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The AngioJet Ultra AVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits ≥ 3 mm in diameter.

AngioJet Ultra AVX Thrombectomy Set is a sterile, single use, disposable set that includes a Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra AVX Thrombectomy Set is used with the AngioJet Ultra Console.

The provided text describes a 510(k) submission for the AngioJet® Ultra AVX® Thrombectomy Set, which is a medical device and not an AI/ML software device. Therefore, many of the requested categories related to AI/ML device performance and ground truth establishment are not applicable.

However, I can extract the relevant acceptance criteria and study information available for this medical device from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states that "Bench and laboratory testing was performed" for biocompatibility and design verification. It does not specify a "test set" in the context of patient data or a specific sample size for a test set. This device is a physical medical device, not an AI/ML algorithm that processes data.

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

Not applicable. Ground truth as typically defined for AI/ML performance evaluation (e.g., expert labels on medical images) is not relevant for this device's non-clinical testing. The "ground truth" for the device's performance is established by meeting predefined engineering and biocompatibility specifications through bench and lab testing.

4. Adjudication method for the test set

Not applicable. This concept is typically relevant for human review of AI outputs or image interpretation, 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 thrombectomy set, a physical medical instrument, not an AI/ML software.

6. 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 an AI/ML algorithm.

7. The type of ground truth used

For biocompatibility, the ground truth is established by the specifications defined in the ISO 10993 standards. For design verification, the ground truth is established by engineering specifications for operational pressure, evacuation, infusion rate, dimensions, leak thresholds, etc.

8. The sample size for the training set

Not applicable. This device is a physical medical instrument and does not involve a "training set" in the context of machine learning.

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

Not applicable, as there is no training set for this device.

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The AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are intended for use with the Angiojet Ultra Console to break apart and remove thrombus from:
upper and lower extremity peripheral arteries ≥ 3.0mm in diameter,
upper extremity peripheral veins ≥ 3.0mm in diameter,
ileofemoral and lower extremity veins ≥ 3.0mm in diameter,
A-V access conduits ≥ 3.0mm in diameter and
for use with the Angiojet Ultra Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are sterile, single use, disposable sets that include a Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are used with the AngioJet Ultra Console.

Here's an analysis of the provided text based on your request:

It's important to note that the provided document (K091593) is a 510(k) summary for medical devices (AngioJet® Ultra DVX® and Xpeedior® Thrombectomy Sets). It describes hardware devices, not a software/AI-driven diagnostic tool. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI device's performance metrics (like accuracy, sensitivity, specificity) and a ground truth established by experts are not directly applicable here.

Instead, this summary focuses on demonstrating substantial equivalence to predicate devices through functional and safety testing, material comparisons, and similar indications for use.

Let's break down why most of your requested points cannot be directly answered from this document, and what can be inferred:

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

• Acceptance Criteria (for a hardware device in 510(k)): The acceptance criteria here are implicitly related to demonstrating that the device performs as intended and is as safe and effective as its predicate devices. This is achieved through various forms of testing.
• Reported Device Performance: The document states: "Representative samples of the device underwent mechanical bench testing to demonstrate safety and effectiveness and appropriate functional and performance characteristics."

Lack of Specifics for AI-focused questions:

The remaining questions (2-9) are designed for evaluating AI/software performance in a diagnostic or predictive context. This document, being for a physical medical device, does not contain the information needed to answer them.

• 2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" of patient data for an AI algorithm here. Bench testing uses representative device samples.
• 3. Number of experts used to establish the ground truth... and their qualifications: Not applicable. No ground truth established by experts for AI output here.
• 4. Adjudication method: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: Not applicable. An MRMC study is for evaluating human performance, often with and without AI assistance. This device is a tool, not a diagnostic AI.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware device.
• 7. The type of ground truth used: Not applicable in the AI sense. The "ground truth" for this device would be established engineering specifications, safety standards, and performance benchmarks against which the bench testing is measured.
• 8. The sample size for the training set: Not applicable. This is not an AI algorithm.
• 9. How the ground truth for the training set was established: Not applicable.

In summary: The K091593 document describes a medical device (a thrombectomy set), not an AI algorithm. Therefore, the detailed questions about acceptance criteria, test sets, ground truth, and expert evaluation pertinent to AI or software are not addressed in this type of submission. The "study" proving its acceptance is the "mechanical bench testing to demonstrate safety and effectiveness and appropriate functional and performance characteristics" and comparison to predicate devices, but the specifics of that testing are not provided in this summary.

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The AngioJet Ultra DVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from

• . Upper and Lower extremity peripheral arteries > 3 mm in diameter
• . Upper extremity peripheral veins > 3 mm in diameter
• Ileofemoral and lower extremity veins ≥ 3 mm in diameter .
• . AV access conduits > 3 mm in diameter and
• . For use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

The AngioJet Ultra Xpeedior Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from

• Upper and Lower extremity peripheral arteries ≥ 3 mm in diameter .
• Upper extremity peripheral veins > 3 mm in diameter .
• lleofemoral and lower extremity veins > 3 mm in diameter .
• . A V access conduits > 3 mm in diameter and
• For use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of ● physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are sterile, single use, disposable sets that include the AngioJet DVX and Xpeedior Thrombectomy catheters and a pump in one combined unit. The AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are used with the AngioJet Ultra Console. A 3-port catheter manifold is used, so that contrast media and other fluids can be injected into the bloodstream where the catheter is positioned.

The provided text is a 510(k) summary for the AngioJet Ultra DVX and Xpeedior Thrombectomy Sets. This document outlines the device's intended use and demonstrates its substantial equivalence to previously cleared predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria as typically found in clinical trials for new medical device approvals or AI/CAD performance assessment.

Instead, the provided text describes an administrative change to a previous 510(k) clearance and the original 510(k) submission which focuses on demonstrating substantial equivalence to predicate devices based on similarities in functional design, materials, indications for use, and principles of operation, supported by bench and biocompatibility testing.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria from the provided text. The document focuses on regulatory clearance through substantial equivalence, not on novel performance evaluation against specific metrics like sensitivity, specificity, etc., usually associated with acceptance criteria for new or AI-powered devices.

Here's a breakdown of what can be extracted or inferred, and what cannot:

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

• Cannot be provided: The document does not define specific acceptance criteria (e.g., minimum sensitivity, specificity, accuracy, or similar quantitative metrics) for the device's performance in breaking apart and removing thrombus. It also does not report specific device performance statistics against such criteria. The "Supporting Information" section mentions "Bench and biocompatibility testing supported using a 3-port catheter manifold and adding labeling instructions," but it doesn't detail performance metrics or acceptance criteria for these tests.

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

• Cannot be provided: The document does not describe a clinical "test set" in the context of diagnostic or AI performance evaluation. The testing mentioned is "Bench and biocompatibility testing," which are typically laboratory-based and do not involve patient data in the same way as a clinical test set for AI/CAD. Therefore, data provenance (country, retrospective/prospective) for such a test set is not applicable or provided.

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

• Cannot be provided: No "ground truth" establishment by experts for a clinical test set is mentioned. This is a 510(k) submission focusing on substantial equivalence, not a clinical trial evaluating diagnostic accuracy against a gold standard.

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

• Cannot be provided: No clinical test set or adjudication process is described.

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:

• Cannot be provided: This device is a mechanical thrombectomy set, not an AI or imaging diagnostic aid for which an MRMC study comparing human readers with and without AI assistance would be relevant. The document does not mention any AI component.

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

• Cannot be provided: This device is a physical medical device (catheter) used by a medical professional. It is not an algorithm, so the concept of "standalone performance" for an algorithm is not applicable.

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

• Cannot be provided: As no clinical test set for diagnostic accuracy is described, no ground truth type is specified. The assessment here is about the device's physical properties and intended function (breaking apart and removing thrombus), likely evaluated through engineered performance tests and simulations, rather than diagnostic "ground truth."

8. The sample size for the training set:

• Cannot be provided: This device is not an AI algorithm, so there is no "training set."

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

• Cannot be provided: Not applicable as there is no AI algorithm or training set discussed.

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The AngioJet Ultra AVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits ≥ 3 mm in diameter.

Each AngioJet Ultra AVX Thrombectorny Set is a sterile, single use, disposable set that includes the AngioJet AVX Thrombectomy catheter and pump in one combined unit. The AngioJet Ultra AVX Thrombectomy Set is used with the AngioJet Ultra Console. A 3-port catheter manifold is used, so that contrast media and other fluids can be injected into the vascular where the catheter is positioned.

The provided text is a 510(k) summary for the AngioJet Ultra AVX Thrombectomy Set, indicating its substantial equivalence to a predicate device. It briefly mentions "Bench and biocompatibility testing supported using a 3-port catheter manifold and adding labeling instructions for using the AngioJet Ultra AVX Thrombectomy Set to inject contrast media and other fluids into the vascular site where the catheter is positioned." However, the document does not contain detailed information about the acceptance criteria or a specific study that proves the device meets those criteria, as requested.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be stated based on the provided text:

• 1. A table of acceptance criteria and the reported device performance: This information is not explicitly provided in the document. The document only generally states that "Bench and biocompatibility testing supported" certain aspects.

• 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.

• 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.

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

• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is an embolectomy catheter, not an AI diagnostic tool, so an MRMC study is not applicable in this context.

• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This device is an embolectomy catheter, not an AI algorithm. Its performance is inherent to its physical design and function, not an algorithm.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated, beyond general "Bench and biocompatibility testing."

• 8. The sample size for the training set: Not applicable for this type of device, as it's not an AI model requiring a training set.

• 9. How the ground truth for the training set was established: Not applicable for this type of device.

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The Fetch Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system and coronary vasculature.

The FETCH Aspiration Catheter is a rapid exchange, low-profile tip, dual lumen catheter that uses a 0.014" (0.36 mm) guide wire to track to the target site. It is used for aspiration of fresh, soft emboli and thrombi Its outer diameter 0.052" (1.33 mm) or 4F allows advancement to the target site through a 6F (0.070" I.D.) guiding catheter. A radiopaque marker is located about 2 mm from the distal tip. FETCH is provided with an extension line, 30 cc syringe, one-way stopcock and a 40 micron collection basket. This basket can be used to filter aspirated blood for laboratory analysis of collected thrombus.

This looks like a 510(k) summary for a medical device called the "Fetch® Aspiration Catheter." This type of document is generally for regulatory submission to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study proving the device meets specific acceptance criteria in the way a clinical trial would for a new drug or novel medical device.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, as typically seen in clinical performance evaluations.

Here's why and what information is present:

• 510(k) Submissions Focus on Substantial Equivalence: The primary goal of a 510(k) summary is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics as the predicate device, or if it has different technological characteristics, that information submitted to FDA does not raise new questions of safety and effectiveness.
• Lack of Performance Metrics/Acceptance Criteria: The document mentions "mechanical testing, biocompatibility testing, and sterility assessment" were performed, but it does not provide specific acceptance criteria (e.g., "device must achieve X% successful thrombus removal") or the quantitative results of these tests against such criteria.
• No Clinical Study Details: There is no description of a clinical study (like a standalone or MRMC study) with human subjects, sample sizes for test/training sets, expert adjudication, or ground truth establishment relevant to clinical performance (e.g., efficacy in thrombus removal in patients).

Based on the provided text, I cannot complete the requested tables and information because the document describes a regulatory submission for substantial equivalence, not a clinical study proving performance against specific acceptance criteria.

The available information is limited to:

• Device Name: Fetch® Aspiration Catheter
• Intended Use: Removal of fresh, soft emboli and thrombi from vessels in the arterial system and coronary vasculature.
• Predicate Devices: The Fetch Aspiration Catheter - K062172 and K070363 (meaning this submission is likely for a modification or new size of an existing device).
• Testing Mentioned (without results or criteria): Mechanical testing, biocompatibility testing, and sterility assessment.

To answer your specific questions, the document would need to be a clinical study report, a performance study report, or similar, which it is not.

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The GuardDOG® Occlusion System is indicated for use in the peripheral vasculature to facilitate the localized infusion of therapeutic or diagnostic fluids, with or without vessel occlusion.

The safety and effectiveness of this device have not been established in the coronary, cerebral, or carotid vasculature.

The GuardDOG System consists of two components: An Occlusion Guidewire and a carbon dioxide (CO2) Inflation Device. The GuardDOG Inflation Device is used to inflate the occlusion balloon and seal the guidewire once it is in position.

I am sorry, but the provided text only refers to mechanical, biocompatibility, sterility, and animal testing without going into the specifics of the acceptance criteria or how the device performance was measured against them. Consequently, I cannot provide an answer following the requested template as it would require information not present in the given document.

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The AngioJet Ultra Spiroflex VG Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries > 3 mm in diameter.

Each AngioJet Ultra Thrombectomy Set is a sterile, single use, disposable set that includes the Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra Thrombectomy Set is used with the AngioJet Ultra Console.

This is a premarket notification (510(k)) for a medical device, the AngioJet Ultra Spiroflex VG Thrombectomy Set, not an AI/ML-driven device. Therefore, the information typically requested for AI/ML device evaluations (such as acceptance criteria for AI performance metrics, sample size for AI test sets, expert ground truth, MRMC studies, or training set details) is not applicable or present in this document.

The document describes the device, its intended use, and states that it underwent bench testing, including but not limited to mechanical testing, biocompatibility, sterility, and comparative testing to demonstrate appropriate functional and performance characteristics.

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

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

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

• Sample Size: Not specified. The document mentions "Representative samples of the devices underwent bench testing."
• Data Provenance: Not applicable in the context of clinical data for AI/ML. The testing was laboratory/bench-based.

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

• Not applicable as this is not an AI/ML device requiring expert interpretation for ground truth. Testing involved engineering and analytical methods.

4. Adjudication method for the test set:

• Not applicable. Testing was based on engineering and performance standards, not expert adjudication of diagnostic outcomes.

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 is not an AI/ML device; an MRMC study is not relevant.

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

• Not applicable. This is a thrombectomy set, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for this device's evaluation would be defined by established engineering specifications, material standards, sterility standards, and functional performance benchmarks consistent with the predicate devices. It is not an "expert consensus," "pathology," or "outcomes data" in the AI/ML sense.

8. The sample size for the training set:

• Not applicable; this is not an AI/ML device.

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

• Not applicable; this is not an AI/ML device.

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The AngioJet Ultra AVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits > 3.0mm in diameter.

Each AngioJet Ultra Thrombectomy Set is a sterile, single use, disposable set that includes the Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra Thrombectomy Set is used with the AngioJet Ultra Console.

The provided text is a 510(k) summary for the AngioJet Ultra AVX Thrombectomy Set. It describes the device, its intended use, and its substantial equivalence to predicate devices, focusing on functional and safety testing. However, it does not detail specific acceptance criteria or a dedicated study with performance metrics in the format requested.

Therefore, I cannot provide the information in the requested table format regarding acceptance criteria and device performance based solely on the provided text. The document refers generally to "bench testing, including but not limited to mechanical testing, biocompatibility, sterility, comparative testing to demonstrate appropriate functional and performance characteristics." This is a broad statement and does not specify the quantitative criteria or the results of such tests.

Furthermore, the document does not contain information about:

• Sample sizes used for test sets.
• Data provenance (country of origin, retrospective/prospective).
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set (as this is not an AI/ML device per the document).
• How ground truth for the training set was established.

This document is a regulatory submission for a medical device (thrombectomy set) based on substantial equivalence to predicate devices, not an AI/ML-based device requiring detailed performance metrics and ground truth establishment in the way the prompt implies.

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The AngioJet Ultra XMI Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries ≥ 2 mm in diameter.
The AngioJet Ultra XVG Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries > 3mm in diameter.
The AngioJet Ultra Spiroflex Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from infra-inguinal peripheral arteries > 2mm in diameter.

Each AngioJet Ultra Thrombectomy Set is a sterile, single use, disposable set that includes the Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra Thrombectomy Set is used with the AngioJet Ultra Console.

I am sorry, but the provided text does not contain information about specific acceptance criteria or a study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for the AngioJet Ultra XMI, XVG, and Spiroflex Thrombectomy Sets, indicating they are substantially equivalent to previously cleared predicate devices.

The "Functional and Safety Testing" section states that "Representative samples of the devices underwent bench testing, including but not limited to mechanical testing, biocompatibility, sterility, comparative testing to demonstrate appropriate functional and performance characteristics." However, it does not provide details on:

• Specific acceptance criteria (e.g., minimum thrombus removal efficacy, max embolization rate).
• Quantitative results of these tests against acceptance criteria.
• The sample size used for the test set.
• Data provenance.
• The number or qualifications of experts.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• Type of ground truth used.
• Training set sample size or how ground truth for it was established.

Without this information, I cannot complete the table or answer the specific questions about acceptance criteria and study details.

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The AngioJet Ultra DVX Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from upper and lower extremity peripheral arteries ≥3 mm in diameter; break apart and remove thrombus from upper extremity and infra-inguinal lower extremity peripheral veins ≥3 mm in diameter; and for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

Each AngioJet Ultra DVX Thrombectomy Set is a sterile, single use, disposable set that includes the Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra DVX Thrombectomy Set is used with the AngioJet Ultra Console.

This document is a 510(k) summary for the AngioJet Ultra DVX Thrombectomy Set, which is a medical device intended to remove thrombus from peripheral arteries and veins. However, it does not contain the specific information required to complete the table and answer all questions related to acceptance criteria and study details.

Here's a breakdown of what can and cannot be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample size: Not specified. The document mentions "representative samples" for bench testing.
• Data provenance: Not specified. These are likely internal lab tests (bench testing) and not human clinical data.

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

• Not applicable. The document describes bench testing, not a study involving ground truth established by experts.

4. Adjudication method for the test set:

• Not applicable. As above, this was bench testing, not a study requiring adjudication.

5. Multi-reader multi-case (MRMC) comparative effectiveness study:

• No. The document does not mention an MRMC comparative effectiveness study. It states "comparative testing to demonstrate appropriate functional and performance characteristics" but this refers to comparison with predicate devices, not human readers with and without AI assistance.
• Effect size: Not applicable, as no such study was performed.

6. Standalone (algorithm only without human-in-the-loop performance) study:

• The device is a physical thrombectomy set used in a medical procedure, not an AI algorithm. Therefore, a standalone (algorithm only) study is not applicable. The bench testing performed could be considered a form of standalone performance evaluation for the physical device.

7. Type of ground truth used:

• For the described bench testing, the "ground truth" would be established by the physical and chemical properties measured during mechanical, biocompatibility, and sterility tests. This is not "expert consensus, pathology, or outcomes data" in the typical sense for a diagnostic device.

8. Sample size for the training set:

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

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

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

In summary:

This 510(k) notification focuses on demonstrating substantial equivalence of the AngioJet Ultra DVX Thrombectomy Set to predicate devices based on functional design, materials, indications for use, and principles of operation, supported by bench testing. It does not provide the detailed information about acceptance criteria or a study with expert-adjudicated ground truth and clinical performance metrics that would be typically found for diagnostic AI devices.

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