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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 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 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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The Rex Medical Cleaner™ Rotational Thrombectomy System is designed for mechanical declotting of synthetic dialysis access grafts.

The Rex Medical Cleaner™ Rotational Thrombectomy System is percutaneous mechanical thrombectomy device which provides an effective means to restore patency to occluded synthetic dialysis access grafts. The device is used in exactly the same manner as the predicate devices.

Based on the provided text, the Cleaner™ Rotational Thrombectomy System is a medical device, and the submission is a Special 510(k) for device modification. This means the device is already cleared, and the submission addresses changes rather than proving initial effectiveness. Therefore, the information typically requested for AI/software-as-a-medical-device (SaMD) studies (like sample size, ground truth, expert adjudication, etc.) is largely "Not Applicable" or not explicitly detailed in this type of submission.

Here's the breakdown of the information as it relates to the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that "Test methodology and acceptance criteria were derived from within Rex Medical and from related ISO standards for evaluation of this device" for the non-clinical tests. However, the specific acceptance criteria and the detailed results of these tests (e.g., in a table format) are not provided in this summary.

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

• Test Set Sample Size: Not applicable/Not provided. The document states "Discussion of Clinical Tests Performed: Not Applicable." This indicates that no clinical studies were performed for this specific 510(k) submission, as it relates to a modification of an already cleared device. The non-clinical tests were likely bench or in-vitro tests, and the "sample size" in that context would refer to the number of devices or components tested, which is not specified.
• Data Provenance: Not applicable/Not provided, as no clinical data is presented for this modification.

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

• Number of Experts: Not applicable. Since no clinical studies were performed, there was no need for experts to establish ground truth in the context of clinical performance evaluation.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. As no clinical studies were performed, no adjudication method for a test set is mentioned.

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

• MRMC Study: No. This device is a mechanical thrombectomy system, not an AI or imaging diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this product.
• Effect Size: Not applicable.

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

• Standalone Performance: No. This device is a mechanical thrombectomy system, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable for a clinical study. For the non-clinical tests, the "ground truth" would be engineering specifications, physical measurements, and performance benchmarks defined by Rex Medical and ISO standards. The specific details of these are not provided.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This document describes a physical medical device, not an AI or machine learning algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

Summary of Device Performance (from the document):

The document states: "The verification testing contained in our submission demonstrates that there are no differences in their technological characteristics due to the device modification, thereby not raising any new issues of safety or effectiveness." This implies that the device, with its modifications, performs identically to the predicate device in terms of safety and effectiveness. The specific details of how this was demonstrated (e.g., quantitative performance data) are not included in this 510(k) summary.

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The Cleaner ™ Rotational Thrombectomy System Kit is designed for mechanical declotting in synthetic dialysis access grafts.

The Rex Medical Cleaner™ Rotational Thrombectomy System Kit is a battery operated, hand held, wall contacting, rotational thrombectomy device which provides an effective means to restore patency to occluded synthetic dialysis grafts. The rotational wire, with integrated soft distal tip, provides an atraumatic approach to mechanical thrombectorny. The Cleaner™ macerates clot into particulate size that is not harmful to the patient.

This document is a 510(k) summary for the Rex Medical Cleaner™ Rotational Thrombectomy System Kit, which is a medical device. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, the input does not contain information on acceptance criteria, reported device performance, sample sizes for test sets, data provenance, number of experts or their qualifications for ground truth, adjudication methods, MRMC studies, standalone performance, or details on training sets.

The relevant sections are:

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

• Acceptance Criteria: Not explicitly stated in the document as performance metrics. The focus is on demonstrating that modifications do not adversely affect safety and effectiveness compared to predicate devices.
• Reported Device Performance:
  • The original Cleaner™ Rotational Thrombectomy System had a specified rotational velocity of 4000 ± 500 RPM.
  • The Cleaner™ Rotational Thrombectomy System Kit has a rotational velocity specified as 3000 - 4500 RPM.
  • "Testing proved that there is no effect on the safety and efficacy of the Cleaner™ Rotational Thrombectomy System Kit with the additions and modification noted above."

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

• Not specified. The document mentions "Verification testing was performed" but does not detail the sample size or data provenance.

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. This device submission is about verifying manufacturing and design changes, not evaluating diagnostic performance against ground truth established by experts.

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

• Not applicable. This type of adjudication is for studies involving multiple readers evaluating a test set against ground truth, which is not the nature of this submission.

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.

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

• Not applicable. This device is a mechanical thrombectomy system, not an algorithm.

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

• Not applicable in the context of diagnostic ground truth. The "ground truth" here is the established safety and effectiveness of the predicate device, against which the modified device is compared to ensure no adverse effects.

8. The sample size for the training set

• Not applicable. This device does not involve a training set as it is not an AI/machine learning product.

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

• Not applicable.

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The Rex Medical Cleaner™ Rotational Thrombectomy System device permits mechanical declotting in synthetic dialysis grafts.

The Rex Medical Cleaner™ Rotational Thrombectomy System is a battery operated, hand held, wall contacting, rotational thrombectomy device which provides an effective means to restore patency to occluded synthetic dialysis grafts. The rotational wire, with integrated soft distal tip, provides an atraumatic approach to mechanical thrombectomy. The Cleaner™ macerates clot into particulate size that is not harmful to the patient.

The provided document pertains to a 510(k) premarket notification for the Rex Medical Cleaner™ Rotational Thrombectomy System. This regulatory submission primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving device performance against specific acceptance criteria in a detailed study format typically seen for novel devices with extensive performance claims.

Based on the information provided, here's an analysis of the acceptance criteria and the study that indicates the device meets them:

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

The document does not explicitly state quantitative acceptance criteria that the device had to meet (e.g., "device must remove X% of clot"). Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices. The performance is reported in terms of comparative characteristics and qualitative success in non-clinical and in-vivo testing.

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

• Test Set Sample Size: The document states that statistical sampling rationale for choosing the number of devices tested was based on ISO 2859-1 sampling plans in accordance with projected lots (batch) size for non-clinical tests. However, the specific number of devices tested for non-clinical performance or the number of animals in the in-vivo study is not provided.
• Data Provenance:
  • Non-Clinical/Bench Testing: The geographical origin of this data is not specified. It is likely internal testing conducted by Rex Medical or a contracted lab.
  • In-Vivo (Animal) Testing: The document explicitly states "In-Vivo (animal) test studies." The geographical origin is not specified, but it would have been prospective testing.

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 type of information is not applicable and not provided for this 510(k) submission. The "ground truth" in this context is established by the physical and functional performance of the device itself (e.g., successful clot maceration, energy output, comparison of physical dimensions) and observed outcomes in animal models, not through expert interpretation of data like in an AI/imaging study.

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

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies involving human interpretation or subjective endpoints, which is not the primary focus of the non-clinical and animal studies described here.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices, which is not what the Rex Medical Cleaner™ is. The device is a mechanical thrombectomy system.

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

This concept is not applicable to a mechanical medical device like a thrombectomy system. There is no "algorithm only" performance separate from the physical device's operation.

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

The "ground truth" for this device's performance was established through:

• Objective measurements and engineering specifications for non-clinical testing (e.g., catheter dimensions, energy output).
• Direct observation of clot maceration and safety outcomes in in-vivo animal studies. This would effectively be a form of direct observation of the physiological effect of the device, akin to outcomes data in a controlled environment.

8. The sample size for the training set

This information is not applicable as there is no "training set" for a mechanical medical device like this, which does not employ machine learning or AI.

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

This information is not applicable for the reasons stated in point 8.

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