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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 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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