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Electrosurgical Pads are Neutral Electrode which is also known as plate, plate electrode, passive, return, or dispersive electrode. They are indicated for use to adhere to the patient over the entire pad surface to complete an electrical circuit during electrosurgery between the electrosurgical generator, the active electrode and the patient.

Solid Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split Electrosurgical Pads are for use with generators that have a CQMS (i.e. REM, ARM, NESSY, etc.).

Electrosurgical Pads are single-use, non-sterile dispersive electrode with or without a pre-attached cord. This devices are used in monopolar surgery to complete the electrical circuit with the generator. Providing a low-impedance path back to the generator through the return electrode helps to prevent unintended RF burns. The Electrosurgical Pads are designed to be compatible with the return electrode monitoring function of compatible OBS generators.

This document is an FDA 510(k) Clearance Letter for "Electrosurgical Pads." It demonstrates no AI/ML algorithm in its description, and therefore, the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI-powered device is not applicable.

The document primarily focuses on demonstrating substantial equivalence of the Electrosurgical Pads to a predicate device and reference devices through:

• Indications for Use comparison: Showing the subject device has the same intended use as the predicate and highly similar indications for use as reference devices.
• Technological Characteristics comparison: Detailing material composition, size, corded/non-corded options, patient weight applicability, and safety/performance standards met.
• Non-clinical performance testing: Listing compliance with relevant IEC and ISO standards for electrical safety, EMC, performance, and biocompatibility.

Therefore, I cannot provide the requested information for an AI/ML device from this document.

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The HOTWIRE™ is indicated for creation of an atrial septal defect in the heart.

The HOTWIRETM is a sterile, single-use guidewire device that delivers radiofrequency (RF) power in a monopolar mode to a distal electrode segment for the creation of an atrial septal defect in the heart. The HOTWIRE is intended to be used in conjunction with compatible third-party intravascular sheaths and/or dilators, such as the Agilis NXT Steerable Introducer, St. Jude Medical (K081645), and third-party RF electrosurgical generator(s), such as the Valleylab FT10 Electrosurgical Platform (K151649) which utilizes a commercially-available Patient Return Electrode (PRE) which is in compliance with IEC 60601-2-2, such as the Valleylab E7507DB (K822572).

The HOTWIRETM is comprised of a stainless steel core wire. The main body of the wire is jacketed with an insulating polymer that provides electrical insulation and facilitates smooth movement of the device through vascular dilators and/or sheaths. The floppy distal segment of the wire has an atraumatic tip with an uninsulated stainless-steel coil, which serves as an electrode, and also provides fluoroscopic visualization. A tungsten marker coil at the tip provides additional radiopacity. The stiff body of the HOTWIRE™ provides support for advancing wire-guided devices into the left atrium after the distal segment has traversed the septum. The proximal insulated portion of the wire has visual markers that align the electrode tip with 3rd party transseptal sheaths and/or dilators. A portion of the proximal wire is uninsulated for placement of an included Adapter Pin that connects to hand pieces used with compatible third-party RF electrosurgical generators.

The provided document is a 510(k) summary for the HOTWIRE™ RADIOFREQUENCY (RF) GUIDEWIRE, demonstrating its substantial equivalence to a predicate device. As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the performance bench testing, animal testing, biocompatibility testing, EMC + Electrical Safety testing, shelf life testing, packaging validation, sterilization validation, and bacterial endotoxin testing conducted to show the device is safe and effective and comparable to the predicate.

Here's the information requested, based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this medical device are primarily established by demonstrating compliance with recognized performance standards and showing substantial equivalence to a legally marketed predicate device. The reported device performance is presented as a summary of various tests, all of which "passed testing" or "met the requirements."

Study Details:

The document describes pre-market testing to establish substantial equivalence for a medical device (HOTWIRE™ RF Guidewire) rather than a study typically associated with AI/software devices (which would involve human readers, ground truth establishment, etc.). Therefore, many of the requested points are not applicable in this context.

Here's how the information aligns with the provided document:

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

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

   • Sample Size: The document repeatedly states "All test samples passed testing," but does not specify the exact number of samples used for each test. This information is typically detailed in the full test reports, not the 510(k) summary.
   • Data Provenance: Not explicitly stated but assumed to be laboratory testing conducted by or for the device manufacturer (Atraverse Medical, Inc.). The animal testing was a GLP (Good Laboratory Practice) study, implying a controlled, prospective design for that component. Country of origin not specified, but the submission is to the U.S. FDA.

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): Not applicable. This device is a guidewire, not an AI/software device requiring human expert annotation for ground truth. "Ground truth" here refers to objective measurements and biological responses verified through standard laboratory and animal testing protocols.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This pertains to expert review and consensus for data labeling/ground truth in AI/software studies, not physical device performance testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a physical medical device (guidewire), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a physical medical device. The "standalone" performance is established through bench and animal testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device's performance is established through:

   • Validated Test Methods and Standards: (e.g., ISO 11070 for tensile strength, ISO 10993 series for biocompatibility, IEC 60601 series for electrical safety).
   • Visual Inspection and Dimensional Measurements: Objective assessments against defined specifications.
   • Biological Responses: Measured in in vitro and in vivo (animal) models, such as cytotoxicity, sensitization, pyrogenicity, hemolysis, and thrombogenicity.
   • Functional Performance: Assessment of characteristics like trackability, handling, and radiopacity in simulated and animal use.

8. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

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The indications for use include general (including urologic, thoracic, plastic and reconstructive, arthroscopic), laparoscopic, and gynecologic procedures where electrosurgical cutting and coagulation of tissue, and sealing (fusion) of vessels and tissue bundles is performed, including such procedures as bowel resections, hysterectomies (both vaginal and abdominal). laparoscopic cholesystectomies, laparoscopically assisted vaqinal hysterectomies, gall bladder procedures, Nissen fundoplication, adhesilysis, oophorectomy, etc. Vessels (arteries, veins, pulmonary arteries, pulmonary veins, lymph) 7mm and smaller in diameter, and bundles as large as will fit in the jaws of the devices can be sealed with the LigaSure™ vessel sealing (tissue fusion) output.

The ForceTriad™ generator is a full-featured electrosurgical generator with monopolar, bipolar, and LigaSure™ vessel sealing outputs. The generator is an electrically isolated, microcontroller-based device, incorporating closed-loop control for all output modes implemented in the microcontroller firmware. The generator incorporates Instant Response™ technology to constantly measure the electrical impedance of the tissue and instantaneously adjust the generator output to maintain the desired power.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ForceTriad™ Electrosurgical Generator:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document explicitly states: "No clinical testing was conducted." Therefore, there is no test set in the traditional sense of patient data. The evaluation was based on non-clinical testing, including software validation and bench testing. The provenance of this non-clinical test data is not specified in terms of country of origin, but it is implied to be internal testing by the manufacturer (Covidien). The testing itself would be considered prospective for the specific software change being evaluated.

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

As no clinical testing was performed and the evaluation focused on software and bench testing, there were no "experts" in the sense of clinical professionals establishing a ground truth on patient data. The ground truth for the non-clinical tests would have been established by engineering and quality assurance personnel, likely using predefined specifications and expected outputs for the software and hardware interfaces. Their specific qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set with human assessment was utilized. The "ground truth" for the non-clinical tests would have been determined through objective measurements and comparisons against technical specifications, not through a consensus-based adjudication process.

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 done. The document explicitly states, "No clinical testing was conducted." Therefore, there is no information about the effect size of human readers with vs. without AI assistance. This submission focuses on a software change for integration, not on a new diagnostic or interpretative AI feature.

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

This device is an electrosurgical generator, which is inherently a human-in-the-loop device. However, the specific software change being evaluated (allowing the generator to interface with an Integrated OR system) was likely tested in a standalone manner relative to its function of communication. The bench testing and software validation would assess the algorithm's ability to correctly interface and transmit data without direct human intervention once configured, but the overall device always requires human operation. The document doesn't explicitly describe a "standalone performance" study in the context of an AI algorithm making decisions, as this is not an AI-driven diagnostic device.

7. The Type of Ground Truth Used:

The ground truth used for this submission was primarily technical specifications and expected system behavior. For software validation, this would involve comparing actual software outputs against designed functional requirements. For bench testing, it would involve verifying that the device communicated correctly with the simulated and actual Olympus EndoAlpha system according to predefined communication protocols and interface standards.

8. The Sample Size for the Training Set:

Not applicable. This submission is for a software modification to an existing device for interoperability. There is no mention of a machine learning or artificial intelligence component that would require a "training set" in the traditional sense. The software development process would involve iterative testing and debugging, but not a distinct training set for an AI model.

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

Not applicable, as there was no training set in the context of machine learning. The "ground truth" for the software development and validation would have been based on the functional specifications and design documents for the integration with the Olympus EndoAlpha endosurgery system, established by Covidien's engineering team.

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