performance testing for its 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a table of numeric acceptance criteria and corresponding performance metrics in the way your prompt expects for AI/software. Instead, the performance is described qualitatively in the "Performance" section:

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

• Sample Size: Not specified quantitatively. The text only mentions "extensive functional, bench and pre-clinical testing."
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This type of information is typically not included in a 510(k) summary for this kind of hardware device.

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

This is not applicable as the device is a surgical instrument, not an AI/software device requiring expert-established ground truth on a dataset. Performance was evaluated through engineering tests and pre-clinical studies.

4. Adjudication method for the test set:

Not applicable.

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 hardware surgical instrument, not an AI system.

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

Not applicable.

7. The type of ground truth used:

For this device, "ground truth" would be established through physical measurements (e.g., sealing strength, thermal spread, hemostasis) and direct observation in pre-clinical studies, rather than expert labels on data.

8. The sample size for the training set:

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

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

Not applicable.

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The EnSeal PowerTip is an electrosurgical instrument for use with the EnSeal Universal electrosurgical generator. It is intended for use during open or faparoscopic, general and gynecologic surgery to cut and seal vessels, cut, grasp and dissect tissue during surgery.

Indications for use include open and laparoscopic general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments.

The cutting tip feature is intended for use in the dissection of tissue planes and the creation of enterotomies and gastrotomies.

The EnSeal PowerTip has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.

EnSeal PowerTip with EnSeal Universal. The functionality of the devices are the same as the predicate devices.

The provided text indicates that the K081129 submission for the "EnSeal PowerTip with EnSeal Universal" is a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting new clinical studies with defined acceptance criteria and detailed performance reporting.

Therefore, the documentation does not contain the specific information requested in your prompt regarding acceptance criteria, a dedicated study proving device performance against those criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance.

Here's what can be inferred from the provided text in relation to your request:

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

• Not Applicable. The submission is a 510(k) for substantial equivalence. It does not present new acceptance criteria or clinical performance data in this format.

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

• Not Applicable. No explicit "test set" in the context of a de novo clinical study is described. The device's safety and effectiveness are established by demonstrating functional similarities and preclinical testing in comparison to predicate devices.
• The provenance is "Preclinical laboratory (bench) and performance tests," suggesting in-house testing rather than human clinical data.

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

• Not Applicable. Ground truth, in the sense of expert consensus on clinical outcomes, is not established or reported for this type of submission.

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

• Not Applicable. No adjudication method is mentioned as there is no described test set requiring one.

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 an electrosurgical instrument, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies are not relevant or performed.

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

• Not Applicable. This is an electrosurgical instrument, not an algorithm, so this concept does not apply.

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

• Not Applicable (in the clinical sense). For a 510(k) based on substantial equivalence, the "ground truth" essentially revolves around the performance characteristics of the predicate devices and whether the new device functions similarly and meets its design specifications during preclinical (bench) testing. The text states: "Preclinical laboratory (bench) and performance tests were executed to ensure the devices function as intended and meet design specifications."

8. The sample size for the training set:

• Not Applicable. This is an electrosurgical instrument, not a learning algorithm or AI.

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

• Not Applicable. This is an electrosurgical instrument, not a learning algorithm or AI.

Summary based on the provided text:

The submission K081129 is a 510(k) for an electrosurgical instrument. Its approval is based on demonstrating substantial equivalence to existing predicate devices (e.g., K031133, K063195, K031079, K051644). The "study" proving the device met criteria was primarily preclinical laboratory (bench) and performance tests aimed at ensuring the device functions as intended and meets design specifications, consistent with the performance of its predicates. There are no detailed clinical study results, acceptance criteria tables, sample sizes for test sets, expert ground truth establishment, or AI-related metrics (like MRMC or standalone performance) reported in this summary.

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The Valleylab LigaSure Advance™ is a 5mm laparoscopic, electrosurgical instrument that incorporates both monopolar and LigaSure™ tissue fusion (bipolar) functionality. It is intended for use with the Valleylab ForceTriad™ energy platform (electrosurgical generator) in general and gynecological, laparoscopic, surgical procedures where ligation of vessels, including lymph vessels, is desired. The monopolar feature of the instrument will be used where electrical dissection through tissue planes and creation of enterotomies or gastrotomies is desired.

Indications for use include general and gynecological, laparoscopic surgical procedures (including urologic, vascular, thoracic and thoracoscopic) where electrosurgical ligation and division of vessels, including lymph vessels, is performed. These procedures include: laparoscopic gastric bypass, laparoscopically assisted vaginal hysterectomy, Nissen fundoplication, laparoscopic colectomy, adhesiolysis, oophorectomy, ctc.

The Valleylab LigaSure Advance™ can be used on vessels up to and including 7mm diameter and tissue bundles as large as will fit in the jaws of the instrument.

The Valleylab LigaSure Advance™ has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The LigaSure Advance™ is a 5mm laparoscopic vessel sealer and divider with integrated monopolar capability for energy-based dissection. The Valleylab LigaSure Advance™ is for use only with the Valleylab ForceTriad™ energy platform (electrosurgical generator), reference 510(k) notification K051644. The device will be offered in two lengths, 34 cm and 44 cm.

The LigaSure Advance™ device will be used to seal vessels, including lymph vessels, up to and including 7mm in diameter and tissue bundles. The sealed vessels and other tissue structures may be divided by the deployment of a mechanical knife that will reside within the shaft of the instrument and extends forward in a slot within the jaws when actuated by a mechanism residing within the handle of the device.

The monopolar capabilities of the device will be used to electrically dissect through tissue planes and to create openings in bowel (enterotomies) and stomach (gastrotomies). This is accomplished through a small electrode that protrudes from the distal end of one of the jaws of the device.

The controls for the device are all located on the handle. The instrument attaches to the generator with "smart" connectors, that identify the instrument type to the LigaSure generator, and a ten (10) foot cable. The instrument is supplied sterile for single-use.

The Valleylab LigaSure Advance™ is a laparoscopic electrosurgical instrument with both monopolar and bipolar (LigaSure™ tissue fusion) functionality. It is intended for use in general and gynecological laparoscopic surgical procedures for vessel ligation and division, and for electrical dissection, enterotomies, and gastrotomies using its monopolar feature. The device can be used on vessels up to 7mm in diameter and tissue bundles that fit within its jaws.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly list quantitative acceptance criteria in a table format. However, it states that "Performance testing and pre-clinical studies were performed to ensure that the LigaSure Advance™ functions as intended, and meets design specifications." The overall acceptance criterion is that the device is "substantially equivalent to the predicate devices, and meets safety and effectiveness criteria."

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

The document mentions "Performance testing and pre-clinical studies" but does not specify the sample size used for these tests.
The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. Given the nature of pre-clinical studies for a medical device prior to market release, it is highly likely that these were prospective studies, typically conducted in animal models or ex vivo tissue models.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned in the provided document. The focus is on demonstrating substantial equivalence to predicate devices, not on comparing human reader performance with and without AI assistance.

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

This device is an electrosurgical instrument for use by surgeons; it is not an AI algorithm. Therefore, the concept of a "standalone" study for an algorithm is not applicable to this device. The performance testing would inherently involve the device being used by operators (likely skilled surgeons or technicians) in pre-clinical settings.

7. The Type of Ground Truth Used:

The document does not explicitly state the specific type of ground truth used for performance testing. However, for a surgical device like this, ground truth would typically involve:

• Direct observation and measurement of seal integrity, burst pressure of sealed vessels, tissue damage, cutting effectiveness, and performance of monopolar dissection in pre-clinical models (e.g., animal studies, ex vivo tissue).
• Histopathological assessment of sealed tissues to confirm effective vessel occlusion and absence of thermal damage affecting surrounding structures.
• Functional assessment of mechanical knife deployment and cutting.

8. The Sample Size for the Training Set:

This device is a hardware electrosurgical instrument, not an AI algorithm that requires a training set. Therefore, the concept of a "training set" sample size is not applicable.

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

As explained above, this device is not an AI algorithm, so there is no training set and therefore no ground truth established for a training set.

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