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The Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set, when used with a compatible vacuum pump, is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within the internal carotid artery and middle cerebral artery M1 segment within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.

The Aspiration Catheter, Delivery Catheter, and Base Camp Sheath comprise the Route 92 Medical HiPoint Reperfusion System. The Route 92 Medical HiPoint Reperfusion System is used with the Route 92 Medical Aspiration Tubing Set and the Route 92 Medical Base Camp Sheath System.

The Aspiration Catheter has a single-lumen, coil-reinforced polymer distal shaft section connected to a proximal control wire. The Delivery Catheter is a single-lumen variable stiffness catheter. Both catheters have hydrophilic coating. The devices are provided sterile and non-pyrogenic and are intended for single use only.

The Route 92 Medical Aspiration Tubing Set is made from high-pressure tubing. An on/off switch is provided to control fluid flow. A suction connector allows connection to an aspiration pump canister and a Luer fitting allows connection to the aspiration catheter.

For the aspiration source, the Aspiration Catheter is used in conjunction with an aspiration pump with prespecified performance parameters that is connected using the Route 92 Medical Aspiration Tubing Set.

The Route 92 Medical Base Camp 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 8 French (F) 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 a 510(k) clearance for the Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set. This is a medical device for treating acute ischemic stroke, not an AI/software device. Therefore, the requested information regarding AI acceptance criteria, data provenance, expert ground truth, MRMC studies, standalone performance, and training set details for an AI model cannot be extracted from this document, as it does not pertain to an AI device.

The document focuses on non-clinical and clinical studies (SUMMIT MAX trial) to demonstrate the safety and effectiveness and substantial equivalence of the mechanical device to a predicate device.

However, I can provide the acceptance criteria and performance data for the mechanical device as presented in the document:

Device: Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set

Study: SUMMIT MAX, a prospective, multi-center, randomized, controlled, interventional, open-label clinical trial.

1. Table of Acceptance Criteria and Reported Device Performance

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The 8F Modified Sheath System is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

The 8F Modified Sheath System is comprised of a Sheath, 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 singlelumen, 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 8F Modified Sheath System and its substantial equivalence to a predicate device (Base Camp® Sheath System, K191717) for FDA clearance. The document focuses on non-clinical testing to demonstrate performance.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various performance tests and their outcomes, uniformly indicating "PASS" and that "The pre-determined acceptance criteria were met." However, it does not explicitly state the specific quantitative acceptance criteria for each test. It only reports that the device met them.

Biocompatibility Testing Acceptance

For biocompatibility, the acceptance criteria are generally qualitative for these types of tests and are implicitly met when the "Conclusion" states no adverse reactions or that requirements were met.

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

The document does not explicitly state the sample sizes used for each of the performance or biocompatibility tests. It refers to "test specimens" or animals (e.g., "guinea pig," "rabbits," "mice") for biocompatibility, but without specific numbers.

• Data Provenance: The data provenance is from non-clinical bench testing and laboratory animal testing. There is no information provided about the country of origin, but given it's an FDA submission, the tests were conducted to international standards (e.g., ISO, ASTM) which are globally recognized. All testing appears to be prospective (conducted specifically 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 is a submission for a medical device (catheter system) where "ground truth" in the clinical sense (e.g., diagnosis, outcome) is not relevant for the non-clinical and biocompatibility studies presented. The "truth" or acceptance is determined by predefined engineering specifications and regulatory standards (ISO, ASTM). The document does not mention the use of human experts to establish ground truth for this type of testing.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human interpretation of data (e.g., medical imaging) to resolve discrepancies. The studies described are objective performance and biocompatibility tests where a result either meets or does not meet a predefined standard.

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 physical medical device (catheter system), not an AI/software device. No MRMC study was conducted or is relevant.

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 or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

As mentioned in point 3, the concept of "ground truth" in the clinical diagnostic sense is not applicable here. For the performance and biocompatibility studies, the "ground truth" is defined by:

• Pre-determined engineering specifications: For dimensional verification, tensile strength, kink resistance, etc.
• International standards and regulatory guidelines: Such as ISO 80369-7:2016 for Luer Integrity, ISO 10555-1:2013 for leakage and burst pressure, and ISO 10993-1 for biocompatibility.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this traditional medical device submission. Training sets are relevant for machine learning or AI models.

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

Not applicable, as there is no training set.

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The Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set is indicated for use 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 054 Aspiration Catheter and Tenzing 5 Delivery Catheter comprise the Route 92 Medical Full Length 054 Reperfusion System. The Route 92 Medical Full Length 054 Reperfusion System is used with the Route 92 Medical Aspiration Tubing Set.

The 054 Aspiration Catheter is a single-lumen, coil-reinforced variable stiffness catheter. The Tenzing 5 Delivery Catheter is a single-lumen variable stiffness catheters are hydrophilically coated. The devices are provided sterile and non-pyrogenic and are intended for single use only.

The Route 92 Medical Aspiration Tubing Set is made from high-pressure tubing. An on/off switch is provided to control fluid flow. A suction connector allows connection to an aspiration pump canister and a Luer fitting allows connection to the aspiration catheter.

For the aspiration source, the Aspiration Catheter is used in conjunction with an aspiration pump with prespecified performance parameters that is connected using the Route 92 Medical Aspiration Tubing Set, along with a legally marketed canister and accessories kit.

The provided document is a 510(k) Premarket Notification from the FDA regarding the Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific performance acceptance criteria based on clinical outcomes or expert-adjudicated ground truth.

Therefore, many of the requested elements for describing an acceptance criteria study, especially those related to AI algorithm performance (e.g., sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance), are not applicable to this type of regulatory submission. This document describes non-clinical testing to ensure the device's functional performance, safety, and compatibility.

Here's an analysis of the available information:

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

The document does not explicitly state numerical acceptance criteria values for each test, but rather generally states "All samples met the pre-determined acceptance criteria." The performance is reported as "PASS" for all tests.

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

The document states "All samples met the pre-determined acceptance criteria" for each test but does not specify the numerical sample sizes (N) for each test set. The data provenance is described as "Non-Clinical Testing" which implies in-vitro or laboratory testing, not human-derived data like images or patient records. Therefore, information like country of origin or retrospective/prospective is not applicable here.

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

Not applicable. The tests are non-clinical, mechanical, and performance-based (e.g., tensile strength, lumen patency). The "ground truth" is based on engineering specifications and adherence to international standards (like ISO) rather than expert interpretation of medical images or clinical outcomes.

4. Adjudication method for the test set

Not applicable. No expert adjudication was involved as the tests are objective, non-clinical measurements.

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 for revascularization, not an AI-powered diagnostic tool. No MRMC study was conducted.

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

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

7. The type of ground truth used

The "ground truth" for the non-clinical tests is based on:

• Engineering specifications: Device dimensions, tensile strength, etc.
• International standards: ISO 11135 for sterility, ISO 80369-7:2021 for Luer integrity, ISO 10555-1:2013 for air/liquid leakage and burst strength.
• Functional performance criteria: In a simulated neurovascular model for deliverability, clot retrieval, etc.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set."

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

Not applicable, as there is no training set.

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The Route 92 Medical Full Length 054 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 054 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 devices are provided sterile and non-pyrogenic and are intended for single use only.

The provided text describes the 510(k) premarket notification for the "Route 92 Medical Full Length 054 Access System." This document focuses primarily on the comparison of the new device to a predicate device and the results of non-clinical performance testing, rather than a study proving the device meets acceptance criteria through clinical or user-based performance.

Therefore, many of the requested details, particularly those related to AI-based device performance, human reader studies, and ground truth establishment for patient data, are not present in this document. The document focuses on physical properties and mechanical performance of the device itself.

Based on the provided text, here's the information that can be extracted about the acceptance criteria and the "study" (non-clinical performance testing):

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each test were "pre-determined" and the performance was reported as "PASS" for all samples, indicating they met these criteria. The specific numerical values or ranges for the acceptance criteria are not provided in this summary.

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

The document states "All samples met the pre-determined acceptance criteria" for each test. However, the specific number of samples used for each non-clinical test is not provided. The data provenance is laboratory testing of the device itself, not human or patient data. It is a non-clinical, bench-top study.

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

Not applicable for this type of non-clinical device testing. The "ground truth" here is adherence to engineering specifications and ISO standards, evaluated through physical measurements and mechanical tests, not expert interpretation of patient data.

4. Adjudication Method for the Test Set

Not applicable. This was not a study involving human interpretation or adjudication. The results were based on physical measurements and performance against established engineering and ISO standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not conducted. This is a non-clinical device clearance, not an AI or diagnostic imaging study.

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

No, this is purely a mechanical/physical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was based on pre-determined acceptance criteria derived from engineering specifications and international standards (e.g., ISO 80369-7:2016, ISO 10555-1:2013).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context.

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

Not applicable. As there is no training set, there is no corresponding ground truth establishment process.

Summary of what the document does describe related to acceptance and proof:

The document demonstrates that the "Route 92 Medical Full Length 054 Access System" meets its non-clinical performance and safety requirements by successfully passing a series of mechanical and physical tests. These tests are conducted to ensure the device performs as intended and is equivalent to the predicate device in terms of function and safety, given its similar design and materials but different dimensions. The "acceptance criteria" are implied to be the specific thresholds or ranges for each test (e.g., tensile strength, leak rate) that the device must meet to be considered safe and effective, and all samples passed these "pre-determined" criteria.

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The Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set is indicated for use 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 Aspiration Catheter and Tenzing 7 Delivery Catheter comprise the Route 92 Medical Full Length 070 Reperfusion System. The Route 92 Medical Full Length 070 Reperfusion System is used with the Route 92 Medical Aspiration Tubing Set.

The Aspiration Catheter is a single-lumen, coil-reinforced variable stiffness catheter. The Tenzing 7 Delivery Catheter is a single-lumen variable stiffness catheters are hydrophilically coated. The devices are provided sterile and non-pyrogenic and are intended for single use only.

The Route 92 Medical Aspiration Tubing Set is made from high-pressure tubing. An on/off switch is provided to control fluid flow. A suction connector allows connection to an aspiration pump canister and a Luer fitting allows connection to the aspiration catheter.

For the aspiration source, the Aspiration Catheter is used in conjunction with an aspiration pump with prespecified performance parameters that is connected using the Route 92 Medical Aspiration Tubing Set, along with a legally marketed canister and accessories kit.

The provided document, a 510(k) K223530 Premarket Notification for the Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set, does not contain information about an AI-powered device or a study involving AI assistance for human readers. It describes a medical device (a catheter system for stroke treatment) and a series of non-clinical, benchtop, and animal studies to demonstrate its safety and effectiveness.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI device's performance, as the document does not pertain to an AI device.

However, I can provide a summary of the acceptance criteria and the studies conducted for the medical device described in the document, as it meets the general structure of the request for device performance and testing.

Acceptance Criteria and Study for the Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set

This document describes the testing and acceptance criteria for a physical medical device, not an AI-powered one. The studies focus on the physical and functional performance of the catheter system.

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists various tests and their corresponding results, with the acceptance criterion implicitly being "PASS" for all samples meeting pre-determined criteria.

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The Route 92 Medical Full Length 070 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 070 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 catheter. Both catheters are hydrophilically coated. The devices are provided sterile and non-pyrogenic and are intended for single use only.

The Route 92 Medical Full Length 070 Access System is a medical device that facilitates the insertion and guidance of microcatheters in the neurovascular system. The provided document focuses on demonstrating the substantial equivalence of the device to a predicate device (Route 92 Medical Full Length 088 Access System, K210635) through non-clinical performance testing.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes various performance tests conducted, with the general acceptance criterion being that "All samples met the pre-determined acceptance criteria." While specific numerical acceptance criteria are not detailed in this summary, the results consistently indicate "PASS" for all tests.

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

The document does not explicitly state the numerical sample size used for each test. Instead, it generally refers to "All samples." The provenance of the data is not specified regarding country of origin or whether it was retrospective or prospective. Given that it's non-clinical performance testing for a 510(k) submission, it's highly probable these were controlled laboratory tests conducted prospectively by the manufacturer.

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

This section is not applicable to this document. The study described is non-clinical performance testing of a physical medical device, not a study involving human interpretation of medical data where expert ground truth would be required. The "ground truth" for these tests are the established engineering specifications and international standards (e.g., ISO standards).

4. Adjudication Method for the Test Set:

This section is not applicable for the same reasons as point 3. Testing involves objective measurements against pre-defined engineering and performance criteria, not expert adjudication of subjective findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through non-clinical performance testing of the device itself, not on evaluating the performance of human readers with or without AI assistance.

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

This section is not applicable. The device is a physical catheter system, not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical performance tests conducted for the Route 92 Medical Full Length 070 Access System is based on pre-determined acceptance criteria derived from established engineering specifications and relevant international standards (e.g., ISO standards). For example, Luer integrity was tested per ISO 80369-7:2016, and air/liquid leakage and static burst per ISO 10555-1:2013. Simulated use testing evaluated deliverability and compatibility against expected performance in a neurovascular model.

8. The Sample Size for the Training Set:

This section is not applicable. There is no "training set" as this is not an AI/ML device.

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

This section is not applicable for the same reasons as point 8.

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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:

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The Route 92 Medical 070 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 070 Access System 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, singlelumen variable stiffness catheter. Both catheters are hydrophilically coated. The Route 92 Medical 070 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.

This document describes the Route 92 Medical 070 Access System, a percutaneous catheter intended to facilitate the insertion and guidance of microcatheters in the neurovascular system. The provided text, K203043, is a 510(k) summary from the FDA, detailing the device's substantial equivalence to a predicate device based on non-clinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally "All samples met the pre-determined acceptance criteria" for each test. The actual numerical thresholds for these criteria are not explicitly stated in this document but are implied to be established standards for such medical devices.

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

• Sample Size: The document repeatedly states "All samples met the pre-determined acceptance criteria" but does not specify the exact number of samples used for each test set.
• Data Provenance: The tests are non-clinical (laboratory/bench testing) and were conducted by the manufacturer (Route 92 Medical, Inc.) to demonstrate substantial equivalence. The country of origin of the data is not explicitly stated but is implicitly the United States, given the FDA submission. The data is prospective for the purpose of this 510(k) submission, as it was generated specifically to support the clearance of this device.

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

• Ground Truth Establishment: For non-clinical performance and biocompatibility testing of a medical device like this catheter, "ground truth" is typically established by recognized international standards (e.g., ISO, ASTM, USP) and engineering specifications. It's not based on expert consensus in the same way as, for example, image interpretation.
• Experts: The document does not mention the use of human experts to establish ground truth for these non-clinical tests. The tests themselves provide the "ground truth" against the established quantitative criteria from the standards.

4. Adjudication Method

• Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or multi-reader reviews involving subjective assessments, especially for diagnostic devices. This is a non-clinical, bench-top testing summary. Therefore, an adjudication method as described is not applicable and was not used. The results are compared directly to predefined quantitative pass/fail criteria.

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

• No MRMC study was done. This device is a physical medical device (catheter system), not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

6. Standalone Performance

• Yes, a standalone performance study was done. All the listed biocompatibility and performance tests are standalone evaluations of the device's physical and biological characteristics without human intervention in the test setup (beyond conducting the test itself). The device itself is not an AI algorithm, so the term "algorithm only" is not directly applicable, but the tests were "device only" performance assessments.

7. Type of Ground Truth Used

• The ground truth used for the non-clinical tests is based on established industry standards and documented engineering specifications/acceptance criteria. These standards include:
  • ISO 10993-1: Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for biocompatibility.
  • ISO 10555-1:2013: Intravascular Catheters - Sterile Single-Use Catheters - Part 1: General Requirements for Air and Liquid Leakage / Static Burst.
  • USP : Particulate Matter in Injections for particulate recovery.
  • Generic acceptance criteria for mechanical properties (Tensile Strength, Kink Resistance, Torsion Resistance, Tip Flexibility, Dynamic Burst, Hydrophilic Coating Integrity, Dimensional Verification) which would be defined by the manufacturer based on expected performance and comparison to predicate devices, and internal design requirements.

8. Sample Size for the Training Set

• Not applicable. This device is a physical medical instrument, not an AI model requiring a training set.

9. How Ground Truth for the Training Set Was Established

• Not applicable. As stated above, this is a physical medical device, not an AI model.

In summary, the K203043 submission demonstrates the substantial equivalence of the Route 92 Medical 070 Access System through comprehensive non-clinical testing. The device met all pre-determined acceptance criteria based on established industry standards and internal specifications, confirming its safety and performance for its intended use.

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The Route 92 Medical 088 Access System, 143 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, 143 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, 143 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.

This document describes the premarket notification for a medical device, the Route 92 Medical 088 Access System, 143 cm, a percutaneous catheter designed to facilitate the insertion and guidance of microcatheters in the neurovascular system.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document categorizes performance testing into Biocompatibility Testing and Engineering Performance Testing. The acceptance criteria for all tests are implicitly stated as "met the pre-determined acceptance criteria," and the results are uniformly "PASS."

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

The document consistently states "All samples met the pre-determined acceptance criteria" for the performance tests, implying that the sample size for each specific test was sufficient to demonstrate compliance. However, the exact numerical sample size for each performance test is not explicitly provided.

• Data Provenance:
  • Biocompatibility: In-vitro and in-vivo tests aligned with ISO 10993-1 standards.
  • Performance Testing: In-vitro bench testing, and in-vivo animal model testing (acute swine model). No specific country of origin is mentioned for the data, but the testing standards (ISO, USP, ASTM) are international.
  • Retrospective/Prospective: The testing described is prospective, specifically designed to evaluate the new device against established standards and a predicate device.

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

This document is for a medical device (catheter), not an AI/imaging device requiring expert interpretation of results. Therefore, the concept of "experts establishing ground truth for a test set" in the context of image interpretation or clinical diagnosis is not directly applicable.

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

• Engineering specifications and validated test methods (e.g., ISO, ASTM, USP standards).
• Performance in animal models, assessed by researchers and potentially, but not explicitly stated, veterinary or interventional specialists.

4. Adjudication Method for the Test Set:

Not applicable in the typical sense of a human-in-the-loop AI study. The "adjudication" is inherent in the quantitative and qualitative PASS/FAIL results generated by the standardized test methods.

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

No, an MRMC study was not conducted. This type of study is primarily relevant for diagnostic imaging AI devices where human readers interpret medical images. This document describes a physical medical device (catheter) and its mechanical/biocompatibility performance.

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

This question is not applicable. This is not an AI algorithm. The device's "standalone" performance is evaluated through the detailed bench testing, biocompatibility testing, and animal studies, which assess the device's intrinsic properties and function without human intervention during the measurement of performance metrics.

7. The Type of Ground Truth Used:

The ground truth for this device's performance is based on:

• Validated Standard Test Methods: International standards (ISO, ASTM, USP) for medical device performance and biocompatibility.
• Predicate Device Comparison: The new device is compared to a legally marketed predicate device (Route 92 Medical 088 Access System, 110 cm, K200121) to demonstrate substantial equivalence, implying the predicate's performance serves as a comparative "ground truth."
• Pre-determined Acceptance Criteria: Internal specifications and performance limits set by the manufacturer based on regulatory requirements and engineering principles.
• Animal Model Observations: Direct observation of device safety and performance in an acute swine model, including angiographic and histological assessments.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI 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 medical 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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