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The CROSSER S6 System is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions. The device is contraindicated for use in carotid arteries.

The CROSSER S6 Catheter is only intended for use with the CROSSER Electronics System. Refer to the CROSSER Electronics System Manual of Operations for proper use.

The CROSSER S6 System consists of a re-usable electronic Generator, Foot Switch, high-frequency Transducer, and single-use CROSSER S6 Catheter.

Each Catheter is connected to the electronic Generator through the Transducer. The Foot Switch is used to activate the system. The Generator and Transducer convert AC power into high-frequency mechanical vibrations which are propagated through a Nitinol core wire to the stainless steel tip of the CROSSER Catheter. The main body of the catheter is constructed from Pebax and a hydrophilic coating which covers the distal end of the catheter.

This document describes the FlowCardia CROSSER S6 System, a medical device designed to assist in navigating guidewires beyond chronic total occlusions in peripheral arteries. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone clinical study with detailed acceptance criteria and performance metrics.

Based on the provided information, a clinical study proving the device meets specific acceptance criteria in the context of human performance, as would be typical for an AI/ML device, was not conducted or reported in this 510(k) summary. This summary focuses on physical and bench testing to demonstrate substantial equivalence to previously cleared devices.

Here's an breakdown of the information that can be extracted and what is NOT available:

1. Table of acceptance criteria and reported device performance:

Note: The acceptance criteria are broadly described as meeting "relevant guidance documents" and performing "similarly to the predicate device." Specific numerical or qualitative targets for each test are not provided in this summary.

Regarding a "study that proves the device meets the acceptance criteria" in the context of an AI/ML device (which this is not) or human clinical performance, the following points are largely absent or not applicable:

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

• Not applicable for a clinical test set in this 510(k) summary. The testing documented here is primarily physical and bench testing. Animal studies were conducted with a predicate device, but no details on sample size or provenance are provided for those.

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 for this 510(k) summary. This type of information would be relevant for clinical studies involving expert interpretation, which is not the focus here.

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

• Not applicable for this 510(k) summary. Adjudication methods are typically used in clinical trials to establish ground truth for ambiguous cases, which is not 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:

• No MRMC comparative effectiveness study was done or reported. This device is a physical catheter system, not an AI/ML diagnostic tool meant to assist 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 (catheter system), not an algorithm.

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

• For the physical tests, the "ground truth" would be established by engineering specifications, material science standards, and performance characteristics of the predicate device.
• For animal studies (with the predicate device), the ground truth for safety and performance would have been established through direct observation, physiological measurements, and potentially necropsy, but no details are provided.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

• Not applicable. As above, no training set.

In summary: The provided document is a 510(k) summary for a physical medical device. It details a series of physical, bench, and biocompatibility tests designed to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating human-machine interaction or AI performance against specific clinical acceptance criteria. The acceptance criteria are generally framed as meeting relevant guidance documents and performing similarly to the predicate.

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The CROSSER® System is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions. The device is contraindicated for use in carotid arteries.

The CROSSER® Catheter is only intended for use with the CROSSER Electronics System. Refer to the CROSSER Electronics System Manual of Operations for proper use.

The CROSSER® System consists of a re-usable electronic Generator, Foot Switch, highfrequency Transducer, and single-use CROSSER Catheter. The CROSSER Over the Wire Catheter is available in two variations:

• CROSSER 14P OTW (014 guidewire compatible flexible), .
• CROSSER 14S OTW (014 guidewire compatible supportive). .

Each Catheter is connected to the electronic Generator through the Transducer. The Foot Switch is used to activate the system. The Generator and Transducer convert AC power into high frequency mechanical vibrations which are propagated through a Nitinol core wire to the Titanium tip of the CROSSER Catheter. The main body of the catheter is constructed from Pebax and a hydrophilic coating which covers the distal end of the catheter.

Here's a breakdown of the acceptance criteria and study information for the FLOWCARDIA, INC. CROSSER System, based on the provided text:

Acceptance Criteria and Device Performance

The documents do not provide a table with specific numerical or quantified acceptance criteria for each test (e.g., "Tensile Strength must be > X Newtons"). Instead, they state that the tests were conducted "to demonstrate that the FlowCardia CROSSER Over the Wire Catheters met the acceptance criteria and performed similarly to the predicate device."

Therefore, the table below reflects the types of tests performed and the general statement of meeting criteria, rather than specific performance metrics.

Study Details

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

   • The document mentions "Design analysis, bench, and biocompatibility testing," but does not specify the sample sizes for these tests.
   • The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It appears to be bench testing performed by the manufacturer.

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

   • This information is not provided. The testing appears to be primarily engineering and physical testing, not dependent on expert medical interpretation for ground truth.

3. Adjudication method for the test set:

   • This information is not provided, as the tests are physical/bench tests rather than clinical evaluations requiring adjudication of expert opinions.

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 MRMC comparative effectiveness study was done. This device is a mechanical catheter system, not an AI-powered diagnostic or assistive technology for human readers.

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

   • This question is not applicable. The device is a mechanical catheter and does not involve an algorithm for standalone performance.

6. The type of ground truth used:

   • For the physical tests, the "ground truth" would be established by engineering specifications, standard test methods, and potentially the performance of the predicate device. For biocompatibility, it would be based on established international standards (e.g., ISO 10993).

7. The sample size for the training set:

   • This question is not applicable. This device is a mechanical catheter and does not involve a "training set" in the context of machine learning or AI.

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

   • This question is not applicable for the reasons mentioned above.

Ask a specific question about this device

The CROSSER System is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions. The device is contraindicated for use in carotid arteries.

The CROSSER Catheter is only intended for use with the CROSSER Electronics System. Refer to the CROSSER Electronics System Manual of Operations for proper use.

The CROSSER System consists of a re-usable electronic Generator, Foot Switch, highfrequency Transducer, and single-use CROSSER Catheter. The CROSSER Catheter is available in three sizes:

• CROSSER 14P (014 guidewire compatible), .
• CROSSER 14S (014 guidewire compatible supportive), .
• CROSSER 18 (018 guidewire compatible). .

Each Catheter is connected to the electronic Generator through the Transducer. The Foot Switch is used to activate the system. The Generator and Transducer convert AC power into high-frequency mechanical vibrations which are propagated through a Nitinol core wire to the Titanium tip of the CROSSER Catheter. The main body of the catheter is constructed from Pebax and a hydrophilic coating which covers the distal end of the catheter.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CROSSER System, as much as can be extracted from the given document:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document heavily relies on "performed similarly to the predicate device" and "met the acceptance criteria" without explicitly stating numerical or qualitative thresholds for each specific test. This is common in 510(k) summaries where detailed raw data and specific thresholds are typically in the full submission, not the public summary.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: The document mentions "a human clinical study" but does not specify the sample size for this study.
• Data Provenance: The document does not specify the country of origin of the data. It indicates the study was a "human clinical study," implying prospective human data.

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

The document does not provide any information about experts used to establish ground truth in the clinical study, nor their number or qualifications. Given the nature of the device (facilitating guidewire placement), the primary "ground truth" would likely be successful guidewire crossing and subsequent procedural outcomes, observed and documented by the interventionalists performing the procedures.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is not an imaging AI diagnostic system that would typically involve a multi-reader study. The clinical study was designed to verify the performance of the device itself in facilitating guidewire placement.

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

This question is not applicable to the CROSSER System. The device is a physical medical device (catheter system), not a standalone algorithm. Its function is to be used with a human operator (interventionalist).

7. The Type of Ground Truth Used

The ground truth for the clinical study was likely procedural success and outcomes data. The "intended use" of the device is to facilitate guidewire placement beyond peripheral artery chronic total occlusions. Therefore, a successful outcome would be the ability to achieve this objective. This would be clinical observation by the treating physicians, rather than pathology or expert consensus on image interpretation.

8. The Sample Size for the Training Set

The document does not mention or imply a "training set" as this is not an AI/machine learning device. The design, bench, and biocompatibility testing inform the device's development (analogous to "training" in a broad sense), but there isn't a specific data set called a "training set" in the context of this traditional device submission.

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

This question is not applicable as there is no "training set" in the context of an AI/machine learning algorithm for which ground truth would be established. The "ground truth" for the device's design and manufacturing revolves around meeting established engineering, material science, and safety standards during its development.

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