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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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The Crosstella RX PTA Balloon Dilatation Catheter is intended to dilate stenosis in the iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

Crosstella RX PTA Balloon Dilatation Catheter (Crosstella 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. Crosstella 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 introduction of a guidewire.

The maximum compatible diameter of a guidewire used together with Crosstella RX in a PTA procedure is 0.018 inches; hence, sheath introducers with a minimum diameter of 4 or 5 Fr have been deemed to be compatible with Crosstella RX. The nominal inflated balloon diameters range from 2.0 mm to 6.0 mm with balloon working lengths of 20 mm to 200 mm. Three different catheter working lengths will be provided: 900, 1500 and 2000 mm.

The Crosstella 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 describes the Crosstella RX PTA Balloon Dilatation Catheter and its substantial equivalence to predicate devices. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The document focuses on the regulatory submission to the FDA (510(k) summary) and details of the device's design, indications for use, and a list of performance and biocompatibility tests conducted. While it states that the device "met all the predetermined acceptance criteria of design verification and validation," it does not provide the actual criteria or the results in a tabulated format.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes for test/training sets, expert details for ground truth, or adjudication methods, as this information is not present in the provided text.

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The Metacross OTW PTA Balloon Dilatation Catheter is intended to dilate stenoral, ilio-femoral, popliteal, infrapopliteal 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.

Metacross OTW PTA Balloon Dilatation Catheter (Metacross OTW) is an over the wire type of balloon dilation catheter, which consists of a distal tube, center tube, proximal tube, balloon, guidewire transition tube, radiopaque markers, manifold, 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 manifold at the proximal end. Metacross OTW has a guidewire lumen at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the guidewire transition tube, center tube and proximal tube to the guidewire port of the manifold for the introduction of a guidewire.

The maximum compatible diameter of a guidewire used together with Metacross OTW in a PTA procedure is 0.035 inches; hence, sheathless guiding catheters and sheaths with a diameter of 5, 6 or 7 Fr have been deemed to be compatible with Metacross OTW. The nominal inflated balloon diameters range from 3.0 mm with balloon working lengths of 20 mm to 200 mm. Three different catheter working lengths will be provided: 650, 900 and 1350 mm.

Here's an analysis of the provided text regarding the Metacross OTW PTA Balloon Dilatation Catheter, addressing your specific questions.

It's important to note that the provided document is a 510(k) summary, which is a regulatory submission for medical devices. These submissions typically focus on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report or a multi-reader, multi-case study that would be typical for AI-powered diagnostic devices. Therefore, some of your questions may not be fully answerable from this type of document, as it pertains to a physical medical device (a balloon catheter) and its performance, rather than an AI/software device.

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

The document lists performance tests but does not explicitly provide a table of acceptance criteria and quantitative reported performance against those criteria. It states that the device "met all the predetermined acceptance criteria of design verification and validation" and that "The results from these tests demonstrate that the technological characteristics and performance criteria of the Metacross OTW are adequate for the intended use of the device and that the device can perform in a manner equivalent to devices currently on the market with the same intended use."

However, we can infer the types of performance criteria based on the tests conducted:

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

The document describes bench testing (in vitro tests) and biocompatibility testing. These are not clinical studies with patient data. Therefore, the concepts of "test set" in the context of clinical data, "country of origin of the data," or "retrospective/prospective" do not apply here.

For the bench tests, the sample sizes for each specific test (e.g., number of balloons tested for burst pressure) are not provided in this summary. Similarly, for biocompatibility, the number of samples or animal subjects (if applicable) is not specified.

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)

This question is not applicable. The product is a physical medical device (balloon catheter), and the "ground truth" for its performance is established through objective engineering and biological tests, not through expert interpretation of clinical images or data.

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

This is not applicable for the same reasons as in question 3. No clinical adjudication method is mentioned as these are bench and biocompatibility tests.

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 balloon catheter, not an AI-powered diagnostic system or an assistive AI for human readers. No MRMC study was conducted or would be relevant for this type of device.

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 catheter, not an algorithm.

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

The "ground truth" for this device's performance is based on:

• Engineering specifications and standards: For mechanical performance tests (e.g., burst pressure is compared against a specified pressure, dimensions against design drawings).
• Established biological safety standards: For biocompatibility tests (e.g., cytotoxicity is measured against established limits for cellular response).
• Predicate device characteristics: The ultimate goal is to demonstrate equivalence to the predicate device's established performance.

8. The sample size for the training set

This is not applicable. No "training set" in the context of machine learning or AI is involved. The device's design and manufacturing processes are developed based on engineering principles and existing knowledge.

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

This is not applicable as there is no training set in the AI/ML sense. The "ground truth" for the various performance tests (dimensional, mechanical, biocompatibility) is established through standardized methodologies, calibrated equipment, and predefined acceptance criteria based on regulatory guidance and engineering principles.

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