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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 FlowCardia FlowMate Injector is intended for use as a sterile saline injector for use as an accessory to the FlowCardia CROSSER CTO Recanalization System.

The FlowMate Injector is a sterile saline injector intended to be used as an accessory to the CROSSER CTO Recanalization System. The CROSSER System consists of a Generator, footswitch, and disposable catheter. The FlowMate Injector is designed to infuse saline at a rate of 0.3ml/sec (18 ml/min) at a maximum back pressure of 200 PSI. The FlowMate Injector is compatible for use with a 150ml disposable sterile syringe and is operated by a footswitch. A jumper cable is supplied with the FlowMate Injector to allow connection to the CROSSER System Generator. The FlowMate Injector is programmed to first start the Injector, and then the CROSSER System Generator each time the footswitch is depressed.

The provided text describes the FlowCardia FlowMate Injector, an accessory intended for use with the FlowCardia CROSSER CTO Recanalization System as a sterile saline injector.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific quantitative thresholds. Instead, it describes a comparative bench testing approach to demonstrate substantial equivalence to a predicate device.

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

The document refers to "comparative bench testing" and lists several functional and safety tests. However, it does not specify the sample size used for these tests. The data provenance is described as "bench testing," indicating laboratory-based studies rather than patient data. No information on country of origin for data is provided, but since it's bench testing, it's typically conducted internally or by a contracted lab. The studies would be considered prospective in nature, as they were conducted specifically for this submission.

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 studies described are bench tests of a physical device's performance (e.g., flow rate, pressure, electrical safety) rather than studies requiring expert interpretation of medical data (like radiology images or pathology slides) to establish "ground truth." The "truth" in these tests is objective measurement against specified parameters.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3. Bench testing of device performance does not typically involve adjudication methods like those used for interpreting medical images or clinical outcomes.

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 study described is a bench performance evaluation, not a clinical study involving human readers.

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

This question is not applicable in the context of this device. The FlowMate Injector is a physical medical device, not an algorithm or AI system that would have a "standalone" algorithmic performance. The tests performed are of the device's functional and safety characteristics.

7. The Type of Ground Truth Used

The "ground truth" for the bench tests consisted of objective engineering specifications and measurements (e.g., whether the device infused saline at 0.3ml/sec, whether it withstood 200 PSI, electrical safety standards compliance). It does not involve expert consensus, pathology, or outcomes data, as it's a non-AI, non-diagnostic device.

8. The Sample Size for the Training Set

This information is not applicable. The FlowMate Injector is not an AI/ML device, and therefore does not have a "training set."

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

This information is not applicable for the same reason as point 8.

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The CROSSER® System is indicated in coronary arteries to facilitate the intra-luminal placement of conventional guidewires beyond chronic total occlusions.

The CROSSER® System consists of a re-usable electronic Generator, Foot Switch, high-frequency Transducer, and single-use CROSSER 14 Over the Wire Catheter.

The CROSSER 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.

The provided text describes a medical device, the FlowCardia CROSSER 14 Over the Wire Catheter, and its 510(k) submission for demonstrating substantial equivalence to a predicate device. However, it does not describe an AI/ML-driven device or a study involving AI for diagnostic or predictive purposes. Therefore, most of the requested information regarding AI acceptance criteria, training/test sets, expert ground truth, MRMC studies, or standalone algorithm performance is not applicable based on the provided text.

The document primarily focuses on physical testing and substantial equivalence to a physical predicate device, not an AI algorithm.

Here's a breakdown of the information that can be extracted from the provided text, and where the requested information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text generally states that the device met acceptance criteria, but it does not detail specific quantitative acceptance criteria or their corresponding performance results in a tabular format as would be typical for an AI/ML device. Instead, it lists functional tests and a general conclusion of similarity to the predicate device.

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

• Test Set Sample Size: Not applicable. This document describes physical device testing, not a dataset for an AI/ML model. The tests listed (Tensile Strength, Torque Strength, etc.) would involve a sample of physical catheters, but the exact number for each test is not specified.
• Data Provenance: Not applicable. This is not a study using clinical data or images. The "data" comes from bench testing of the physical device.

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 studies (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for the physical tests would be established by engineering specifications and industry standards.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of expert opinions or classifications.

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 document does not describe an AI device or a study involving human readers.

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

Not applicable. This document is about a physical medical device, not an algorithm.

7. The type of ground truth used

For the physical tests, the "ground truth" would be engineering specifications, established testing protocols, and comparison to the predicate device's measured performance in similar tests.
(e.g., "Tensile Strength" would be measured by a machine to a specified breaking point).

8. The sample size for the training set

Not applicable. There is no AI/ML training set in this context.

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

Not applicable. There is no AI/ML training set in this context.

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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.

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The MicroSheath LP is a single lumen catheter intended to create a pathway for other devices in the coronary or peripheral vasculature.

The FlowCardia MicroSheath LP a single lumen catheter, 123 cm in length, with a standard luer fitting at the proximal end. The catheter is available in two tip shapes, straight and angled. The distal tip is atraumatic to help facilitate vessel navigation. A single radiopaque marker on the straight version of the MicroSheath LP and five radiopaque markers on the angled version aid in fluoroscopic visualization. The MicroSheath LP is 6F Sheath/7Fr Guide compatible.

The provided text describes a 510(k) summary for the FlowCardia MicroSheath LP Catheters, comparing it to a predicate device, the VP Sheath. The text focuses on establishing substantial equivalence rather than a clinical study with human readers or AI. Therefore, much of the requested information (e.g., sample sizes for training/test sets, expert qualifications, MRMC studies, human reader improvement with AI) is not applicable or cannot be extracted from this document.

Here's the information that can be extracted or deduced from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document primarily states that the device "met the acceptance criteria and performed similarly to the predicate devices" without explicitly listing numerical acceptance criteria for each test. The acceptance criteria are largely implied as being "similar to" or "equivalent to" the predicate device and meeting relevant guidance documents for safety and efficacy.

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

• Sample Size for Test Set: Not applicable or not specified. The study involved bench testing and design analysis, not a clinical test set with patient data.
• Data Provenance: Not applicable, as no human data or clinical study is described. The tests are physical and bench-based.

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

• Number of Experts & Qualifications: Not applicable. The ground truth for engineering and material performance tests is established through objective measurements and accepted engineering standards, not expert consensus on interpretations.

4. Adjudication method for the test set

• Adjudication method: Not applicable. There was no clinical test set requiring adjudication. The evaluation was based on objective physical and mechanical 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

• MRMC Study: No. This document describes the 510(k) clearance process for a physical medical device (catheter), not an AI-powered diagnostic or imaging device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

• Standalone Study: No. This is not an algorithm or AI device.

7. The type of ground truth used

• Ground Truth Type: For the physical tests, the "ground truth" would be the objective measurements of the device's physical properties (e.g., tensile strength in Newtons, precise dimensions, flexibility measurements) and their comparison to established engineering standards, regulatory requirements, and the characteristics of the predicate device. For biocompatibility, it would be compliance with biological safety standards.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. There is no AI or machine learning component described, so no training set was used.

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

• Training Set Ground Truth: Not applicable, as there was no training set.

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The CROSSER LP System is indicated in coronary arteries to facilitate the intra-luminal placement of conventional guidewires beyond chronic total occlusions.

The CROSSER System consists of a re-usable electronic Generator, Foot Switch, highfrequency Transducer, and single-use CROSSER LP 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 LP Catheter. The main body of the catheter is constructed from Pebax and a hydrophilic coating which covers the distal end of the catheter.

The provided document is a 510(k) summary for the FlowCardia CROSSER LP System, a medical device used to facilitate the placement of guidewires beyond chronic total occlusions in coronary arteries. It primarily focuses on demonstrating substantial equivalence to a predicate device through physical and functional testing, rather than an AI-powered diagnostic system.

Therefore, many of your requested categories are not applicable to the information contained within this document. The document describes a traditional medical device (catheter system), not an AI algorithm.

Here's a breakdown of the applicable and non-applicable information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines functional tests performed, which serve as the acceptance criteria for the device's performance. However, it does not provide a table format with specific numerical acceptance criteria and a corresponding numerical reported performance for each test. Instead, it states that "the FlowCardia CROSSER LP System met the acceptance criteria and performed similarly to the predicate device."

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

• Test Set Sample Size: Not explicitly stated for each functional test. The document mentions "Design analysis, bench, and biocompatibility testing were conducted."
• Data Provenance: Not applicable in the context of an AI study. These are bench and lab tests, not clinical data sets from specific countries.

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

• Not Applicable. This device is proven through physical and functional testing, not through expert-labeled data sets for an AI algorithm.

4. Adjudication Method for the Test Set:

• Not Applicable. Again, this refers to expert consensus for AI ground truth, which is not relevant here.

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

• No. This type of study is for evaluating human readers with and without AI assistance. The FlowCardia CROSSER LP System is a physical medical device.

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

• Not Applicable. This is not an AI algorithm.

7. Type of Ground Truth Used:

• For the functional and bench tests, the "ground truth" is defined by the engineering specifications and performance requirements for a catheter system.
• Animal studies were also conducted "to establish initial safety and performance," which serves as an in-vivo form of ground truth for safety and general performance.

8. Sample Size for the Training Set:

• Not Applicable. This is not an AI algorithm requiring a training set.

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

• Not Applicable. This is not an AI algorithm.

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The MicroSheath XL is a single lumen catheter intended to create a pathway for other devices in the peripheral vasculature.

The FlowCardia MicroSheath™ XL is a single lumen catheter that is available in four lengths: 53cm, 73cm, 93cm or 123cm, and three different tip configurations: vertebral, internal mammary artery, and multipurpose. All MicroSheath XL catheters have a standard lucr fitting at the proximal end. A radiopaque distal tip aids in fluoroscopic visualization. The distal tip is atraumatic to help facilitate vessel navigation. The MicroSheath XL is also 7F Sheath compatible.

The provided text is a 510(k) summary for the FlowCardia MicroSheath XL Catheters. It details the device's design, intended use, and its substantial equivalence to predicate devices, rather than a study with acceptance criteria and device performance in the context of an AI/algorithm or similar medical device.

Therefore, the requested information elements related to AI/algorithm performance, ground truth establishment, expert adjudication, MRMC studies, standalone performance, and sample sizes for test/training sets are not applicable to this document.

However, I can extract the information that is relevant to the "acceptance criteria" and "study" as presented in this 510(k) summary for a traditional medical device.

Acceptance Criteria and Study for FlowCardia MicroSheath XL Catheters

The FlowCardia MicroSheath XL Catheters demonstrate substantial equivalence to predicate devices through various physical and bench test data, rather than clinical study data with statistical acceptance criteria as would be found for an AI model.

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable for this type of device and submission. The "test set" here refers to physical devices undergoing bench testing. The data provenance is from internal FlowCardia, Inc. testing.

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

Not applicable. Ground truth for physical tests is established by engineering specifications and direct measurement, not expert review.

4. Adjudication Method for the Test Set

Not applicable. Physical tests follow defined protocols; there is no expert adjudication process.

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 is not an AI/algorithm-based device.

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

Not applicable. This is not an AI/algorithm-based device.

7. The Type of Ground Truth Used

For physical tests, the "ground truth" is based on:

• Engineering specifications and design requirements.
• Measurements and observations against established standards and predicate device performance.

8. The Sample Size for the Training Set

Not applicable. This device does not use a "training set" in the context of machine learning.

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

Not applicable. This device does not use a "training set."

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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 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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The CROSSER System is indicated in coronary arteries to facilitate the intra-luminal placement of conventional guidewires beyond chronic total occlusions.

The CROSSER System consists of a re-usable electronic Generator, Foot Switch, high frequency Transducer, and single-use CROSSER 14 Catheter. The CROSSER 14 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 14 Catheter. The main body of the catheter is constructed from Pebax and a hydrophilic coating which covers the distal 90cm of the catheter.

The provided text describes the FlowCardia CROSSER System and its 510(k) submission (K062868). It primarily focuses on demonstrating substantial equivalence to a predicate device, the Intraluminal Therapeutics (ILT) Safe-Cross System, through technological characteristics, physical test data, and clinical study data.

However, the document does not contain specific acceptance criteria, detailed device performance metrics, or the full study design typically expected for a comprehensive report on device performance against acceptance criteria. It mentions that "the FlowCardia CROSSER System met the acceptance criteria and performed similarly to the predicate device" in physical tests and that a "clinical study... demonstrated substantially equivalent safety and effectiveness," but it does not elaborate on what those criteria were or the specific results.

Therefore, much of the requested information cannot be extracted directly from the provided text. I will provide what can be inferred or explicitly stated.

Acceptance Criteria and Device Performance Study Data - FlowCardia CROSSER System (K062868)

The provided 510(k) summary indicates that various tests were conducted to demonstrate the substantial equivalence of the FlowCardia CROSSER System to its predicate device. While it states that the system "met the acceptance criteria," it does not specify what those acceptance criteria were in quantitative terms for most of the tests. Similarly, detailed device performance metrics are not reported.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document states that the device "met the acceptance criteria" but does not explicitly define these criteria or report specific performance values against them. The information below is inferred from the types of tests mentioned.

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

• Sample Size for Test Set: Not specified in the provided text. The document only mentions "clinical study of the FlowCardia CROSSER System" without detailing the number of patients or cases.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective nature). The text simply refers to a "clinical study."

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

This information is not provided in the given text.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

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

This information is not provided in the given text. The study mentioned is a "clinical study" to demonstrate substantial equivalence, but it's not described as an MRMC study comparing human readers with and without AI assistance. The device itself is a percutaneous catheter, not an AI-powered diagnostic tool.

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

This information is not applicable as the device is a physical medical instrument (percutaneous catheter), not an algorithm or AI system for standalone performance evaluation without human intervention. The "Generator" is an electronic component that powers the catheter, not a diagnostic algorithm.

7. Type of Ground Truth Used

For the "clinical study," the ground truth would likely be based on clinical outcomes (e.g., successful crossing of chronic total occlusions, patient safety, absence of major adverse cardiac events) as assessed by interventional cardiologists or relevant medical professionals during the procedure and follow-up. However, the specific method for establishing this ground truth (e.g., expert consensus, pathology, long-term outcomes data) is not detailed in the provided text.

8. Sample Size for the Training Set

This information is not applicable as the device is a physical medical instrument and not an AI/machine learning model that requires 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 (not an AI/ML model).

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