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The speX 14/18 Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral and coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.

The speX Support Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and/or coronary vasculature.

The device consists of a support catheter body with a luer end. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents.

The provided text is a 510(k) premarket notification for a medical device called the "speX Support Catheter." This document is a regulatory submission to the FDA for market clearance, arguing that the new device is substantially equivalent to a previously cleared predicate device.

Crucially, this document focuses on demonstrating substantial equivalence to a predicate device, not on proving that an AI/ML powered device meets specific performance criteria through a clinical study where AI assists human readers or performs standalone analysis.

Therefore, most of the requested information regarding acceptance criteria, study design (sample sizes, ground truth, experts, adjudication methods, MRMC studies, standalone AI performance), and training set details for an AI-powered device is not applicable to this document.

The document discusses performance data in general terms for a physical medical device (catheter), not a digital health/AI product. The "performance data" mentioned (Simulated Use Testing, Particulate Testing) are engineering and biocompatibility tests typical for physical medical devices, not clinical performance studies for an AI algorithm.

Here's what can be extracted and what cannot:

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

• Acceptance Criteria (Implicit for a medical device approval): The device must demonstrate a safety and effectiveness profile similar to the predicate device and meet "specified criteria" in performance testing. The text states: "The speX Support Catheter met all specified criteria and did not raise new safety or performance questions."
• Reported Device Performance:
  • "Simulated Use Testing" was performed.
  • "Particulate Testing" was performed.
  • Result: "The speX Support Catheter met all specified criteria and did not raise new safety or performance questions."
  • Conclusion: "Based on the performance testing the speX Support Catheter was found to have a safety and effectiveness profile that is similar to the predicate device." And "The design testing performed for the speX Support Catheter demonstrated that the performance of the device is equal to the legally marketed predicate devices."

2. Sample sizes used for the test set and the data provenance:

• Not applicable. This document describes testing for a physical medical device (catheter), not an AI algorithm. The "test set" concept in the context of AI (i.e., a dataset of images/cases for algorithm evaluation) is not relevant to this submission. The "Simulated Use Testing" likely involved a certain number of tests on physical prototypes, but specific sample sizes and data provenance (country of origin, retrospective/prospective) are not detailed because they are not required for this type of submission for a physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth in the context of medical images or diagnostic AI systems is not relevant for this physical device.

4. Adjudication method for the test set:

• Not applicable. No adjudication method for a test set is mentioned, as it's not an AI study.

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. No MRMC study was done, as this is not an AI-powered device.

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

• Not applicable. No standalone AI algorithm performance was evaluated.

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

• Not applicable. Ground truth for diagnostic accuracy is not relevant for this physical device. The "ground truth" for a physical device's performance would be engineering specifications and safety standards, which are implicitly met.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of AI for this physical device.

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

• Not applicable. There is no "ground truth for the training set" for this physical device.

In summary, the provided document is a regulatory filing for a physical medical device (a catheter) demonstrating substantial equivalence to a predicate device, not an AI/ML powered device. Therefore, the specific details requested about AI model validation and performance criteria are not present in this document.

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The speX Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.

The speX Support Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and/or coronary vasculature. The device consists of a support catheter body with a luer end. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents.

The provided document is a 510(k) summary for the speX Support Catheter, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that an AI-driven device meets specific acceptance criteria.

As such, the information requested in the prompt, which is typically relevant for AI/ML medical devices, is largely absent from this document. The document describes a physical medical device (a support catheter), and the "performance data" refers to physical and mechanical tests of the catheter, not the performance of an algorithm.

Therefore, I cannot provide most of the requested information based on the provided text.

Here is what I can extract:

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

Based on the document, specific numerical acceptance criteria and reported device performance are not explicitly detailed in a table format. The document states:

• "The modified speX Support Catheter met all specified criteria and did not raise new safety or performance questions."
• "Based on the performance testing the modified speX Support Catheter was found to be substantially equivalent to the predicate device."

The types of tests performed were:

• Simulated Use Testing
• Component/Assembly Integrity Testing
• Corrosion Resistance Testing
• Lubricity Testing

2. Sample sized used for the test set and the data provenance:

• This information is not available in the provided text, as the study involves physical device testing, not AI data analysis.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not applicable/not available, as the study pertains to physical device performance and not diagnostic or interpretive tasks requiring expert ground truth in the context of AI.

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

• This information is not applicable/not available for this type of physical device 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:

• This information is not applicable. This document describes a physical medical device, not an AI system that assists human readers.

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

• This information is not applicable. This document describes a physical medical device, not an algorithm.

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

• This information is not applicable. For physical device testing, "ground truth" would typically refer to established engineering specifications, mechanical properties, and functional requirements, as opposed to medical diagnoses.

8. The sample size for the training set:

• This information is not applicable/not available as this is a physical medical device, not an AI model requiring a training set.

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

• This information is not applicable/not available as this is a physical medical device, not an AI model.

Ask a specific question about this device

The speX Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.

The speX Support Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral vasculature. The device is an over the wire single lumen catheter with a proximal female hub and a distal flexible part with a radiopaque tapered tip. The distal end of the catheter has a lubricious coating. The speX Support Catheter is 0.035" guidewire compatible and has working lengths of: 50cm, 90c, 135cm and 150cm.

This document describes the speX Support Catheter, a medical device, and the testing conducted to demonstrate its substantial equivalence to predicate devices, as required for 510(k) premarket notification. The information provided focuses on various performance tests to ensure the device meets predefined criteria.

Here's an analysis of the provided text to extract the requested information:

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

The document states that "The speX Support Catheter met all specified criteria and did not raise new safety or performance questions." This implies that for each test listed, there were predefined acceptance criteria, and the device successfully met them. However, the specific quantitative acceptance criteria for each test are not explicitly detailed in the provided text, nor are the precise performance results for each test (e.g., "Tensile Strength: X N met requirement of >Y N").

2. Sample size used for the test set and the data provenance:

The document mentions that "All testing was performed on test units representative of finished devices." However, it does not specify the sample size (N) used for any of the individual tests. It also does not provide information on the data provenance such as country of origin or whether the studies were retrospective or prospective. These are typically bench or lab tests, not clinical studies with human subjects in the context of device performance evaluation for 510(k) clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to the type of device performance testing described. The tests listed (e.g., tensile strength, pressure test, biocompatibility) are laboratory-based engineering and biological evaluations, not studies requiring expert interpretation of diagnostic images or clinical outcomes to establish a "ground truth." The ground truth is established by the validated test methods themselves.

4. Adjudication method for the test set:

This information is not applicable to the type of device performance testing described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert consensus is needed to establish ground truth for diagnostic accuracy, which is not the case here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable. The speX Support Catheter is a physical medical device (a catheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant.

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

This information is not applicable. As stated above, this is a physical medical device, not an algorithm.

7. The type of ground truth used:

The ground truth for the device performance tests is based on established engineering and biological standards and specifications for medical devices. For example, tensile strength would be measured against a predefined minimum force it must withstand, biocompatibility against established limits for toxicity, irritation, etc. These are objective measurements and comparisons to predefined critical values, not expert consensus, pathology, or outcomes data in the typical sense for diagnostic or prognostic devices.

8. The sample size for the training set:

This information is not applicable. The speX Support Catheter is a manufactured device, not a machine learning model. Therefore, there is no "training set."

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

This information is not applicable as there is no training set for this device.

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