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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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