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The VentiV 7Fr – 12Fr MP Mechanical Thrombectomy System and VentiV Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.

The VentiV Mechanical Thrombectomy System devices are single-use, sterile, short-term use medical devices designed to remove fresh soft emboli, debris, and thrombi from the peripheral vasculature. The System includes (1) VentiV Mechanical Aspirator and (1) VentiV 7Fr - 12Fr catheters and dilators.

Based on the provided text, the device in question is the VentiV 7Fr - 12Fr MP Mechanical Thrombectomy System. This is a medical device, not an AI/ML powered device, therefore no acceptance criteria related to AI/ML device performance (like sensitivity, specificity, AUC, human reader studies etc.) are mentioned.

The information provided describes the regulatory submission for premarket notification (510(k)) of a medical device, asserting its substantial equivalence to a legally marketed predicate device. The document details the physical and functional characteristics of the device and how they compare to the predicate, as well as the non-clinical testing performed.

Therefore, the specific information requested in the prompt about acceptance criteria and study proving AI/ML device performance (e.g., acceptance criteria for AI performance metrics, sample size for test sets, expert adjudication, MRMC studies, standalone AI performance, ground truth establishment for AI models, training set details) is not applicable to this document as it pertains to a mechanical medical device, not an AI/ML powered one.

However, I can extract the general acceptance criteria and the type of study performed to prove this mechanical device meets its intended use, based on the non-clinical testing conducted.

Acceptance Criteria and Study for the VentiV 7Fr - 12Fr MP Mechanical Thrombectomy System

Given that the device is a mechanical thrombectomy system and not an AI/ML powered device, the "acceptance criteria" discussed in this document relate to the performance and safety of the physical device compared to its predicate, rather than AI-specific metrics. The "study" refers to non-clinical bench testing.

1. Table of Acceptance Criteria (Implied) and Reported Device Performance (Non-Clinical)

While an explicit, quantifiable table of acceptance criteria for performance metrics is not provided in a format typical for AI/ML devices, the document states that all necessary verification steps met "pre-determined acceptance criteria" to demonstrate substantial equivalence. The reported performance refers to the device passing simulated use tests.

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

• Sample Size for Test Set: The document mentions "non-clinical testing" and refers to "test units" without specifying precise numerical sample sizes. This typically refers to a number of physical device units tested in a lab setting.
• Data Provenance: The data is generated from non-clinical bench testing rather than patient data. Therefore, concepts like "country of origin of the data," "retrospective," or "prospective" are not applicable. It's laboratory-generated data.

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

• Not Applicable. As this is a mechanical device, there is no "ground truth" established by experts in the context of image interpretation or clinical diagnosis. The "ground truth" for performance is based on direct physical measurements, simulations, and engineering specifications.

4. Adjudication Method for the Test Set:

• Not Applicable. There is no "adjudication" in the sense of reconciling expert opinions for a test set, as this is bench testing of a physical device. Performance is objectively measured against specifications.

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

• No. An MRMC study is not mentioned because this is a mechanical device, not an AI/ML diagnostic system intended to assist human readers with interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Not Applicable. This is a mechanical medical device, not an algorithm, so independent algorithmic performance is not relevant.

7. The Type of Ground Truth Used:

• For this mechanical device, the "ground truth" for performance and substantial equivalence is established through:
  • Bench Testing: Direct physical measurements, engineered simulations (e.g., simulated vessels, simulated thrombi), and performance against predefined engineering specifications.
  • Regulatory Standards: Compliance with relevant international standards (e.g., ISO 10993 for biocompatibility) and FDA guidance for medical device testing.
  • Predicate Device Performance: The predicate device itself serves as a "ground truth" benchmark for demonstrating substantial equivalence in function and safety.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device that requires a "training set" of data.

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

• Not Applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.

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The Aspire Aspirator G is a piston syringe to inject fluids into, or aspirate fluids from, the body.

The Subject Device is a single-use, hand-held, and general-purpose aspirator configured with a barrel, plunger, and handles. The front handle is pivotally connected the back handle and distally connected to the barrel. The back handle is pivotally connected to the front handle and distally connected to the plunger. Squeezing the handles creates a mechanical advantage to move the plunger inside the barrel. The handle design also prevents the plunger from being pulled completely out of the barrel during use. The main difference between the Subject Device and the Predicate is the addition of a basic off-the-shelf pressure gauge and change from a one-piece to two-piece button between the handles.

Here's a breakdown of the acceptance criteria and study information for the Aspire Mechanical Aspirator G based on the provided FDA 510(k) summary:

The document describes non-clinical (bench) testing to demonstrate substantial equivalence to a predicate device, rather than a clinical study of AI performance. Therefore, many of the requested categories related to AI performance, human readers, and ground truth establishment (which are typically relevant for AI/ML device submissions) are not applicable here.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by confirming the Subject Device performs the same as the Predicate device across various bench tests. The reported performance is that the Subject Device confirms to these tests.

Study Details (Non-Clinical Bench Testing)

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

   • Sample Size: Not explicitly stated in the provided document. The tests listed are standard for medical devices of this type and would typically involve a statistically relevant number of units, but the specific quantity is not given.
   • Data Provenance: Not applicable as this is bench testing of physical device performance, not data-driven AI. The tests confirm manufacturing standards and device functionality.

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

   • Not applicable. This is a physical device, and performance is measured against established engineering standards (e.g., ISO, ASTM, MIL-STD) and predicate device performance, not expert human interpretation.

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

   • Not applicable. This is objective bench testing against measurable standards, not subjective human assessment requiring adjudication.

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

   • No. This is a mechanical aspirator, a physical medical device, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant.

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

   • Not applicable. This is a physical device; there is no algorithm or AI component. The "standalone" performance here refers to the device itself operating according to its design specifications.

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

   • The "ground truth" for this type of device is defined by engineering specifications and recognized industry standards (e.g., ISO, ASTM, MIL-STD) for performance characteristics like leakage, force, and sterilization efficacy. The predicate device's established performance also serves as a benchmark for equivalence.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device requiring a training set.

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

   • Not applicable, as there is no training set for an AI/ML model.

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The Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspirator is indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.

The Subject Device includes (1) Aspire Aspirator and (1) MAX 7F - 11F Catheter. Subject Device and the Predicate are single-use, sterile, and short-term use medical devices designed to remove fresh soft emboli, debris, and thrombi from the peripheral vasculature. The Subject Device's Intended Use and Fundamental Scientific Principle are the same as the Predicate. The Predicate and Subject Device are the same in the way they are inserted into the body over a guidewire and advanced to the target arterial or venous peripheral vascular anatomy. The Subject Device and Predicate share the same core Aspirator to create thrombectomy force. MAX 7 - 11F Catheters may be connected to basic syringes and other aspiration pumps. Aspire Mechanical Aspirators may be connected to other catheters. The Subject Device does not add any new materials or manufacturing processes to the manufacturing process.

The provided FDA 510(k) summary for the Aspire MAX 7-11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator primarily focuses on establishing substantial equivalence to a predicate device through non-clinical testing. It explicitly states that clinical testing was not required for this determination. Therefore, a study demonstrating the device meets acceptance criteria through clinical performance (like an MRMC study or standalone AI performance) and an associated table of acceptance criteria with reported performance are not present in this document.

The document discusses non-clinical testing which confirmed the device meets specifications and intended use. However, it does not provide specific acceptance criteria or detailed performance metrics from these non-clinical tests in a format that lends itself to the requested table. The summary states:

"Non-clinical testing in this Submission confirms the Subject Device passes simulated use tracking. simulated aspiration, and simulated thrombectomy in the peripheral vasculature with test units accelerated aged up to 3-years. Accordingly, non-clinical testing confirms the Subject Device meets specifications, intended use, demonstration of claims, and equivalence to Predicate."

Based on the provided document, here's what can be extracted regarding acceptance criteria and the study:

Since the document explicitly states "Clinical testing is not required for the determination of substantial equivalence," and focuses on non-clinical testing, much of the requested information (like sample size for test sets, ground truth establishment, expert qualifications, MRMC studies, standalone AI performance) is not applicable or detailed in this submission.

Regarding the requested information:

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

The document mentions that non-clinical testing confirmed the device "meets specifications, intended use, demonstration of claims, and equivalence to Predicate." However, specific quantitative acceptance criteria and their corresponding reported performance values from these non-clinical tests are not provided in this public summary. For example, it doesn't state "Aspiration force must be > X N; achieved Y N."

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

• Test set: Not explicitly stated for non-clinical tests in terms of specific numbers of devices or simulated scenarios. It refers to "test units accelerated aged up to 3-years."
• Data Provenance: Not applicable as this is non-clinical/simulated data, not patient 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 for non-clinical, simulated tests would be based on engineering specifications and physical measurements, not expert human interpretation.

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

• Not applicable for non-clinical testing.

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. The document explicitly states "Clinical testing is not required for the determination of substantial equivalence." MRMC studies are associated with clinical performance evaluation, particularly for imaging devices involving human interpretation, which is not the case here.

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 AI algorithm.

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

• For the non-clinical tests, the "ground truth" would be the engineering specifications, physical principles, and laboratory measurements confirming the device's mechanical capabilities (e.g., aspiration force, tracking ability, thrombectomy effectiveness in simulated environments).

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a "training set."

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

• Not applicable.

In summary, the provided document is a 510(k) summary for a mechanical device, not an AI/imaging device. As such, the detailed information typically requested for AI performance studies (like MRMC, standalone AI, training/test sets, expert adjudication) is not found here because it's not relevant to this type of submission. The primary "proof" of meeting acceptance criteria for this device, as presented, is through successful completion of non-clinical, simulated performance tests demonstrating its equivalence to a predicate device and adherence to engineering specifications.

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The Aspire RX-LP6 Aspiration Catheter and Aspirator are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

An "Aspire RX-LP6 Aspiration Catheter" includes (1) RX-LP6 Aspiration Catheter and (1) Aspire Aspirator 30ml.

• Aspire RX-LP6 Aspiration Catheters (RX-LP6 Aspiration Catheter and Aspire Aspirator): 6F -Guide Cath compatible rapid exchange catheter with 4.8mm long distal aspiration opening, 1.0mm wide distal and 1.1mm wide proximal aspiration lumen, 0.054" outer diameter (OD) single lumen aspiration shaft, and removable stylet.
• Aspire Aspirator 30ml. -

Aspire RX-LP6 Aspiration Catheters are single-use, sterile, short-term use, and non-pyrogenic medical devices designed for use with piston syringes to remove fresh, soft emboli and thrombi from the peripheral and coronary vasculature. The Aspire RX-LP6 Aspiration Catheter operating and scientific principle is the same as predicate devices. The catheter is inserted into the body over a guidewire and through a sheath or guide catheter to the target anatomy. A syringe is then connected to the catheter and the aspiration is manually created with the syringe.

Similar to predicate devices, industry standard intravascular catheter components and materials are used:

• -Clear proximal polycarbonate female luer lock,
• Stainless steel core wire. -
• Clear Main Shafts, -
• Embedded platinum iridium radiopaque marker, -
• Clear polycarbonate barrel piston syringe. -

Aspire RX-LP6 Aspiration Catheters do not add any new materials, or manufacturing processes to the manufacturing process.

Same as predicates, all RX-LP6 Aspiration Catheters may be connected to piston syringes including the Aspire Mechanical Aspirator. Aspirators may be connected to other catheters to aspirate fluids and thrombus.

Here's a breakdown of the acceptance criteria and study information for the Aspire RX-LP6 Aspiration Catheter, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary primarily focuses on confirming the device's equivalence to predicate devices and adherence to recognized standards. It doesn't explicitly list numerical acceptance criteria with corresponding performance metrics for all tests in a single table, but rather states that the device "passes all testing and meets specifications." For some categories, it lists the types of tests performed.

Here's an aggregated table based on the non-clinical testing section:

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

• Sample Size for Test Set: The document does not specify the exact sample sizes used for each non-clinical test. It generally states that "testing confirms the suitability" and "subject devices passed all biocompatible tests," implying sufficient samples were used for each test performed.
• Data Provenance: The data is from non-clinical testing (bench testing, in vitro testing, etc.) conducted by the manufacturer, Control Medical Technology, LLC. It appears to be prospective for the device being evaluated, as it describes tests specifically performed on the Aspire RX-LP6 Aspiration Catheter. There is no mention of country of origin for the data for these specific tests, but the company is US-based (Utah).

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

This information is not applicable as the study did not involve human interpretation or subjective assessment that would require "experts" to establish ground truth. The "ground truth" for non-clinical tests is based on objective measurements and established scientific standards/methods.

4. Adjudication Method for the Test Set

This information is not applicable as the testing was non-clinical and did not involve human adjudication for a test set.

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 information is not applicable. The device is an aspiration catheter, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.

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

This information is not applicable. The device is a physical medical device (catheter and aspirator), not an algorithm or software. Its performance is evaluated through non-clinical bench testing and in vivo aspiration, rather than as a standalone algorithm.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical tests was established by:

• Objective Measurements: Such as dimensional inspections, force measurements (tensile strength, kink, torque), and aspiration volumes/effectiveness.
• Established Scientific Standards and Guidance: Adherence to ISO standards (e.g., ISO 10555-1, ISO 7886-1, AAMI/ANSI/ISO 11135, ISO 10993 series) and USP standards (e.g., USP , USP ), which define acceptable performance parameters and test methodologies.
• Comparison to Predicate Devices: Performance was also deemed acceptable by demonstrating equivalence to "currently marketed Pronto, Export, and Xpress-Way aspiration systems" based on comparable results in aspiration efficacy and other performance characteristics.

8. The Sample Size for the Training Set

This information is not applicable. The Aspire RX-LP6 Aspiration Catheter is a physical medical device, not an AI model requiring a training set.

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

This information is not applicable for the same reason as above; there is no training set for a physical medical device.

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The Aspire MAX 5 and MAX 6 Aspiration Catheters and Aspirator are indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.

An Aspire MAX Aspiration Catheter includes (1) Aspire MAX 6 Aspiration Catheter and (1) Aspirator 30ml. Aspire MAX Aspiration Catheters and MAX Aspiration Catheters are single-use, sterile, short-term use, and non-pyrogenic medical devices designed for use with manually operated piston syringes to remove fresh, soft emboli and thrombi from the peripheral and coronary vasculature. The Aspire MAX Aspiration Catheter operating and scientific principle is the same as predicate devices. The catheter is inserted into the body over a guidewire and through a sheath or guide catheter to the target anatomy. A piston syringe is then connected to the catheter and the aspiration is manually created with the piston syringe.

Similar to predicate devices, industry standard intravascular catheter components and materials are used:

• Clear proximal polycarbonate female luer lock,
• -Stainless steel braid,
• Clear Pebax and Vestamid Shafts, -
• -Embedded platinum iridium radiopaque marker,
• Clear polycarbonate barrel piston syringe. -

Aspire MAX Aspiration Catheters do not add any new materials, manufacturing processes, colorants, or dyes to the manufacturing process.

Same as predicates, all MAX Aspiration Catheters may be connected to piston syringes including the Aspire Aspirator. Aspirators may be connected to other aspiration catheters.

The provided document is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for the Aspire MAX Aspiration Catheter. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device's absolute safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval) device. Therefore, the information provided for acceptance criteria and study that proves the device meets the acceptance criteria is framed within the context of substantial equivalence testing and non-clinical performance, rather than a clinical study with human patients.

Based on the document, here's a breakdown of the requested information:

Acceptance Criteria and Device Performance (Non-Clinical)

The document does not present a formal table of "acceptance criteria" with specific quantitative thresholds for clinical performance metrics (e.g., sensitivity, specificity, or clinical outcome improvements). Instead, the acceptance criteria are implicit in demonstrating substantial equivalence to legally marketed predicate devices through a series of non-clinical tests and comparisons of design, materials, and operating principles.

The "Device Performance" is demonstrated by passing these non-clinical tests, indicating the device functions as intended and is comparable to predicate devices.

Table of Comparison (derived from the document):

Study Details:

This submission relies on non-clinical testing to demonstrate substantial equivalence, not a clinical study. Therefore, some of the requested information (like expert consensus for ground truth or MRMC studies) is not applicable in this context.

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

   • The document does not explicitly state "sample sizes" in terms of number of devices tested for each non-clinical test. It states "Non-clinical testing confirms the Aspiration Catheters and Aspirator passes all testing and meets specifications."
   • Data Provenance: The tests were conducted as part of the regulatory submission process for the device manufacturer, Control Medical Technology. The location of the testing facilities (e.g., Ethox and Nelson Labs mentioned for biocompatibility) would likely be in the US, but this is not explicitly stated as the origin of data.
   • Retrospective or Prospective: The testing was prospective, specifically conducted for this 510(k) submission.

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

   • Not applicable. This was a non-clinical testing submission for substantial equivalence. "Ground truth" in this context refers to the defined specifications and parameters of the tests (e.g., tensile strength, aspiration volume, particulate limits) which are derived from industry standards (e.g., ISO, AAMI) and predicate device characteristics, not expert clinical consensus on patient data.

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

   • Not applicable. As this was non-clinical testing, there was no adjudication of expert opinions. Test results are objectively measured against defined 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 is a medical device (catheter and aspirator), not an AI/imaging device, and no clinical study was performed. The concept of "human readers" and "AI assistance" is not relevant to this submission.

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

   • Not applicable. This is a physical medical device.

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

   • The "ground truth" for this 510(k) submission is established by engineering specifications, performance metrics derived from industry standards (ISO), and the characteristics of predicate devices that have already been legally marketed. For example, catheter dimensions, material properties, aspiration volume, and leak integrity are measured and compared against established parameters or the performance of predicate devices.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that involves a training set. The device design and manufacturing process are established through engineering and validated through non-clinical testing.

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

   • Not applicable. No training set was involved.

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