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The Zenith Flex Aspiration System, including the 046 Zenith Flex Catheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump, is indicated in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.

The InNeuroCo 046 Zenith Flex Catheter is a variable stiffness catheter that has a catheter shaft reinforced with Nitinol to provide support. The proximal section has an embedded nitinol flat wire cross coil that transitions to a nitinol round wire sinqle coil in the distal end. It has a radiopaque Platinum/Iridium marker band on the distal end. The 046 Zenith Flex Catheter is available with an internal diameter of 0.046 inches. The outer diameter is 0.058 inches along the proximal shaft and 0.056 inches at the distal tip. The 046 Zenith Flex Catheter is available in two working lengths: 153 cm, and 160 cm. The 046 Zenith Flex Catheter has a PTFE-lined lumen to reduce friction as it travels over a guidewire. Accessories included with the device are a Tuohy-Borst Hemostasis Valve and peel-away introducer. The 046 Zenith Flex Catheter is supplied sterile, non-pyrogenic, and intended for single use only.

The other system components are: the Aspiration Tubinq Set and the VC-701 Cliq Aspirator Pump. The Aspiration Tubing Set is provided sterile and is intended for single use only. The aspiration pump is provided non-sterile and is used in multiple procedures.

The provided document is a 510(k) premarket notification for a medical device, the Zenith Flex Aspiration System (046 Zenith Flex Catheter). It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Penumbra 3 Max) and a reference device (071 Zenith Flex System).

The document does not describe an AI/ML-driven medical device, nor does it detail a study involving human readers or the establishment of ground truth in the context of diagnostic AI. Instead, it details the physical and mechanical performance testing of a catheter and its accessories. Therefore, many of the requested details, such as those related to AI algorithm performance, ground truth, expert adjudication, or MRMC studies, are not applicable to this document.

However, I can extract the acceptance criteria and performance information as presented for the physical device.

Here's a breakdown of the requested information based on the provided document:

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

The document provides a comprehensive table of non-clinical tests, their methods, acceptance criteria, and conclusions. Since the "performance" for all these tests is simply stated as having "met the acceptance criteria" or "passed," this table effectively serves as the performance report. I will summarize key categories, as a direct copy of the entire table would be extensive.

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 repeatedly states that "test samples" were used for various non-clinical (benchtop) and animal tests, and that these samples "met the acceptance criteria." However, it does not explicitly state the specific sample size (N) for each individual test. It implies N>0 and that enough samples were tested to demonstrate compliance.
• Data Provenance:
  • Non-Clinical (Bench) Testing: This was conducted by InNeuroCo, Inc. (location: Sunrise, Florida, USA). The testing was done in a controlled lab environment.
  • Animal Testing: Conducted in swine, implying a prospective study design for the animal component. The document does not specify the country of origin for the animal study, but given the company's US location and FDA submission, it's likely primarily US-based or conducted under equivalent regulatory standards.
  • Clinical Data (Literature Review): A review of "published clinical study articles" was conducted. This refers to existing, likely retrospective, clinical data from external sources and studies. No new clinical trials were performed for this submission.

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

• Not applicable. This document describes a physical medical device (catheter system) and its performance validation through bench and animal testing. It does not involve diagnostic imaging or AI for which ground truth established by experts would be relevant. The "ground truth" for this device's performance is objective measurements (e.g., dimensions, burst pressure, tensile strength, successful thrombi removal in models) and histopathological/angiographic assessments in animal models.
• A "physician" was involved in "simulated use testing," but this was for usability and performance in a benchtop model, not for establishing a diagnostic ground truth. Their qualifications are not specified beyond being a "physician."

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

• Not applicable. As an AI/ML related concept, adjudication by multiple experts is not relevant to the physical and mechanical testing of a catheter system.

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, not applicable. This document is for a physical medical device (catheter) and does not involve AI or human readers for diagnostic purposes.

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

• No, not applicable. This is not an AI/ML device.

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

• For non-clinical bench testing: The "ground truth" for acceptance was based on predefined physical, mechanical, and performance specifications (e.g., measurements being within specified ranges, successful functional outcomes like thrombi removal, absence of leaks or degradation).
• For animal testing: The "ground truth" for effectiveness and safety was based on angiographic assessment of revascularization and histopathological assessment.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so there is no "training set."

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

• Not applicable. As there is no AI/ML component, there is no training set or associated ground truth establishment process in that context.

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The Zenith Flex System, including the Zetheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump, is indicated in the revascularization of patients with acute secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral - M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.

The Zenith Flex System consists of the Zenith Flex Catheter, the VC-701 Cliq Aspiration Pump and the Aspiration Tubing Set. The InNeuroCo Zenith Flex Catheter is a variable stiffness catheter shaft reinforced with Stainless-Steel and Nitinol to provide support. The Stainless-Steel is wound as a double coil in the proximal section and the Nitinol is a single coil in the distal section. It has a radiopaque Platinum/Iridium marker band on the distal end. The distal 25 cm of the Zenith Flex Catheter has a hydrophilic coating. The Zenith Flex Catheter is available with an internal diameter of 0.0715 inch. The outer diameter is of 0.0850 inch in the proximal section, and tapers to a nominal of 0.082 inch in the distal section. The Zenith Flex Catheter is available in three working lengths: 115 cm, 125 cm, and 132 cm. Accessories included with the device are a Tuohy-Borst Hemostasis Valve and two peel-away Introducers and a Scout introducer. The Scout may be used to introduce the Zenith Flex Catheter into distal vasculature, thereby helping the device reach the target anatomy. The Zenith Flex Catheter is supplied sterile, nonpyrogenic, and intended for single use only. The off-the-shelf aspiration pump is provided non-sterile.

This document is a 510(k) summary for the Zenith Flex System, a medical device for revascularization in acute ischemic stroke. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical (bench and animal) testing rather than clinical study. Thus, it does not describe a study involving an AI component or complex ground truth establishment for diagnostic output.

Here's an analysis based on the provided text, addressing your points where information is available:

1. A table of Acceptance Criteria and Reported Device Performance

The document provides extensive tables summarizing non-clinical testing. Here's a consolidated and simplified version of the information, focusing on the Zenith Flex Catheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump:

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

• Test Set Sample Size: The document does not explicitly state numerical sample sizes for each non-clinical test (e.g., "N=X catheters were tested"). It refers to "test samples" for bench testing and describes animal testing involving "several arteries of swine." For some tests, it states that results were "leveraged" from a previous submission (K171672 or K152202), implying a previous sample size was deemed sufficient for those components/materials.
• Data Provenance: The data is primarily from non-clinical (bench and animal) testing.
  • Animal Testing: Performed on "swine." There's no indication of country of origin for the animal study, but given the FDA submission, it's presumed to be from a facility following GLP (Good Laboratory Practices). The study was prospective in nature for this device.
  • Bench Testing: Performed in a lab setting. No country of origin is specified, but again, standard practice for FDA submissions implies testing in a controlled environment.
  • Leveraged Data: Some results are leveraged from previous 510(k) submissions (K171672 for Zenith Catheter, and K152202 for Corrosion, for an "Intermediate Catheter"). This suggests the data was generated at an earlier time for similar or identical components/processes.

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

There is no mention of "experts" in the context of establishing ground truth for a test set in the way one would for an AI/diagnostic device. The "ground truth" here is based on:

• Standardized Test Methods: Adherence to ISO, ASTM, and USP standards (e.g., ISO 10993-1, ISO 10555-1, ASTM F1929-12, USP 788, etc.). These methods define the criteria and procedures for measuring various physical, chemical, and biological properties.
• Animal Model Outcomes: In the animal study, effectiveness was assessed via "angiographic assessment of revascularization" and safety via "angiographic assessment and histopathological assessment." These assessments would be performed by qualified veterinary or medical professionals (e.g., veterinarians, pathologists), but their specific number or qualifications are not provided here.
• Physician Feedback: For "Simulated Use - Bench" and "Simulated Use - Usability" tests, it states "simulated use testing by a physician in a benchtop model." The number and specific qualifications of these physicians are not detailed.

4. Adjudication Method for the Test Set

Not applicable in the context of this submission. Adjudication typically applies to human interpretation of diagnostic data, which is not the primary focus here. The assessment of non-clinical tests relies on quantitative measurements against pre-defined acceptance criteria, or expert observation (e.g., pathologist reading histology slides), but not formal adjudication of conflicting expert opinions for ground truth.

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

No, an MRMC study was not done. This type of study is specifically designed for evaluating the impact of AI on human reader performance in diagnostic imaging, which is not relevant for this device. The submission explicitly states: "No clinical study was conducted as bench and animal testing was determined sufficient for verification and validation purposes."

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

This device, the Zenith Flex System (catheter, aspiration tubing, pump), is a physical medical device, not a software algorithm or AI tool. Therefore, "standalone" performance in the sense of an algorithm operating independently is not applicable. Its performance is measured through its physical and functional properties, and its interaction with biological systems (in the animal model).

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

• Quantitative Measurements: Direct measurements of physical properties against engineering specifications (e.g., diameter, length, tensile strength, burst pressure, leak rates).
• Biocompatibility Standards: Adherence to ISO 10993 guidelines, which define acceptable biological responses.
• Angiographic and Histopathological Assessment: For the animal study, the "effectiveness" (revascularization) and "safety" (tissue response, thrombus formation) endpoints were evaluated using these clinical and pathological methods. This is the closest to "outcomes data" or "pathology" in your list.
• Physician Feedback: For simulated use, "predetermined user needs" served as the criteria.

8. The Sample Size for the Training Set

Not applicable. This is a traditional medical device (catheter system), not an AI/machine learning device. Therefore, there is no "training set."

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

Not applicable, as there is no training set for this device.

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The Zenith Support Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

The InNeuroCo Zenith Support product consists of a catheter, a hemostasis valve, and a split sheath introducer. The Zenith Support catheter is a single lumen, variable stiffness catheter that has an outer polymer shaft and is reinforced with a Stainless Steel cross coil. The Zenith Support catheter has a radiopaque Platinum/Iridium marker band on the distal end. The Zenith Support is available with an internal diameter of 0.074 inches and a nominal outer diameter of 0.086 inches. There are three working lengths available: 95 cm, 105 cm, and 115 cm in either diameter. The Zenith Support catheter has a PTFE-lined lumen throughout the catheter shaft. The catheter is flexible and has a hydrophilic coating. The Zenith Support catheter is inserted through a guide catheter or vascular sheath, provides access to the target site, and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst hemostasis valve with an extension luer and a split sheath introducer. The Zenith product line is supplied sterile, non-pyrogenic, and intended for single use only.

This request concerns the InNeuroCo Zenith Support Catheter, a percutaneous catheter used for introducing interventional devices into the peripheral and neuro vasculature. The provided document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study for novel device acceptance criteria.

The information primarily revolves around non-clinical data and justifications for not re-testing certain parameters due to the device's similarity to its predicate. Therefore, detailed information on ground truth establishment, expert qualifications, adjudication methods, or MRMC studies is not available as this type of submission typically relies on a comparison to an already approved device.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a "SUMMARY OF NON-CLINICAL DATA" (page 8, "Table 1: Non-Clinical Testing Analysis") which serves this purpose. Many tests were not re-tested for the Zenith Support Catheter because no material changes were made from the predicate device (Zenith 074) and manufacturing processes were identical or within the predicate's tolerance.

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

Due to the nature of a 510(k) summary relying on substantial equivalence, specific sample sizes for re-tested parameters (like Simulated Use - Bench) are not explicitly stated. For most tests, the data provenance is essentially inherited from the predicate device (Zenith 074) and another reference device (InNeuroCo SDA) because the new device's materials and manufacturing are identical or within tolerance. The document indicates these are non-clinical studies (benchtop and animal models for predicate devices). The geographical origin of the data is not specified beyond the manufacturer being based in Florida, USA. All studies are retrospective in relation to the current device's testing, as they refer to data from predicate devices.

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

This information is not provided. For non-clinical tests, "ground truth" is typically established by laboratory procedures and measurements against defined standards (e.g., ISO, ASTM). For the "Simulated Use - Bench" test, it states it was conducted "by a physician," implying at least one expert, but qualifications and number are not detailed.

4. Adjudication Method for the Test Set

Not applicable/not provided. This type of detail (e.g., 2+1, 3+1 consensus) is typical for clinical studies, especially those involving expert interpretation of medical images, which is not the focus of this non-clinical submission.

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 medical device (catheter), not an AI/Software as a Medical Device (SaMD) product. Therefore, MRMC studies and AI-assisted performance metrics are not relevant or performed for this submission.

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

Not applicable. The device is a physical catheter, not an algorithm.

7. The Type of Ground Truth Used

For the majority of the non-clinical tests not re-performed, the "ground truth" (or accepted performance) is based on:

• Established performance of the predicate device (Zenith 074): This implies that the predicate device previously met these standards.
• International Standards (ISO 10993, ISO 10555-1, ISO 594-1, ISO 594-2, ISO 11135) and ASTM standards (ASTM F1929-12, ASTM F88-09, ASTM F1980): These standards define methodologies and acceptable ranges for material properties, biocompatibility, and device functionality.
• USP 788: For particulates.

For the re-tested "Simulated Use - Bench" test, the ground truth was "predetermined user needs," likely established through design validation or clinical input.

8. The Sample Size for the Training Set

Not applicable. The Zenith Support Catheter is a physical medical device. The concept of "training set" is relevant for AI/machine learning models, which this device is not.

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

Not applicable as there is no "training set" for this physical device.

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The 091 Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasulature.

The InNeuroCo, Inc. 091 Long Sheath is a variable stiffness catheter that has a catheter shaft reinforced with a stainless steel double coil. It has a radiopaque Platinum/lridium marker band on the distal end. The distal 10 cm of the 091 Long Sheath Catheter has a hydrophilic coating. The catheter has a nominal outer diameter of 0.109 inches and a nominal inner diameter of 0.091 inches. It is available in three working lengths: 70 cm, and 90 cm. The 091 Long Sheath has a PTFE-lined lumen. The 091 Long Sheath is inserted at a vascular access point to provide access to the target site and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst Hemostasis Valve and a Vessel Dilator. The 091 Long Sheath is supplied sterile, non-pyrogenic, and intended for single use only.

The provided text is a 510(k) summary for the InNeuroCo 091 Long Sheath peripheral, coronary, and neuro vasculature catheter. It outlines the device's characteristics and its comparison to a predicate device, along with the results of performance testing to demonstrate substantial equivalence.

Based on the provided document, here's a description of the acceptance criteria and the study proving the device meets these criteria:

This document describes the validation of a medical device, the InNeuroCo 091 Long Sheath, for regulatory approval. It is not an AI/ML device, and therefore several of the requested sections (e.g., number of experts, adjudication methods, MRMC study, standalone performance, training set details) are not applicable as they relate to the validation of AI/ML algorithms, not traditional medical devices like catheters.

Acceptance Criteria and Device Performance Study for the InNeuroCo 091 Long Sheath

The InNeuroCo 091 Long Sheath is a percutaneous catheter intended for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. The study conducted was a series of non-clinical (bench and animal) tests to demonstrate substantial equivalence to a legally marketed predicate device (Stryker AXS Infinity LS, K152876).

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The exact sample sizes for each specific test are not explicitly enumerated in the provided summary table. The statements typically indicate "Test samples" or "All samples," implying that a sufficient number were tested according to the referenced ISO or ASTM standards.
• Data Provenance: The data is a mix of:
  • Direct testing: For many bench tests (e.g., Visual Inspection, Leaks, Particulates, Simulated Use, Catheter Burst, Tensile, Kink Resistance, Torque, PTFE Liner inspection, Hydrophilic Coating Integrity, Labeling Legibility, Barcode, Sterilization, Bacterial Endotoxin, Shelf Life). These tests were conducted on the 091 Long Sheath.
  • Leveraged data: For all biocompatibility tests, Chemical Compatibility, Hub compatibility, and Corrosion, data was leveraged from previously approved InNeuroCo devices (Super Distal Access K161262, Zenith Catheter K171672, and Intermediate Catheter K152202). This leveraging is justified by stating that the materials and manufacturing processes are equivalent.
  • Animal Testing: Product evaluated within a porcine model for angiographic evaluation.
• Retrospective/Prospective: All described testing appears to be prospective (new tests conducted for this device and leveraged results from other devices), not retrospective analysis of existing clinical data.
• Country of Origin: Not specified in the document, but given the FDA 510(k) submission, it would be expected to follow US or internationally recognized standards. The company address is in Florida, USA.

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

• Not Applicable. This is a traditional medical device (catheter) validation, not an AI/ML algorithm. Ground truth for device performance is established through standardized physical, chemical, biological, and animal testing, not human expert interpretation of data.
• For "Simulated Use" testing, it mentions "by a physician," indicating one or more physicians were involved in that specific assessment, but their number and specific qualifications are not detailed beyond "physician."

4. Adjudication Method for the Test Set

• Not Applicable. As this is not an AI/ML study, there is no need for adjudication of conflicting expert opinions on a dataset. Test results are objective measurements against defined acceptance criteria.

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

• No. This type of study is specifically designed for evaluating the impact of AI on human reader performance, which is not relevant for the validation of a physical medical device like a catheter.

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

• Not Applicable. There is no AI algorithm being validated in this submission. The "device" is a physical catheter.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established by:
  • Standardized Test Methods: Adherence to established international (ISO, ASTM, USP) and industry standards for material properties, mechanical performance, biocompatibility, and sterility.
  • Physical Measurements: Objective measurements of dimensions, burst pressure, tensile strength, etc.
  • Chemical/Biological Assays: Results from biocompatibility tests (e.g., cytotoxicity, hemolysis, pyrogenicity, sensitization) and bacterial endotoxin tests.
  • Functional Demonstrations: Successful performance in simulated use environments and in an animal model (porcine model for angiographic evaluation, showing no vessel injury).
  • Predetermined Specifications: Comparison against established product specifications and the performance of the predicate device.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device, so there is no "training set."

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

• Not Applicable. As there is no AI/ML training set, this question is not relevant.

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The Zenith is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

The InNeuroCo Zenith product consists of a catheter, a hemostasis valve, two split sheath introducers, and a Scout introducer. The Zenith catheter is a single lumen, variable stiffness catheter that has an outer polymer shaft and is reinforced with a Stainless Steel cross coil. The Zenith catheter has a radiopaque Platinum/lridium marker band on the distal end. The Zenith product line is available in two internal diameters: 0.065 inches and 0.074 inches. The 0.065 catheter has a tapered design and is 0.079 inches outer diameter in the distal end and a 0.081 inches outer diameter in the proximal end. The 0.074 catheter has a nominal outer diameter of 0.086 inches. There are three working lengths available: 115 cm, 125 cm, and 132 cm in either diameter. The Zenith catheter has a PTFE-lined lumen throughout the catheter shaft. The catheter is flexible and has a hydrophilic coating. The Zenith catheter is inserted through a quide catheter or vascular sheath, provides access to the target site, and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst hemostasis valve with an extension luer and two split sheath introducers. There is another introducer, named Scout, which provides support to the Zenith catheter while tracking to target site. The Zenith product line is supplied sterile, nonpyrogenic, and intended for single use only.

The provided text describes the regulatory clearance (510(k)) of a medical device, the "Zenith" percutaneous catheter, and a summary of non-clinical data supporting its substantial equivalence to predicate devices. The document does not describe an AI/ML-enabled device or a study involving human readers or comparative effectiveness with AI. Therefore, several aspects of your request (e.g., sample sizes for test set/training set, number of experts, adjudication method, MRMC study, standalone performance, provenance of data) are not applicable to this document.

However, I can extract the acceptance criteria and study conclusions for the non-clinical performance and biocompatibility tests described.

Here's the information derived from the document, focusing on the available details:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the specific requested points that are relevant to this type of device clearance:

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

• The document does not explicitly state the sample sizes for each non-clinical test performed (e.g., how many catheters were burst-tested, how many animals in the angiographic evaluation). It refers to "test samples" or "units tested."
• The data provenance is from non-clinical laboratory and animal studies (e.g., ISO standards, ASTM standards, porcine model). It is not human subject data, so concepts like "country of origin" or "retrospective/prospective" as they apply to clinical studies are not applicable.
  • For biocompatibility tests, it mentions "extract human blood" for some hemolysis tests.
  • For the Angiographic Evaluation, it explicitly states it was a "porcine model."

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

• This is not applicable as the studies described are non-clinical (laboratory and animal testing). The "ground truth" for these tests comes from adherence to established scientific and regulatory standards (e.g., ISO 10993, ASTM, USP) and predefined physical/chemical limits.
• For "Simulated Use - Bench," it mentions "by a physician," implying one or more physicians were involved in the benchtop evaluation, but their number and specific qualifications are not detailed beyond "physician."

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

• Not applicable to non-clinical laboratory or animal studies. Ground truth is determined by test results against defined acceptance 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. This device is a percutaneous catheter, not an AI/ML diagnostic or assistive device.

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

• Not applicable. This is not an algorithm/AI device.

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

• For non-clinical tests, the "ground truth" is determined by meeting predefined technical specifications, industry standards (e.g., ISO, ASTM), and biological safety parameters. For example, a burst pressure test's ground truth is a numerical value compared to a specification. For biocompatibility, it's the absence of adverse biological reactions per standard protocols. For the animal study, it's the absence of "clinically significant injury."

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires training data.

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

• Not applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.

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The Super Distal Access (SDA) is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

The Super Distal Access (SDA) is a single lumen, variable stiffness catheter and has a shaft reinforced with a Stainless Steel/Nitinol coil. The SDA has a radiopaque Platinum/Iridium marker band on the distal end. The catheter has a maximum outer diameter of 0.084 inches. It has a tapered design that includes a nominal inner diameter of 0.062 inches in the distal end and 0.068 inches in the proximal end. There are three working lengths available: 115 cm, 125 cm, and 135 cm. The Super Distal Access has a PTFE-lined lumen in the distal end a Polyimide/PTFE-lined lumen in the proximal end. The catheter is flexible and has a hydrophilic coating. The SDA is inserted through a guide catheter or vascular sheath, provides access to the target site, and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst hemostasis valve with an extension luer and a split sheath introducer. The SDA is supplied sterile, non-pyrogenic, and intended for single use only.

The provided text describes the non-clinical performance testing for the Super Distal Access (SDA) device to demonstrate its substantial equivalence to a predicate device. It includes acceptance criteria and conclusions for various tests.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance:

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

• Sample Size: The document repeatedly states "SDA test samples met the acceptance criteria". However, it does not specify the exact sample size (N) used for each test.
• Data Provenance: The biocompatibility tests were "conducted pursuant to 21CFR58, Good Laboratory Practices." The animal testing occurred in a "porcine model". Other non-clinical tests mention "conditioned samples" or "test samples". The origin of the data (country) is not explicitly stated, but the submission is to the U.S. FDA. The tests are prospective as they were conducted for the purpose of this submission to demonstrate substantial equivalence of the new device.

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):

• For the "Simulated Use - Bench" test, it states the product was evaluated "by a physician in a benchtop model." It does not specify the number or qualifications of this physician or any other experts involved in establishing ground truth for other tests. These appear to be laboratory and engineering tests rather than requiring expert clinical "ground truth" in the diagnostic sense.

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

• The document does not describe any adjudication method. The tests are primarily objective performance metrics against pre-defined acceptance criteria, not subjective interpretations 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:

• No, this document does not describe an MRMC comparative effectiveness study. This is a 510(k) submission for a medical catheter (Super Distal Access), not an AI-powered diagnostic device. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

• No, this document does not describe any algorithm-only or human-in-the-loop performance studies. As mentioned, 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 this device's performance is established by objective measurements and observations against engineering standards, biocompatibility guidelines (e.g., ISO 10993 series, ASTM standards, USP 788), and pre-defined specifications. For example, for "Biocompatibility - Material Mediated Pyrogen", the ground truth is the measured febrile reaction in test subjects. For "Radiographic Detectability", the ground truth is visibility under fluoro imaging. In some cases, such as "Animal Testing - Angiographic Evaluation", the "ground truth" is absence of vessel injury observed in a porcine model.

8. The sample size for the training set:

• This concept is not applicable here. This is a physical medical device undergoing non-clinical performance testing, not a machine learning model that requires a training set.

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

• This concept is not applicable here, as there is no training set for a machine learning model.

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