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The Route 92 Medical Full Length 088 Access System is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system.

The Route 92 Medical Full Length 088 Access System is comprised of a Support Catheter and a Delivery Catheter. The Support Catheter is a single-lumen, variable stiffness catheter. The Delivery Catheter is a hubbed, single-lumen variable stiffness catheters are hydrophilically coated. The Route 92 Medical Full Length 088 Access System is intended for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system. The devices are provided sterile and non-pyrogenic and are intended for single use only.

The provided text describes a 510(k) premarket notification for a medical device, the Route 92 Medical Full Length 088 Access System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical studies. Therefore, the information requested about acceptance criteria and studies proving the device meets those criteria in the context of efficacy for a new therapeutic claim, a multi-reader multi-case study, or standalone algorithm performance, is not directly applicable in the same way it would be for a de novo submission or a PMA.

Instead, the document details non-clinical (biocompatibility and performance) testing to show the new device performs similarly safely and effectively to its predicate.

Here's an analysis based on the provided text:

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

The document doesn't explicitly state "acceptance criteria" in a quantitative, numerical format for each performance test, but rather implies them via "All samples met the pre-determined acceptance criteria" or similar statements. The "Reported device performance" is summarized as "PASS" for all tests, indicating that they met these unquantified criteria.

Biocompatibility Testing:

2. Sample sized used for the test set and the data provenance:
The document does not specify the exact sample sizes (N-numbers) for each performance test. It consistently states "All samples met the pre-determined acceptance criteria," implying that a sufficient number of units were tested according to the relevant standards. The data provenance is non-clinical (laboratory testing) rather than clinical (human subjects). No country of origin is specified for the testing data. All testing appears to be retrospective in the sense that it was conducted on manufactured devices before the 510(k) 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, and its performance is evaluated against engineering and biological standards in non-clinical lab settings, not through expert-reviewed "ground truth" like in AI/diagnostic imaging studies.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as this refers to expert review processes for clinical data, which is not present in this 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:
No, an MRMC comparative effectiveness study was not done. This device is an access system (catheter) and not an AI-powered diagnostic tool. The submission focuses on substantial equivalence based on material properties and mechanical performance, not on AI assistance for human readers.

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 an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance are the established international and industry standards (e.g., ISO, USP) and the pre-determined engineering specifications for the device's physical and biological characteristics.

8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device 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 this device.

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The Route 92 Medical 088 Access System, 110 cm, is indicated for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system.

The Route 92 Medical 088 Access System, 110 cm, is comprised of a Support Catheter and a Delivery Catheter. The distal portion of the Support Catheter is a single-lumen, variable stiffness catheter. Like the predicate device, the proximal portion is a stainless-steel control wire. The Delivery Catheter is a hubbed, single-lumen variable stiffness catheter. Both catheters are hydrophilically coated. The Route 92 Medical Access System, 110 cm, is intended for use with compatible guide catheters in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the neurovascular system. The devices are provided sterile and non-pyrogenic and are intended for single use only.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Route 92 Medical 088 Access System, 110 cm:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance criteria in two main sections: Biocompatibility Testing and Performance Testing. For both, the acceptance criterion is implicitly "PASS" meaning the device met pre-determined criteria for each test. Specific quantitative acceptance criteria are not detailed in this summary.

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

The document states "All samples met the pre-determined acceptance criteria" for various performance tests, but does not specify the exact sample size for any of the individual tests. The provenance of the data (e.g., country of origin, retrospective or prospective) is also not provided. Many tests mention adherence to ISO standards, implying controlled laboratory conditions, but details about the test setting are not available. The Biocompatibility and Performance tests are "Non-Clinical Testing."

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

This information is not provided as the tests conducted are primarily non-clinical, mechanical, and material-based, not involving human interpretation of medical images or patient outcomes that would typically require expert ground truth establishment in that manner. For the "Simulated Use Testing," "Radiopacity," and "Contrast Delivery," and "In Vivo Thromboresistance" which involve models and animals, the experts involved in conducting and evaluating these tests are not specified.

4. Adjudication Method for the Test Set:

An adjudication method is not applicable and therefore not mentioned, as the tests are primarily objective physical and chemical characterizations, rather than assessments requiring human judgment or consensus from multiple reviewers for a "ground truth" determination.

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

No, an MRMC comparative effectiveness study was not conducted. This document describes a 510(k) submission for a medical device (catheter system), not an AI or imaging diagnostic tool. Therefore, human reader performance with or without AI assistance is not relevant to this submission.

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

No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not an algorithm or software.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is defined by the specifications and acceptable ranges established by industry standards (e.g., ISO) and the manufacturer's pre-determined acceptance criteria. For "Simulated Use Testing," "Radiopacity," "Contrast Delivery," and "In Vivo Thromboresistance," the ground truth would be based on direct observation and measurement within the respective models (neurovascular model, animal model), demonstrating the device's functional integrity and performance as intended. No human pathology, outcomes data, or expert consensus in the medical diagnostic sense is mentioned as ground truth.

8. The Sample Size for the Training Set:

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

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

This information is not applicable as this is a physical medical device, not an AI model requiring a training set and associated ground truth.

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The Route 92 Medical Sheath System is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

The Route 92 Medical Sheath System is comprised of a Sheath, a Dilator, a Navigating Catheter, and an RHV (rotating hemostasis valve). The Sheath is a single-lumen, variable stiffness catheter with a radiopaque marker on the distal end. The inner lumen of the catheter is compatible with 8F or smaller catheters. The Dilator may be placed within the Sheath to facilitate percutaneous introduction of the Sheath into a femoral artery. The Dilator has a radiopaque marker at the distal tip. The Navigating Catheter is a single-lumen, variable stiffness catheter with a radiopaque marker at the distal tip. The Navigating Catheter is compatible with the Sheath and has a shaped distal end to facilitate placement. All of the catheters are coated with hydrophilic coating.

The provided text describes the 510(k) summary for the Route 92 Medical Sheath System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study to establish new acceptance criteria and prove its performance. Therefore, the information requested about acceptance criteria and a study proving the device meets those specific acceptance criteria (as would be applied to a novel device or AI software) is not directly present in the provided document.

Instead, the document details non-clinical testing to demonstrate the device's safety and performance against established standards and equivalence to a predicate device. The "acceptance criteria" here are implicitly the "PASS" results for each test, indicating conformity to pre-determined specifications or regulatory requirements.

Here's an attempt to answer your questions based on the provided text, while acknowledging the focus on substantial equivalence:

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

Since this is a 510(k) submission, the acceptance criteria are not explicitly defined numerical targets specific to a new AI model's performance but rather general standards and successful completion of tests demonstrating safety and equivalence.

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

The document generally states "All samples met the pre-determined acceptance criteria" for performance tests and provides results for biocompatibility tests (e.g., "All animals treated had were clinically normal" for acute systemic toxicity). It does not specify precise sample sizes for each non-clinical test.

• Sample Size: Not explicitly stated for most tests, often referred to as "all samples" or "animals" depending on the test type.
• Data Provenance: Not applicable in the context of these non-clinical, lab-based tests on device components/products. The tests are designed to evaluate the physical and biological characteristics of the device itself, not data from human subjects or retrospective/prospective studies in the clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. The tests conducted are non-clinical, laboratory-based evaluations of device properties (e.g., tensile strength, biocompatibility, dimensions). They do not involve expert interpretation of data or images to establish a "ground truth" as would be required for an AI-powered diagnostic device.

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

This is not applicable for non-clinical, laboratory-based testing of device characteristics. Adjudication methods are typically used in clinical studies or for establishing ground truth in diagnostic accuracy studies involving human interpretation.

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. The provided document is for a "Percutaneous Catheter" device, which is a physical medical instrument, not an AI software. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not conducted.

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

No. This is a physical medical device, not an algorithm or AI.

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

This is not applicable as the tests are non-clinical hardware evaluations. The "ground truth" broadly refers to the established scientific and engineering principles, international standards (e.g., ISO), and pre-determined specifications against which the device's performance is measured.

8. The sample size for the training set

This is not applicable as the device is a physical medical instrument and no AI/machine learning model was trained.

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

This is not applicable as there is no training set for an AI/machine learning model.

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The Route 92 Medical Delivery Catheter is indicated for use with compatible catheters in facilitating the insertion and guidance of catheters into a selected blood vessel in the neurovascular system.

The modified Route 92 Medical Delivery Catheter is a single-lumen, variable stiffness, hydrophilically coated catheter with a flexible tapered tip. The tapered tip is delineated by two radiopaque markers. On the proximal end is a luer hub for guidewire introduction and fluid or contrast injection. The devices are provided sterile and non-pyrogenic and are intended for single use only. During use, a standard neurovascular guidewire may be inserted through the Delivery Catheter. The Delivery Catheter is inserted through a compatible catheter. The Delivery Catheter and compatible catheter are advanced to the targeted location under fluoroscopy using standard endovascular techniques.

The provided document is a 510(k) summary for the Route 92 Medical Delivery Catheter. It describes the device, its intended use, and the performance testing conducted to demonstrate substantial equivalence to a predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state the quantitative acceptance criteria for each test. Instead, it generally states "All samples met the pre-determined acceptance criteria" under the "Results" column. The "Test Method" column describes how the device was tested, implying the criteria are inherent to or defined by these methods.

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

The document does not specify the sample size used for any of the performance tests. It refers to "test specimens" and "samples" but no quantities.
The data provenance (country of origin, retrospective/prospective) is not mentioned. These are bench tests, so patient data provenance is not applicable.

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 as the document describes bench performance testing of a medical device (catheter), not a diagnostic device involving expert interpretation or ground truth establishment in a clinical sense. The "ground truth" for these tests would be the fulfillment of engineering specifications and standards.

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

This information is not applicable for the type of bench testing described. Adjudication methods are typically used in clinical studies where expert consensus is needed to establish a ground truth for diagnostic or interpretative tasks.

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

An MRMC comparative effectiveness study was not done. This document describes bench testing for a physical medical device (catheter), not an AI-assisted diagnostic tool or an imaging product that would involve human readers.

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

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

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

For this type of device and testing, the "ground truth" refers to engineering specifications, established industry standards (e.g., ASTM, ISO), and the performance characteristics of the predicate device. The tests demonstrate that the device meets these pre-defined physical and functional requirements. It is a comparison against established benchmarks for mechanical and material integrity.

8. The sample size for the training set

This is not applicable as the document describes a physical medical device and its bench testing, not an AI/machine learning model that requires a training set.

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

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

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The Route 92 Medical Delivery Catheter is indicated for use with compatible catheters in facilitating the insertion and guidance of catheters into a selected blood vessel in the neurovascular system.

The Delivery Catheter is a single-lumen, variable stiffness catheter with a flexible, tapered tip delineated by two radiopaque markers. The distal shaft of the Delivery Catheter has a hydrophilic coating. On the proximal end is a hypotube attached to a luer hub for guidewire introduction. This proximal hypotube includes a fluoro-saver marker indicating when the tip of the catheter is about to exit a long femoral sheath/guide. The devices are provided sterile and non-pyrogenic and are intended for single use only. During use, a standard neurovascular guidewire may be inserted through the Delivery Catheter. The Delivery Catheter is inserted through a compatible access catheter. The Delivery Catheter and access catheter are advanced to the targeted location under fluoroscopy using standard endovascular techniques.

This document describes the premarket notification (510(k)) for the Route 92 Medical Delivery Catheter. The submission aims to demonstrate substantial equivalence to a predicate device, not to perform a comparative effectiveness study or validate an AI/ML algorithm. Therefore, many of the requested elements for describing AI-related studies are not applicable.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each test are typically "PASS," meaning the samples met pre-determined criteria. The document states "All samples met the pre-determined acceptance criteria" for nearly all non-clinical performance tests. Specific quantitative acceptance criteria are not provided within this summary for most tests, but they would have been defined in the full test protocols.

2. Sample Size for Test Set and Data Provenance

This submission is for a medical device (catheter) and relies on non-clinical (bench and biocompatibility) testing, not a clinical study involving human patient data or a "test set" in the context of an AI/ML algorithm.

• Sample Size (Test Set): The specific number of samples for each bench test is not provided in this summary. For biocompatibility, animal testing (Guinea Pig Maximization, Acute Systemic Injection, Pyrogen, Thromboresistance in animal model) was performed, but the exact number of animals per test is not detailed.
• Data Provenance (e.g., country of origin, retrospective/prospective): Not applicable for bench and biocompatibility testing of a physical device. Biocompatibility data was leveraged from the predicate device (K180201), indicating it was previously generated.

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

Not applicable. Ground truth, in the context of expert consensus, is typically used for AI/ML image analysis or diagnostic devices. This submission involves physical device performance and safety testing.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" requiring adjudication by experts.

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

Not applicable. This is not a diagnostic device or an AI/ML algorithm being compared to human readers. It is a delivery catheter.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is not an AI/ML algorithm.

7. Type of Ground Truth Used

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

• Pre-defined technical specifications and engineering requirements.
• International standards (e.g., ISO 10993-1, ISO 80369-7, ISO 10555-1, ISO 11607-1/2, USP <788>).
• Laboratory measurements and observations during bench testing.
• Biological responses observed in animal models (for biocompatibility).

8. Sample Size for the Training Set

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

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

Not applicable. There is no training set for this device.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is a combination of Biocompatibility Testing and Performance Testing - Bench.

• Biocompatibility Testing: Evaluated the biological safety of the device materials. These tests were leveraged from the predicate device (Route 92 Medical Access System, K180201) because the subject device is identical in materials, design, and manufacturing processes. The tests included Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogen, Hemocompatibility (Complement Activation, PTT, Hemolysis, Thromboresistance), and Genotoxicity (Bacterial Mutagenicity, In Vitro Mouse Lymphoma). All tests reported "PASS" or conclusions indicating the device is safe and biocompatible within accepted medical device standards.
• Performance Testing - Bench: Evaluated the physical and mechanical performance characteristics of the catheter. Most of these tests were also leveraged from the predicate device (K180201) due to identical design. Tests included Dimensional Verification, Luer Integrity, RHV Sealing, Tensile Strength, Kink Resistance, Torsion Resistance, Tip Flexibility, Air Leakage, Liquid Leakage, Hydrophilic Coating Integrity, Particulate Recovery, Corrosion Resistance, Catheter Burst Pressure, Catheter Flow Rate, Simulated Use Testing, Packaging Integrity, and Radiopacity. All tests reported "PASS," indicating that the samples met their pre-determined acceptance criteria.

The summary concludes that: "The successful completion of the performance testing listed in the following table demonstrates that the Route 92 Medical Delivery Catheter is suitable for its intended use." And "based on the identical design and materials of construction between the subject and predicate devices and the completed non-clinical testing, the subject Route 92 Medical Delivery Catheter is substantially equivalent to the predicate Route 92 Medical Access System (K180201)."

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