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SoundBite™ Crossing System - Peripheral is indicated to facilitate the intra-luminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions. The SoundBite™ Crossing System -Peripheral is not intended for use in the carotid arteries.

The SoundBite™ Crossing System - Peripheral is a recanalization tool, designed to help physicians place conventional guidewires or treatment devices in the intraluminal space beyond chronic total occlusions in the peripheral vasculature. The SoundBite™ Crossing System - Peripheral consists of the reusable mobile SoundBite™ Console, the single-use sterile SoundBite™ Active Wire 18, and their accessories.

The SoundBite™ Console generates controlled mechanical pulses (i.e., shock waves) which are transmitted to the SoundBite™ Active Wire 18 and cause the distal tip of the wire to accelerate axially in a reciprocating motion, acting like a micro-jackhammer.

The SoundBite™ Active Wire 18 is similar in construction to other commercially available CTO crossing wires, with friction reducing PTFE coating (except for the distal tip), a radiopaque marker near the tip, and enhanced flexibility at the distal end. It has an outer diameter of 0.46 mm (0.018") and it is 300 cm long, with a working length of 150 cm; the proximal end flares up to a larger diameter for connection to the console. The single-use SoundBite™ Active Wire 18 is supplied sterile with a shelf life of 24 months.

Here's an analysis of the acceptance criteria and study findings for the SoundBite™ Crossing System - Peripheral, based on the provided document:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria in a table format with pre-defined thresholds for performance metrics. However, it reports the primary and secondary endpoints observed in the clinical study, which implicitly serve as the performance measures. The primary endpoint was technical success of the device.

Based on the study summary, here's a representation of the reported performance:

Study Details

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

   • Test Set Sample Size: 52 patients.
   • Data Provenance: The document states it was a "single-arm clinical study involving 52 patients with documented symptomatic infrainguinal chronic total occlusions (CTO)." It does not specify the country of origin, but given the submission is to the US FDA and the company is based in Canada, it's likely a multi-national or North American study. The study is prospective in nature as it involved actively evaluating the device in clinical conditions.

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

   • The document mentions "independent physician adjudication" for adverse events but does not specify the number or qualifications of experts used to establish the ground truth (e.g., initial diagnosis of CTO or assessment of technical success) for the main efficacy endpoints. The "ground truth" for CTO diagnosis was "confirmed angiographically."

3. Adjudication method for the test set:

   • The document explicitly mentions "independent physician adjudication" for adverse events. For the primary and secondary efficacy endpoints, the method details are not provided.

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, an MRMC comparative effectiveness study was not done. This device is a medical instrument (crossing system for CTOs), not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of human readers improving with or without AI assistance is not applicable here.

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

   • Not applicable. This device is a physical medical instrument requiring human operation, not a standalone algorithm.

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

   • CTO diagnosis: Confirmed angiographically.
   • Technical Success: Defined as the ability to facilitate the treatment of target lesions by allowing additional crossing and/or treatment devices to cross the CTO. This would be based on procedural success documented by the operating physician and confirmed radiographically.
   • Adverse Events: Based on clinical observation and "independent physician adjudication."
   • Secondary Endpoints: Based on procedural and post-procedural clinical/radiographic observation.

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not an AI model requiring a training set in the conventional sense. The "training" of the device's design and manufacturing processes comes from extensive bench, animal, and usability testing.

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

   • Not applicable. As the device is not an AI model, a "training set" with ground truth as commonly understood for AI is not relevant. The device development involved design verification and validation testing, risk assessment, and comparison to reference devices through bench and animal testing. These processes validate technical specifications and safety rather than "train" an algorithm.

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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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