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The Evolution® Mechanical Dilator Sheath Set, Evolution® Shortie Mechanical Dilator Sheath Set, SteadySheath™ Evolution® Tissue Stabilization Sheath, and SteadySheath™ Evolution® Shortie Tissue Stabilization Sheath are intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.

The Evolution® Mechanical Dilator Sheath Set is constructed of two coaxial sheaths connected to a handle capable of mechanically rotating the inner sheath. In use, the coaxial sheaths are advanced over an indwelling catheter or cardiac lead. The inner sheath (available in 9, 11, and 13 French diameters) is designed to rotate in a clockwise manner by pulling the trigger in the handle assembly. As the inner sheath is advanced, the rotation of the sheath assists in dilation of any binding tissue which may be anchoring the catheter or lead to the inner vascular or inner cardiac wall. The outer coaxial sheath can be used to stabilize the cardiac wall at the point of lead/catheter tip attachment to allow for detachment and removal (counter traction technique). The device has a working length of 40.6 centimeters.

The Evolution® Shortie Mechanical Dilator Sheath Set is constructed of two coaxial sheaths connected to a handle capable of mechanically rotating the inner sheath. The outer sheath has winged control tabs located at its proximal (handle) end. The sheaths are advanced over an indwelling catheter or cardiac lead. The inner sheath (available in 9 and 11 French diameters) is designed to rotate in clockwise manner by pulling the trigger in the handle assembly. As the inner sheath is advanced, the rotation of the sheath assists in dilation of any binding tissue which may be anchoring the catheter or lead to the inner vascular or inner cardiac wall. The outer coaxial sheath can be used to stabilize the cardiac wall at the point of lead/catheter tip attachment to allow for detachment and removal (counter traction technique). The device has a working length of 13.6 centimeters.

The SteadySheath™ Evolution® Tissue Stabilization Sheath and SteadySheath™ Evolution® Shortie Tissue Stabilization Sheath are designed to be used in place of the standard outer sheath that is supplied as part of the Evolution family of mechanical/controlled-rotation dilator sheath sets. They are provided for use in situations where better sheath tip visibility and/or tissue stabilization is desired. In its role as an Evolution outer sheath, the SteadySheath™ works in concert with the inner Evolution braided inner sheath to assist in the removal of cardiac leads or related catheters by bypassing and/or disrupting transvenous binding scar tissue. The SteadySheath™ has a highly radiopaque, textured stainless steel tip that helps stabilize tissue so that better binding scar tissue control and disruption can be achieved.

The provided document is a 510(k) premarket notification for a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a clinical study for a novel device. Therefore, a direct fit for all requested categories for a standalone performance or MRMC study as typically seen with AI algorithms will not be available.

However, I can extract the information relevant to the device's engineering performance testing which serves as its "acceptance criteria" for substantial equivalence.

Here's the information derived from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each design verification test performed (e.g., how many devices were subjected to Push and Flex testing). The data provenance is internal laboratory testing simulating use, not clinical data from patients or a specific country of origin. This was retrospective in the sense that the testing was performed on manufactured devices to support the 510(k) submission.

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

This question is not applicable. The "ground truth" for these engineering tests is defined by the physical properties and functionality of the device under simulated stress, as measured by standard laboratory equipment and protocols, not by expert human interpretation.

4. Adjudication Method for the Test Set

This question is not applicable. The tests are objective design verification tests with pass/fail criteria, not subjective assessments requiring adjudication.

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

No. This is a medical device for percutaneous dilation (mechanical tool), not an AI-based diagnostic or assistive software. Therefore, an MRMC study is not relevant.

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

No. This is a physical medical device. The "standalone performance" is documented by the engineering tests described in the table above, not an algorithm's performance.

7. The Type of Ground Truth Used

The "ground truth" for these engineering tests is determined by objective physical measurements demonstrating the device's mechanical integrity, functionality, and sterility under specified simulated use conditions. This is based on engineering specifications and performance standards, not pathology, outcomes data, or expert consensus in a clinical context.

8. The Sample Size for the Training Set

This question is not applicable. This device is not an AI algorithm requiring a training set. The performance is assessed on physical prototypes or production units subjected to engineering tests.

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

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

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The Evolution® RL Controlled-Rotation Dilator Sheath Set and the Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set are intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.

The Evolution® RL Controlled-Rotation Dilator Sheath Set is constructed of two coaxial sheaths connected to a handle capable of mechanically rotating the inner sheath. In use, the coaxial sheaths are advanced over an indwelling catheter or cardiac lead. The inner sheath (available in 9. 11. and 13 French diameters) is designed to rotate in either a uni-rotational or bi-rotational manner by pulling the trigger in the handle assembly. As the inner sheath is advanced, the rotation of the sheath assists in dilation of any binding tissue which may be anchoring the catheter or lead to the inner vascular or inner cardiac wall. The outer coaxial sheath can be used to stabilize the cardiac wall at the point of lead/catheter tip attachment to allow for detachment and removal (counter traction technique). The device has a working length of 40.6 centimeters.

The Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set is constructed of two coaxial sheaths connected to a handle capable of mechanically rotating the inner sheath. The outer sheath has winged control tabs located at its proximal (handle) end. The sheaths are advanced over an indwelling catheter or cardiac lead. The inner sheath (available in 9 and 11 French diameters) is designed to rotate in in either a uni-rotational manner by pulling the trigger in the handle assembly. As the inner sheath is advanced, the rotation of the sheath assists in dilation of any binding tissue which may be anchoring the catheter or lead to the inner vascular or inner cardiac wall. The outer coaxial sheath can be used to stabilize the cardiac wall at the point of lead/catheter tip attachment to allow for detachment and removal (counter traction technique). The devices have a working length of 13.6 centimeters.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the medical device:

The provided document describes physical and mechanical performance testing for the Evolution® RL Controlled-Rotation Dilator Sheath Set and Evolution® Shortie RL Controlled-Rotation Dilator Sheath Set. It does not present a clinical study involving human patients or AI assistance. The "acceptance criteria" and "reported device performance" are based on engineering and laboratory tests.

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

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

Regarding the other requested information:

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

• The document does not specify the sample sizes (number of units tested) for any of the engineering or laboratory tests.
• The data provenance is from Cook Vascular, Inc. in the U.S.A. The tests are described as prospective laboratory and engineering tests, performed to meet design requirements.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This device clearance is based on mechanical, physical, and biocompatibility testing, not on a diagnostic or interpretive task that would require expert human judgment to establish a "ground truth." Therefore, there were no specific clinical experts establishing ground truth in the context of the tests described. The "experts" would be the engineers and scientists conducting and evaluating the specified tests against predetermined performance criteria.

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

• This concept is not applicable here. Adjudication methods like 2+1 or 3+1 are used in clinical studies where multiple experts evaluate cases and a consensus or tie-breaking mechanism is needed for ground truth. The tests described are objective engineering measurements.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC comparative effectiveness study was done. This document is for a medical device (dilator sheath) and does not involve AI or human "readers" evaluating images or data.

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

• No standalone (algorithm-only) performance study was done. This device is a mechanical tool and does not employ an algorithm or AI.

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

• The "ground truth" for the engineering and biocompatibility tests was based on predefined objective performance metrics and regulatory standards (e.g., "not kink, buckle, or fracture," "withstand a minimum of 20 pounds of pull force," "functional through 1000 cycles," "peel force of less than 8 pounds," and compliance with ISO 10993-1 for biocompatibility).

8. The sample size for the training set

• This concept is not applicable as this is not an AI/machine learning device. There was no training set.

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

• This concept is not applicable as there was no training set.

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The Cook Vascular Blood Flow Monitor - Model DP-M350 is intended for monitoring blood flow in vessels intraoperatively, and following micro-vascular procedures, re-implantation, and free-flap transfers. The Swartz Doppler Flow Probe is supplied sterile and is intended for one-time use.

The proposed device is monitor unit that generates a (20 MHz) signal and conducts it to an attached probe that contains a piezo-electric crystal which transmits and then receives Doppler frequency sound waves. The returning signal is amplified and projected via the proposed monitoring unit as an audible output. The monitor unit has two input channels and also provides an adjunct visible (LED) indicator that is used as a complimentary information source to the primary audible indicator. The predicate device was submitted as a system, the proposed device is only the monitoring unit.

The Cook Vascular, Inc. Blood Flow Monitor - Model DP-M350 is a monitoring unit that generates a 20 MHz signal and transmits and receives Doppler frequency sound waves via an attached probe. The returning signal is amplified and projected as an audible output. The monitor unit also features two input channels and a visible LED indicator as a complementary information source.

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

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the device's acceptance criteria are demonstrated through a series of engineering and performance tests, rather than a clinical performance study with statistical metrics like sensitivity or specificity. The "acceptance criteria" are implied by the successful completion of these tests.

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

The provided text does not specify sample sizes for any of the tests conducted. The studies appear to be engineering and performance verification tests of the device itself, rather than studies involving patient data. Therefore, data provenance in terms of country of origin or retrospective/prospective nature for a clinical test set is not applicable here.

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

This information is not provided in the document. The tests described are engineering validations, not studies requiring expert interpretation of clinical data to establish ground truth.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable given the nature of the tests described (engineering and performance validation).

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

No, an MRMC comparative effectiveness study was not done. The study described focuses on the technical performance and safety of the device itself, not on its impact on human reader performance.

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

The device itself is a blood flow monitor that provides an audible and visual output to a human user; it is not an algorithm that operates standalone without human involvement in the diagnostic or monitoring process. Therefore, the concept of a "standalone" algorithm performance study as typically understood in AI/imaging is not applicable to this device. The tests performed are for the device's technical functionality, which is its standalone performance.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed would be the engineering specifications, regulatory standards (e.g., electrical safety standards, EMC standards), and design requirements for each test category. For instance, for "Electrical Safety Testing," the ground truth is compliance with relevant electrical safety standards. For "Software Validation," the ground truth is that the software performs according to its design specifications. There is no mention of expert consensus, pathology, or outcomes data as ground truth.

8. The Sample Size for the Training Set

This information is not applicable. The Cook Vascular, Inc. Blood Flow Monitor - Model DP-M350 is a hardware device with associated software, not an AI/machine learning algorithm that requires a "training set" in the conventional sense.

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/machine learning algorithm. The "ground truth" for the device's development would be its design specifications and validated engineering principles.

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The Cook Vascular VITAL-JECT Power Injectable Safety Infusion Set is intended to be used to administer solutions and medications into vascular implant ports. When used with a power Injectable vascular implant port, the Cook Vascular Safety Infusion Set is indicated for power injection of contract media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s using contrast with a maximum viscosity of 11.8cP.

In addition, to minimize the risk of accidental needle stick after use, the attached safety guard fully encapsulates the needle when manually activated during withdrawal.

The Cook Vascular VITAL-JECT Power Injectable Safety Infusion Set is intended to administer solutions and medications into vascular implant ports. In addition, to minimize the risk of accidental needle stick after use, the attached safety guard fully encapsulates the needle when manually activated during withdrawal.

When used with a power Injectable vascular implant port, the Cook Vascular Safety Infusion Set is indicated for power injection of contract media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s using contrast with a maximum viscosity of 11.8cP.

The device consists of a protector cap, female luer lock, PVC tubing, two each 4 inch tubing length, a pinch clamp, with a needle free y-site, a butterfly wing, a safety needle guard, an AISI 304 (19 ga) stainless steel needle and a needle sheath.

The components and the processes use to manufacture these solution administration sets are the same as the currently legally marketed by Command Medical, K033515 HuberPRO™ Safety Huber Infusion Set.

Cook Vascular, Inc. will label and sterilize the final product. The proposed device is manufactured exactly the same as the currently marketed device. (K033515)

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Cook Vascular VITAL-JECT™ Power Injectable Safety Infusion Set:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria with specific pass/fail thresholds for each test. Instead, it describes general conclusions about performance. The key performance aspect highlighted is the ability to withstand power injection.

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

• Sample Size for Test Set:
  • For the performance tests (Dynamic Failure Flow, Instantaneous Burst, Static Pressure, Life Cycle Power Injection Tests), a specific sample size is not explicitly stated in the provided summary.
  • For Bioburden testing, nine individual infusion sets were tested.
• Data Provenance: The data appears to be prospective testing conducted by Cook Vascular, Inc. or its contractors. The country of origin is implicitly the USA, where Cook Vascular, Inc. is based and the submission was made to the FDA.

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

• Not applicable for this type of device and study. The testing described involves engineering and microbiological performance metrics, not clinical interpretation by experts to establish a "ground truth." The ground truth is objective performance characteristics measured through laboratory testing.

4. Adjudication Method for the Test Set:

• Not applicable. This study involves objective laboratory tests with measurable outcomes, not subjective assessments requiring adjudication by multiple experts.

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 document describes a 510(k) submission for a physical medical device (infusion set), not an AI/software-as-a-medical-device. Therefore, no MRMC study or AI-related comparative effectiveness was performed or applicable.

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

• No. As mentioned, this is not an AI/algorithm-based device.

7. The Type of Ground Truth Used:

• The "ground truth" for the performance tests (flow, pressure, burst, life cycle) are engineering specifications and physical measurements designed to assess the device's functional integrity under intended use conditions.
• The "ground truth" for sterilization tests (Bioburden, Endotoxin, EO Residuals, Sterility) are established microbiological and chemical standards for medical device sterilization.

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" as this is not an AI/machine learning device. The design, components, and manufacturing processes leverage those of a previously cleared predicate device (K033515 HuberPRO™ Safety Huber Infusion Set), which serves as a benchmark for substantial equivalence rather than a training set in the AI sense.

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

• Not applicable. As there is no training set, there's no ground truth established for one. The basis for safety and effectiveness is substantial equivalence to a predicate device, supported by the described physical and microbiological testing.

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The devices are for use in patient therapy requiring repeated vascular access for infusion therapy, power injected diagnostic techniques using contrast media, and blood infusion/withdrawal. For the power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec using media with a maximum viscosity of 11.8 cP.

The proposed device is exactly the same as the predicate devices.

The provided document describes a 510(k) premarket notification for the Cook Vascular, Inc. Vital-Port Vascular Access System Power Injectable Port. This submission aims to establish a safe and effective way to conduct power injection studies using the device, which was previously marketed without specific claims or instructions for this procedure. The current submission focuses on demonstrating the device's suitability for power injectable diagnostic techniques using contrast media.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

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

The document does not explicitly state the numerical sample size for the "test set" in terms of how many individual devices were tested. It refers to "the flowing tests" implying multiple instances or scenarios were subjected to testing.

The data provenance is from Cook Vascular, Inc., a company based in Vandergrift, PA, USA. The tests described are prospective (laboratory testing performed for the purpose of this submission) and are likely simulated rather than using human or animal subjects, as they focus on physical performance under specific conditions.

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 in this context. The "ground truth" for this medical device submission is the physical performance and safety characteristics of the device under specific mechanical stress and fluid flow conditions. It's established through engineering tests, not through expert clinical consensus or interpretation of observational data. The tests are designed to measure objective physical properties of the device.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to the process of resolving discrepancies in expert interpretations of clinical data or images. Since the "test set" involves laboratory-based engineering parameter testing (e.g., flow rates, pressure limits, burst tests), there is no need for such adjudication. The results are objective measurements.

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

An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or AI algorithms where human interpretation is involved. The Cook Vascular, Inc. Vital-Port is a physical vascular access system, not an imaging device or an AI diagnostic tool.

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

This is not applicable. The device is not an algorithm or an AI system. Its performance is entirely mechanical and physical.

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

The "ground truth" for the device's performance related to power injection is established through physical and mechanical engineering tests. These tests evaluate:

• Dynamic Failure Flow Test: Measures flow characteristics and potential failure modes under dynamic conditions.
• Instantaneous Burst Test: Assesses the device's ability to withstand sudden, high-pressure events.
• Static Burst Test: Determines the maximum pressure the device can tolerate under prolonged static conditions.
• Puncture Life Test: Evaluates the number of times the septum can be punctured before degradation or failure.
• Cyclic Test: Assesses durability under repeated stress cycles.
• Life Cycle Power Injection Test: Simulates repeated power injection procedures to evaluate long-term performance and integrity.

The "ground truth" for the operational parameters (5 mL/sec, 11.8 cP, 325 psi) is derived directly from the results of these tests, confirming that the device can safely tolerate these conditions.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI or machine learning model. The device's performance is determined by its physical design and materials, which are verified through direct testing, not through training data.

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

This information is not applicable as there is no training set for this type of device.

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The Cook Vascular EVOLUTION Mechanical Dilator Sheath Set is for use in the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.

The proposed device is a polypropylene dilator with a semi-threaded stainless steel tip, This stainless steel tip is used to dilate tissue surrounding an indwelling catheter or foreign object. In addition, an ergonomic handle to be used as a "drive mechanism" will be included. The device will be made with 7.0 and 9.0 French sizes. It will be supplied sterile, intended for one-time use.

The provided document describes a 510(k) premarket notification for the Cook Vascular EVOLUTION Mechanical Dilator Sheath Set. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a specific study report with performance metrics. Therefore, many of the requested details are not present in the provided text.

Here is an analysis based on the available information:

Acceptance Criteria and Reported Device Performance

The document lists various tests performed but does not specify the acceptance criteria for these tests or provide quantitative results for the device's performance against any set criteria. It merely states that the "results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use."

Since specific acceptance criteria (e.g., "Buckling force > X Newtons") and corresponding reported performance values are not provided, this table cannot be fully populated from the given text.

Additional Information on the Study:

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

   • Sample Size: Not specified. The document only lists the types of tests performed (Buckling, Binding, Bond Strength, Pull Testing, Handle Cycling, Device Performance) but does not provide any details on the number of units tested for each.
   • Data Provenance: Not specified. The data and testing would presumably be conducted by Cook Vascular, Inc. (Vandergrift, PA, USA) as part of their internal quality and regulatory processes, but this is not explicitly stated. It is a "Special 510(k) Premarket Submission," which often relies on internal testing to demonstrate equivalence.

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 mentioned. The tests described are engineering/mechanical performance tests (e.g., buckling, bond strength), not clinical studies requiring expert interpretation of results or establishment of clinical ground truth.

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

   • Not applicable/Not mentioned. This concept is relevant for clinical studies or image interpretation tasks where human readers might disagree. For the described mechanical tests, the results would typically be objectively measured against predefined engineering specifications.

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. This is a conventional medical device (mechanical dilator sheath), not an AI-powered diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.

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

   • No. This is a mechanical device, not an algorithm, so this concept is not applicable.

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

   • Not applicable in the conventional sense. The "ground truth" for the mechanical tests would be the pre-defined engineering specifications and performance requirements for the device's function (e.g., "the dilator must not buckle under X force"). The tests confirm adherence to these functional requirements.

7. The sample size for the training set:

   • Not applicable. This is a mechanical device, not an AI model, so there is no "training set."

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

   • Not applicable, as there is no training set for a mechanical device.

Summary of what is present:

The document serves as a 510(k) summary, which aims to demonstrate "substantial equivalence" of the EVOLUTION Mechanical Dilator Sheath Set to existing predicate devices. It lists the types of tests performed (Buckling Test, Binding Test, Bond strength, Pull Testing, Handle Cycling Test, Device Performance) as evidence of reliable design and performance. However, it does not provide specific quantitative acceptance criteria or the actual test results that would illustrate the device's performance against these criteria. The approval by the FDA (K061000) indicates that the provided information was deemed sufficient to establish substantial equivalence.

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The Cook Vascular PERFECTA™ EDS Ergonomic Intermittent Activation Switch is an accessory to the Cook Vascular PERFECTA™ Electrosurgical Dissection System. The intended use of the Cook Vascular PERFECTA™ EDS Ergonomic Intermittent Activation Switch is to add the option of continuous or intermittent activation to the Electrosurgical Dissection System when the footswitch is depressed. The Cook Vascular PERFECTA™ EDS Ergonomic Intermittent Activation Switch is supplied nonsterile and is reusable.

The Cook Vascular PERFECTA™ EDS Ergonomic Intermittent Activation Switch is an accessory that can be used with the Cook Vascular PERFECTA™ Electrosurgical Dissection System. This device adds the option to automatically activate the Valley(ab Force FX electrosurgical generator at a predetermined rate when the footswitch is depressed.

The provided text is a 510(k) Premarket Notification for the "Cook Vascular PERFECTA™ EDS Ergonomic Intermittent Activation Switch". This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set), and effect sizes of AI assistance cannot be extracted from this document.

The document states:

• Substantial Equivalence: "This device is similar with respect to indications for use, materials and physical construction to predicate devices in terms of section 510(k) substantial equivalency."
• Predicate Device: ArthroCare Timer (510(k) DC# K021519).

The basis for clearance is demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or if there are different technological characteristics, that they do not raise different questions of safety and effectiveness and that the device is as safe and effective as the predicate device. This typically involves non-clinical performance data (e.g., electrical safety, EMC, biocompatibility) and comparison to the predicate, rather than a clinical study with acceptance criteria and a detailed statistical analysis of performance metrics.

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The SERPENTA™ Coronary Sinus Introducer System is intended for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus. SERPENTA™ Coronary Sinus Introducer System is supplied sterile and intended for one time use

The Cook Vascular SERPENTA™ Coronary Sinus Introducer System consists of two Teflon (PTFE) introducer sheaths (7 Fr. and 10 Fr.) with varying shaped curves, two Teflon (PTFE) dilators (7 Fr. and 10 Fr.) two silicone Peel-Away introducer valves (D.C.# K010128), a hydrophilic coated guide wire with a torque handle, a 10cc plastic syringe and a stainless steel introducer needle. Some sets include a polyethylene obturator.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or a study that proves the device meets specific criteria for the Cook Vascular SERPENTA™ Coronary Sinus Introducer System. The document is a 510(k) premarket notification summary from the FDA, which primarily focuses on establishing substantial equivalence to predicate devices, device description, and indications for use.

Therefore, I cannot populate the table or answer the questions related to acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies based on the provided text.

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The COOK- Swartz Doppler Flow Probe and Monitor System is intended for monitoring blood flow in vessels intraoperatively, and following reconstructive micro-vascular procedures, re-implantation, and free flap transfers. The COOK-Swartz Doppler Flow Probe is supplied sterile and intended for one time use

The Modified COOK-Swartz Doppler Flow Probe is intended for monitoring blood flow through vessels in patients intraoperatively and during reconstructive vascular procedures. The COOK-Swartz Doppler Flow Probe is supplied sterile, and nonpyroqenic and is intended for one-time use. Reasonable assurance of biocompatibility of the body fluid/tissue contacting materials comprising the device is provided by their established history of use in medical product manufacturing.

The provided document is a 510(k) summary for a Special 510(k) Device Modification for the COOK-Swartz Doppler Flow Probe. This type of submission is for modifications to a legally marketed device and primarily focuses on demonstrating substantial equivalence to the predicate device, rather than providing extensive de novo clinical study data to demonstrate novel performance against acceptance criteria.

Therefore, the document does not contain the detailed information typically found in a clinical study report that establishes acceptance criteria and then proves the device meets those criteria.

Here's a breakdown of what can be extracted and what is missing, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not present in the document. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (COOK-Swartz Doppler Flow Probe D.C. #K964001) based on intended use, material composition, and method of operation. It does not provide specific performance metrics or acceptance criteria for the modified device.

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

This information is not present in the document. Since it's a 510(k) for a device modification showing substantial equivalence, a formal "test set" with a specified sample size for performance evaluation in the way a de novo clinical study would isn't typically included in this summary.

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

This information is not present. The document doesn't describe a study involving expert panels for ground truth establishment.

4. Adjudication Method

This information is not present. No adjudication method is mentioned as there is no description of a study involving multiple readers or complex diagnostic interpretations requiring consensus.

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

This information is not present. There is no mention of an MRMC study or any comparison of human readers with and without AI assistance. The device in question is a Doppler flow probe, which is a diagnostic tool, not an AI-assisted diagnostic software.

6. Standalone (Algorithm Only) Performance Study

This information is not present. The device is hardware (a probe), not a standalone algorithm. Therefore, "algorithm-only" performance is not applicable.

7. Type of Ground Truth Used

This information is not present. Given that the submission is for a device modification demonstrating substantial equivalence to a predicate, a new "ground truth" establishment for performance validation is not usually required or detailed in this type of submission summary.

8. Sample Size for the Training Set

This information is not present. The document does not describe the development of an algorithm that would require a "training set."

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

This information is not present, as no training set or ground truth for an algorithm is mentioned.

Summary of the Document's Approach:

The provided document (K022649) is a Special 510(k) Device Modification for the COOK-Swartz Doppler Flow Probe. The core of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (COOK-Swartz Doppler Flow Probe D.C. #K964001).

The argument for equivalence is based on:

• Intended Use: "monitoring blood flow through vessels in patients intraoperatively and during reconstructive vascular procedures." (The modified device also adds "and following reconstructive micro-vascular procedures, re-implantation, and free flap transfers" which is also aligned with the predicate's expanded indications as K964001's indications include "monitor blood flow intraoperatively, during intraoperative neuro-vascular procedures, and following reconstructive micro-vascular procedures, re-implantation and free flap transfer.")
• Material Composition: "biocompatibility of the body fluid/tissue contacting materials comprising the device is provided by their established history of use in medical product manufacturing."
• Method of Operation: Implied to be similar as it's a modification to an existing device.
• Manufacturing: "manufactured according to specified process controls and a Quality Assurance Program, undergoing packaging and sterilization procedures similar to the currently marketed and distributed COOK-Swartz Doppler Flow Probe D.C. #K964001."

No new clinical data, performance criteria, or "proof of meeting acceptance criteria" in the sense of a novel functional claim are presented in this summary. The FDA's letter explicitly states: "We have determined the device is substantially equivalent... You may, therefore, market the device, subject to the general controls provisions of the Act." This confirms that the modification was deemed equivalent without requiring new, extensive performance studies detailed in this summary.

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