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The Guidant FLEX 10® MIS Ablation Probe is indicated for the surgical ablation of soft tissue and striated, cardiac, and smooth muscles. The system is a device indicated for use, under direct visualization, in surgical procedures, including minimally invasive cardiac surgery procedures. The probes ablate the target tissue by creating an inflammatory response, or thermal necrosis.

The FLEX 10® MIS Ablation Probe is designed for use in conjunction with the Guidant 1000 Series Microwave Generator. The Ablation Probe is an intraoperative, sterile, single-use, hand-held device that applies microwave energy to tissue. The Ablation Probe is comprised of a 24-cm-long, rigid handle with position indicators, a metallic shaft, a proximal control tube, a flexible sheath featuring black numbered markings together with right and left hand side markings, a detachable distal control tube, and a guide lead with sutures. The Ablation Probe further includes a 2-m-long insulated coaxial cable, which attaches to the generator output cable connector. The Microwave Generator's output (2450 MHz) is conducted through the output cable connector, into the cabling of the Ablation Probe, and out the antenna at the distal section of the Ablation Probe. The emitted microwave energy is directed toward the target tissue from the active surface opposite the corresponding numbered marking (segment), and creates a continuous lesion approximately 26 mm long. The black side-markings indicate the sides of the sheath. The numbered markings designate each numbered segment of the sheath and correspond to the position indicators on the handle. The ablations are created by independently activating the microwave ablation element at one or more of the corresponding numbered segments, which are selected by moving the sliding ring on the handle.

The Guidant FLEX 10® MIS Ablation Probe is indicated for the surgical ablation of soft tissue and striated, cardiac, and smooth muscles. The system is a device indicated for use, under direct visualization, in surgical procedures, including minimally invasive cardiac surgery procedures. The probes ablate the target tissue by creating an inflammatory response, or thermal necrosis.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly list specific numerical acceptance criteria for the device's performance. Instead, it states a general conclusion about meeting established criteria.

2. Sample Size and Data Provenance

The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It only refers to "verification testing."

3. Number and Qualifications of Experts for Ground Truth

The document does not mention the use of experts to establish ground truth for a test set. This type of information would typically be relevant for studies involving subjective assessment (e.g., image interpretation), which is not explicitly described here.

4. Adjudication Method

The document does not describe any adjudication method. This is generally relevant when multiple experts are involved in assessing data for ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. There is no mention of human readers or "AI vs. without AI assistance." The device is a medical probe, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

The document does not refer to a standalone performance study in the context of an algorithm. The device described is a physical medical device (ablation probe), not a software algorithm or AI. The "verification testing" would likely refer to engineering and functional tests of the physical device.

7. Type of Ground Truth Used

The document does not specify the type of ground truth used. Given the nature of the device (an ablation probe), the "verification testing" would likely involve objective measurements of the ablation lesion's characteristics (size, temperature, tissue necrosis) rather than subjective assessments requiring expert consensus, pathology, or outcomes data in the usual sense of a diagnostic device. The ground truth would likely be established through physical measurements and observations in a laboratory or preclinical setting.

8. Sample Size for the Training Set

The document does not mention a training set sample size. Training sets are typically associated with algorithmic development (e.g., machine learning), and this device is a physical medical instrument.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a training set, the document does not provide information on how its ground truth was established.

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The HI-TORQUE WHISPER VIEW GUIDE WIRE is intended to aid in the placement of a Guidant implantable coronary venous lead in the coronary venous vasculature.

The guide wire is comprised of a stainless steel tapered core with a flexible tip, jacketed by tungsten-loaded polyurethanc on the distal portion and polytetrafluoroethylenc (PTFE) on the proximal portion of the wire. The polyurethane is covered with a hydrophilic coating to increase lubricity. The guide wire is 190 cm long with a maximum outer diameter of 0.0145. The guide wires are available with cither a straight distal tip that is shapeable, or a preformed 'J' distal tip shaped specifically for accessing the coronary sinus.

The provided text describes a 510(k) submission for a medical device, the HI-TORQUE® WHISPER VIEW™ Guide Wire. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than performing a separate de novo study with novel acceptance criteria.

Therefore, the information you're requesting regarding explicit acceptance criteria and a detailed study proving the device meets them, especially in the context of AI/ML performance, ground truth, and expert adjudication, is not present in this document. The submission relies on verification testing to show equivalence to the predicate device.

Here's an analysis based on the provided text, addressing your points where possible, and indicating where information is not available:

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

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

• Sample size for test set: Not provided.
• Data provenance: Not provided (e.g., country of origin, retrospective/prospective). The document describes "verification testing," but details about the test set are absent.

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

• This information is not applicable/not provided. The submission is for a physical medical device (guide wire) and not an AI/ML-based diagnostic system that would typically involve establishing ground truth from expert interpretations of data.

4. Adjudication method for the test set

• This information is not applicable/not provided. As above, this pertains to expert review of data for AI/ML systems.

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. This is a physical device, not an AI/ML application. An MRMC study is not relevant to this submission.

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

• No. This is a physical device, not an AI/ML algorithm.

7. The type of ground truth used

• Not explicitly stated in the sense of 'ground truth' for an AI/ML system. For a physical medical device, "ground truth" would relate to the physical and functional properties of the device meeting engineering specifications and performance expectations. The document refers to "verification testing" comparing the device to its predicate.

8. The sample size for the training set

• Not applicable/not provided. This is a physical device, not an AI/ML model that requires a training set.

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

• Not applicable/not provided. As above, this is for an AI/ML model.

Summary from the document:

The submission focuses on demonstrating substantial equivalence of the HI-TORQUE® WHISPER VIEW™ Guide Wire to the predicate device, HI-TORQUE® WHISPER™ Guide Wire (K030019). The modifications are an increased tungsten load in the polyurethane coating and a change in the tempering method for the stainless steel wire core.

The study (referred to as "verification testing") demonstrated that the modified device:

• "meets established acceptance criteria" (though these criteria are not detailed in the provided text).
• "performs in a manner equivalent to the predicate device."
• Raised "no new safety or effectiveness issues."

This implies that the "acceptance criteria" were primarily related to the physical, mechanical, and functional performance of the guide wire, ensuring it operates safely and effectively in the same way as the predicate device. The evidence for meeting these criteria comes from internal "verification testing" conducted by the manufacturer, rather than external clinical trials or studies involving human experts interpreting diagnostic output.

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The RX ACCUNET™ 2 Embolic Protection System is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the portery at the site of filter basket placement should be between 3.25 mm and 7.0 mm.

The RX ACCUNET™ 2 Embolic Protection System is a filtration type embolic protection device, filtering distal to the interventional site. The System consists of the RX ACCUNET™ Delivery System and a second-generation RX ACCUNET™ 2 Recovery Catheter. The RX ACCUNET™ 2 Embolic Protection System is delivered via a Delivery Sheath with a flexible tip coil that facilitates movement of the Sheath through tortuous anatomy. Once across the lesion, the Filter Basket is expanded in the arterial lumen by peeling the Delivery Sheath from the guide wire using the torque device and peel away adapter. At the conclusion of the interventional procedure, the Filter Basket is collapsed inside the Recovery Catheter. Once collapsed, the entire system is removed as a single unit. The Recovery Catheter has a radiopaque tip to facilitate movement though tortuous anatomy

This document is a 510(k) summary for the RX ACCUNET™ 2 Embolic Protection System. It outlines the device's substantial equivalence to a predicate device and provides an overview of its intended use and technological characteristics.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in the format of a numerical target for specific performance metrics. Instead, it relies on the concept of substantial equivalence to a predicate device (RX ACCUNET™ Embolic Protection System, K024418).

The "performance" is implicitly deemed acceptable if the new device demonstrates similar safety and effectiveness to the predicate.

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

• Test Set Sample Size: The document does not specify a numerical sample size for the "in vivo studies." It simply states "in vivo studies." It's common in 510(k) submissions for device modifications to refer to previous studies or a cumulative understanding rather than detailing new, large-scale clinical trials for minor changes.
• Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. It only mentions "in vitro bench tests and in vivo studies." Given the context of a 510(k) submission, these would typically be internal company studies or studies conducted under contract for the company.

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

This information is not provided in the given text. The document refers to "in vivo studies" but does not detail the methodology for establishing ground truth, such as expert review, for these studies.

4. Adjudication Method for the Test Set:

This information is not provided in the given text.

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 to this document. The RX ACCUNET™ 2 Embolic Protection System is a medical device (filtration type embolic protection device), not an Artificial Intelligence (AI) or software as a medical device (SaMD) product. Therefore, MRMC studies and AI-assisted improvements for human readers are not relevant.

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

This is not applicable for the same reasons as point 5. It's a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The document does not explicitly state the type of ground truth used for the "in vivo studies." For an embolic protection system, "safety and effectiveness" in vivo would likely involve:

• Outcomes data: Such as rates of stroke, TIA, or other neurological events post-procedure, as well as the amount and type of embolic material captured by the filter.
• Imaging: Assessment of vessel patency and absence of new lesions.
• Histopathology: Analysis of captured embolic material (if possible and relevant to the study design).

However, the specific methods are not detailed. The phrase "demonstrated the safety and effectiveness" is a general conclusion.

8. The Sample Size for the Training Set:

This is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set. The "training" for such devices typically involves design iterations, bench testing, and potentially animal studies.

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

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

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The ACCUNET™ Embolic Protection System and the RX ACCUNET™ Embolic Protection System are indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of filter basket placement should be between 3.25 mm and 7.0 mm.

The ACCUNET™ Embolic Protection System is an over-the-wire, filtration-type, embolic protection device, filtering distal to the interventional site. The ACCUNET™ System is delivered via a Delivery System, utilizing a flexible tip coil that facilitates movement of the Sheath through tortuous anatomy. Once the Guide Wire is across the lesion, the Filter Basket is expanded in the artery lumen by removing the Delivery Sheath. At the conclusion of the interventional procedure, the Filter Basket is collapsed inside the Recovery System, retaining any potential embolic collected during the procedure. The system and any captured embolic particles are then removed through the guiding catheter or sheath.

Like the ACCUNET™ Embolic Protection System, the RX ACCUNET™ Embolic Protection System is a filtration type embolic protection device, filtering distal to the interventional site. The RX ACCUNET™ System is delivered in a Delivery Sheath with a flexible tip coil that facilitates movement of the Sheath through tortuous anatomy. Once across the lesion, the Filter Basket is expanded in the arterial lumen by advancing the Filter Basket from the Delivery Sheath from the Guide Wire using the torque device. At the conclusion of the interventional procedure, the Filter Basket is collapsed inside the Recovery Catheter. Once collapsed, the entire system is removed as a single unit.

The provided text describes the ACCUNET™ Embolic Protection System and the RX ACCUNET™ Embolic Protection System. It outlines the indications for use and mentions several studies conducted to demonstrate its safety and effectiveness. However, it does not explicitly provide a table of acceptance criteria with reported device performance or detail the specific acceptance criteria for each test. Instead, it generally states that the device was considered "substantially equivalent" to a predicate device and that studies demonstrated acceptable functional performance.

Here's an attempt to structure the available information regarding acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a direct table of acceptance criteria with corresponding performance metrics. It rather indicates a general claim of "substantially equivalent."

2. Sample Sizes and Data Provenance:

• Clinical Trials (ARCHeR 1, ARCHeR 2, ARCHeR 3):
  • Sample Size (Total): 657 patients.
  • Data Provenance: United States (45 clinical sites) and five sites outside of the United States.
  • Retrospective/Prospective: Prospective, non-randomized, multi-center, single-arm clinical trials.
• Animal Studies:
  • Sample Size: Not explicitly stated, but performed in non-atherosclerotic swine.
• In Vitro Testing:
  • Sample Size: Not explicitly stated, but included biocompatibility, sterilization, packaging and shelf-life, and product performance testing.

3. Number of Experts and Qualifications for Ground Truth - Test Set:

The document does not mention the use of experts to establish ground truth for a test set in the context of device performance, as it is a medical device for embolic protection rather than an AI/diagnostic software. The clinical trials aimed to demonstrate the device's safety and effectiveness in patients, with outcomes being the primary measure.

4. Adjudication Method for the Test Set:

Not applicable in the context of this medical device approval, as there is no "test set" in the sense of a dataset requiring expert adjudication for ground truth. Clinical outcomes from the ARCHeR trials were used.

5. MRMC Comparative Effectiveness Study:

Not applicable. This is a medical device, not an AI or imaging diagnostic software that would involve human readers.

6. Standalone Performance Study:

The clinical trials (ARCHeR) evaluated the performance of the ACCUNET™ and RX ACCUNET™ Embolic Protection Systems in conjunction with the ACCULINK™ and RX ACCULINK™ Carotid Stent Systems. Therefore, it's not strictly a "standalone" or "algorithm-only" performance in isolation, but rather its performance as part of a therapeutic system. The animal and in-vitro studies also assessed the device's performance directly.

7. Type of Ground Truth Used:

• Clinical Trials (ARCHeR): The "ground truth" was based on clinical outcomes in patients (e.g., primary endpoint rates which would likely include stroke, MI, death), as defined by the study protocols.
• Animal Studies: In vivo functional performance and biological responses.
• In Vitro Testing: Adherence to established performance standards and guidance documents.

8. Sample Size for the Training Set:

Not applicable. This is a medical device, not an AI algorithm that requires a training set. The term "training set" is typically used in machine learning. The clinical trials served as the pivotal studies for demonstrating device effectiveness and safety.

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

Not applicable, as there is no "training set" in this context.

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The OMNILINK® .018 Biliary Stent System is indicated for palliation of malignant strictures in the biliary tree.
The OMNILINKR® .018 Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.

The OMNILINK® .018 Biliary Stent System is comprised of a stainless steel, balloonexpandable stent pre-mounted onto an over-the-wire (OTW) delivery catheter. This system is designed for percutaneous placement in the common bile duct and intended to treat malignant strictures in the biliary tree.
The OMNILINK® Biliary Stent consists of a dual stent design, fabricated from a single piece of 316L medical grade stainless steel tubing. The delivery catheter's central lumen is designed to permit the use of a 0.018" guide wire to facilitate advancement of the catheter to and through the stricture to be dilated. Once the delivery system is placed in the desired location, the stent expands upon inflating the balloon with contrast medium. The balloon provides an expandable segment of known diameter and length at specific pressures. In addition, the balloon has two radiopaque markers to aid in stent prositioning. The stent is designed to remain in the biliary duct as a permanent implant.
The subject OMNILINK® .018 Biliary Stent System consists of additional stent sizes of 110 5.0, 6.0, 7.0mm stent diameter, 12 and 16mm stent lengths, and 4.0mm stent diameter x 18mm stent length. The stent and delivery system are supplied sterile and intended for single use only.

The provided text describes a 510(k) submission for a medical device, the OMNILINK® .018 Biliary Stent System. While it details the device, its intended use, and substantial equivalence to predicate devices, it does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The document states: "The safety and effectiveness of the subject OMNILINK® .018 Biliary Stent System has been demonstrated through data collected from in vitro bench tests and analyses." This indicates that performance data was collected, but the specifics requested in your prompt (like acceptance criteria, sample sizes, ground truth, expert involvement, or comparative effectiveness studies) are not present in this document.

Therefore, I cannot populate the table or answer the specific questions based on the provided text. The document is primarily a regulatory submission summarizing the device and its equivalence, rather than a detailed report of clinical or performance studies.

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The ABSOLUTE™ .035 Biliary Self-Expanding Stent System is intended for palliation of malignant strictures in the biliary tree.

The ABSOLUTE™ Biliary Self-Expanding Stent System is comprised of the ABSOLUTE™ stent pre-mounted on an over-the-wire delivery system. The delivery catheter consists of three coaxial members (an inner member, a retractable outer member, and an outer, outer member), a guide wire lumen, a distal soft tip and a proximal handle with retraction and locking features. The distal section of the outer member constrains the stent on the inner member. Deployment of the ABSOLUTE™ stent occurs when the outer member is retracted by activating the retraction features in the handle.

The provided text is a 510(k) Summary for the Guidant ABSOLUTE™ .035 Biliary Self-Expanding Stent System. It declares substantial equivalence to predicate devices based on technological characteristics and performance data. However, it does not contain the detailed information required to fill out the requested table and study details.

Specifically, the document states:

• "The results of the in vitro bench tests and analyses demonstrated the safety and effectiveness of the ABSOLUTE™ .035 Biliary Self-Expanding Stent System."

This is a general statement and does not provide:

1. A table of specific acceptance criteria.
2. Reported device performance against those criteria (e.g., specific measurements, thresholds, or statistical results).
3. Details about the study design (sample sizes, data provenance, ground truth establishment, expert qualifications, etc.).
4. Information on MRMC studies or standalone algorithm performance.

Therefore, I cannot extract the requested information from the provided text. The document focuses on demonstrating substantial equivalence through a summary of technological characteristics and a general assertion of safety and effectiveness from bench tests, rather than providing the detailed clinical or performance study data one would expect for an AI/device performance study with specific acceptance criteria.

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To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA), percutaneous transluminal angioplasty (PTA) and compatible stent devices during therapeutic intravascular procedures.

The HI-TORQUE BALANCE UNIVERSALIM Guide Wire is a steerable guide wire available in a maximum diameter of 0.0137" and in lengths of 175 cm, 190 cm and 300 cm. The distal segment of the guide wire, up to the hypotube, is coated with hydrocoat to reduce friction for improved guide wire movement within the catheter. The distal tip is offered in a straight shapeable configuration and a pre-shaped "J" configuration. The proximal core has a maximum diameter of 0.0137". The proximal end of the guide wire is coated with PTFE, which reduces friction of the wire within a catheter. The Balance Universal™ Guide Wire is DOC® extendable in the 175 cm and 190 cm lengths.

The provided text describes a 510(k) summary for the HI-TORQUE BALANCE UNIVERSAL™ Guide Wire. However, it does not contain the detailed performance study information required to answer all the posed questions. The text explicitly states:

"In vitro bench testing performance evaluations demonstrated that the HI-TORQUE BALANCE UNIVERSAL™ Guide Wire met the acceptance criteria and performed similarly to the predicate devices. No new safety or effectiveness issues were raised during the testing program and therefore, the HI-TORQUE BALANCE UNIVERSAL™ Guide Wire may be considered substantially equivalent to the predicate devices."

This is a general statement and lacks the specific details about acceptance criteria, the study design, sample sizes, ground truth establishment, or expert involvement that are typically associated with performance studies involving AI or complex medical device efficacy.

Therefore, for many of your questions, the answer will be "Information not provided in the input text."

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

Study Details

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

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

   • Not provided in the input text. The text only mentions "In vitro bench testing performance evaluations."

2. 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 / Not provided in the input text. The study described is "in vitro bench testing," which would not typically involve human experts establishing ground truth in the way described for clinical or imaging data.

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

   • Not applicable / Not provided in the input text. This is not relevant for an in vitro bench testing study.

4. 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. The device is a guide wire, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study or AI-related information is mentioned.

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

   • Yes, in essence. The "in vitro bench testing" represents a standalone evaluation of the physical device's performance against pre-defined criteria, without human intervention in the performance measurement itself (though humans design and conduct the tests). However, this is not an "algorithm" in the context of AI.

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

   • Not explicitly stated in the input text, but inferred from "in vitro bench testing." The "ground truth" would likely be objective measurements of physical properties (e.g., tensile strength, friction, flexibility, torque transmission, coating integrity) against engineering specifications or established industry standards for guide wires, rather than medical "ground truth" like pathology or clinical outcomes.

7. The sample size for the training set

   • Not applicable / Not provided in the input text. The concept of a "training set" is typically for machine learning algorithms, which this device is not. For a physical device, manufacturing and process validation would involve numerous samples, but these aren't "training sets" in the AI sense.

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

   • Not applicable / Not provided in the input text. (See point 7).

In summary, the provided document is a 510(k) summary for a medical device (a guide wire), not for an AI diagnostic tool. Therefore, many of the questions asked, particularly those related to AI performance, human readers, and clinical data/expert consensus, are not applicable or the information is not present in this type of regulatory submission summary. The "study" described is limited to "in vitro bench testing."

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The RAPIDO™ Cut-Away™ Cutter is intended to facilitate RAPIDO™ Cut- Away™ Guiding Catheter removal after the Guidant coronary venous lead is positioned.

The Cutter is an accessory manufactured for use with the RAPIDO Cut-Away Guiding Catheter, for the treatment of Congestive Heart Failure. The Cutter attaches to the lead and cuts one wall of the guiding catheter as it is removed from the patient, allowing the guiding catheter to be removed from the lead. This new removal process is necessitated by the larger IS-1 terminal pin that future leads will incorporate. The Cutter currently has only one manufacturing configuration.

The Cutter consists of three sections; A handle, a stainless steel blade and a lead management section. The lead management section stabilizes the lead, prior to, and during the cutting procedure. After the lead has been fixed in the patient, the cutter is connected to the lead body as close to the catheter hub as possible. Holding the cutter stationary and fixed to a surface, the doctor pulls the catheter against the cutter blade. The hub is cut first and then the catheter section.

The provided text describes a medical device, the RAPIDO™ Cut-Away™ Cutter, and its clearance through the 510(k) pathway. This means it was found substantially equivalent to a predicate device, not necessarily that a full clinical study demonstrating its effectiveness against specific acceptance criteria was conducted or described in detail in this summary.

Based on the provided information, I can extract what is explicitly stated or can be reasonably inferred. Many of your requested details (e.g., sample size for the test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not typically part of a 510(k) summary for a device like this (a mechanical cutter) and are not included in the provided text. The performance data section is brief and refers to "acceptance criteria" but does not detail them.

Here's a breakdown of what can be provided from the text, with an acknowledgment of the missing information for other sections:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: Not specified. It's highly likely to be internal engineering/bench testing rather than human clinical data, given the device type and 510(k) summary context.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable/not specified. This type of device's performance evaluation typically relies on objective physical testing rather than expert-established ground truth in a diagnostic sense.
• Qualifications of Experts: Not applicable/not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not specified.

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

• MRMC Study: No, an MRMC study was almost certainly not done. This type of study is relevant for diagnostic imaging or interpretation tasks, not for a mechanical cutter.

6. If a Standalone (Algorithm Only) Performance Study was done

• Standalone Study: Not applicable. This is a mechanical device, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: For this mechanical device, "ground truth" would likely be defined by engineering specifications and objective measurements (e.g., successful cutting, intact lead after cutting, material integrity, force required). The summary states "Testing demonstrated that the RAPIDO Cut-Away Cutters met the acceptance criteria," implying these objective measures were successfully achieved.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/not specified. This is a mechanical device, not an AI/ML algorithm.

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

• How Ground Truth was Established: Not applicable.

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The IS-1 Hemostasis Valve with the Wire Guide is indicated for maintaining a seal around the IS-1 lead terminal pin while flushing the lead lumen and/or during introduction/withdrawal of interventional devices.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA to Guidant Corporation regarding the IS-1 Hemostasis Valve. This type of document is a regulatory approval and does not contain the kind of detailed study information (acceptance criteria, sample sizes, ground truth establishment, MRMC studies, etc.) that would typically be associated with performance evaluation of a device, especially an AI/ML medical device.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the device (IS-1 Hemostasis Valve) was approved based on its substantial equivalence to existing predicate devices, not on a new, comprehensive performance study with the kind of metrics you've requested. The 510(k) process for such devices relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Therefore, I cannot extract the information you've requested from this document because it is not present within this regulatory approval letter. The document does not describe acceptance criteria for performance, detailed study designs, sample sizes for training or test sets, expert qualifications, or the use of AI/ML algorithms.

In summary, none of the requested information can be provided based on the given document.

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The Guidant Vaso View® Endoscopic Vessel harvesting system is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for patients requiring blunt dissection of tissue including dissection of blood vessels, separation of the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissection along the saphenous vein or radial artery for use in coronary artery bypass grafting. Thorascopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels, and other tissues of the chest wall.

The VasoView System is made up of 6 components including:

• 1. Blunt Tip Trocar (BTT) with Syringe,
• 2. 5 mm Extended Length Endoscope,
• 3. Uniport Plus Dissection Cannula,
• 4. VasoView Dissection Cannula,
• 5. Uniport BiSector and
• 6. Uniport Bipolar Scissors.

These are the exact same devices used for saphenous vein harvesting and have been previously cleared by FDA. Each device is described below.

BTT:
The BTT is a single use device provided sterile. The BTT is used to provide a port of access for insertion of endoscopic instruments into an incision site. The device consists of a valve body assembly with a balloon on the sleeve. The valve body assembly contains an internal flapper valve and seal to prevent gas leakage when instruments are inserted or withdrawn. It also includes built-in converters to allow insertion of instruments of different diameters than the main seal and an external one-way valve for gas insufflation. To minimize leakage and secure the port, the distal end of the sleeve has a balloon. A 30cc syringe is provided for inflation/deflation of the balloon.

5mm Extended Length Endoscope:
The 5mm Extended Length Endoscope is a multi-use product supplied non-sterile and must be cleaned and sterilized prior to use. The device is used to visualize endoscopic cavities. It consists of a stainless steel shaft containing optics. The proximal end has an eyepiece, for camera attachment, and a light cable post for light cable connection.

Uniport Plus Dissection Cannula
The Uniport Plus Dissection Cannula is a single use device provided sterile. The Uniport Plus Dissection Cannula is designed to be used in conjunction with the 5mm Extended Length Endoscope. The cannula has a removable conical tip and four lumens to house the endoscopes, vessel cradle/distal lens washer and bipolar instrument for ligation and division of vessel branches. The vessel cradle/distal lens washer is independently controlled by a slider button on the handle of the device for retraction and blunt dissection of tissue as well as washing of the distal tip of the scope. The bipolar instrument is inserted independently into the cannula and can be controlled at the proximal end for blunt dissection.

Dissection System:
The Dissection System is a single-use device provided sterile. It is designed to be used in conjunction with a 5mm Extended Length Endoscope. The cannula has a tapered tip for tunneling, which separates tissue planes, forming a cavity. The cannula tip may also be used for dissection and isolation of structures in the cavity. This tip is clear for endoscopic visualization during tunneling. An elliptical bulb aid tissue separation. A handle is provided to assist with advancement of the cannula.

Uniport BiSector:
The Uniport BiSector is a single use device provided sterile. The Uniport BiSector is a 5mm flexible endoscopic ligating forcep and is intended to be used with the Uniport Dissection Cannula. Bipolar coagulation is achieved using electro surgical energy under endoscopic visualization. Transection is achieved through mechanical actuation of the slide button. This device is intended to be used with the bipolar outputs of compatible generators.

Bipolar Scissors:
The Bipolar Scissors are a single use device provided sterile. The Bipolar Scissors are 5mm cutting and bipolar coagulation scissors and are intended to be used with the Dissection Cannulas. Mechanical cutting and bipolar coagulation is achieved using electrosurgical energy under endoscopic visualization. This device is intended to be used with the bipolar outputs of compatible generators.

Here's an analysis of the provided text regarding the Guidant VasoView Endoscopic Vessel Harvesting System, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative "acceptance criteria" in the traditional sense (e.g., a specific sensitivity or specificity threshold). Instead, it relies on demonstrating substantial equivalence to predicate devices and presenting clinical data to support an indication expansion.

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

• Test Set Sample Size: "over 84 cases"
• Data Provenance: The document does not explicitly state the country of origin. It does not clarify whether the cases were retrospective or prospective, but the phrasing "results of over 84 cases demonstrate" suggests previously performed procedures that were analyzed (retrospective).

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

This information is not provided in the given 510(k) summary. The document focuses on the outcome of the procedures rather than the assessment by experts to establish a "ground truth" in a diagnostic sense.

4. Adjudication Method for the Test Set

This information is not provided in the given 510(k) summary. Given the nature of a surgical device and the focus on safety and effectiveness of the procedure itself, a formal "adjudication method" for a test set ground truth (as seen in AI diagnostics) is not typically applicable in this context.

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 device is a surgical instrument, not an AI diagnostic tool. The concept of "human readers improve with AI" is not relevant to this submission. The study focuses on the safety and effectiveness of the surgical system itself.

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

• No, a standalone (algorithm only) performance study was not done.
• This device is a surgical instrument used by a surgeon. It is not an AI algorithm. Its performance is intrinsically linked to its use by a human operator.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the safety and efficacy of the endoscopic radial artery harvesting procedure performed using the VasoView system. This would have been established through:

• Clinical Outcomes Data: This would include factors like successful harvesting of the radial artery, complication rates (e.g., vessel damage, nerve injury, infection), patient recovery, and potentially long-term patency of the harvested vessel (though long-term data might not be within the scope of a 510(k) submission focused on a device rather than a full procedure outcome study).
• Surgical Observations: Direct observation of the procedure by experienced surgeons to assess ease of use, visualization, and efficiency.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The VasoView system is a hardware surgical device, not a machine learning algorithm that requires a "training set." The previous 510(k) clearances (K904993, K945975, K960637, K974608, K981700, K992353) for the individual components likely involved various forms of design verification, validation, and potentially clinical experience, but not in the sense of a "training set" for an algorithm.

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

This information is not applicable/not provided as there is no "training set" in the context of an AI algorithm. The device's "ground truth" (its ability to perform its function safely and effectively) would have been established through a combination of:

• Bench testing: Verifying mechanical properties, material compatibility, and functional performance.
• Pre-clinical (animal) studies: Assessing tissue interaction and procedural feasibility.
• Clinical experience and literature: Leveraging existing knowledge and previous clearances of similar devices and the components of the VasoView system for saphenous vein harvesting. The indication expansion to radial artery harvesting then required additional clinical data to specifically demonstrate safety and effectiveness for that new use.

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