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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 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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