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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 da Vinci E-200 Electrosurgical Generator is intended to deliver high-frequency energy for cutting, coagulation and vessel sealing of tissues in da Vinci robotic procedures, and non-robotic open and laparoscopic procedures.

The da Vinci E-200 is an electrosurgical unit (ESU) designed to provide high-frequency (HF) traditional monopolar, bipolar, and advanced bipolar outputs intended for cutting, coagulation and/or vessel sealing of tissues. The da Vinci E-200 is intended to be used with the IS4000/IS4200 da Vinci surgical systems, and also operate as a standalone electrosurgical generator. When connected to the da Vinci surgical system, the E-200 provides HF output to da Vinci instruments. Control and status messages are passed between the E-200 and the da Vinci system through an Ethernet communication cable. The E-200 is also compatible with open and laparoscopic third-party handheld monopolar and bipolar instruments, fingerswitch equipped instruments (where applicable) and Intuitive provided auxiliary footswitches. The primary function of the E-200 Electrosurgical Generator is to allow a surgeon to deliver HF output to cut, seal, or coagulate tissue during surgery. The user interface includes audible indicator tones, LED indicators on the front of the generator, and status messages provided on its LCD display.

The provided text is a 510(k) Summary for the da Vinci E-200 Electrosurgical Generator. It focuses on demonstrating substantial equivalence to a predicate device through verification and validation activities. However, it does not resemble a study report for an AI/ML device, which would typically include acceptance criteria, specific performance metrics like AUC, sensitivity, specificity, and details about human reader studies or ground truth establishment relevant to AI/ML performance.

The document describes standard medical device testing, such as:

• Design Verification (bench testing): Hardware, EMC, Electrical Safety, Software (including Cybersecurity), System interface, Instrument compatibility, Packaging, and Labeling.
• Design Validation (in-vivo porcine model): Safety and efficacy evaluation, including accessories and compatible systems in a simulated surgical setting.
• Thermal effects testing: Comparing the new monopolar "Low" coagulation mode to a reference device (Valleylab FT-10 Energy Platform).
• Neutral electrode contact quality monitor (CQM) study: Conformance to IEC standards with a specific neutral electrode pad.
• Capacitive coupling behavior evaluation: Comparing to the predicate device.
• Human factors evaluation: Safety and effectiveness in various configurations.

Therefore, I cannot extract the information required for an AI/ML device acceptance criteria and study from this document. The questions posed in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are specific to the evaluation of AI/ML algorithms and are not addressed in this 510(k) summary for an electrosurgical generator.

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The ESG-400 is an electrosurgical generator intended for tissue cutting and coagulation in open, laparoscopic and endoscopic surgery in conjunction with electrosurgical accessories and ancillary equipment.

The POWERSEAL Sealer and Divider is a bipolar electrosurgical device intended for use in laparoscopic/minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. POWERSEAL devices can be used on vessels (arteries and veins, pulmonary arteries, pulmonary veins) up to and including 7 mm, lymphatics, and tissue bundles. POWERSEAL devices are indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, sleeve gastrectomy, hysterectomy, oophorectomy.

The POWERSEAL Sealer and Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the POWERSEAL devices for these procedures.

The subject device ESG-400 is a reusable, non-sterile electrosurgical generator that features different mono- and bipolar cutting and coagulation modes. The maximum output power is 320 W. The front panel features a touch screen GUI that displays current settings, connection status, and allows access to menus for editing settings, procedures, and preferences. Compatible accessories include previously cleared footswitches.

The POWERSEAL 5mm laparoscopic curved jaw sealer divider is an electrosurgical bipolar device with an integral extending cutting blade. It features a pistol grip handle and will be provided in shaft lengths of 23, 37, and 44 cm. The POWERSEAL devices are sterile, single-use, hand-held bipolar electrosurgical instruments designed for use with Olympus electrosurgical generators to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics. The jaws are designed to seal vessels, and grasp and dissect tissue during open and minimally invasive general surgical procedures using high frequency (HF) energy. A hand actuated mechanism opens and closes the jaws. A second control initiates bipolar energy delivery for sealing. A separate control activates a blade for tissue division.

The provided text details the 510(k) submission for the Olympus Electrosurgical Generator ESG-400 and Accessories, and the POWERSEAL Curved Jaw Sealer and Divider, Double Action. The study described focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria and proving direct performance against them in a traditional sense. The performance data provided is primarily in the context of comparative testing to established predicate devices.

Here's an attempt to extract the information requested, with indications where the information is not explicitly available in the provided document:

1. Table of acceptance criteria and the reported device performance

The document doesn't explicitly state specific numerical acceptance criteria for performance metrics (e.g., burst pressure in mmHG, or a specific range for coagulation time). Instead, it states that the device "met all acceptance criteria" for biocompatibility and that "performance requirements defined in the User Requirements Specification and Design Specification were met for both subject devices, and that they exhibit comparable performance characteristics to the predicate device and reference devices."

The performance is described qualitatively as being "comparable" or having "equivalent technology and performance" to predicate/reference devices. For example, for vessel sealing, the key performance indicator mentioned is "vessel burst pressure testing."

Therefore, a table of acceptance criteria and reported numerical performance values cannot be fully constructed from the provided text in the typical quantitative manner.

Table 1: Acceptance Criteria and Reported Device Performance (as inferred and stated qualitatively)

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

• Test Set Sample Size: The document does not specify exact sample sizes for the "test set" in terms of number of cases or samples for the animal studies or bench testing (e.g., how many vessels were sealed for burst pressure testing). It only states that "ex-vivo Vessel Burst Pressure testing was conducted."
• Data Provenance (Country of Origin, Retrospective/Prospective): Not explicitly stated. The studies were likely conducted in a controlled lab or animal facility. The document refers to FDA guidance documents, which are for U.S. regulatory submissions, but doesn't specify where the actual testing took place. It also doesn't specify if the animal studies or bench tests were retrospective or prospective, though performance testing is generally prospective.

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

This type of information (number of experts, their qualifications, and their role in establishing ground truth) is typically related to clinical studies involving human interpretation or pathology. The reported studies are primarily bench (ex-vivo) and animal studies. Therefore, this information is not applicable in the context of the provided document. The "ground truth" for these studies would be objective measurements (e.g., burst pressure from instrumentation) rather than expert consensus on clinical findings.

4. Adjudication method for the test set

This is also typically relevant for clinical studies with human interpretation. For bench and animal studies (e.g., measuring vessel burst pressure), the "adjudication" is typically through objective measurements and statistical analysis, not a consensus process among experts as described by methods like 2+1 or 3+1. Therefore, this information is not applicable in the context of the provided document.

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

• MRMC Study Done: No. This study is for an electrosurgical device, not an AI-assisted diagnostic tool involving human readers.
• Effect Size of Human Readers: Not applicable.

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

• Standalone Performance: Not applicable to this type of device. The device itself is an electrosurgical tool, not an algorithm, and it is used by a human surgeon.

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

For the performance testing, the ground truth was established through objective physical measurements in bench and animal studies:

• Biocompatibility: In vitro and in vivo (animal tissue/systems) tests following ISO 10993 standards.
• Electrical/Thermal Safety & EMC: Measurements against IEC standards.
• Vessel Sealing Performance: Chronic and acute animal studies demonstrating seal performance, and ex-vivo vessel burst pressure testing. The "ground truth" here would be the measured burst pressure values and observed tissue effects.

8. The sample size for the training set

The document describes an electrosurgical device, not a machine learning or AI algorithm in the context of diagnostic imaging. Therefore, the concept of a "training set" in this context is not applicable. The "training" for such a device involves engineering design, prototyping, and testing against specifications and regulatory standards.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm being developed.

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ESG-410:
The electrosurgical generator, in conjunction with electrosurgical accessories and ancillary equipment, is intended for cutting and coagulation of tissue in the following medical fields:

• Open surgery
• Laparoscopic surgery
• Endoscopic surgery
  Only for use by a qualified physician in an adequate medical environment.

PK Cutting Forceps (CF-PK0533):
The PK Cutting Forceps are indicated for electrosurgical coagulation, mechanical cutting, and grasping of tissue during the performance of laparoscopic and open general surgical procedures.

ESG-410 Generator:
The subject device ESG-410 is a reusable, non-sterile electrosurgical generator that features different mono- and bipolar cutting and coagulation modes. The maximum output power is 320 W. The front panel of the proposed ESG-410 features a touch screen GUI (graphical user interface) that displays the connection status of accessories and peripherals connected to the electrosurgical generator. Soft keys are integrated into the GUI to switch between the output sockets, to enter the Menu in order to edit settings/ procedures (e.g. create/ edit user-defined settings/ procedures), to edit preferences (e.g. select language, touch tone control, output volume, or brightness) and to show service options (e.g. software version identifier, for service and maintenance purposes) or to assess user-defined settings and procedures.

PK Cutting Forceps:
The PK Cutting Forceps are a bipolar electrosurgical device that may be utilized in laparoscopic and open general surgery to grasp, coagulate, transect, dissect and retract tissue. The PK Cutting Forceps were cleared via K142759. They are currently intended to be used only with the existing ESG-400 generator per the Indications for Use statement. This submission will demonstrate compatibility with the new ESG-410 generator, and the Indications for Use statement will remove a specific generator model and the compatible generators will be reflected in the labeling. Minor modifications, which did not affect safety and effectiveness, were assessed via internal documentation since the original clearance and will be identified within the submission.

The provided text describes a 510(k) premarket notification for an electrosurgical generator (ESG-410) and accessories, including PK Cutting Forceps. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or safety through large-scale clinical trials.

Therefore, the information you're asking for, particularly regarding acceptance criteria tied to device performance in terms of patient outcomes or diagnostic accuracy, and detailed MRMC studies with expert adjudication and effect sizes, is not typically found in a 510(k) submission for a device like an electrosurgical generator.

The "acceptance criteria" for this type of device are primarily related to meeting recognized electrical safety, electromagnetic compatibility (EMC), thermal safety, software validation, and functional performance standards. The "study that proves the device meets the acceptance criteria" refers to a series of bench and non-clinical/preclinical tests designed to show that the new device performs comparably to the predicate device and meets relevant performance standards.

Let's break down what is available in the document related to your questions, and where specific requested information is not applicable or provided.

Acceptance Criteria and Reported Device Performance

The core "acceptance criterion" for a 510(k) submission is substantial equivalence to a predicate device. This is demonstrated by showing similar technological characteristics, intended use, and comparable safety and effectiveness. "Performance" here largely refers to meeting technical specifications and demonstrating similar tissue effects to the predicate, not clinical outcomes in patients.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Detailed Responses to Specific Questions:

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

   • See table above. The "performance" for this type of device is predominantly technical and functional performance against standards and predicate devices, not clinical effectiveness in terms of patient outcomes.

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

   • Sample Size: The document does not specify "sample sizes" in the typical clinical study sense for test sets of patients or cases. Instead, it refers to "bench studies" and "preclinical (simulated use) evaluation and testing of tissue effects." For tissue effects, it mentions "three clinically relevant tissue types were evaluated in all applicable modes." This implies material samples or ex-vivo tissue, not a patient cohort.
   • Data Provenance: The tests are described as bench and preclinical (simulated use), conducted by the manufacturer (Olympus Winter & Ibe GmbH) and contract manufacturer (STEUTE TECHNOLOGIES GMBH & CO. KG), both located in Germany. There is no mention of country of origin of patient data as no clinical studies were deemed necessary. The studies were non-clinical/preclinical.

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

   • This question is not applicable to this submission. Ground truth, in the context of diagnostic AI or similar devices, is established by expert review (e.g., radiologists) for specific patient cases. This device is an electrosurgical generator. Its "ground truth" is its ability to adhere to technical specifications, produce specific electrical waveforms, and achieve desired tissue effects in a controlled, non-clinical environment, which is assessed through engineering and physical measurements. No human expert "ground truth" for a test set of medical images/cases is mentioned or relevant here.

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

   • Not applicable. Adjudication methods are used in clinical studies where multiple readers interpret cases and their consensus/disagreement needs to be resolved to establish ground truth or compare diagnostic performance. This is a technical performance and safety submission for an electrosurgical device, not a diagnostic 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:

   • No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic devices to assess how AI assistance impacts human reader performance. The ESG-410 is an electrosurgical generator, a surgical tool, and does not involve human "readers" interpreting images with or without AI assistance. Clinical and animal studies were explicitly stated as "not necessary."

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

   • The ESG-410 contains "software," and "software validation activities were performed." This implies standalone testing of the software's functionality, but not in the context of an "algorithm only" performance for things like diagnostic accuracy (e.g., a standalone AI imaging algorithm). For this device, standalone performance refers to its ability to generate the correct electrical outputs and control the surgical modes as programmed. This was part of the "non-clinical (electrical, dimensional, functional, stability)" testing.

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

   • The "ground truth" for this device's performance is based on engineering specifications, physical measurements of electrical output waveforms, and qualitative/quantitative assessment of tissue effects in simulated environments (preclinical/bench testing). This is not a "ground truth" derived from human experts, pathology, or patient outcomes data, as no clinical studies were performed.

8. The sample size for the training set:

   • Not applicable/Not mentioned. This is not an AI/machine learning device that requires a training set of data for an algorithm to learn from in the typical sense (e.g., imaging data for a diagnostic algorithm). The software validation refers to standard software development life cycle processes, not machine learning model training.

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

   • Not applicable. As explained above, there's no "training set" in the context of machine learning for this device. Its software and functional parameters are designed and validated based on established engineering principles and performance standards for electrosurgical devices, rather than learned from a data set with pre-established ground truth labels.

In summary, the provided FDA 510(k) document details a substantial equivalence claim for an electrosurgical generator and its accessories. The "acceptance criteria" and "proof" provided are consistent with a regulatory pathway for electrical surgical devices, focusing on meeting established technical performance standards and demonstrating comparability to predicate devices through bench and preclinical testing, rather than extensive clinical studies or AI algorithm performance validation metrics typical for imaging diagnostics.

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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 Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialties as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, adhesiolysis, hysterectomy, oophorectomy, etc.

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

The Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Dividers (models LF1723, LF1737 and LF1744) are sterile, single-use, hand-held bipolar electrosurgical instruments designed for use with the Covidien electrosurgical generators to ligate (seal) and divide (cut) vessels, tissue bundles and lymphatics during open and minimally invasive general surgical procedures using radio frequency (RF) energy. A hand actuated mechanism allows the user to open and close the instrument jaws. When the instrument jaws are correctly placed over tissue or vessel to be sealed, the user operates a second control to initiate delivery of bipolar energy, which seals the tissue. When the sealing cycle is complete, the user operates a separate control to activate a knife, which divides the tissue along the seal line.

The request is for information on the acceptance criteria and study proving device performance for the Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Dividers (models LF1723, LF1737, and LF1744), as detailed in the FDA 510(k) summary K182588.

Based on the provided document, the device is a reprocessed version of a legally marketed predicate device. The submission primarily focuses on demonstrating that the reprocessed device is substantially equivalent to the original predicate device (Covidien LigaSure Maryland Jaw One Step Sealer/Dividers with 510(k) K141153) through performance testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the functional characteristics of the proposed reprocessed devices have been evaluated and found to be equivalent to the predicate devices. The acceptance criteria are implied to be that the reprocessed device performs comparably to the new predicate device across various tests.

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

The document does not specify the exact sample sizes used for each of the performance tests. It broadly states "The functional characteristics of the proposed devices have been evaluated..." without providing numerical details for the test sets.

The data provenance is not explicitly stated in terms of country of origin. Given it is an FDA submission for a device manufactured by "Surgical Instrument Service and Savings Inc (dba Medline ReNewal)" and the predicate is from "Covidien," it can be inferred that the testing and data would be primarily from the United States, following U.S. regulatory guidelines. The data is retrospective in the sense that it relies on established standards and comparisons to an already legally marketed predicate device, rather than a novel prospective clinical trial for the reprocessed device's primary effectiveness.

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

The document does not mention the use of experts to establish ground truth for this type of device comparison study. The tests listed are primarily engineering and laboratory-based performance evaluations (e.g., electrical, mechanical, material, and in-vitro or ex-vivo tissue property tests). For biocompatibility and histopathology, qualified laboratories and pathologists would perform the evaluations, but their specific number and qualifications are not detailed in this summary.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of clinical outcomes or interpretations by multiple readers/experts. The testing involves objective measurements against established engineering and biological standards.

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 a study involving AI or human readers for diagnostic interpretation. It is a performance evaluation of a reprocessed surgical instrument.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" for the performance evaluation of this reprocessed device is established by:

• Predicate Device Performance: The primary ground truth is the established safety and effectiveness of the legally marketed predicate device (Covidien LigaSure Maryland Jaw One Step Sealer/Dividers, K141153). The reprocessed device is deemed substantially equivalent if its performance matches or falls within acceptable ranges compared to the predicate.
• Industry Standards: Compliance with international and national standards (e.g., IEC 60601 series for electrical safety, ISO standards for biocompatibility and sterilization, and internal performance specifications), which represent a form of accepted "ground truth" for device safety and performance.
• Laboratory-based measurements: Objective measurements of physical, chemical, and biological properties through various tests (e.g., burst pressure, protein residuals, cytotoxicity).
• Histopathology: Evaluation of tissue effects, performed by qualified personnel (likely pathologists), forms a 'ground truth' for tissue interaction.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. This is not a machine learning or AI device.

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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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