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The support catheter is intended for use during coronary and peripheral interventional procedures to guide and support guidewires, traverse discrete portions of the vasculature, allow for guidewire exchanges and provide a conduit for infusion of saline solution, diagnostic contrast agents and therapeutic agents.

The subject Support Catheter is an over-the-wire (OTW) single-lumen catheter with a tapered atraumatic tip. The catheter is available in fifteen (15) size models compatible with standard 0.014", 0.018" and 0.035" diameter guidewires and with effective lengths of 65 cm, 90 cm, 135 cm, 150 cm and 180 cm. The distal end of the catheter incorporates three (3) distal radiopaque markers to assist with fluoroscopic guidance and estimating distances. A hydrophilic coating on the distal end assists with catheter advancement. The proximal end of the catheter has a molded manifold with a female luer connection in fluid communication with the catheter lumen. The catheter lumen is used for guidewire passage and exchanges as well as fluid infusion. The catheter guidewire size and length are printed on the strain relief. The device is supplied sterile and intended for single use only.

The provided text is a 510(k) summary for the QXMédical Support Catheter. It outlines the device's description, intended use, and a comparison to a predicate device, focusing on non-clinical testing to demonstrate substantial equivalence.

However, the document does not describe a study involving an AI/software device or statistical performance metrics (like sensitivity, specificity, AUC) typically associated with such devices and their acceptance criteria. Instead, it refers to a medical device (a catheter) that undergoes physical, mechanical, and biocompatibility testing. The "acceptance criteria" discussed are related to these non-clinical performance aspects of a physical device, not an AI algorithm.

Therefore, I cannot extract the information required by your prompt, such as:

• A table of acceptance criteria and reported device performance: The document lists mechanical and performance tests (e.g., visual/dimensional inspections, kink resistance, tensile strength, fluid flow rates) but does not provide numerical acceptance criteria or the specific results for these tests. It simply states that the tests provide "reasonable assurance that the device meets the established performance criteria and will perform as intended."
• Sample sized used for the test set and the data provenance: Not applicable to this type of device and testing.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: Not applicable in the context of an AI study. The "ground truth" for a physical device is its performance against engineered specifications.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

The relevant section from the document states:

"### Summary of Non-Clinical Testing:
The subject Support Catheter underwent mechanical, performance, and biocompatibility assessments to support a determination of substantial equivalence. These tests provide reasonable assurance that the device meets the established performance criteria and will perform as intended. The testing did not raise any new questions of safety and effectiveness.

Clinical Testing

Clinical evaluation was not required for this device."

In summary, this document is for a physical medical device (catheter) and discusses non-clinical engineering and biocompatibility testing, not the performance evaluation of an AI or software algorithm against clinical ground truth data. Therefore, most of your prompt's questions, which are geared towards AI/machine learning device evaluations, cannot be answered from this text.

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The Occlusion Balloon Catheter is indicated for temporary occlusion of large vessels, including the superior vena cava, in applications including perioperative occlusion and emergency control of hemorrhage.

The Occlusion Balloon Catheter is a multi-lumen catheter which has a compliant polyurethane balloon with a maximum diameter of 32mm at 60cc inflation volume. The balloon has a nominal length of 80mm. The device is constructed with a blended PEBA shaft and is available in two models; one model is compatible with 8Fr (or larger) introducer sheaths and one model is compatible with 10Fr (or larger) introducer sheaths. Both models provide the same balloon performance with respect to sizing and occlusion. The two models are intended for individual physician preference for patient-specific sheath selection. The device has an effective length of 90cm and is compatible with 0.035" diameter guidewires. Three (3) platinum-iridium radiopaque marker bands are placed on the shaft to facilitate balloon placement in the anatomy prior to inflation. The proximal end of the catheter has an integral PEBA bifurcation manifold with female luer ports to allow communication with the balloon inflation lumen and guidewire lumen. A PVC extension tube (with stopcock) is connected to the balloon inflation port to facilitate handling. The device is a single use, sterile device.

The provided text describes a 510(k) premarket notification for an Occlusion Balloon Catheter. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria and reporting its performance.

Therefore, many of the requested items (e.g., acceptance criteria table, sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable and cannot be extracted from this document because the submission method relies on demonstrating equivalence through non-clinical testing and comparison to predicate devices, not through a clinical trial with specific performance metrics against acceptance criteria.

Here's what can be extracted based on the provided text:

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

• Not Applicable. The document does not provide specific quantitative acceptance criteria or reported performance metrics against such criteria in the context of a clinical study. It lists a series of non-clinical tests performed to ensure the device meets established performance criteria and will perform as intended for substantial equivalence.

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

• Not Applicable. No clinical test set or data provenance is detailed, as clinical evaluation was not required. The tests performed were non-clinical (mechanical, performance, biocompatibility).

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)

• Not Applicable. No ground truth for a test set was established using experts, as no clinical study requiring such ground truth was conducted.

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

• Not Applicable. No adjudication method for a test set is mentioned, as no clinical study requiring this was conducted.

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, nor does the device involve AI.

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 (expert consensus, pathology, outcomes data, etc)

• Not Applicable. No ground truth of this nature was used, as clinical studies involving such data were not performed. The "ground truth" for this submission was based on successful completion of non-clinical performance and mechanical tests to demonstrate substantial equivalence to the predicate device.

8. The sample size for the training set

• Not Applicable. No training set is mentioned, as this is a medical device submission based on substantial equivalence and non-clinical testing, not a machine learning model.

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

• Not Applicable. No training set or ground truth for it was established.

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The Boosting Catheter is intended for use in conjunction with guiding catheters or sheaths during coronary and peripheral interventional procedures to guide and support interventional devices, including guidewires, traverse discrete portions of the vasculature, allow for interventional device exchanges and provide a conduit for infusion of saline solution, diagnostic contrast agents and therapeutic agents.

The Boosting Catheter is an over-the-wire percutaneous catheter with an atraumatic tip. The catheter has an effective length of 150cm and available in four (4) diameter models; each compatible with various guiding catheters or sheaths as shown in the following table:

| Catalog
Number | Model
Number | Catheter
I.D. | Catheter
O.D. | Compatible
Guiding Catheter | Compatible
Sheath |
|-------------------|-----------------|------------------|------------------|--------------------------------|------------------------|
| BC52-150 | 9005-001 | 0.052" | 0.064" | 6 Fr (0.066" MIN ID) | 5 Fr (0.066" MIN ID) |
| BC57-150 | 9005-002 | 0.057" | 0.068" | 6 Fr (0.070" MIN ID) | 5.5 Fr (0.072" MIN ID) |
| BC63-150 | 9005-003 | 0.063" | 0.076" | 7 Fr (0.078" MIN ID) | 6 Fr (0.079" MIN ID) |
| BC72-150 | 9005-004 | 0.072" | 0.086" | 8 Fr (0.088" MIN ID) | 7 Fr (0.092" MIN ID) |

The Boosting Catheter is constructed with a proximal manipulation shaft connected to a distal tube or guiding catheter segment. The manipulation shaft is used to advance the distal tube segment over a guidewire and through a guiding catheter (or sheath) to a desired location in the coronary or peripheral vasculature. Once positioned, diagnostic or interventional devices (including guidewires) may be delivered or exchanged though the guiding catheter and the Boosting Catheter distal tube segment. Further, procedural fluids (such as saline, contrast agents or therapeutic agents) can be delivered through the guiding catheter and the distal tube segment to a desired location in the coronary or peripheral vasculature. The distal tube segment has two (2) radiopaque markers to facilitate fluoroscopic guidance and a lubricious outer coating to assist with catheter advancement. The manipulation shaft has a molded handle and strain relief to assist with handling. The strain relief is printed with the catheter dimensional information. The device is supplied sterile and intended for single use only.

This document is a 510(k) premarket notification for a medical device called the "Boosting Catheter." It is a regulatory submission to the FDA demonstrating that the new device is substantially equivalent to legally marketed predicate devices, and therefore does not require a premarket approval application (PMA).

Here's an analysis of the provided text with respect to acceptance criteria and supporting studies:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a pass/fail format, which is typical for a detailed engineering report. Instead, it states that the device underwent various non-clinical tests to demonstrate substantial equivalence. The overall "acceptance criteria" can be inferred as meeting the performance that allows for a substantial equivalence determination to the predicate devices.

The "reported device performance" is summarized in general terms under the "Summary of Non-Clinical Testing" section. The document claims that these tests "provide reasonable assurance that the device meets the established performance criteria and will perform as intended."

Inferred Acceptance Criteria & Reported Performance (from the document):

Specific Information Requested and Located:

1. A table of acceptance criteria and the reported device performance: As described above, an explicit table is not provided. The document lists the types of tests performed (mechanical, performance, and biocompatibility) and states that the device "meets the established performance criteria and will perform as intended."

2. Sample size 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: This information is not provided in the document for any of the non-clinical tests.
   • Data Provenance: This information is not specified for the non-clinical tests. Since it's a device submission, the testing would typically be conducted by the manufacturer or a contracted lab.

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

   • Not applicable. The document describes non-clinical, laboratory-based testing (mechanical, performance, biocompatibility). These types of tests do not typically involve human experts establishing "ground truth" in the way a clinical study or image interpretation study would. Ground truth for these tests is based on objective measurements and established scientific/engineering methodologies.

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

   • Not applicable. This concept typically applies to clinical studies where expert consensus is needed for diagnoses or outcome assessments. For non-clinical device testing, results are usually objectively measured and compared against specifications.

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, an MRMC comparative effectiveness study was not done. The device is a "Boosting Catheter" (a physical medical device, not an AI or imaging device).
   • No AI component is mentioned, so improvement with AI assistance is not relevant.

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

   • No. This question is not applicable as the device is a physical catheter, not an algorithm.

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

   • For the non-clinical tests (mechanical, performance, biocompatibility), the "ground truth" refers to objective physical and chemical measurements compared against predefined engineering specifications and regulatory standards. For example, tensile strength would be measured by a machine and compared to a specified minimum strength. Biocompatibility would be assessed against ISO 10993 standards and measured cytotoxicity, hemolysis, etc.

8. The sample size for the training set:

   • Not applicable. There is no "training set" as this is a physical medical device, not an AI/machine learning model.

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

   • Not applicable. As stated above, there is no training set mentioned for this device.

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The Access & Support Catheter is intended for use during coronary and peripheral interventional procedures to guide and support guidewires, traverse discrete portions of the vasculature, allow for guidewire exchanges and provide a conduit for infusion of saline solution, diagnostic contrast agents and therapeutic agents.

The Access & Support Catheter is an over-the-wire (OTW) single-lumen catheter with an atraumatic tapered tip. The catheter is offered in twelve (12) size models as outlined in the following table. The catheter shaft consists of high density polyethylene (HDPE) with distal platinum/iridium markerbands. The distal 40 cm outer portion of all catheters have a hydrophilic coating. The proximal portion includes a PEBA strain relief with a HDPE manifold which incorporates a female luer connection which communicates with the catheter lumen. The catheter through lumen is used to pass the catheter over the appropriate guidewire or for infusion. When used for infusion, the maximum infusion pressure should not exceed 300 psi. The catheter guidewire compatibility size and length are printed on the strain relief. All models are compatible with 5 Fr introducer sheaths and 6 Fr guiding catheters. All devices are provided sterile and intended for single use only.

The provided text is a 510(k) Summary for a medical device called the "Access & Support Catheter." It outlines the device's design, intended use, and a comparison to predicate devices, primarily focusing on non-clinical performance data. It explicitly states that "All tests demonstrated the materials, manufacturing processes, and design of the Access & Support Catheter met the established performance criteria and will perform as intended." However, the document does not contain information about a study proving the device meets acceptance criteria in the context of clinical performance or algorithm-based diagnostics.

Instead, it describes the results of non-clinical bench testing and biocompatibility tests to demonstrate substantial equivalence to predicate devices, focusing on physical properties and material safety.

Therefore, many of the requested categories for a study proving acceptance criteria (especially those related to human readers, ground truth establishment for a test set, and multi-reader multi-case studies) are not applicable to the information provided.

Here's a summary based on the provided text, highlighting the absence of information for certain criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various non-clinical tests conducted and states that performance criteria were met. It does not provide specific numerical acceptance criteria or detailed quantitative performance results for each test in a table format. Instead, it offers a qualitative statement of compliance.

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

• Sample Size: Not specified for individual non-clinical tests. The text indicates that "The Access & Support Catheter has been evaluated using the following in vitro bench testing." This implies testing of device units, but the number of units tested for each criterion is not provided.
• Data Provenance: The tests are described as "in vitro bench testing" and "Biocompatibility tests," indicating laboratory-based, non-clinical data. No country of origin is mentioned for data, but the submitter is QXMédical, LLC, based in White Bear Lake, MN, USA. The data is retrospective in the sense that it was generated prior to submission for regulatory review.

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

• Not applicable. The ground truth for this device is based on objective measurements and established standards for mechanical and biocompatibility performance, not expert consensus on medical images or clinical outcomes.

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

• Not applicable. See explanation for point 3.

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 not an AI-enabled diagnostic device, and no MRMC study was conducted or mentioned.

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

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

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

• The ground truth for non-clinical performance (mechanical, material, and biocompatibility) is based on established engineering specifications, material standards, and biological safety standards (e.g., ISO standards for biocompatibility). The tests objectively demonstrate that the device meets these predefined physical and biological requirements.

8. The sample size for the training set:

• Not applicable. As a physical medical device submission, there is no "training set" in the context of machine learning or AI.

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

• Not applicable. See explanation for point 8.

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The Stent Graft Balloon Catheter is intended for temporary occlusion of large vessels, or to expand vascular prostheses.

The OXMédical Stent Graft Balloon Catheter is a multi-lumen catheter which has a compliant polyurethane balloon with a maximum diameter of 50mm at 60cc inflation volume. The device is constructed with an 8Fr diameter blended PEBA shaft and is available in two usable lengths, 65 cm and 100 cm. The device is compatible with 12Fr (or larger) introducer sheaths and 0.038" diameter (or smaller) guidewires. Two platinum-iridium radiopaque marker bands are placed within the balloon to facilitate balloon placement prior to inflation. The proximal end of the catheter has an integral PEBA bifurcation manifold with female luer ports to allow communication with the balloon inflation lumen and guidewire lumen. A PVC extension tube (with stopcock) is connected to the balloon inflation port to facilitate handling. The device is a single use, sterile device.

This is a 510(k) premarket notification for a medical device (Q50® PLUS Stent Graft Balloon Catheter), not an AI/ML device. Therefore, the typical "acceptance criteria" and "study" information regarding device performance in an AI/ML context (such as accuracy, sensitivity, specificity, sample size, ground truth, expert consensus, MRMC studies, etc.) are not applicable here.

Instead, for a medical device like this, acceptance criteria typically refer to the specifications that the device must meet through various engineering, mechanical, and biological tests to demonstrate safety and effectiveness for its intended use, and substantial equivalence to a predicate device.

Here's how to interpret the provided information in the context of a 510(k) submission for a non-AI/ML medical device:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, the "acceptance criteria" are the specifications that each mechanical, performance, and biocompatibility test must meet. The "reported device performance" is that "All tests met specifications."

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

• Sample Size: The document does not explicitly state the sample sizes for each mechanical, performance, or biocompatibility test. Regulatory submissions for medical devices typically involve testing a statistically representative number of units for each test, but the exact numbers are not provided in this summary.
• Data Provenance: Not applicable in the context of an AI/ML algorithm's test set. The data provenance here would refer to the source of the physical devices tested (e.g., manufactured at QXMédical's facility). The testing is prospective for the submission, meaning tests were performed specifically for this device and submission.

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

Not applicable. This device is a physical medical instrument, not an AI/ML algorithm requiring expert-established ground truth for image or data interpretation. The "ground truth" for this device's performance is established by engineering and laboratory measurements against predefined specifications.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in medical image reading for AI/ML validation). The performance of this device is assessed directly through physical and chemical 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. MRMC studies are specifically designed to assess the impact of AI on human reader performance, which is not relevant for a physical catheter.

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

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

7. The Type of Ground Truth Used

The "ground truth" for this medical device is the adherence to established engineering specifications, material properties, and performance benchmarks as defined by relevant industry standards and internal design requirements. This is verified through:

• Direct physical measurement (e.g., dimensions, compliance, tensile strength).
• Functional testing (e.g., inflation, deflation, occlusion, compatibility).
• Biocompatibility assessments (following ISO standards, often involving chemical analysis and biological assays).

8. The Sample Size for the Training Set

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

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

Not applicable. See point 8.

In summary, the provided information details a traditional medical device 510(k) submission, not an AI/ML device. The "study" proving the device meets acceptance criteria is the comprehensive non-clinical testing program described, which demonstrated that all aspects of the device's mechanical function, performance, and biocompatibility met the defined specifications and showed substantial equivalence to the predicate device.

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