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The R2P Metacross RX PTA balloon dilatation catheter is intended to dilate stenoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

R2P Metacross RX PTA Balloon Dilatation Catheter (R2P Metacross RX) is a rapid exchange balloon dilation catheter, which consists of a distal tube, proximal tube, balloon, guidewire transition tube, radiopaque markers, hub, and strain relief. A balloon is attached to the distal end of the catheter, and it can be inflated and deflated using the inflation device connected to the hub at the proximal end. R2P Metacross RX has a lumen (guidewire transition tube) at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the balloon and distal tube to the guidewire port for the exit of a guidewire.

The maximum compatible diameter of a guidewire used together with R2P Metacross RX in a PTA procedure is 0.035 inches. Additionally, sheath introducers with a minimum diameter of 6 Fr have been deemed to be compatible with R2P Metacross RX. The nominal inflated balloon diameters range from 3.0 mm to 8.0 mm with balloon working lengths of 20 mm to 200 mm. The catheter working length is 2000 mm.

The R2P Metacross RX is provided with the following accessory device:

• Flushing Needle: provided per one catheter device for the purpose of flushing and filling of the guidewire lumen with heparinized saline before use.

This document is a 510(k) Pre-Market Notification from the FDA for a medical device called the "R2P Metacross RX PTA Balloon Dilatation Catheter." It focuses on demonstrating substantial equivalence to a previously cleared predicate device, the "Metacross RX PTA Balloon Dilatation Catheter (K150865)." The device is a rapid exchange balloon dilation catheter intended for dilating stenoses in various arteries and for stent post-dilatation.

Here's an analysis of the provided text in relation to your request about acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document summarizes that "The R2P Metacross RX met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." However, it does not provide a specific table of acceptance criteria with corresponding performance metrics. Instead, it lists the types of performance tests conducted.

Important Note: The document consistently states "The results from these tests demonstrate that the technological characteristics and performance of the R2P Metacross RX are substantially equivalent to the predicate device" and "The R2P Metacross RX met all the predetermined acceptance criteria." However, it does not provide the numerical values of these criteria or the test results. This is common in 510(k) summaries, which aim to briefly summarize the evidence of substantial equivalence rather than provide full detail which is present in the full submission.

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

The document mentions "bench testing" and "in vitro tests." This implies that the testing was conducted on samples of the manufactured device.

• Sample Size: Not explicitly stated. The phrase "the subject device" suggests that multiple units would have been tested to ensure reproducibility and statistical validity, but exact numbers are not provided.
• Data Provenance: The testing was conducted internally by or for Kaneka Corporation (the submitter) as part of their design verification and validation activities. It is a retrospective analysis of newly generated compliance data as part of the device development process. There is no mention of country of origin of the data beyond the submitter's location (Tokyo, Japan) or official correspondent's location (Rockville, MD, USA).

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

This section is not applicable to this type of device submission. The device is a hardware interventional catheter, not an AI/software device that requires expert-established ground truth for interpretation of images or other data. The "ground truth" for this device's performance is objective measurements (e.g., pressure, dimensions, time) obtained during standardized bench testing.

4. Adjudication Method for the Test Set:

This section is not applicable for the same reasons as point 3. Adjudication methods like "2+1" or "3+1" are relevant for expert consensus in cases like image annotation or diagnostic accuracy studies, which are not part of this 510(k) submission for a physical device.

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:

This is not applicable. The device is a physical medical instrument (a balloon catheter), not an AI/software diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this submission.

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

This is not applicable. The device is a physical medical instrument, not a standalone algorithm.

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

The "ground truth" for this device's performance is derived from objective, quantitative measurements obtained during standardized bench tests. Examples include:

• Measurement of balloon dimensions and compliance.
• Pressure at which the balloon bursts.
• Time for inflation/deflation.
• Force required to kink or break the catheter.
• Particle counts.

These are not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic tool would be.

8. The sample size for the training set:

This is not applicable. This is a hardware device submission, not an AI/machine learning model where a "training set" of data would be used.

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

This is not applicable for the same reasons as point 8.

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