Search Results

The Pro-PICC catheter with valve technology is indicated for short and long peripheral access to the central venous system for intravenous therapy and power injection media, and allow for central venous pressure monitoring. For blood sampling, infusion, or therapies, use a 4F or larger catheter. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.

The Pro-PICC®07 with Valve Technology is an open-ended lumen catheter designed for power injection. The catheters are an extension of the Medcomp® Pro-PICC®CT (K091953 and K092347). The Pro-PICC®67 with Valve Technology is comprised of a soft radiopaque polyurethane material. The lumen has a reverse taper design and is connected to the extensions via a soft pliable hub with suture wing for secure placement. The catheter lumen terminates through an extension to a female luer-lock connector. Assembled within each luer is a Bi-directional valve that can control fluid flow in two directions. The valve is normally closed but opens when flow is induced in either direction. Each extension is marked with the lumen gauge size, "Valved CT Catheter" or "Do Not Power Inject", and the maximum flow rates. The transition between lumen and extension is housed within a molded hub. The hub is marked with the catheter French size. The outside diameter of the lumen increases gradually near the hub to aid in kink resistance and to provide a mechanical obstruction to bleeding from the venotomy. The lumen is marked with depth marks every centimeter.

The Pro-PICC® with Valve Technology catheter is available in additional French sizes and either a single, double, or triple lumen. The catheter has a usable length of 50cm to 60cm depending on French size with depth markings in 5cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion.

The catheter is packaged sterile in a variety of trav configurations with the necessary accessories to facilitate catheter insertion.

The provided text appears to be a 510(k) summary for a medical device (Medcomp® Pro-PICC® with Valve Technology), rather than a study report detailing acceptance criteria and performance data for an AI/algorithm-based device.

Therefore, many of the requested categories for AI device studies (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set details, and how ground truth was established for training and test sets) are not applicable or cannot be extracted from this document.

However, I can extract information related to the performance data (bench/performance data) as described in the document, which pertains to the physical device rather than an AI algorithm.

Here's the information that can be extracted, with notes on where the requested AI-specific information is not available:

Acceptance Criteria and Study for Medcomp® Pro-PICC® with Valve Technology

1. Table of Acceptance Criteria and Reported Device Performance

Notes on AI-Specific Information (Not Applicable/Available from this document):

• This document describes a physical medical device (catheter), not an AI algorithm. Therefore, there are no specific AI-driven acceptance criteria for metrics like sensitivity, specificity, AUC, or F1-score that would be relevant for an AI system.
• The "performance" referred to in the document relates to the physical and functional characteristics of the catheter (e.g., pressure injection capabilities, material properties), not algorithmic performance.

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

• Not Applicable. This document is for a physical medical device, not an AI algorithm. There is no mention of a "test set" in the context of an AI algorithm's performance evaluation. The "testing" mentioned refers to bench testing of the physical catheter.

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

• Not Applicable. This document is for a physical medical device. "Ground truth" in the context of expert consensus for image or data interpretation is not relevant here.

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

• Not Applicable. This document is for a physical medical device. Adjudication methods are relevant for expert review in AI studies, not for 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

• Not Applicable. This document is for a physical medical device. MRMC studies are specific to evaluating the impact of AI on human reader performance, which is not relevant here.

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

• Not Applicable. This document is for a physical medical device. There is no "algorithm only" performance reported, as there is no AI algorithm.

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

• Not Applicable. For the bench and biocompatibility testing, the "ground truth" would be established by validated measurement techniques, chemical analyses, and adherence to relevant ISO standards, rather than expert consensus on image interpretation or pathology.

8. The sample size for the training set

• Not Applicable. This document describes a physical medical device, not an AI algorithm. There is no concept of a "training set" for this type of device submission.

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

• Not Applicable. As there is no training set for an AI algorithm, this question does not apply.

Summary of Relevant Information from the Document:

The document is a 510(k) premarket notification for a physical medical device, the Medcomp® Pro-PICC® with Valve Technology, a catheter. The core of the submission is to demonstrate substantial equivalence to existing predicate devices.

• Study Objective: To demonstrate that the Medcomp® Pro-PICC® with Valve Technology is substantially equivalent to legally marketed predicate devices.
• Study Types:
  • Bench/Performance Testing: Conducted in accordance with applicable international standards and FDA guidance documents, and internal engineering testing methods (specifically for pressure injection, where no FDA standard exists). The document states these tests "effectively demonstrate the proposed devices are equivalent to the predicate devices."
  • Biocompatibility Testing: All materials used were tested on the complete, finished device, demonstrating they meet the requirements of ISO 10993.
• Conclusion: The device meets performance criteria of design verification as specified by ISO standards, guidance documents, and internal test protocols. It has the same intended use, operation, and function as the predicates, with no differences raising new safety or effectiveness issues, thus demonstrating substantial equivalence.

Ask a specific question about this device

The 3F PRO-PICC® " catheter is indicated for short term or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media, and allows for central venous pressure monitoring. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.

The 3F PRO-PICC of catheter is an open-ended lumen catheter designed for power injection and pressure monitoring. The 3F PRO-PICC® " catheter is comprised of a soft radiopaque probate monitorial. The lumen has a reverse taper design and is connected to the extension via a soft pliable hub with suture wing for secure placement. The clamp on the extension tube prevents air/fluid communication. The female luer connector provides the connection for intravenous administration. The power injectable extension line is purple in color to differentiate it from non-power injectable catheters. The extension is also is printed with the words power injectable. The I.D. Ring within the clamp contains information regarding checking for blood return and flushing along with rate of infusion for power injection.

The 3F PRO-PICC® C catheter is available with a single lumen. The catheter has a usable length of 50cm with depth markings in 5 cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion.

The catheter is packaged sterile in a variety of tray configurations with the necessary accessories to facilitate catheter insertion.

The 3F PRO-PICC® CT catheter is a medical device designed for short to long-term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and central venous pressure monitoring. The acceptance criteria and the study proving its performance are primarily outlined in the "Bench / Performance Data" section of the 510(k) summary (page 1).

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The studies mentioned are referred to as "internal engineering testing methods" and "performance testing... in accordance with applicable international standards and FDA guidance documents."

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)

• The document does not mention the use of experts to establish ground truth for any test set. The evaluation relies on "internal engineering testing methods" and adherence to "international standards and FDA guidance documents," which typically involve engineering and quality control personnel, not clinical experts for ground truthing in this context.

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

• The document does not describe any adjudication method. This type of method is typically used in clinical trials involving human readers assessing medical images or outcomes, which is not the nature of the "Bench / Performance Data" presented here for a catheter.

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

• No MRMC comparative effectiveness study was done. This is a physical medical device (catheter), not an AI-powered diagnostic tool, so such a study would not be applicable.

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

• No standalone algorithm performance was done. This is a physical medical device, not an algorithm. The performance evaluation focuses on its physical and material properties (e.g., pressure injection, biocompatibility, substantial equivalence to predicate devices).

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

• For the performance tests, the "ground truth" is established by the specified international standards, FDA guidance documents, and internal engineering testing methods. For biocompatibility, it's defined by the requirements of ISO 10993. For substantial equivalence, it's a direct comparison against the characteristics and performance of the identified predicate devices. There is no mention of expert consensus, pathology, or outcomes data being used for ground truth.

8. The sample size for the training set

• The document does not mention a training set sample size. This is a physical device, and the testing methods described are typically verification and validation tests against established specifications rather than machine learning model training.

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

• Not applicable, as there is no mention of a training set or machine learning components for this device.

Ask a specific question about this device

The PRO-PICC ® C catheter is indicated for short term or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusions, or therapies, use a 4F or larger catheter. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.

• Designed for peripheral vein catherization
• Comprised of a polyurethane material
• The lumen is connected to the extensions by a hub with a suture wing for placement.
• Clamps are provided on the extension tubes to prevent air/fluid communication.
• A female luer connector provides the connection for intravenous administration.
• Maximum recommended pressure limit setting 300 psi.
• Maximum indicated power injection flow rate 5cc/sec.

Let's break down the information provided about the Medcomp PRO-PICC® CT device to address your questions.

It's important to note that this document is a 510(k) summary for a medical device which is demonstrating substantial equivalence to a predicate device. This type of submission relies on showing that a new device is as safe and effective as a legally marketed device, rather than proving absolute safety and effectiveness for the first time. Therefore, the "study" described focuses on performance testing against established standards and comparison to a predicate, rather than clinical trials with human subjects in the way an AI-driven image analysis tool might.

Acceptance Criteria and Study Details for PRO-PICC® CT

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

For the PRO-PICC® CT, the "acceptance criteria" are implied by compliance with recognized international standards and the performance of the predicate device. The "reported device performance" is essentially that the device met these standards and performed comparably to the predicate.

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 for Test Set: Not explicitly stated as a "sample size" in the context of clinical trials. The testing refers to objective performance testing of manufactured devices against specifications and standards, not a set of clinical data or patient samples. The number of physical units tested to ensure compliance for each standard (e.g., how many catheters were burst tested for pressure limits) is not provided.
• Data Provenance: The testing was conducted by Medcomp, Inc., a US-based company, for a US FDA submission. The nature of this technical performance testing would be considered prospective, as it's performed specifically for the submission. It's not clinical data, but rather engineering/materials 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)

This type of information is not applicable to this 510(k) submission.

• The ground truth for this device is based on engineering specifications, material science, and compliance with recognized international standards (ISO standards) for medical devices.
• The "experts" involved would be Medcomp's engineers, quality assurance personnel, and potentially external testing labs, whose qualifications would be in engineering, materials science, and medical device regulations rather than clinical expertise in establishing diagnostic ground truth. No number or specific qualifications are provided in this summary.

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

This is not applicable to this type of device submission. Adjudication methods are typically used in clinical studies or studies involving human interpretation (e.g., radiology readers) where there might be disagreement in establishing ground truth from qualitative data. Here, the "truth" is determined by objective physical measurements and adherence to specified performance metrics.

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. This is a physical medical device (PICC catheter), not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies, AI assistance, or human reader improvement are not relevant here.

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

This is not applicable. Again, this is a physical medical device, not an algorithm or AI system.

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

The "ground truth" for the PRO-PICC® CT's performance evaluation is:

• Compliance with International Standards: Specifically ISO 10993-1, ISO 10555-1, ISO 10555-3, and ISO 594-2. The standards themselves define acceptable performance thresholds.
• Engineering Specifications: Such as the 300 psi pressure limit and 5cc/sec flow rate.
• Predicate Device Performance: The previous PRO-PICC®-CT (K081904) serves as the benchmark for demonstrating "substantial equivalence."

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of this device. Training sets are used in machine learning for AI/algorithms. This submission is for a physical medical device.

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

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

Ask a specific question about this device

The PRO-PICC® C catheter is indicated for short term or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media and allows for central venous pressure monitoring when a 20gauge or larger lumen is used. For blood sampling, infusion or therapies use a 4F or larger catheter. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.

The PRO-PICC catheter is an open-ended lumen catheter designed for power injection. The catheters are an extension of the Medcomp® PRO-LINE® CT Power Injectable CVC (K053345) and PRO-PICC® CT (K081904) catheter line. The PRO-PICCo CT catheter is comprised of a soft radiopaque polyurethane material. The lumen has a reverse taper design and is connected to the extensions via a soft pliable hub with suture wing for secure placement. Clamps are provided on the extension tubes to prevent and fluid communication. Female luer connectors provide the connection for intravenous administration. The power iniectable extension lines are purple in color to differentiate it from non-power injectable catheters. The extensions are also is printed with the words power injectable. The I.D. Ring within the clamp contains information regarding checking for blood return and flushing along with rate of infusion for power injection. The dual lumen catheter has one purple colored clamp and one natural colored clamp allowing units to designate power injection on one side and infusion; blood withdraw and pressure monitoring on the other although both lumens are capable of power injection.

The PRO-PICC catheter is available in additional French sizes and either a single or double lumen. The catheter has a usable length of 50cm to 60 cm depending on French size with depth markings in 5 cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion.

The catheter is packaged sterile in a variety of tray configurations with the necessary accessories to facilitate catheter insertion.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medcomp PRO-PICC CT device:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes a traditional 510(k) submission, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance acceptance criteria for a new device type. Therefore, explicit, quantitative, and standalone acceptance criteria in the typical sense (e.g., "sensitivity must be > X%") are not present.

Instead, the acceptance criteria are implicitly met by demonstrating that the PRO-PICC CT is substantially equivalent to established predicate devices in terms of:

Important Note: The document explicitly states: "Performance standards for pressure injection have not been established by FDA under section 514 of the Federal Food, Drug and. Cosmetic Act. Testing is based upon internal engineering testing methods." This reinforces that quantitative, pre-defined FDA-mandated performance metrics for the specific function of "power injection" were not applicable as acceptance criteria in this submission.

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

• Sample Size: Not applicable. This submission relies on substantial equivalence and bench testing, not a clinical study with a "test set" of patients or data in the way an AI/ML device would.
• Data Provenance: Not applicable. The "data" refers to engineering bench test results and biocompatibility testing of materials, not clinical data from specific geographic regions.

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

• Number of Experts: Not applicable. There is no "ground truth" establishment by external medical experts for a clinical test set in this 510(k) submission.
• Qualifications of Experts: Not applicable. The evaluation is based on engineering testing and comparison to existing predicate devices.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. There is no "test set" requiring adjudication by multiple readers or experts.

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:

• MRMC Study: No. This device is a physical catheter, not an AI/ML-driven diagnostic or assistive tool for human readers.

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

• Standalone Performance: Not applicable. This device is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

• Ground Truth: In the context of this 510(k), the "ground truth" for the device's acceptable performance is primarily derived from:
  • Predicate Device Performance: The established safety and effectiveness of the existing predicate devices (K053345, K081904, K070996).
  • Bench Test Results: Internal engineering testing demonstrating the device meets its design specifications and performs as intended, consistent with the predicates.
  • Biocompatibility Standards: Compliance with ISO 10993 for materials used.

8. The Sample Size for the Training Set:

• Sample Size: Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

• Ground Truth Establishment: Not applicable. This is not an AI/ML device requiring a training set with established ground truth.

In summary, the provided document details a traditional 510(k) submission for a physical medical device (catheter) that demonstrates substantial equivalence to predicate devices through bench testing and material biocompatibility, rather than through clinical studies with defined test sets, expert-driven ground truth, or AI/ML performance metrics.

Ask a specific question about this device

The PRO-PICC m C catheter is indicated for short term or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion, or therapies, use a 4F or larger catheter. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.

The PRO-PICC m C catheter is a triple lumen open-ended picc designed for power injection through one designated lumen. The catheter is an extension of the Medcomp® Pro-Line™ CT Power Injectable CVC (K053345) and Power Injectable Implantable Port (K070003) catheter line. The PRO-PICC m C catheter is comprised of a soft radiopaque polyurethane material. The lumen has a reverse taper design and is connected to the extensions via a soft pliable hub with suture wing for secure placement. Clamps are provided on the extension tubes to prevent air/fluid communication. Female luer connectors provide the connection for intravenous administration. The designated power injectable extension line and clamp material are purple in color to differentiate it from the non-power injectable extensions and the purple lumen identifies it as a power injectable catheter. The center extension also is printed with the words power injectable. The I.D. Ring within the clamp on the power extension contains information regarding checking for blood return and flushing along with rate of infusion for power injection. Injectable CVC. The PRO-PICC m ™ catheter is available in 6F triple lumen. The catheter has a usable length of 60 cm with depth markings in 5 cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion. The catheter is packaged sterile in two radiology versions and two nursing configurations with the necessary accessories to facilitate catheter insertion.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: Medcomp® PRO-PICC ™ CT Peripherally Inserted Central Catheter

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "in vitro testing was performed" without specifying the number of units tested.
• Data Provenance: In vitro testing was performed. The country of origin for the testing is not specified, but the submitter is based in Harleysville, PA, USA. The testing is not retrospective or prospective in the clinical sense, as it was lab-based in vitro testing.

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

• No human experts were used to establish ground truth for this in vitro test set. The acceptance criteria are based on engineering standards (ISO 10555-1, 10555-3) and internal engineering protocols, which are objective, measurable performance parameters.

4. Adjudication Method for the Test Set

• Not applicable. As the ground truth was established by objective engineering standards and measurements, no human adjudication was required.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. Clinical studies were explicitly not deemed necessary. The device's safety and effectiveness were demonstrated through in vitro testing and comparison to legally marketed predicate devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device is a physical medical catheter, not a software algorithm. Therefore, "standalone (algorithm only)" performance is not a relevant concept for this product.

7. The Type of Ground Truth Used

• Objective Engineering Standards and Measurements: The ground truth for the device's performance was established using objective measurements against established international engineering standards (ISO 10555-1, 10555-3) and internal engineering protocols. These standards define the acceptable range for physical and chemical properties (e.g., burst pressure, flow rate, leakage).
• Biocompatibility Standard: For biocompatibility, the ground truth was meeting the requirements of ISO 10993.

8. The Sample Size for the Training Set

• Not applicable. This refers to a physical medical device, not a machine learning algorithm. Therefore, there is no "training set." The design and materials are based on existing, cleared predicate devices and engineering principles.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. As there is no "training set" in the context of this device, this question is not relevant. The device's design is informed by established engineering principles and prior validated devices.

Ask a specific question about this device

The PRO-PICC m C catheter is indicated for short term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion, or therapies, use a 4F or larger catheter. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.

The PRO-PICC m C catheter is a triple lumen open-ended picc designed for power injection through one designated lumen. The catheter is an extension of the Medcomp® Pro-Line™ CT Power Injectable CVC (K053345) and Power Injectable Implantable Port (K070003) catheter line. The PRO-PICC m C catheter is comprised of a soft radiopaque polyurethane material. The lumen has a reverse taper design and is connected to the extensions via a soft pliable hub with suture wing for secure placement. Clamps are provided on the extension tubes to prevent air/fluid communication. Female luer connectors provide the connection for intravenous administration. The designated power injectable extension line and clamp material are purple in color to differentiate it from the non-power injectable extensions and the purple lumen identifies it as a power injectable catheter. The center extension also is printed with the words power injectable. The I.D. Ring within the clamp on the power extension contains information regarding checking for blood return and flushing along with rate of infusion for power injection.

The PRO-PICC m C catheter is available in 6F triple lumen. The catheter has a usable length of 60 cm with depth markings in 5 cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion.

The catheter is packaged sterile in two radiology versions and two nursing configurations with the necessary accessories to facilitate catheter insertion.

The provided document, K072509, is a 510(k) premarket notification for a medical device, the PRO-PICC™ CT catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel efficacy through clinical trials with specific acceptance criteria in the manner of a new drug or a highly innovative device.

Therefore, the study design and acceptance criteria outlined would be for in vitro (bench) testing designed to show the device performs similarly to or within acceptable limits compared to the predicate device, or to established industry standards (ISO). There are no clinical studies described, nor are there any AI components involved.

Here's a breakdown of the requested information based on the provided text, with a recognition that many items are not applicable in this context:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the testing was performed to "assure reliable design and performance in accordance with ISO 10555-1 and 10555-3 and internal engineering protocol." It does not provide specific numerical acceptance criteria or results, but rather a statement of compliance.

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

• Sample Size for Test Set: Not explicitly stated for specific in vitro tests. Typically, in vitro testing for device performance involves a specified number of samples (e.g., 5-10 devices per test condition) to demonstrate consistency and compliance with standards.
• Data Provenance: The document refers to "in vitro testing" and internal engineering protocols. This indicates the testing was conducted prospectively in a laboratory setting by the manufacturer (Medcomp®). There is no mention of country of origin for the data as it's not patient data.

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

• Not applicable. This device submission relies on in vitro engineering testing against established standards, not expert-derived ground truth based on patient data. There are no experts reviewing test images or clinical outcomes.

4. Adjudication Method for the Test Set

• Not applicable. As described above, this is an in vitro device performance study, not a study involving human interpretation of data requiring adjudication.

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 device is a physical medical catheter, not an AI or imaging analysis tool. No MRMC study was conducted.

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

• Not applicable. This device is a physical medical catheter, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is defined by international standards (ISO 10555-1, 10555-3, 10993) and the manufacturer's internal engineering protocols. These standards specify acceptable limits for various physical and material properties (e.g., burst pressure, flow rates, biocompatibility), which form the basis of the "ground truth" for demonstrating device safety and reliable performance.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI or machine learning device; therefore, there is no "training set."

9. How the Ground Truth for the Training Set was Established

• Not applicable. There is no training set for this type of device.

Ask a specific question about this device