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The SUPERPIPE Angiographic Catheter is intended for use in angiographic procedures. It delivers radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system.

Angiographic Catheter consists of a catheter hub, a strain relief tubing, catheter shaft (including braided section and non-braided section) and catheter tip. It is comprised of a two-layer construction featuring stainless steel mesh sandwiched between layers of polyamide elastomers of the catheter braided section. The non-braided section is comprised of layers of polyamide elastomers. And the soft catheter tip is comprised of the mixture of polyurethane and polyamide elastomers. The device is offered in lengths of 80cm, 100cm and 110cm.

This is a 510(k) summary for the SUPERPIPE Angiographic Catheter, which is a medical device for delivering radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system. The document focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria in a study involving AI or human readers for diagnostic tasks.

Therefore, most of the requested information regarding acceptance criteria and a study proving the device meets them, especially in the context of AI and human reader performance, is not available in this document. This document details the engineering and biocompatibility testing performed to demonstrate that the device is safe and effective for its intended use, mainly comparing it to a predicate device.

Here's a breakdown of the available information based on your request:

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

The document lists performance tests conducted, but it does not explicitly state specific quantitative acceptance criteria or the numerical results/performance metrics for each test. Instead, it states that "Performance (bench) testing and biocompatibility testing were performed to demonstrate that the proposed device performs as intended and does not raise new questions of safety or efficacy compared to the predicate devices."

The tests performed include:

• Non-Clinical Performance Testing (per ISO 10555-1):

  • Catheter Sizes
  • Catheter Surface
  • Catheter Color
  • Side Holes
  • Catheter Hub
  • Distal Tip
  • Distal Shape
  • Freedom from Leakage
  • Peak Tensile Force of Catheter
  • Burst Pressure under Static Conditions
  • Radio-detectability
  • Torsion Transmissibility
  • Torque strength
  • Kink test
  • Push and withdrawal Ability
  • Simulated Use
  • Flow rate
  • EO and ECH Residual
  • Sterile
  • Bacterial Endotoxin
  • Visual Inspection test of the inner pouch
  • Sealing-strength of the Inner Pouch
  • Dye Leakage Test of the Inner Pouch

• Biocompatibility Testing:

  • Cytotoxicity study
  • Sensitization study
  • Intracutaneous study
  • Acute systemic toxicity study
  • Pyrogen study
  • Hemolysis study
  • In-vivo thromboresistance study
  • Complement activation assay

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

This information is not provided in the document. The testing described is bench testing and biocompatibility testing, not clinical studies involving patient data or test sets in the context of AI performance evaluation.

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 information is not applicable and not provided. The device is an angiographic catheter, and the evaluation is based on engineering and biocompatibility tests, not diagnostic accuracy requiring expert interpretation or ground truth establishment in a clinical imaging context.

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

This information is not applicable and not provided.

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 information is not applicable and not provided. This document does not describe an AI medical device.

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

This information is not applicable and not provided. This document does not describe an AI medical device.

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

This information is not applicable and not provided. The "ground truth" for the performance tests would be the established engineering standards (e.g., ISO 10555-1) and biocompatibility test methods, not clinical outcomes or expert consensus.

8. The sample size for the training set

This information is not applicable and not provided. This document does not describe an AI medical device requiring a training set.

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

This information is not applicable and not provided.

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Quick-Cross® Extreme Support Catheters are intended to guide and support a guide wire during access of the vasculature, allow for wire exchanges and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

All models have 3 radiopaque markers spaced equally along the distal shaft to aid in estimating geometry within the vascular system. The most distal radiopaque marker is positioned within 3 mm of the distal catheter tip. A standard female luer is placed on the proximal end of each model. The catheter is coated with a lubricious, hydrophilic coating, Predicate devices of this type with similar intended uses have been classified into Class II. The support catheters are single-use and provided in sterile packaging.

The Spectranetics Quick-Cross Extreme Support Catheters are physical medical devices, not AI/ML (Artificial Intelligence/Machine Learning) software. Therefore, the questions related to AI/ML specific criteria such as acceptance criteria for AI models, sample sizes for test/training sets, ground truth establishment by experts, and MRMC studies, do not apply to this submission.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through comparisons of material, design, construction, specifications, intended use, and performance, primarily through bench testing.

Here's an interpretation of the relevant information provided:

1. Table of acceptance criteria and the reported device performance:

The document doesn't explicitly list a table of "acceptance criteria" against which a device's performance is measured in a quantitative manner as one might see for an AI/ML device. Instead, the acceptance criteria are inherent in demonstrating substantial equivalence to predicate devices. The "reported device performance" is a summary statement that these criteria were met through comparative testing.

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 mentions "comparative laboratory testing" and "samples produced under routine manufacturing conditions" for device integrity and functionality. However, specific sample sizes (e.g., number of catheters tested for burst pressure) are not provided. The data provenance (country of origin, retrospective/prospective) is also not specified, but it's implied to be internal laboratory testing conducted by Spectranetics Corporation.

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 is not applicable as the submission pertains to a physical medical device. Ground truth, in the context of AI/ML, refers to annotated data. For this device, "ground truth" would more accurately be defined by established engineering and material science standards and physical measurements. No external experts are mentioned for establishing ground truth in this context; rather, internal engineering and quality control procedures would have been followed.

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

Not applicable for a physical device submission focused on bench testing and substantial equivalence.

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 support catheter, not an AI/ML diagnostic or assistive device for human readers.

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)

For this physical device, the "ground truth" is fundamentally based on established engineering specifications, material properties, and performance benchmarks set by international standards (ISO and ANSI/AAMI) and comparative data against the predicate devices. This includes physical dimensions, material biocompatibility, mechanical strength (burst pressure), and flow characteristics (infusion rates).

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

Not applicable. There is no training set for a physical medical device.

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