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To facilitate the placement of devices during diagnostic or interventional procedures.

The TXM Hydrophilic Guidewire is a hydrophilic coated device which is constructed with a nitinol inner core which is covered with a polyurethane outer layer coated with a lubricious coating to minimize friction during use. The TXM Hydrophilic Guidewire outer diameter is 0.035" and is available in a variety of lengths ranging from 80 cm to 260 cm. The TXM Hydrophilic Guidewire is also constructed in stiff and standard shaft configuration with straight or angled distal tip. The device is supplied sterile and is intended for single use only.

This is a 510(k) premarket notification for a medical device (TXM Hydrophilic Guidewire), not for an AI/ML powered medical device. Therefore, the requested information regarding acceptance criteria and studies proving the device meets them in the context of AI/ML performance metrics (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information) is not applicable here.

This document describes the substantial equivalence of the TXM Hydrophilic Guidewire to a predicate device (Hydrophilic Coated Guidewire, K133155). The acceptance criteria and "study" are in the context of demonstrating this substantial equivalence through bench testing, biocompatibility testing, and sterilization testing.

Here's an analysis of the provided text based on the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list numerical "acceptance criteria" for each test. Instead, it states that "The TXM Hydrophilic Guidewire met the predetermined acceptance criteria." and then reports "Pass" for each test, indicating conformity. The applicable standards or internal test methods implicitly define the acceptance criteria.

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: The document does not specify the exact number of devices tested for each bench test or biocompatibility test. It only indicates that tests were performed on "non-aged devices (T=0) as well as on devices subject to 2 years of accelerated aging (T=2)." This implies at least two groups of samples for most tests.
• Data Provenance: Not applicable in the context of an AI/ML device. For physical device testing, the data is generated internally by the manufacturer (Texas Medical Technologies, Inc.) through their testing processes. There's no mention of country of origin for test data, as it's product performance data. The tests are prospective, as they are performed on newly manufactured devices for regulatory submission.

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. For a physical medical device, "ground truth" is established by direct measurement and observation against engineering and biological standards, not by expert consensus in the way it is for AI/ML image interpretation. The "experts" would be the engineers, technicians, and biologists performing and interpreting the standardized tests, but their specific number and qualifications are not detailed in this type of submission.

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

Not applicable. Adjudication methods are relevant for human interpretation tasks, especially in AI/ML performance evaluation where human experts might disagree. For device bench testing, the results are objectively measured against predefined criteria.

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, as this is a physical medical device, not an AI-powered diagnostic or interpretive tool. MRMC studies are used to evaluate AI performance with human readers.

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

Not applicable, as this is a physical medical device, not an AI algorithm.

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

For this device, the "ground truth" is defined by established engineering and biological standards (e.g., ISO, ASTM, FDA Guidance documents, USP). Deviations from these standards constitute a "failure." For example:

• Bench Testing: Mechanical properties (e.g., tensile strength, flexibility, lubricity) are measured directly and compared against predefined ranges or thresholds specified in the applicable standards.
• Biocompatibility Testing: Biological responses (e.g., cytotoxicity, irritation, sensitization) are assessed using standardized in-vitro and in-vivo assays, and the absence of unacceptable biological reactions indicates compliance.
• Sterilization Testing: Sterility Assurance Level (SAL) of 10^-6 is the standard ground truth for terminal sterilization.

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. As there is no AI/ML algorithm, there is no "training set" or ground truth establishment for it. The design specifications of the device are based on engineering principles and regulatory requirements, not learned from data.

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The TXM Support Catheters are percutaneous, single lumen catheters designed for use in the peripheral vascular system. TXM 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.

The TXM Support Catheter is an over the wire (OTW) single lumen catheter with atraumatic tapered tip. The distal tip catheter shaft has 6 radiopaque markers (including the tip) that works as an aid to estimate positioning within the vasculature. It consists of a lubricious inner liner made from Teflon, and stainless steel braid over the liner and an outer layer that consists of clear Nylon 12 polymer. One gold marker band is positioned on the proximal side of the tip. A polycarbonate hub is attached to the proximal end of the TXM Support Catheter. The TXM Support Catheter system is offered in 8 models, four with a straight tip and four with an angled tip, and the angled tip configuration has an angle of 30°. All models will have an outer diameter of the 4 French size (0.052") and an inner diameter of 0.039" tapered down to 0.0355" towards the distal tip so that is compatible with a 0.035" guidewires. The device is available in lengths of 65cm, 90cm. 135cm, and 150cm. The catheter is coated with a lubricious hydrophilic coating. The device is supplied sterile and is intended for single use only.

This document describes the TXM Support Catheter and its substantial equivalence to a predicate device, focusing on bench and biocompatibility testing. It is a 510(k) submission, used for medical devices that are substantially equivalent to a legally marketed predicate device.

Here's an analysis of the provided text in relation to your request about acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a summary of bench testing performed on the TXM Support Catheter. For each test, it lists the applicable standard or internal test method and indicates "Pass" for both non-aged (T=0) and accelerated-aged (T=2) devices. While it doesn't explicitly state quantitative acceptance criteria for each test in a compact table, the "Pass" result implies that the device met these criteria.

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

The document mentions "Testing was performed on non-aged devices (T=0) as well as on devices subject to 2 years of accelerated aging (T=2)." However, the specific sample sizes for each test are not provided. The data provenance indicates that these were bench tests, meaning they were performed in a laboratory setting. There is no information regarding country of origin of the data as it's not clinical data, and the tests are inherently prospective in nature for a new device.

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

This report describes bench testing for a medical device (catheter), not a diagnostic or prognostic algorithm involving human interpretation of medical images or data. Therefore, the concept of "ground truth established by experts" and their qualifications as you might typically find in AI/CADe submissions is not applicable here. The "ground truth" for these tests is defined by the technical specifications, standards (like ISO or ASTM), and internal test methods that define acceptable performance for physical and material properties.

4. Adjudication Method for the Test Set:

Similar to point 3, adjudication methods are not applicable for these types of bench tests. The evaluation of test results against predefined acceptance criteria is typically a technical assessment by engineers or technicians, not a consensus-based adjudication process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a MRMC comparative effectiveness study was not done. This document is for a physical medical device (catheter), not an AI or imaging diagnostic software. Therefore, the concept of human readers improving with or without AI assistance is not relevant.

6. Standalone (Algorithm Only) Performance:

No, a standalone (algorithm only) performance study was not done. This is a physical support catheter, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" for the performance testing cited is based on engineering specifications, recognized industry standards (ISO, ASTM), and internal test methods. These standards and specifications define the expected physical, chemical, and functional properties of the device. For example, for "Air Leakage," the ground truth is defined by the criteria within ISO 10555-1.

8. Sample Size for the Training Set:

Not applicable. This document describes a physical medical device, not an AI or machine learning model that requires a training set.

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

Not applicable. As there is no training set for a physical device, there is no ground truth to be established for it in this context.

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The Guiding Sheath Introducer is intended for use in the hospital catheterization laboratory for the percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and therapeutic procedures.

The Guiding Sheath is intended for intravascular use for the introduction of interventional/diagnostic devices to the human vasculature. The Guiding Sheath is designed to work as a vessel introducer and a guiding catheter. It consists of a lubricous inner liner made from Teflon, and a stainless steel coil over the inner liner. The outer shaft consists of colored Polyether block amide. A Radiopaque Marker band is attached to the distal end of the shaft for radiopacity. The Distal end of the shaft is atraumatic. The Proximal end of the catheter is attached to a Hemostatic Valve. The device is available in three inner diameter sizes of 4Fr, 5Fr, and 6Fr; consisting of 0.063", 0.076" and 0.087" (throughout the shaft) respectably. A lubricious hydrophilic coating shall be applied to the outer diameter of the Catheter Sheath for improved trackability through the vasculature. The device contains a separate Dilator shaft made of two different materials depending on the size. For the 4Fr, Grilamid is used for the body and the Luer attached to the proximal end as well. For the 5Fr and 6F, high densiy polyethylene (HDPE) is used for the body and the Luer attached to the proximal end as well. The distal end of the Dilator is tapered for ease of access to the vessel. The device is available in lengths of 45cm and 90cm. The device is supplied sterile and is intended for single use.

The document provided describes a medical device, the TXM Guiding Sheath, and its testing for substantial equivalence to a predicate device. It does not contain information about an AI/ML powered device, and therefore does not include details such as a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, or training set specifics.

Here is an analysis of the acceptance criteria and study that was conducted:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a non-AI/ML medical device (catheter introducer), and its acceptance criteria are based on meeting performance standards for physical attributes, safety, and biocompatibility, rather than diagnostic accuracy metrics like sensitivity or specificity.

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

The document describes bench testing and biocompatibility testing.

• Bench Testing: The sample sizes for each specific bench test are not explicitly stated in the provided text. However, it indicates that testing was performed on "non-aged devices (T=0) as well as on devices subject to 2 years of accelerated aging (T=2)." This implies a test set composed of new devices and aged devices. The provenance is internal laboratory testing.
• Biocompatibility Testing: The sample sizes (e.g., number of animals for in-vivo tests or replicates for in-vitro tests) are not explicitly stated. The provenance is internal laboratory testing following ISO standards.

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

Not applicable. This is a medical device, not an AI/ML diagnostic or prognostic tool. The "ground truth" for these performance tests is defined by meeting physical specifications, regulatory standards (ISO, ASTM), and biological safety parameters, which are assessed by technical personnel and validated according to established test methodologies.

4. Adjudication Method for the Test Set

Not applicable. This is a medical device performance and safety evaluation against predefined standards, not a diagnostic assessment requiring expert adjudication of results. Each test outcome (e.g., pass/fail, quantitative measure) is evaluated against its specific acceptance criterion.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study (comparing human readers with and without AI assistance) is relevant for AI/ML-powered diagnostic devices, not for a physical medical device like a guiding sheath.

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

No. This concept applies to AI/ML algorithms, not physical medical devices.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is defined by:

• Pre-established engineering specifications (e.g., dimensions, strength).
• Compliance with recognized international standards (e.g., ISO 10555, ASTM F88, ISO 10993 for biocompatibility) and internal test methods that align with these standards.
• Biological responses in validated in-vitro and in-vivo models (for biocompatibility).

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML algorithm involved that would require a training set. The device itself is the product being tested.

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

Not applicable, as there is no training set for an AI/ML algorithm.

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The Guiding Catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vasculature.

The TXM Guiding Catheter is a guiding catheter, for application in intravascular vessels. It consists of a lubricous inner liner made from Teflon, a stainless steel braid over the inner liner. The outer shaft consists of durometer hardness and different lengths of colored Polyether block amide. A Polycarbonate hub is attached to the proximal end of the Guiding Catheter. A strain relief is placed at the proximal end of the Guiding Catheter and over the distal end of the device shafts will have an outer diameter of 5 French sizes (0.070") and 6 French sizes (0.082) respectively for each catheter. The 5 French sizes will have an inner diameter of 0.058" and the 6 French sizes will have an inner diameter of 0.070". The device is available in length of 100cm. The device is supplied sterile and is intended for single use.

This document is a 510(k) premarket notification for a guiding catheter, indicating its substantial equivalence to a predicate device. It doesn't describe the evaluation of an AI/ML powered device, but rather a traditional medical device (catheter). Therefore, most of the requested information regarding AI/ML device evaluation (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable or cannot be extracted from this document.

However, I can extract the acceptance criteria and results for the bench testing and biocompatibility testing as presented for this traditional medical device.

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, the "acceptance criteria" are implied by meeting the specified standards or internal test methods, and the "reported device performance" is a simple "Pass" or "Fail" against those criteria.

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 document refers to "non-aged devices (T=0)" and "devices subject to 3 years of accelerated aging (T=3)" for bench testing, but the specific number of devices tested for each test is not detailed. The data provenance is also not specified, as this is a device submission focused on bench and biocompatibility testing, not clinical data.

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. This is a traditional medical device (catheter) and does not involve AI/ML or expert evaluation for establishing ground truth.

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

Not applicable. This is a traditional medical device (catheter) and does not involve AI/ML or expert adjudication for test sets.

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 traditional medical device (catheter) and does not involve AI/ML.

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

Not applicable. This is a traditional medical device (catheter) and does not involve AI/ML.

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

The "ground truth" for this device's evaluation is primarily based on meeting the specifications outlined in recognized international and national standards (e.g., ISO 10555, ASTM F640-12, ISO 10993 series, USP) and internal test methods. For example, for tensile strength, the ground truth is simply whether the device withstood the specified force according to the standard. For biocompatibility, it's whether the biological responses fall within acceptable limits defined by the ISO 10993 series.

8. The sample size for the training set

Not applicable. This is a traditional medical device (catheter) and does not involve AI/ML or training sets.

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

Not applicable. This is a traditional medical device (catheter) and does not involve AI/ML or training sets.

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The IntraNovo Microcatheter is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremittes, and all coronary vessels. The Microcatheter is also intended for drug infusion in intra-arterial therapy and infusion of embolic materials for hemostasis. The Microcatheter should not be used in cerebral vessels.

The IntraNovo Microcatheter (the "IntraNovo 21" or the "Microcatheter") is an infusion catheter intended for intravascular use. The Microcatheter consists of a single lumen. The shaft consists of a lubricous inner liner made from polytetrafluoroethylene (PTFE) with a stainless steel coil over the inner liner. The outer liner consists of different lengths of colored polyether block amide with varying durometers hardness. A lubricious hydrophilic coating covers the distal end of the IntraNovo Microcatheter. One radiopaque marker band is placed at the distal end of the Microcatheter and above the stainless steel coil. A polycarbonate hub is attached to the proximal end of the Microcatheter with a strain relief placed over the distal end of the hub. The device shaft has an outer diameter of 2.9 French size on the proximal end and 2.4 French size on the distal end with an inner diameter of 0.021" throughout the shaft. The device is available in lengths of 110 cm and 130 cm. The following accessories are included with the Microcatheter: a stainless steel steam shaping mandrel to allow for manual shaping of the distal tip and a 3.0 mL syringe.

The provided text describes a 510(k) premarket notification for the IntraNovo Microcatheter, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device through bench testing. It does not contain information about clinical studies with human participants or a multi-reader, multi-case comparative effectiveness study. Therefore, several aspects of the requested information, such as sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC study details, and standalone algorithm performance, are not applicable or cannot be extracted from this document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the IntraNovo Microcatheter "met the predetermined acceptance criteria" for all tests. However, the specific quantitative acceptance criteria for each test are not provided in the table. Only the "Test Results (T=0) and (T=2)" which uniformly indicate "Pass" are given.

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

This document describes bench testing of a physical device, not a study involving a test set of data. The "test sets" here refer to batches of manufactured devices used for physical and mechanical evaluations. The document does not specify the sample size for devices used in each bench test, nor does it refer to data provenance in terms of country of origin or retrospective/prospective nature, as these are concepts typically associated with clinical or imaging data sets. The testing was performed on "non-aged devices (T=0) as well as on devices subject to 2 years of accelerated aging (T=2)."

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. This is not a study assessing diagnostic performance or requiring expert ground truth. The "ground truth" for these tests would be the measured physical and mechanical properties of the device against engineering specifications.

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

Not applicable. As noted above, this is not a study requiring adjudication of interpretations.

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 pertains to the 510(k) clearance of a physical medical device (microcatheter) and does not involve AI or human readers.

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

Not applicable. This document pertains to the 510(k) clearance of a physical medical device (microcatheter) and does not involve an algorithm.

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

The "ground truth" for the bench tests would be the established engineering specifications and performance requirements for the device, often derived from relevant ISO standards (e.g., ISO 10555) or internal test methods. These are objective measurements rather than subjective expert consensus or pathology.

8. The sample size for the training set

Not applicable. This document describes bench testing for device clearance, not the development or evaluation of an algorithm based on a training set.

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

Not applicable.

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The PTA 14 Balloon Dilatation Catheter OTW is intended to dilate stenoses in the iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae.

The PTA 14 Balloon Dilatation Catheter OTW is a 0.014" Over-The-Wire (OTW) PTA Balloon Dilatation Catheter with a semi-compliant inflatable balloon mounted on the distal end of the catheter. It is designed for carrying out percutaneous transluminal angioplasty (PTA) in the peripheral vessels. The balloon catheter has a coaxial shaft design. The outer lumen is used for balloon inflation and the inner lumen (guide wire lumen) permits the use of a guide wire with a maximum outer diameter of 0.014 inch. The proximal segment of the catheter includes one female luer-lock port connected to the inflation lumen, and one female luer-lock for the guide wire lumen. The PTA 14 Balloon Dilatation Catheter is compatible with a 4 Fr. introducer sheath. The device is supplied sterile and is intended for single use.

The document is a 510(k) premarket notification for the "PTA 14 Balloon Dilatation Catheter OTW". This type of submission is for medical devices, and focuses on demonstrating substantial equivalence to a predicate device, rather than proving clinical efficacy or diagnostic accuracy for an AI/ML product. As such, the information typically requested for AI/ML device evaluations (e.g., sample size for test/training sets, data provenance, ground truth establishment by experts, MRMC studies, standalone performance) is not applicable or provided in this document.

The document details performance and safety testing directly related to the physical characteristics and interaction of the catheter with the human body.

Here's the information parsed from the document based on the provided categories, with a clear indication that many categories relevant to AI/ML are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a "Testing Summary" (Section 7) and a "Bench Testing Table" (Table 7.1.1) along with a "Summary of Biocompatibility Testing" (Table 7.2.1). For each test, the acceptance criteria are implied by the "Pass" result and the "Applicable Standard or Internal Test Method" column. The reported device performance is that all tests "Passed" the predetermined acceptance criteria. Specific quantitative acceptance criteria are not detailed in this summary, but are referred to by the internal test methods or referenced standards.

Biocompatibility Tests (All Met Predetermined Acceptance Criteria)

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 Applicable as this document describes performance testing for a physical medical device (catheter), not an AI/ML software. The "test set" refers to physical samples of the device itself (both unaged and aged), which were subjected to various bench and biocompatibility tests. No human patient data or imaging data is involved.

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. Ground truth, in the context of AI/ML, refers to expert-labeled data. For a physical device, performance is evaluated against engineering specifications and established standards, not expert consensus on data interpretation.

4. Adjudication method for the test set

This information is Not Applicable. Adjudication methods like 2+1 or 3+1 are used in AI/ML studies to resolve discrepancies among expert readers when establishing ground truth for data interpretation. This is not relevant for the bench and biocompatibility testing of a physical medical 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 information is Not Applicable. An MRMC study is a type of clinical study used to evaluate the diagnostic accuracy of a reader (human or AI) on multiple cases, often comparing different reading paradigms (e.g., with or without AI assistance). This document is for a physical medical device and does not involve AI or human readers for diagnostic interpretation.

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

This information is Not Applicable. This concept applies to AI/ML algorithms where performance is evaluated without human intervention. The device in question is a physical catheter, not an algorithm.

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

This information is Not Applicable in the AI/ML sense. For this device, the "ground truth" aligns with the acceptance criteria derived from engineering specifications and recognized international standards (e.g., ISO, ASTM, FDA Guidance). Device performance is measured directly against these defined physical, mechanical, and biological benchmarks.

8. The sample size for the training set

This information is Not Applicable. "Training set" refers to data used to train an AI/ML model. This device is a physical product and does not involve AI/ML.

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

This information is Not Applicable. As there is no training set for an AI/ML model, there is no ground truth to establish for it.

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