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The RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

The RapidCross PTA Rapid Exchange Balloon Dilatation Catheter (RapidCross catheter) is a rapid exchange (RX) coaxial catheter compatible with 0.014" guidewires, with a distally mounted semi-compliant inflatable balloon and an atraumatic, tapered tip. The distal portion of the catheter has a lubricious coating. The manifold includes an inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of

The provided text describes a 510(k) summary for the RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices through bench testing and biocompatibility testing, not on clinical acceptance criteria or a study proving performance against such criteria in the context of diagnostic or AI-driven systems.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable to this type of device submission. This is a premarket notification for a physical medical device, not a diagnostic algorithm or image analysis software.

Here's a breakdown of the relevant (and non-relevant) information based on the provided text:

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

• Acceptance Criteria: The document states that "The RapidCross catheter met all acceptance criteria for the bench testing with results similar to the predicates." However, specific numerical acceptance criteria for each test (e.g., "Balloon Burst Strength must be > X psi") are not detailed in this summary.
• Reported Device Performance: The document lists the types of tests performed. It doesn't provide specific numerical results, but rather states that the device performed "similar to the predicates" and "met all acceptance criteria."

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

• Sample Size: Not specified for any of the bench tests.
• Data Provenance: The testing was "Bench testing" and "biocompatibility testing." This is laboratory/engineering data, not clinical data from patients. Country of origin is not relevant for this type of testing.

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. This relates to physical device performance and biocompatibility, not diagnostic interpretation requiring expert ground truth.

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

• Not applicable. This applies to clinical data interpretation, not bench 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

• Not applicable. This is a physical medical device, not an AI or diagnostic tool.

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)

• Ground Truth: For bench testing, the "ground truth" is typically defined by engineering specifications, validated test methods, and industry standards (e.g., ISO, ASTM). For biocompatibility, it's defined by ISO 10993-1.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an algorithm that requires a training set.

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

• Not applicable. This is a physical medical device.

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The RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The RapidCross PTA Rapid Exchange Balloon Dilatation Catheter (RapidCross catheter) is a rapid exchange (RX) coaxial catheter compatible with 0.014" guidewires, with a distally mounted semi-compliant inflatable balloon and an atraumatic, tapered tip. The distal portion of the catheter has a lubricious coating. The manifold includes an inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. The balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating or working section of the balloon. On the 150 mm and 210 mm devices, two additional marker bands denote the middle of the balloon body. A guidewire lumen starts at a guidewire port located 35 cm from the catheter tip and extends to the distal tip. The 90 cm useable length devices have proximal depth marks printed on the proximal shaft at lengths of 55 cm and 65 cm from the distal tip while the 170 cm useable length devices have depth marks at 90 cm and 100 cm to serve as a reference during catheter insertion.

The RapidCross catheter is available in balloon sizes ranging from 2 mm to 4 mm in diameter and 20 mm to 210 mm in length; and, all sizes are compatible with 4 F sheaths.

The provided document is a 510(k) summary for the RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter. It focuses on establishing substantial equivalence to predicate devices based on bench testing and biocompatibility, rather than clinical studies with human subjects or AI-based performance metrics. Therefore, many of the requested categories are not applicable.

Here's an analysis of the available information:

Acceptance Criteria and Device Performance

The document states that "The RapidCross catheter met all acceptance criteria for the bench testing with results similar to the predicates." It also lists various bench tests performed.

Study Information:

This document describes a premarket notification for a medical device (RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter) seeking substantial equivalence. The "study" referenced is a series of non-clinical, bench-top tests and biocompatibility assessments, not a clinical trial or AI model validation study.

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

   • Sample Size: Not specified for each individual bench test. The number of devices tested for each parameter is not provided.
   • Data Provenance: The tests were "internal Risk Analysis procedures" and "bench testing." This likely refers to in-house laboratory testing by the manufacturer (ev3 Inc. in Plymouth, MN, USA). The data is prospective in the sense that the tests were conducted specifically for this submission.

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. This is a physical device and the "ground truth" for its performance is determined by established engineering and materials science standards and test methods (e.g., measuring burst pressure, dimensions, tracking force). There were no human experts establishing ground truth in the context of diagnostic interpretation.

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

   • Not Applicable. This concept is relevant for studies involving human interpretation or clinical endpoints. For bench testing of physical properties, the results are typically quantitative measurements against predefined specifications.

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:

   • Not Applicable. This device is a physical medical instrument (a balloon catheter), not an AI diagnostic or assistance tool. Therefore, MRMC studies and AI-related effectiveness metrics are not relevant.

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

   • Not Applicable. See above. There is no algorithm being tested in standalone mode.

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

   • Engineering Specifications and Biocompatibility Standards. The "ground truth" for this device's performance is its adherence to internal design specifications, industry standards for medical devices (e.g., ISO 10993-1 for biocompatibility), and comparability to legally marketed predicate devices.

7. The sample size for the training set:

   • Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

   • Not Applicable. See above.

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