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Balloon dilatation of the femoral, popliteal and infra popliteal arteries. These catheters are not designed to be used in the coronary arteries.

The ReeFlex™ is a balloon dilation catheter for angioplasty. It consists of a stainless steel guidewire shaft that extends from the proximal hub to the distal tip of the catheter. This stainless steel shaft has a spiral cut positioned at its distal end. The spiral cut is laser cut. A heat shrinkable layer is used to seal the spiral cut and ensure that the contrast solution remains in the inflation lumen only and does not leak into the guidewire lumen. This bodybond material is fused onto the outside diameter of the stainless steel shaft. A copolymer inflation lumen extends from the proximal hub of the catheter to the proximal shoulder of the balloon. The lumen of the shaft is used for the purpose of inflating and deflating the balloon. This outer is thermally fused to the balloon's proximal shoulder.

The balloon material is a Nylon blend. Low profile radiopaque bands are used to locate the balloon under fluoroscopy. These bands are swaged onto the bodybond material sealing the spiral cut section of the guidewire lumen.

This document describes the testing and conclusions for the ClearStream Technologies Ltd. ReeFlex over the wire Peripheral Transluminal Angioplasty (PTA) Catheter, seeking substantial equivalence to its predicate device, the ReeKross.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comprehensive in vitro testing performed according to FDA guidance documents and ISO standards, with the goal of demonstrating comparable performance to the predicate device. Specific numerical acceptance criteria are not explicitly stated in the provided text, but the conclusion states that the "technological characteristics and performance criteria of the ReeFlex PTA catheter are comparable to the predicate devices."

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

• Sample Size: Not explicitly stated. The document mentions "numerous device similarities" and that "VP 462 and VP 563 were carried out on the ReeFlex." However, the exact number of devices tested for each in vitro test is not provided.
• Data Provenance: The testing was "in vitro," meaning it was conducted in a laboratory setting. No information on country of origin of data or whether it was retrospective/prospective is applicable for in vitro testing.

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

Not applicable. The described testing is in vitro (bench testing) and does not involve human subjects or expert assessment for ground truth. The "ground truth" for these tests would be the established engineering and performance specifications for PTA catheters.

4. Adjudication Method for the Test Set

Not applicable. This was in vitro bench testing; there was no need for expert adjudication.

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

No. This document describes in vitro bench testing for a medical device (PTA catheter), not an AI or imaging-related product that would typically undergo an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is not an algorithm or AI product.

7. The Type of Ground Truth Used

The ground truth implicitly used for the in vitro testing is the established performance specifications and safety standards for PTA catheters, as well as the performance characteristics of the legally marketed predicate device (ReeKross). The comparison is against these pre-defined engineering and regulatory benchmarks.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable. There is no training set for this device.

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Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.

The ReeKross family of over the wire PTA catheters are a balloon dilation catheter for angioplasty. They consist of a stainless steel guidewire shaft that extends from the proximal hub to the distal tip of the catheter. This stainless steel shaft has a spiral cut positioned at its distal end. The spiral cut is laser cut and passivated following completion. A polymer bodybond material is used to seal the spiral cut and ensure that the contrast solution remains in the inflation lumen only and does not leak into the guidewire lumen. This bodybond material is fused onto the outside diameter of the stainless steel shaft. A copolymer inflation lumen extends from the proximal hub of the catheter to the proximal shoulder of the balloon. The lumen of the shaft is used for the purpose of inflating and deflating the balloon. This outer is thermally fused to the balloon's proximal shoulder.

The balloon material is a Nylon/Pebax blend. Low Profile Platinum Radiopaque bands are used to locate the balloon under fluoroscopy. These bands are swaged onto the bodybond material sealing the spiral cut section of the guidewire lumen.

The provided document is a 510(k) Premarket Notification for the ClearStream Technologies PTA Catheters, seeking substantial equivalence to a predicate device. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving its safety and effectiveness through clinical trials with specific acceptance criteria as you might see for a novel device or a Premarket Approval (PMA) application.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria, specific study designs (like multi-reader multi-case studies), ground truth establishment, or sample sizes for diagnostic performance metrics that are typical for AI/ML device evaluations.

Here's a breakdown of why the requested information isn't present and what the document does provide:

1. A table of acceptance criteria and the reported device performance:

   • Not Applicable. This submission demonstrates substantial equivalence to a predicate device (Savvy Long, K072947) based on "intended use, design characteristics and general physical characteristics." There are no explicit quantitative acceptance criteria or reported performance metrics (e.g., sensitivity, specificity, accuracy) for the device's diagnostic or clinical performance mentioned. The document states, "Performance testing and compliance with recognized standards have established substantial equivalence with regard to safety and effectiveness," implying a battery of engineering and bench tests, but no specific clinical performance targets.

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. The document describes an angioplasty catheter, which is a medical device used for intervention, not an AI/ML diagnostic algorithm. Therefore, there's no "test set" of data in the context of an AI/ML algorithm's evaluation. The "testing" referred to is likely engineering verification and validation (V&V) related to the physical and functional aspects of the catheter, not a dataset for an algorithm.

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. As above, there's no "test set" or "ground truth" establishment for an AI/ML algorithm's performance in this type of device submission.

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

   • Not Applicable.

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 a physical medical device (catheter), not an AI/ML system requiring human reader assistance or evaluation.

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

   • Not Applicable. This is a physical medical device.

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

   • Not Applicable. For a physical device like a catheter, "ground truth" relating to diagnostic performance as understood for AI/ML is not relevant. Its "performance" is assessed through engineering specifications (e.g., burst pressure, tensile strength, flow rates, steerability) and potentially pre-clinical animal studies or limited human clinical data (though not detailed here) to ensure it performs its intended mechanical function safely and effectively.

8. The sample size for the training set:

   • Not Applicable. There is no AI/ML algorithm being "trained" for this device.

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

   • Not Applicable.

Summary of Device and Approval Process based on the document:

This 510(k) submission is for the ClearStream Technologies PTA Catheters (ReeKross™, ReeKross™14, and ReeKross™18), which are balloon dilation catheters used for angioplasty in femoral, popliteal, and infra-popliteal arteries.

The basis for clearance is substantial equivalence to a predicate device, the Savvy Long manufactured by ClearStream Technologies Ltd (K072947). The document states that the new device is equivalent in:

• Intended use
• Design characteristics
• General physical characteristics

The conclusion for approval is based on "Performance testing and compliance with recognized standards," which the FDA determined "established substantial equivalence with regard to safety and effectiveness" to the predicate device. This implies a set of standard engineering and bench tests for catheter performance (e.g., balloon inflation/deflation, burst pressure, trackability, pushability, material compatibility, radiopacity) but no clinical study data, comparative effectiveness data, or AI-specific validation is presented because it is not an AI/ML device.

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Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.

A family of semi-compliant coaxial design catheters in various sizes. Each catheter has a balloon mounted on its distal tip. A hub/"Y" connector consists of a through lumen, allowing the catheter to track over a guidewire, and a balloon port used to inflate the balloon. To locate the balloon under fluoroscopy platinum iridium bands are provided at the shoulders of the balloon for all sizes. The proximal end of the catheter is provided with a transparent hub which allows easy observation of air bubbles. The hub is designed to facilitate easy removal of air bubbles during the preparation of the balloon.

The provided text, K072947 Premarket Notification - ClearStream Technologies PTA Catheters, describes the 510(k) submission for the Savvy Long and Sleek Peripheral Transluminal Angioplasty (PTA) Catheters. This document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study to prove meeting those criteria in the context of device performance metrics like sensitivity, specificity, etc.

It operates under the assumption that if the new device is substantially equivalent in intended use, design characteristics, and general physical characteristics, and satisfies recognized standards, then it can be marketed.

Therefore, many of the requested categories for AI/diagnostic device studies are not applicable to this 510(k) submission.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance Study (as per the provided document):

The document does not explicitly state "acceptance criteria" in terms of specific performance metrics (like sensitivity, specificity, accuracy) that an AI/diagnostic device would have. Instead, the "acceptance criteria" for this device's premarket notification revolved around demonstrating substantial equivalence to a legally marketed predicate device and compliance with recognized standards.

The document states: "Performance testing and compliance with recognized standards have established substantial equivalence." This is the core "study" and "conclusion" for this type of device submission. The specific details of this performance testing are not provided in the 510(k) summary, but are typically included in the full submission to the FDA.

Table of Acceptance Criteria and Reported Device Performance:

Given the nature of this 510(k) for a medical catheter (Class II medical device), the acceptance criteria are not in terms of diagnostic performance metrics like those for an AI system. Instead, they relate to functional performance and safety to ensure substantial equivalence. The document does not provide a table with quantitative performance data. The "reported device performance" is summarized as having "established substantial equivalence" through performance testing and compliance with recognized standards.

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

• Not Applicable / Not Provided: This 510(k) summary does not describe a clinical study or a test set in the context of diagnostic accuracy for a software algorithm. The "performance testing" referenced would typically involve bench testing and potentially some in-vivo animal testing to confirm functional performance and safety, not a human clinical test set for diagnostic accuracy with provenance details.

2. 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: There is no mention of experts establishing a "ground truth" for a test set, as this is not a diagnostic device relying on expert interpretation.

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

• Not Applicable: No test set or adjudication process is described in the context of diagnostic accuracy.

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: This is a physical medical device (catheter), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.

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

• No: This is a physical medical device, not a standalone algorithm.

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

• Not Applicable: For a physical device like a catheter, "ground truth" would relate to its physical properties meeting specifications (e.g., balloon burst pressure, catheter dimensions) and its safety and efficacy in an in-vivo model (animal or human), which is assessed through a different set of methods than diagnostic ground truth. The document speaks of "performance testing."

7. The sample size for the training set:

• Not Applicable: This is a physical device, not an AI algorithm requiring a training set.

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

• Not Applicable: No training set or associated ground truth establishment for a training set is relevant or mentioned.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence of a PTA catheter to a predicate device through performance testing and compliance with recognized standards. It does not contain the detailed information regarding acceptance criteria or studies that would be present for an AI/diagnostic device, due to the fundamental difference in device type and regulatory pathway expectations.

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