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The Proximal Seal System is intended for use by cardiac surgeons during CABG procedures to maintain hemostasis and to facilitate the completion of a proximal anastomosis without application of an aortic clamp.

The HEARTSTRING® III Proximal Seal System delivers a hemostatic seal device designed to enable the proximal anastomosis of an aortic graft without the need for an aortic clamp during coronary artery bypass graft (CABG) surgery. The Proximal Seal System is comprised of the Proximal Seal, Delivery Device, Loader and the Aortic Cutter. The proximal Seal is a semi-spherical shaped device that is delivered into the aorta via the punch hole site and provides a sealed region to facilitate the proximal anastomosis. The Loader is a mechanism that rolls the Proximal Seal and loads the Seal into the Delivery Device. The Delivery Device is a plastic injected molded device that is used to deploy the Seal inside of the aorta. The HEARTSTRING® Aortic Cutter creates the aortotomy and hole opening in the aorta for the anastomosis.

This 510(k) summary for the HEARTSTRING® III Proximal Seal System does not contain the detailed information necessary to answer all aspects of your request regarding acceptance criteria and a definitive study proving the device meets those criteria. The provided text primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's description and intended use.

Here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "The results of the verification testing demonstrate that the Guidant HEARTSTRING® III Proximal Seal System meet the established acceptance criteria and performs in a manner equivalent to the predicate devices."

However, the actual specific acceptance criteria (e.g., maximum allowable blood leakage, deployment success rate, seal integrity under specific pressures, etc.) and the quantifiable reported device performance against those criteria are not provided in this summary.

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

This information is not available in the provided text. The summary mentions "verification testing" but does not detail the sample size (number of tests, number of devices/simulations, patients, etc.) or the provenance (e.g., country of origin, retrospective/prospective).

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

This information is not available in the provided text. The nature of this device (a surgical tool for hemostasis) suggests that "ground truth" would likely be established through physical performance testing rather than expert review of data like images.

4. Adjudication Method for the Test Set

This information is not available in the provided text.

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

A MRMC study is typically performed for devices that involve human interpretation of medical images or data where the AI assists in that interpretation. The HEARTSTRING® III Proximal Seal System is a physical surgical device. Therefore, a MRMC study is not applicable and was not performed.

6. Standalone (Algorithm Only) Performance Study

The HEARTSTRING® III Proximal Seal System is a physical medical device, not an algorithm or AI. Therefore, a standalone (algorithm only) performance study is not applicable and was not performed. The performance data mentioned refers to the physical device's performance through "verification testing."

7. Type of Ground Truth Used

Based on the nature of the device (a surgical tool for hemostasis), the ground truth for performance testing would likely be based on objective physical measurements and observations during simulations, bench testing, and potentially animal or cadaveric studies. For example, ground truth could involve:

• Absence of bleeding/hemostasis.
• Integrity of the seal under specified pressure.
• Successful deployment.
• Ease of use or deployment time.
• Mechanical strength and durability.

However, the specific methods for establishing ground truth are not detailed in this summary.

8. Sample Size for the Training Set

This information is not applicable as the HEARTSTRING® III Proximal Seal System is a physical device and does not involve AI or machine learning that would require a "training set."

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

This information is not applicable for the same reason as above.

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To facilitate the placement of interventional percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA) catheters, and other interventional devices including: intravascular stents, intravascular ultrasound devices and intravascular drug eluting stents.

The Hi-Torque ADVANCE™ and ADVANCE LITE™ Guide Wires are steerable guide wires available in a maximum diameter of 0.0140" and in lengths of 190 cm DOC® extendable length and a 300 cm exchange length. The distal segment of the guide wire 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 end of the guide wire is coated with polytetrafluorethylene (PTFE) and Microglide, which reduces friction of the wire within a catheter.

The provided text describes a 510(k) summary for the HI-TORQUE ADVANCE™ and ADVANCE LITE™ Guide Wires. This is a medical device submission, and the information requested about acceptance criteria and studies (especially those relating to AI, human readers, ground truth, and training sets) is typically found in detailed performance study reports, not in a 510(k) summary. A 510(k) summary aims to establish substantial equivalence to a predicate device, often through bench testing.

Based on the provided text, I can extract the following:

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

The document states: "In vitro bench testing performance evaluations demonstrated that the Hi-Torque ADVANCE™ and ADVANCE LITE™ Guide Wires meet the acceptance criteria and performed comparable to the predicate device." However, the specific acceptance criteria (e.g., tensile strength, friction coefficient, tip flexibility thresholds) and the quantitative reported device performance values are not detailed in this 510(k) summary. It only states that the criteria were met and performance was comparable to the predicate device.

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

The document does not specify the sample size used for the in vitro bench testing. It also does not explicitly state the data provenance (e.g., country of origin) because it's in-vitro bench testing, not clinical data from patients.

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 the type of data presented. The study described is in-vitro bench testing of a guide wire, which involves engineering and material science evaluations, not expert-based assessment of medical images or patient conditions to establish "ground truth."

4. Adjudication method for the test set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations of clinical data, which is not what was performed for this device's bench 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

There is no indication of an MRMC study or any involvement of AI in this 510(k) summary. This document pertains to the market clearance of a medical device (guide wire) based on its physical performance, not an AI-powered diagnostic tool.

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

This question is not applicable. No algorithm or AI component is mentioned for this medical device.

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

For in-vitro bench testing, "ground truth" would typically refer to established engineering standards, material specifications, and physical measurements (e.g., force, dimension, friction) using calibrated equipment. The document indicates the device "met the acceptance criteria," implying comparison against such standards, but it doesn't elaborate on the specific nature of these criteria.

8. The sample size for the training set

This question is not applicable as there is no mention of a "training set" for an algorithm. The study is a bench test of a physical medical device.

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

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

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The Guidant OMNILINK® .035 Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.

The OMNILINK® .035 Biliary Stent System is a balloon-expandable stent compused of .16L medical grade stainless steel. The stent is pre-mounted onto an over-the-wire (OT)N) lefivery catheter. The OMNILINK® .035 Biliary Stent System consists of a dual stent design, fabricated from a single piece of 316L medical grade stainless steel tubing. The stent designs are based on a series of zigzagging rings with multiple articulations per ring. The stents are available in two designs which primarily differ in strut width and the length of the basic cell. One design is used for stent sizes 5.0mm -- 7.0mm and the other for stent sizes 8.0mm -- 10.0mm. The delivery system is an over-the-wire, co-axial design with a balloon at the distal end. The delivery catheter's central lumen is designed to permit the use of a 0.035" 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 positioning. The stent is designed to remain in the biliary duct as a permanent implant. The subject device OMNILINK® .035 Biliary Stent System consists of stent sizes of diameters ranging from 5.0mm - 10.0mm with stent lengths of 12, 16, 18, 28, 38, 58mm and delivery system length of 80 and 135cm. The stent and delivery system are supplied sterile and is intended for single use only.

The provided text is a 510(k) summary for a medical device, the OMNILINK® .035 Biliary Stent System. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study proving the device meets specific acceptance criteria through performance data.

Therefore, many of the requested elements (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not detailed in this type of regulatory submission.

Here's an analysis based on the information provided:

Acceptance Criteria and Device Performance

The provided document does not contain a table of specific quantitative acceptance criteria or corresponding reported device performance metrics from a study. As a 510(k) summary, its primary purpose is to establish substantial equivalence to predicate devices, not to present novel performance data against defined acceptance criteria.

The submission states: "No performance standards have been established for Biliary Stents under Section 514 of the Food, Drug and Cosmetic Act." This indicates that there are no government-mandated acceptance criteria, and the document itself does not specify internal company acceptance criteria for a new performance study.

Absence of a Comprehensive Study Description

The document indicates that studies validating the performance of this specific iteration of the device against new, defined criteria were likely not conducted or, if they were, the details are not included in this summary. The "Performance Data" section simply states, "No performance standards have been established for Biliary Stents under Section 514 of the Food, Drug and Cosmetic Act."

The changes described for this 510(k) (optimized manufacturing parameters, revised test methods, addition of process monitoring, updates to product labeling, and related updates to product specification) suggest modifications to an existing device rather than a new device requiring extensive clinical trials to establish de novo performance.

Given this, the following points cannot be answered from the provided text:

2. Sample sizes used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance: Not applicable (this is a physical medical device, not an AI system).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not applicable (not an AI system).
9. How the ground truth for the training set was established: Not applicable.

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The Guidant HERCULINK® ELITE Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.

The RX HERCULINK ELITE Biliary Stent System features a balloon expandable stent composed of L605 Cobalt Chromium. The stent design is based upon a series of zigzaqqing rings with multiple links per ring. The stent is available in 12mm, 15mm, and 18mm lengths. The delivery system is a rapid exchange, co-axial design with a balloon at the distal end. The proximal lumen provides for inflation of the balloon with contrast medium. The central distal lumen permits use of a guidewire to facilitate advancement of the catheter to and through the stricture to be dilated. The balloon has radiopaque marker(s) to aid in positioning the balloon in the stricture, and is designed to provide an expandable seament of known diameter and length at specified pressures. Markers located on the proximal outer shaft help the physician gauge the dilatation catheter position relative to the guiding catheter tip.

The Guidant RX HERCULINK® ELITE™ Biliary Stent System is intended for palliation of malignant strictures in the biliary tree. The device's substantial equivalence was established through a comparison to predicate devices (HERCULINK® PLUS Biliary Stent System (K010684) and Cordis Palmaz BLUE .018 Transhepatic Biliary Stent System (K040413)) and performance data from in vitro bench tests, analyses, and biocompatibility testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria with numerical targets. Instead, it relies on demonstrating substantial equivalence to predicate devices and satisfactory results from bench testing and biocompatibility studies. The device performance is generally stated as meeting requirements for safety and effectiveness without specific metrics.

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

The document states that the performance data was derived from "in vitro bench tests and analyses and biocompatibility testing." No specific "test set" in the context of clinical data (e.g., patient cases) or a defined statistical sample size for such a set is mentioned.

• Sample Size: Not applicable/not specified for a clinical test set. Performance data relies on in vitro bench tests and biocompatibility testing, not human subject data.
• Data Provenance: Not applicable for a clinical test set. The data originates from internal laboratory (in vitro) testing and biocompatibility studies. No country of origin for clinical data is relevant, and the data is retrospective in the sense of being internal lab testing rather than prospective clinical trials.

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

This information is not applicable to the provided document. The submission relies on engineering bench tests and preclinical biocompatibility studies, not on an expert-adjudicated clinical test set. Therefore, no experts established ground truth in this context.

4. Adjudication Method for the Test Set

This information is not applicable. There was no clinical test set requiring an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document describes an in vitro and biocompatibility study, not a clinical study involving human readers or patient cases.

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

This question is not applicable as the device is a physical medical device (biliary stent system), not an AI algorithm. Its performance is inherent to its physical design, material, and mechanical properties, evaluated through bench testing.

7. The Type of Ground Truth Used

The ground truth used was based on engineering specifications, material science standards, and established biocompatibility testing protocols. For example, the success of a "bench test" would be determined by whether the stent met predefined mechanical tolerances or performance characteristics (e.g., expansion diameter, radial strength, fatigue resistance). Biocompatibility is assessed against recognized standards for materials in contact with the body.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of an AI/ML algorithm for this physical device submission. The device is designed, manufactured, and tested, not "trained" on data.

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

This information is not applicable. As there is no training set for an AI/ML algorithm, no ground truth was established for it.

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For use with compatible, transvenous, left ventricular, pace/sense leads

The ACUITY Steerable Stylet is intended for delivery of the ACUITY Steerable Lead in the coronary veins. The stylets come in either soft or standard stiffness, and in three lengths (to match the ACUITY Steerable Lead lengths).

The stylet consists of a stainless steel wire with a polypropylene knob/cap assembly at the proximal end. The distal end of the wire has a taper and terminates in a bullet shaped tip. Both soft and standard stylets have the same base wire diameter. The difference in stiffness is due to a slight difference in the diameter within the taper at the distal end of the wire.

This document describes the ACUITY™ Steerable Stylet Accessory, a Class II medical device, and its substantial equivalence to predicate devices. The information provided is for regulatory clearance and focuses on device characteristics and testing to meet acceptance criteria, rather than a detailed study comparing its performance against specific clinical metrics.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "Testing demonstrated that the ACUITY Steerable Stylet met the acceptance criteria." However, it does not provide a specific table of acceptance criteria with corresponding performance metrics. The information focuses on demonstrating substantial equivalence to existing predicate devices rather than proving specific clinical safety and effectiveness through quantified performance targets.

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

The document does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The "Testing Data" section broadly states that "Testing demonstrated that the ACUITY Steerable Stylet met the acceptance criteria" without detailing the nature or scope of this testing.

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

This information is not provided. The document is concerned with the physical and functional characteristics of a medical device (a stylet) for regulatory clearance, not with image interpretation or diagnostic performance that would typically involve establishing ground truth by medical experts.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided. As mentioned above, the evaluation does not involve diagnostic interpretation or human reader performance that would necessitate an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

This information is not applicable and not provided. The device is a mechanical accessory (a stylet), not an AI-powered diagnostic tool. Therefore, an MRMC study or an assessment of AI assistance for human readers is irrelevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This information is not applicable and not provided. The device is a physical stylet, not an algorithm, so standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used:

This information is not provided. Given the nature of the device (a stylet), "ground truth" as typically understood in a diagnostic study (e.g., pathology, clinical outcomes) is not the primary focus. The focus is on physical and functional characteristics, and comparison to predicate devices, implying engineering and material testing rather than clinical outcome studies for establishing "ground truth."

8. The Sample Size for the Training Set:

This information is not applicable and not provided. The device is not an AI algorithm that requires a training set.

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

This information is not applicable and not provided. The device is not an AI algorithm that requires a training set or ground truth for its development.

Summary of the Study and Acceptance Criteria (Based on the Provided Text):

The "study" described is a premarket notification (510(k)) submission to the FDA, not a clinical trial or performance study as might be conducted for an AI diagnostic device. The core assertion made is of "substantial equivalence" to legally marketed predicate devices.

• Acceptance Criteria (Implied): The implied acceptance criteria are that the ACUITY™ Steerable Stylet Accessory possesses "technological characteristics such as Intended Use, material, nominal diameter, assembly, dispensing hoop design, package pouch, sterilization method, sterilization indicator, and shelf life" that are substantially equivalent to the predicate devices and that it meets unspecified internal "acceptance criteria" from internal testing. The ultimate acceptance criterion for the FDA is that the device is "substantially equivalent" to predicate devices, meaning it is as safe and effective.
• Reported Device Performance: The document states, "Testing demonstrated that the ACUITY Steerable Stylet met the acceptance criteria." It also lists the technological characteristics that were found to be substantially equivalent to the predicate devices. No specific quantitative performance metrics are provided.
• Study Type: This is a pre-market regulatory submission demonstrating substantial equivalence, not a clinical effectiveness study. It mentions internal "testing" but does not detail the methodology, sample sizes, or specific results of this testing. The focus is on comparing the new device's characteristics to those of established, legally marketed devices.

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The EASYTRAK® 2 Stylet is intended to aid in the placement of a Guidant THE EXS FIRAK® 2 implantable venous lead in the coronary venous vasculature.

The EASYTRAK® 2 Stylet is designed for delivery of the EASYTRAK® 2 lead in the coronary veins. The stylets come in three lengths corresponding to the lengths of the EASYTRAK® 2 leads.

The EASYTRAK® 2 Stylet consists of a stainless steel wire with a polypropylene hub at the proximal end. The distal end of the wire has a stop-coil designed to prevent the stylet from exiting through the distal end of the lead.

Here's an analysis of the provided 510(k) summary regarding the EASYTRAK® 2 Stylet, focusing on acceptance criteria and study information:

Based on the provided document (K052965), the information about acceptance criteria and the study that proves the device meets them is very limited. This is typical for 510(k) submissions, especially for devices seeking substantial equivalence where extensive clinical trials with detailed performance metrics are often not required if the device is sufficiently similar to a predicate.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states that testing was performed and the device met the acceptance criteria. However, it does not explicitly list what those acceptance criteria were or provide specific quantitative results for the device performance beyond a general statement of compliance. This typically means the tests related to engineering performance (e.g., tensile strength, flexibility, material compatibility, dimensional accuracy) and possibly simulated use, which are usually compared against internal design specifications derived from the predicate devices.

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

• Sample Size: Not specified.
• Data Provenance: Not specified. Given the nature of a 510(k) for a stylet, the testing would almost certainly be internal, non-clinical (benchtop) testing. There is no indication of clinical data, animal studies, or data from specific countries.

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

This is not applicable as the studies described are not clinical studies requiring expert ground truth for interpretation (e.g., image reading, disease diagnosis). The testing would have focused on engineering specifications and physical properties.

4. Adjudication method for the test set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical trials involving human interpretation of data, where discrepancies need to be resolved. This document describes non-clinical engineering and 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

This is not applicable. MRMC studies are related to evaluating diagnostic devices, often AI-driven, and involve multiple human readers interpreting cases. The EASYTRAK® 2 Stylet is a mechanical accessory, not a diagnostic or AI-powered device.

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

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

7. The type of ground truth used

This is not applicable in the sense of clinical ground truth (e.g., pathology, outcomes data). For engineering testing, "ground truth" would be established by validated test methods and reference standards against which the device's physical and functional properties are measured. For example, a "pull test" might have an acceptance criterion of "withstands X Newtons of force," and the ground truth for whether the device passes is an objective measurement of the force it withstood.

8. The sample size for the training set

This is not applicable as 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

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

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The VasoView® HemoPro™ 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 cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or radial artery for use in coronary artery bypass grafting. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.

The Guidant VasoView® HemoPro™ Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube and VasoView® HemoPro™ Harvesting Tool for cutting and sealing of vessel branches. The C-Ring/distal lens washer is independently controlled by a C-Ring Slider on the handle of the device that retracts the vessel and washes the distal tip of the Endoscope. The Harvesting Tool can be extended/retracted from the main cannula by inserting it into the Tool Adapter Port, and rotated independently. The Harvesting Tool has two curved Jaws. One Jaw contains the heating elements for branch cutting and sealing; the second Jaw is longer and has a serrated inner edge. Cutting and sealing of vessel branches is achieved in two steps: (1) capture of the branch between the Jaws of the Harvesting Tool and then (2) simultaneous coagulation and ligation of the branch with the Jaws using direct current. Both steps are achieved by mechanical application of the Activation Toggle. Positioning of the device, cutting, and sealing are performed under endoscopic visualization. This device is intended for specific use with the

The Guidant VasoView® HemoPro™ Endoscopic Vessel Harvesting System (K052274) is a Class II electrosurgical cutting and coagulation device. This device is intended for use in minimally invasive surgery for vessel harvesting, primarily in endoscopic surgery for arterial bypass. It is indicated for cutting tissue, controlling bleeding through coagulation, and blunt dissection of tissue, including blood vessels, ducts, and other structures in extraperitoneal or subcutaneous spaces, as well as thoracic space.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document states that "The results of the verification testing demonstrate that the Guidant VasoView® HemoPro™ Endoscopic Vessel Harvesting System meet the established acceptance criteria and performs in a manner equivalent to the predicate devices." However, the specific quantitative acceptance criteria (e.g., specific thresholds for sealing strength, cutting time, or tissue damage) and the reported performance values that met these criteria are not explicitly detailed in the provided text. The document broadly states equivalence to predicate devices (VV4 - K030512 and VV6 - K041981) regarding design, materials, method of delivery, and intended use.

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

The document mentions "verification testing" and "testing program" but does not specify any sample sizes for the test set. It also does not provide information on data provenance (e.g., country of origin of the data, retrospective or prospective).

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

The provided text does not mention the use of experts to establish ground truth for a test set, nor does it specify their number or qualifications. This type of information is typically relevant for studies involving qualitative assessments or image-based diagnostics, which does not appear to be the primary focus of the performance data for this device.

4. Adjudication Method for the Test Set:

Since the document does not mention the use of experts or qualitative assessments for a test set, there is no information provided on any adjudication method.

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 device is an electrosurgical cutting and coagulation device and not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device, and no such study is mentioned or implied.

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

This device is a surgical instrument and not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable to this device, and no such study is mentioned.

7. The Type of Ground Truth Used:

The document indicates that the performance data for the device involved "verification testing" to ensure it "meet the established acceptance criteria." Given the nature of a surgical device, the ground truth would likely be established through objective measurements and assessments of physical performance characteristics such as:

• Sealing efficacy (e.g., burst pressure, hemostasis)
• Cutting performance (e.g., clean cuts, time to cut)
• Tissue damage assessments (e.g., thermal spread, charring)
• Durability and mechanical integrity
• biocompatibility (though not explicitly mentioned in the performance data section, it would be a standard part of device testing).

This "ground truth" would be determined by engineering and biological testing rather than expert consensus on a diagnostic outcome or pathology.

8. The Sample Size for the Training Set:

The concept of a "training set" is typically associated with machine learning and AI development. As this is a medical device and not an AI algorithm, there is no mention or applicability of a training set in the provided information. The device's performance is likely validated through traditional engineering and biological testing.

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

As there is no training set for this type of device, there is no information provided on how ground truth for a training set was established.

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The RX ACCUNET™ Embolic Protection System is indicated for use as a guide wire 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 RX ACCUNET™ 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, the RX ACCUNET Recovery Catheter, Shapeable Tip Design and the RX ACCUNET™ 2 Recovery Catheter, Low-Profile, Flexible Tip Design all packaged together in one chipboard carton. The RX ACCUNET™ 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 one of the provided Recovery Catheters. Recovery Catheter selection will be based on physician preference and/or patient anatomy. Once collapsed, the entire system is removed as a single unit. The Recovery Catheters have radiopaque tips to facilitate movement though tortuous anatomy.

The provided text is a 510(k) premarket notification for the RX ACCUNET™ Embolic Protection System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study results with precise acceptance criteria and detailed performance data like a PMA (Premarket Approval) would.

Therefore, many of the requested elements for a detailed study description are not present in this document. The document explicitly states that "No changes were made to any of the individual components of the RX ACCUNET™ Embolic Protection System" and that the submission is for a "3 in 1 packaging configuration." The "Performance Data" section only mentions "packaging integrity studies."

Based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as numerical performance targets (e.g., specific sensitivity, specificity, accuracy thresholds). The overarching acceptance criterion for a 510(k) is "substantial equivalence" to a predicate device.
• Reported Device Performance: The only performance data mentioned is related to "packaging integrity studies." No clinical performance metrics (like efficacy in embolic capture, complication rates, or patient outcomes) are provided for the device itself.

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

• Test Set Sample Size: Not applicable/not provided for clinical performance testing, as no new clinical study data on device performance is presented. The submission focuses on packaging changes and substantial equivalence.
• Data Provenance: Not applicable for clinical performance. The packaging studies would likely be internal Guidant testing.

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

• Not applicable, as no new clinical test set requiring expert ground truth establishment for device performance is described.

4. Adjudication Method for the Test Set

• Not applicable, as no new clinical test set requiring adjudication is described.

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

• No, a TRMC study was not done, as this is solely a 510(k) submission for a packaging change, demonstrating substantial equivalence, not a new clinical study for effectiveness.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This device is a medical device (embolic protection system), not an AI algorithm.

7. Type of Ground Truth Used

• Not applicable for clinical performance. For the packaging studies, the "ground truth" would be the verified integrity and sterility of the packaged device after testing.

8. Sample Size for the Training Set

• Not applicable, as no new clinical performance data or AI model training data is described.

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

• Not applicable.

Summary derived from the document:

The 510(k) K052166 for the RX ACCUNET™ Embolic Protection System "3 in 1 packaging configuration" is a submission demonstrating substantial equivalence to previously cleared predicate devices (RX ACCUNET™ Embolic Protection Systems K042218 and RX ACCUNET™ 2 Recovery Catheter K042908).

The document explicitly states:

• "No changes were made to any of the individual components of the RX ACCUNET™ Embolic Protection System."
• The "Technological Characteristics" are considered "substantially equivalent" in materials, biocompatibility, performance properties, sterilization, and packaging to the currently marketed predicate devices.

The only performance data mentioned are packaging integrity studies, which "demonstrated the safety and effectiveness of the proposed RX ACCUNET™ Embolic Protection System '3 in 1 packaging configuration.'" No details about these packaging studies (sample size, specific tests, acceptance criteria for packaging) are provided in this summary.

This 510(k) does not present a new clinical study to prove the device meets specific performance criteria beyond the existing predicate devices. The "study" referenced in the document is effectively the demonstration of substantial equivalence through comparison of technological characteristics and confirmation of packaging integrity for the new configuration.

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The RX ACCUNET™ Embolic Protection System is indicated for use as a guide wire 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 RX ACCUNET™ Embolic Protection System is a filtration type embolic protection system consisting of the RX ACCUNET™ Guide Wire, the RX ACCUNET™ Delivery System and the RX ACCUNET™ Recovery Catheter. The RX ACCUNET™ Embolic Protection System is 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™ Embolic Protection System. It does not contain information about a study with acceptance criteria and reported device performance in the context of an AI/ML device.

The provided text focuses on demonstrating substantial equivalence of the RX ACCUNET™ Embolic Protection System to a legally marketed predicate device (K042218). This is a regulatory filing for a medical device that appears to be a physical device (embolic protection system) and not an AI/ML-driven software device. Therefore, the questions related to AI/ML device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable to the information contained in this document.

The document discusses:

• Device Name: RX ACCUNET™ Embolic Protection System
• Intended Use: As a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) during angioplasty and stenting in carotid arteries, for artery diameters between 3.25 mm and 7.0 mm.
• Substantial Equivalence: The device is stated to be substantially equivalent to the RX ACCUNET™ Embolic Protection System (K042218) with minor design refinements to the filter basket end and additional in-process testing.

Without a study described in the provided text that evaluates the device against specific performance criteria (as would be typical for an AI/ML driven system), it is not possible to answer the questions about acceptance criteria, device performance, sample sizes, ground truth, or expert involvement.

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The VasoView® 6 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 cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or radial artery for use in coronary artery bypass grafting. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.

The Guidant VasoView® 6 Harvesting Cannula is designed for use in conjunction with the 7 mm Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring wire, endoscope washer tube and Bipolar Bisector for ligation and division of vessel branches. The C-Ring/endoscope washer is independently controlled by a C-Ring Slider on the handle of the device for retraction of the vessel as well as washing of the distal tip of the Endoscope. The Bipolar Bisector can be extended/retracted/rotated with the Bisector Carriage, and mechanical cutting is achieved with the toggle located on the Bisector Carriage. Bipolar coagulation is achieved using electrosurgical energy. Positioning of the device, coagulation, and mechanical cutting are performed under endoscopic visualization. This device is intended for use with the bipolar outputs of compatible generators.

The Guidant VasoView® 6 Harvesting Cannula is designed for use in conjunction with a 7 mm Endoscope for minimally invasive vessel harvesting.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

The provided document summarizes that the Guidant VasoView® 6 Harvesting Cannula "meet the established acceptance criteria and performs in a manner equivalent to the predicate devices." However, the specific quantitative acceptance criteria are not explicitly detailed in the provided text. The document refers to "the established acceptance criteria" but does not define them. Similarly, the "reported device performance" is not quantitatively presented, but rather asserted to be equivalent to predicate devices.

Therefore, for the request, a table of acceptance criteria and reported device performance cannot be fully populated with specific metrics directly from the input. Instead, what can be stated is the general claim of equivalence.

Study Details:

1. Sample Size used for the Test Set and Data Provenance:

   • The document does not specify the sample size used for the test set (number of devices tested, number of procedures simulated, or number of patients if applicable).
   • The data provenance (e.g., country of origin, retrospective/prospective) is not mentioned. The testing appears to be verification testing, likely conducted in a lab environment rather than a clinical trial.

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

   • The document does not mention using experts to establish ground truth for a test set. The performance data refers to "verification testing," which typically involves engineering or lab-based assessments against specifications, rather than clinical ground truth established by expert review.

3. Adjudication Method for the Test Set:

   • Not applicable/Not mentioned. Since no expert review or clinical assessment for ground truth is indicated, there is no mention of an adjudication method.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No such study was done or mentioned. The device is a surgical instrument, not a diagnostic imaging device that would typically involve human readers.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • Not applicable/Not mentioned. This device is a surgical tool, not an algorithm. Its performance is intrinsically tied to human operation.

6. Type of Ground Truth Used:

   • Not explicitly stated in terms of clinical ground truth. The "Performance data" section refers to "verification testing," suggesting the ground truth was based on engineering specifications, design requirements, and performance characteristics compared to predicate devices, rather than clinical outcomes, pathology, or expert consensus on clinical findings.

7. Sample Size for the Training Set:

   • Not applicable/Not mentioned. The device is a physical surgical instrument, not an AI/ML algorithm that requires a training set.

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

   • Not applicable/Not mentioned. As it's not an AI/ML algorithm, there is no training set or associated ground truth.

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