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Atherectomy of the peripheral vasculature and to break apart and remove thrombus from the peripheral arteries in patients with occlusive atherosclerotic disease.

The Revolution Peripheral Atherectomy System is sterile, single-use device designed for atherectomy of the peripheral vasculature and to break apart and remove thrombus from the peripheral arteries in patients with occlusive atherosclerotic disease.

The Revolution device incorporates a flexible drive shaft designed to track over the Revolution guidewire. Attached to the distal end of the drive shaft is a diamond coated spheroid shaped burr which rotates at high speed to ablate occlusive material and restore luminal patency. Power is derived from a mains source and converted using the reusable power supply. During treatment, the rotating burr ablates material into fine particles. This particulate is conveyed proximally by a mechanical means through the catheter and handle into a collection receptacle that resides outside the patient. The device is available in 145cm, 200cm, and 60cm lengths with burr diameters of 1.33mm, 1.66mm, 2.00mm, and 2.33mm.

The Revolution Peripheral Atherectomy System consists of the following components:

1. Single-use Revolution Device (provided sterile)
2. Single-use Revolution .014" Guidewire (provided sterile)
3. Single-use infusion assembly (provided sterile)
4. Single-use collection receptacle (provided sterile)
5. Single-use guidewire clip (provided sterile)
6. Reusable power supply (provided non-sterile)

The provided document is a 510(k) summary for the Revolution™ Peripheral Atherectomy System. It describes the device, its intended use, and compares it to a predicate device (K191419). However, it does not contain any information regarding clinical studies, AI/algorithm performance, or human reader effectiveness with or without AI assistance.

The document details non-clinical performance data and testing methods used to demonstrate substantial equivalence, focusing on the physical and functional aspects of the device in simulated environments. It does not provide the kind of information requested in points 1-9, which are typically associated with AI/ML device approval studies.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance related to an AI/ML algorithm.
2. Sample sizes used for a test set, or data provenance.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study results or effect sizes for human reader improvement with AI.
6. Standalone algorithm performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document pertains to the clearance of a mechanical medical device (Atherectomy System), not an AI-powered diagnostic or assistive tool.

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The Revolution Peripheral Atherectomy System is intended for atherectomy of the peripheral vasculature and to break apart and remove thrombus from the peripheral arteries with occlusive atherosclerotic disease.

The Revolution Peripheral Atherectomy System is sterile, single-use device designed for atherectomy of the peripheral vasculature and to break apart and remove thrombus from the peripheral arteries in patients with occlusive atherosclerotic disease.

The Revolution device incorporates a flexible drive shaft designed to track over the Revolution guidewire. Attached to the distal end of the drive shaft is a diamond coated spheroid shaped burr which rotates at high speed to ablate occlusive material and restore luminal patency. Power is derived from a mains source and converted using the reusable power supply. During treatment, the rotating burr ablates material into fine particles. This particulate is conveyed proximally by a mechanical means through the catheter and handle into a collection receptacle that resides outside the patient. The device is available in 145cm and 60cm lengths with burr diameters of 1.33mm, 1.66mm, and 2.00mm.

The Revolution Peripheral Atherectomy System consists of the following components:

1. Single-use Revolution Device (provided sterile)
2. Single-use Revolution .014" Guidewire (provided sterile)
3. Single-use infusion assembly (provided sterile)
4. Single-use collection receptacle (provided sterile)
5. Single-use guidewire clip (provided sterile)
6. Reusable power supply (provided non-sterile)

This document describes the Revolution™ Peripheral Atherectomy System, a medical device. The information provided outlines the acceptance criteria and the study conducted to prove the device meets these criteria.

Here's the breakdown as requested, based on the provided text:

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

The document provides primary safety and effectiveness endpoints with predefined success criteria, which can be interpreted as acceptance criteria.

Comment: The document explicitly states, "Both primary endpoints met the predefined IDE study success criteria."

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

• Sample Size:
  • Total Patients Enrolled: 121
  • Evaluated for 30-day Primary Safety Endpoint (ITT population): 113 patients
  • Evaluated for Primary Effectiveness Endpoint (PP population): 123 lesions (from 121 enrolled subjects)
• Data Provenance:
  • Country of Origin: U.S. (17 U.S. centers)
  • Study Design: Prospective, multi-center, non-randomized, single-arm study (REVEAL clinical study).

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)

The document mentions two independent groups involved in establishing ground truth for the clinical study:

• Independent Clinical Events Committee (CEC): Adjudicated the primary safety endpoint (MAE). The number of experts is not specified, nor are their exact qualifications, but they are identified as an "independent" committee.
• Independent Angiographic Core Laboratory: Evaluated residual stenosis for the primary effectiveness endpoint. The number of experts is not specified, nor are their exact qualifications, but they are identified as an "independent" core lab.

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

• Safety Endpoint: "adjudicated by the independent Clinical Events Committee (CEC)." The specific voting mechanism (e.g., 2+1) is not provided.
• Effectiveness Endpoint: "evaluated by an independent Angiographic Core Laboratory." This implies a systematic evaluation, but the specific adjudication method (e.g., multiple readers, consensus) is not detailed.

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 that an MRMC comparative effectiveness study involving human readers with and without AI assistance was conducted or reported in this document. This study is for a medical device (atherectomy system), not an AI algorithm for diagnostic reading.

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

This question is not applicable. The device is a physical atherectomy system used in a procedure, not a diagnostic algorithm. Therefore, "standalone" performance in the context of an algorithm does not apply. The performance evaluated is the device's ability to achieve clinical outcomes (safety and effectiveness) when used by a human operator.

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

The ground truth for the clinical study was established through a combination of:

• Adjudicated Clinical Outcomes Data: For the safety endpoint (MAE), adjudicated by an independent Clinical Events Committee.
• Core Lab Measurements/Expert Interpretation of Imaging: For the effectiveness endpoint (residual stenosis), evaluated by an independent Angiographic Core Laboratory based on angiographic measurements.

8. The sample size for the training set

The document describes a clinical study to evaluate safety and effectiveness. It does not mention a training set in the context of machine learning or AI. This is a clinical trial for a physical medical device.

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

As there is no mention of a training set or AI model in the provided text, this question is not applicable.

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The Aspiration Pump is intended for general suction use in hospitals or clinics.

The Aspiration Pump is a portable suction / aspirator / vacuum system which is used to remove debris, blood and other bodily fluids through the application of continuous negative pressure. The Aspiration Pump includes two suction / vacuum ports on the input side, each with individual flow control valves and standard 6% Luer taper connectors. A 500cc collection bag is attached to the output side of the Aspiration Pump for collection of removed debris, blood and bodily fluids.

The Rex Medical Aspiration Pump is a powered suction pump intended for general suction use in hospitals or clinics. The provided document is a 510(k) Summary, which details the device's characteristics and the testing performed to demonstrate its substantial equivalence to predicate devices.

Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria alongside performance data in a single, consolidated table. Instead, it lists various non-clinical performance tests and their outcomes (Pass/Fail) and compares the device's design features with predicate devices. Based on the "Summary of Aspiration Pump Backflow Testing," a specific acceptance criterion is stated:

For other tests, such as pressure, battery life, voltage comparison, IPA resistance, flow rate, and maximum volume, the report simply states "Pass," indicating that the device met the predefined acceptance criteria for these tests, although the specific numerical criteria are not detailed in this summary.

Study Details

The document refers to a series of non-clinical performance tests (in vitro and in vivo studies, and testing to standards) to demonstrate the safety and effectiveness of the Rex Medical Aspiration Pump and its substantial equivalence to predicate devices. No human clinical trials were performed.

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

   • Backflow Testing: Two liquid aspiration pumps were each tested three times, totaling 6 test runs.
   • Other In-vitro and In-vivo testing: Specific sample sizes for other tests (Pressure Study, Battery Life Study, Flow Rate Study, Efficacy Study, etc.) are not specified in this summary.
   • Data Provenance: The studies were internal company tests or performed by third-party testing labs (e.g., UL Test Report). The country of origin of the data is not explicitly stated, but given the FDA submission, it's likely conducted in the US or under internationally recognized standards. The studies are by nature prospective tests performed on the device prototypes or production samples.

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

   • As this is a non-clinical device that performs a physical function (suction), the "ground truth" is established through engineering and scientific measurements and adherence to technical specifications, not through expert clinical consensus on interpretations. Therefore, there is no mention of experts establishing ground truth in the context of clinical interpretation, as it is not applicable. The tests would be performed by qualified engineers or technicians.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where subjective interpretations or disagreements among experts need to be resolved. For non-clinical performance tests, results are objectively measured against predefined 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:

   • Not applicable. This device is a physical medical instrument (a suction pump), not an AI algorithm for diagnostic imaging or similar applications where human readers' performance would be evaluated with or without AI assistance. No MRMC study was performed.

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

   • Not applicable. This device is a physical medical instrument, not a software algorithm. Its performance is intrinsically standalone in the sense that it performs its function (suction) independent of human-in-the-loop diagnostic decision-making.

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

   • The "ground truth" for the non-clinical tests is based on predefined engineering specifications, international standards (e.g., ISO, AAMI, ASTM), and the expected physical behavior of a medical suction pump, such as flow rates, vacuum pressure, battery life, and absence of backflow.

7. The sample size for the training set:

   • Not applicable. This device is a physical medical instrument subject to engineering testing. It does not involve a "training set" in the context of machine learning or AI.

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

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

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The Option(TM) ELITE Vena Cava Filter 100cm System is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following conditions:

• Pulmonary thromboembolism when anticoagulant therapy is contraindicated;

• Failure of anticoagulant therapy in thromboembolic diseases;

• Emergency treatment following massive pulmonary embolism when anticipated benefits of conventional therapy are reduced:

• Chronic, recurrent pulmonary embolism when anticoagulation therapy has failed or is contraindicated

The filter may be retrieved according to the instructions supplied in section entitled "Optional Procedure for Filter Retrieval" in patients who no longer require a filter can be performed only by jugular approach

The Option™ ELITE Vena Cava Filter is designed for the prevention of recurrent pulmonary embolism via percutaneous delivery in the inferior vena cava (IVC).

The Option ELITE Vena Cava Filter 100cm System is designed for IVC filter insertion, delivery, deployment and placement via the popliteal and antecubital approach.

The self-centering Option™ ELITE Filter is laser cut from nickel -titanium alloy (Nitinol) tubing. The Option™ ELITE Filter consists of shape memory Nitinol struts emanating from a central location and is designed for optimal clot capture. Retention anchors (retention hooks) are located at the caudal portion of the filter. These anchors are intended for filter fixation to the vessel wall. The Option™ ELITE Filter is intended to be used in caval diameters up to 30mm. A retrieval hook is centrally located at the cranial extremity.

The constrained Option™ ELITE Filter is flexible and expands to the internal diameter of the IVC upon deployment. The Option™ ELITE Filter imparts an outward radial force on the luminal surface of the vena cava to ensure proper positioning and stability. The Option™ ELITE Filter is designed to prevent pulmonary embolism while maintaining caval patency through central filtration.

The introduction kit is comprised of a filter housed in a filter cartridge, Catheter Sheath Introducer (5F ID), Angiographic Vessel Dilator with an open end, and a Pusher with deployment marker. The Angiographic Vessel Dilator has side holes and 2 radiopaque markers, separated by 32mm (between the marker bands), that provide linear measurement of the inferior vena cava and assists in angiographic visualization when radiopaque contrast is delivered. The pusher advances the filter through the Catheter Sheath Introducer up to the deployment marker, and is then used to fix the filter in place during uncovering. The distal end of the Catheter Sheath Introducer can be controlled by rotating the entire device to position the Catheter Sheath Introducer in the center of the vena cava. The Filter Cartridge houses the Option™ ELITE Filter. The body of the Cartridge has text and colored arrows printed on it that identify assembly orientation; femoral is printed in green and jugular is printed in blue. The femoral orientation is used for the popliteal approach and the jugular orientation is used for the antecubital approach. The arrow of the desired access site will point into the Catheter Sheath Introducer hub. The Angiographic Vessel Dilator is designed to provide angiorraphic visualization and linear measurement of the vasculature when used in conjunction with the delivery of radiopaque contrast media to the vena cava.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Option™ ELITE Vena Cava Filter 100cm System:

The document is a 510(k) premarket notification for a medical device. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than providing extensive clinical efficacy studies typically required for a PMA (Premarket Approval). Therefore, the "studies" described are primarily non-clinical and focus on demonstrating equivalence in performance and safety.

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implied to be that the device performs as safely and effectively as the predicate device, particularly for the modifications made (increased length for new access approaches). There isn't an explicit table of acceptance criteria for diagnostic performance metric.

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

Study Description:

The study was a non-clinical performance testing effort, focused on demonstrating the safety and performance of the device's modifications, specifically the increased length to allow for new access approaches (antecubital and popliteal).

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

• Sample Size: The document does not specify a numerical sample size for the simulated use testing. It states "A simulated use model... was used for testing." It's likely that a sufficient number of tests were performed to demonstrate consistency, but this detail is not provided.
• Data Provenance: The data is generated from non-clinical bench testing and simulated use testing conducted by the manufacturer, Rex Medical, L.P. The origin is the manufacturer's testing facilities (implied, likely USA given the submission to the FDA).
• Retrospective or Prospective: This is a prospective non-clinical study, as the tests were designed and conducted specifically to support this 510(k) submission.

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

Not applicable for this type of non-clinical, bench-testing study. Ground truth in this context relates to the physical and mechanical performance of the device, which is evaluated against engineering specifications and industry standards, not against expert medical diagnoses.

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

Not applicable. This was not a human-reader study requiring adjudication of interpretations. The "adjudication" was implicitly done by engineers/scientists evaluating the physical performance and measurements against pre-defined acceptance criteria.

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

Not applicable. This device is a physical medical implant (vena cava filter), not an AI/software-as-a-medical-device (SaMD) that assists human readers in interpreting medical images.

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

Not applicable. This is not an algorithm or SaMD.

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

The "ground truth" for this non-clinical study was based on:

• Engineering specifications and design requirements: The device had to perform within specified ranges for deployment forces, tilt angles, and other mechanical parameters.
• Risk assessment: The potential failure modes identified in the risk assessment guided the testing.
• Relevant ISO standards: ISO 10555-1 (Sterile, single-use intravascular catheters) and ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) provided the framework for testing methodology and performance expectations for certain aspects, particularly biocompatibility and catheter characteristics.
• Predicate device performance: The ultimate "ground truth" for substantial equivalence is that the modified device performs comparably to the predicate.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable.

Summary of Study:

The study was a series of non-clinical bench and simulated use tests conducted by Rex Medical. The primary objective was to demonstrate that modifications to the Option™ ELITE Vena Cava Filter System (specifically the increased length for new access approaches) did not negatively impact its safety and efficacy, maintaining substantial equivalence to its predicate device (K133243). The tests evaluated aspects like deployment forces, filter tilt, integrity of the system, and adherence to relevant ISO standards, ensuring the modified device continued to perform as intended and was safe for its stated indications for use. No clinical trials or human-reader studies were conducted or required for this 510(k) submission.

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The Cleaner™ Rotational Thrombectomy System is indicated for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts.

The Cleaner™ Rotational Thrombectomy System is indicated for mechanical declotting and controlled and selective infusion of physician-specified fluids, including thrombolytics, in the peripheral vascular.

The Cleaner™ Rotational Thrombectomy System is a percutaneous infusion system that utilizes a rotating sinusoidal wire to increase the dispersion of delivered solution. The devices employ mechanical rotation of a flexible "S" shaped dispersion wire at 4000 RPM which creates a fluid vortex within the treatment site. Contrast media and physician specified solutions, including thrombolytics, may be infused through the catheter lumen to a side hole at the distal end. The dispersion wire uses mechanical rotation to allow the infused solution to penetrate the clot increasing the effectiveness of the treatment. Any residual clot can be aspirated through an introducer sheath prior to restoration of flow. The distal soft tip is a radiopaque a-traumatic tip on the distal end of the dispersion wire. The devices are sterile and single-use disposable.

This FDA 510(k) summary for the Cleaner™ Rotational Thrombectomy System does not include specific acceptance criteria or a detailed study description with performance metrics in numerical form. It refers to general "bench testing and animal studies" and "performance testing" to support substantial equivalence.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, or expert involvement as these are not present in the provided document.

However, I can extract information related to the types of studies conducted and general conclusions:

1. A table of acceptance criteria and the reported device performance
Not provided in the document. The document states: "Results of bench testing and animal studies demonstrate Cleaner™ Rotational Thrombectomy System is as safe and effective as the legally marketed predicate device." However, no specific performance metrics or acceptance criteria are listed.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided in precise detail. The document mentions "A GLP animal study was conducted" but does not specify the number of animals or the species used, or the country of origin. It's prospective by nature of being an animal study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not provided in the document.

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

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device for physical intervention, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the animal study, the ground truth would be based on direct observation of vessel patency and potentially pathology/histology of the treated vessels. The document states "The animal testing show the Cleaner Rotational Thrombectomy System successfully restores patency to occluded vessels." This implies visual assessment of vessel patency as the outcome.

8. The sample size for the training set
Not applicable. This is a physical device, not a machine learning algorithm requiring a training set.

9. How the ground truth for the training set was established
Not applicable. This is a physical device, not a machine learning algorithm.

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The Option (TM) ELITE Vena Cava Filter System is intended for the prevention of recurrent pulmonary embolion (PE) via placement in the vena cava in the following conditions:

• · Pulmonary thromboembolism when anticoagulant therapy is contraindicated;
• · Failure of anticoagulant therapy in thromboembolic diseases;
• · Emergency treatment following massive pulmonary embolism when anticipated beaeffits of conventional therapy are realised;
• · Chronic, recurrent pulmonary embolism when anticoagulation therapy has failed or is contraindicated

The filter may be retrieved according to the instructions supplied in section entitled "Optional " in patients who no longer require a filter. Retrieval of the fitter can be performed only by jugular approach.

The Option™ ELITE Vena Cava Filter is designed for the prevention of recurrent pulmonary embolism via percutaneous delivery in the inferior vena cava (IVC).

The self-centering Option™ ELITE Filter is laser cut from nickel - itanium alloy (Nitinol) tubing. The Option™ ELITE Filter consists of shape memory Nitinol struts emanating from a central location and is designed for optimal clot capture. Retention anchors (retention hooks) are located at the proximal or caudal portion of the filter. These anchors are intended for filter fixation to the vessel wall. The Option™ ELITE Filter is intended to be used in caval diameters up to 30mm. A retrieval hook is centrally located at the cranial extremity.

The constrained Option™ ELITE Filter is flexible and expands to the internal diameter of the IVC upon deployment. The Option™ ELITE Filter imparts an outward radial force on the luminal surface of the vena cava to ensure proper positioning and stability. The Option™ ELITE Filter is designed to prevent pulmonary embolism while maintaining caval patency through central filtration.

The introduction kit is comprised of a filter housed in a filter cartridge, Catheter Sheath Introducer (5F ID), Angiographic Vessel Dilator with an open end, and a Pusher with deployment marker. The Angiographic Vessel Dilator has side holes and 2 radiopaque markers, separated by 32mm (between the marker bands), that provide linear measurement of the inferior vena cava and assists in angiographic visualization when radiopaque contrast is delivered. The pusher advances the filter through the Catheter Sheath Introducer up to the deployment marker, and is then used to fi x the filter in place during uncovering. The location of the distal end of the Catheter Sheath Introducer can be controlled by rotating the entire device to position the Catheter Sheath Introducer in the vena cava. The Filter Cartridge houses the Option™ ELITE Filter. The body of the Cartridge has text and colored arrows printed on it that identify assembly orientation, femoral is printed in green and jugular is printed in blue. The arrow of the desired access site will point into the Catheter Sheath Introducer hub. The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when used in conjunction with the delivery of radiopaque contrast media to the vena cava.

The provided text describes a 510(k) submission for the REX MEDICAL Option™ ELITE Vena Cava Filter System. This document focuses on the substantial equivalence of the modified device to a predicate device, rather than the development and validation of an AI/ML-driven medical device.

Therefore, the information required to describe the acceptance criteria and study proving an AI/ML device meets those criteria (e.g., sample sizes for training/test sets, expert qualifications, ground truth establishment, MRMC studies, standalone performance) is not available in the provided text.

The document discusses:

• Device Description: The physical characteristics and mechanism of the vena cava filter.
• Intended Use: The clinical conditions for which the filter is designed.
• Technological Characteristics: How the device is similar to its predicate.
• Modifications: Specific changes made to the Option™ ELITE compared to its predecessor (e.g., number and type of retention hooks, sheath material/design, alternate implantation procedure).
• Non-Clinical Performance Testing: A brief mention that testing was derived from risk assessment and aimed to evaluate safety and effectiveness of design modifications, with acceptance criteria derived from Rex Medical and related ISO standards. However, it does not specify what those acceptance criteria were in detail, nor does it present the results in a table format that would demonstrate meeting those criteria. It also doesn't detail the study that proves this, beyond saying "performance testing."
• Conclusion: A statement of substantial equivalence based on performance testing and similarities.

In summary, this document is a regulatory submission for a physical medical device, not an AI/ML diagnostic or therapeutic device. As such, the requested information regarding AI/ML device acceptance criteria and validation studies (like those featuring human readers, ground truth consensus panels, training datasets, etc.) is not applicable and is not present in the provided text.

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The Cleaner™ Rotational Thrombectomy System is indicated for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts.

The Cleaner "1" Rotational Thrombectomy System is a 7F percutaneous mechanical thrombectomy catheter. It is a sterile, single use disposable device. Its handle contains a battery operated motor that spins a flexible "S" shaped guidewire at approximately 4000rpm. The wall contacting rotational wire, with integrated soft distal tip, permits atraumatic mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts. The wire creates a fluid vortex as it spins that macerates clot and allows it to be aspirated through the introducer sheath.

The provided text describes a 510(k) summary for the Cleaner Rotational Thrombectomy System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel efficacy through detailed clinical studies with specific acceptance criteria and detailed performance metrics as one might find for a de novo or PMA submission.

Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not explicitly present in the provided document. The document states that "bench testing and animal studies demonstrate Cleaner™ Rotational Thrombectomy System is as safe and effective as the legally marketed predicate device." It also mentions "Non-Clinical Performance Testing" derived from risk assessment and ISO standards, but does not provide specific details on the acceptance criteria or results.

Based on the provided text, here’s a breakdown of what can be inferred or is directly stated, and what cannot be answered:

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

• Cannot be provided. The document states that "Test methodology and acceptance criteria were derived from within Rex Medical and from related ISO standards for evaluation of this device," but it does not specify these criteria or the reported performance metrics against them. The conclusion simply states the device is "substantially equivalent" to the predicate.

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

• No test set for clinical performance is mentioned. The testing described is "bench testing and animal studies," which are non-clinical. No sample sizes for these are provided, nor is their provenance or study design (retrospective/prospective) detailed.

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

• Not applicable / Cannot be provided. There's no mention of a clinical test set requiring expert ground truth establishment.

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

• Not applicable / Cannot be provided. There's no mention of a clinical test set requiring adjudication.

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 study was mentioned. This device is a mechanical thrombectomy system, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device's evaluation as described.

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

• Not applicable. This is a physical medical device, not a standalone algorithm. Its performance is inherent to its mechanical function.

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

• Not applicable for clinical ground truth. For the non-clinical "bench testing and animal studies," the ground truth would be physical measurements and observations of the device's mechanical performance in relevant models, but the specific types are not detailed.

8. The sample size for the training set

• Not applicable. This device does not use machine learning, so there is no training set in the typical sense.

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

• Not applicable. As above, no machine learning training set is mentioned.

Summary of what the document does state:

• Device: Cleaner™ Rotational Thrombectomy System.
• Intended Use: Mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts.
• Predicate Devices: Cleaner™ Rotational Thrombectomy System (K091029 and K060904).
• Testing Conducted: "Bench testing and animal studies" to demonstrate safety and effectiveness, and "Non-Clinical Performance Testing" derived from risk assessment and ISO standards.
• Conclusion: The device is "substantially equivalent" to the predicate devices based on this testing and similarities in intended use, materials, technological characteristics, principle of operation, and design features.

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The SplitWire Percutaneous Transluminal Angioplasty Scoring device is indicated for the use with percutaneous transluminal angioplasty (PTA) catheters to facilitate dilation of stenoses in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries and treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The SplitWire Percutaneous Transluminal Angioplasty Scoring Device is designed to facilitate the dilatation of stenoses. The SplitWire device is intended to be used with a percutaneous transluminal angioplasty balloon catheter. The SplitWire device consists of two (2) wires that are joined at the distal end. The larger wire (scoring wire) has a triangular profile near the distal end, that when the balloon is inflated applies pressure to the lesion being treated. The smaller wire (tracking wire) is used to position the PTA balloon catheter in the proper location adjacent to the lesion. There are two (2) radiopaque markers bands on the tracking wire that indicate the location for the PTA balloon catheter placement. The distal section of the SplitWire is designed to be atraumatic with a radiopaque coil for visibility. The distal section is coated with a soft polymer.

I am sorry, but based on the provided document, there is insufficient information to complete your request. The document describes a medical device called the "SplitWire Percutaneous Transluminal Angioplasty Scoring Device" and its 510(k) summary for FDA clearance. It discusses the device's intended use, a comparison to a predicate device, and some non-clinical testing performed.

However, the document does NOT contain details about:

• Specific acceptance criteria for device performance (e.g., quantitative metrics like sensitivity, specificity, accuracy).
• Reported device performance against such criteria.
• The sample size of a test set as this device is not an AI/algorithmic device needing such a set for performance evaluation.
• Data provenance for a test set.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
• Standalone (algorithm-only) performance, as this is a physical medical device, not an algorithm.
• The type of ground truth used (pathology, outcomes data, etc.) in the context of an AI device.
• Sample size for a training set (again, this is not an AI/algorithmic device).
• How ground truth for a training set was established.

The "testing" mentioned in the document refers to engineering and biocompatibility bench testing, and animal studies typical for a physical medical device, not the evaluation of an AI algorithm's diagnostic performance.

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The UltraStream Chronic Hemodialysis Catheter is designed for chronic hemodialysis and apheresis.

The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressures. The device is used in the same manner as the predicate device and other substantially equivalent 510(k) cleared devices.

This document describes a Special 510(k) submission for a device modification, the UltraStream Chronic Hemodialysis Catheter. The submission aims to demonstrate substantial equivalence to a predicate device, the Hemo-Stream™ True Over the Wire Dialysis Catheter (K071422).

Here's the analysis based on your request, but please note that this document is for a medical device modification and not an AI/Software as a Medical Device (SaMD). Therefore, many of the requested criteria related to AI/SaMD studies (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of submission. The provided document details a comparison of physical and functional characteristics of the new catheter with its predicate, supported by non-clinical testing.

Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" for a Special 510(k) of this nature is demonstrating substantial equivalence to a previously cleared predicate device, meaning the new device is as safe and effective as the predicate. This is achieved by showing that the new device has similar technological characteristics and the non-clinical testing supports that there are no new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a device modification, the "acceptance criteria" is essentially the successful demonstration of substantial equivalence to the predicate device, based on the non-clinical tests performed. The "reported device performance" is that these tests revealed the subject device to be substantially equivalent to the predicate device.

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

• Not applicable for this type of medical device modification. The submission relies on non-clinical comparative functional and material testing, performed in a lab setting, not on patient data or clinical datasets.

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

• Not applicable. No expert ground truth establishment for a test set in the context of an AI/SaMD product. The ground truth for device performance is established via standardized engineering and material testing protocols.

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

• Not applicable. There is no "test set" in the sense of a dataset requiring expert adjudication for ground truth. Performance is determined by engineering measurements and observations.

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

• Not applicable. This is a physical medical device (catheter), not an AI/SaMD product. MRMC studies are used for evaluating AI-assisted diagnostic tools.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• The "ground truth" for this device modification is the established performance and safety profiles of the predicate device, as determined by previous clearances and regulatory standards (e.g., ISO standards, FDA guidance documents). The new device is evaluated against these benchmarks through bench testing and material testing.

8. The sample size for the training set:

• Not applicable. No training set exists as this is not an AI/machine learning device.

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

• Not applicable. No training set exists.

Summary of what was done (based on the provided text):

• Type of Study: Non-clinical comparative functional testing and material testing.
• Purpose: To demonstrate substantial equivalence of the modified UltraStream Chronic Hemodialysis Catheter to its predicate, the Hemo-Stream™ True Over the Wire Dialysis Catheter (K071422).
• Methods:
  • Functional Testing: Performed based on ISO 10555-1 and the FDA's Reviewer Guidance for Long Term and Short Term Intravascular Catheters. This would involve specific tests to measure flow rates, pressure resistance, strength, durability, etc., in a lab setting.
  • Material Testing: Included ISO 10993 Biocompatibility Testing to ensure the materials used are safe for human contact.
  • Bench Testing: A general term for laboratory testing of the device's physical and mechanical properties.
• Results/Conclusion: "Testing results revealed the subject device to be substantially equivalent to the predicate device." The submission concluded that there were "not any differences in their technological characteristics thereby not raising any new questions of safety and effectiveness."
• Clinical Studies: "Not applicable as there are no new indications for use which must be supported by clinical data." This confirms that no human clinical trials were performed or required for this particular modification.

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The Cleaner™ Rotational Thrombectorny System is indicated for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts.

The Cleaner™ Rotational Thrombectorny System is a 5.8Fr perculaneous mechanical thrombectorny catheter. It is a sterile, single use disposable device. Its handle contains a battery operated motor that spins a flexible "S" shaped guidewire at approximately 4000 rpm. The wall contacting rotational wire, with integrated soft distal tip, permits atraumatic mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts. The wire creates a fluid vortex as it spins that macerates clot and allows it to be aspiration through an introducer sheath.

The provided text describes a medical device, the Cleaner™ Rotational Thrombectomy System, and its regulatory submission. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/algorithm-driven device.

The document is a 510(k) summary for a thrombectomy catheter. The "Non-Clinical Performance Testing" section mentions: "The expanded indications for use to include native vessel dialysis fistulae are based on the bench testing and animal data presented in the performance section of the submission. A GLP animal study was conducted utilizing the Cleaner Rotational Thrombectomy System in a Lagomorph IVC model."

This indicates that an animal study and bench testing were performed to support the expanded indications, but these are not for an AI/algorithm-driven device, nor do they detail specific acceptance criteria for performance metrics that would be relevant to such a device (e.g., sensitivity, specificity, accuracy).

Therefore, the requested information regarding acceptance criteria and a study proving an AI/algorithm-driven device meets those criteria cannot be extracted from this document, as the device is a mechanical thrombectomy system.

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