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The Surefire Spark Infusion System is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

The Surefire Spark Infusion System is a 0.021" lumen microcatheter with a seff-expanding tip at the distal end. The Surefire Spark serves as the conduit for physician-specified agents such as contrast agents, flush solutions, and embolic beads. It is compatible with standard guide wires up to 0.018", and embolic hydrogel particles 500um or less in size and glass microspheres 110um or less in size. The Surefire Spark has a PTFE inner liner to provide a lubricious surface for passage of physician-specified agents and other accessory devices. The device is hydrophilically coated. The soft, pliable, self-expanding tip is sized for use in vessels of 1.5-3.5mm.

There are two radiopaque markers located at the distal end of the Surefire Spark to aid in positioning of the self-expanding tip. When in correct position, the self-expanding tip is designed to improve infusion efficiency of compatible embolic agents while maintaining antegrade flow in various size vessels.

The Surefire Spark Infusion System is provided sterile (EtO) for single patient use.

The Surefire Infusion Systems will be available in the following sizes:

Inner Diameter: 0.021 inch, Length: 120 cm, Tip / Vessel Size: 1.5 - 3.5 mm
Inner Diameter: 0.021 inch, Length: 150 cm, Tip / Vessel Size: 1.5 - 3.5 mm

The Surefire Spark Infusion System is a medical device and the provided text describes its 510(k) premarket notification to the FDA. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a traditional clinical study with quantifiable acceptance criteria for diagnostic performance metrics like sensitivity or specificity.

Therefore, many of the requested categories for a study proving device acceptance (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this type of device and regulatory submission as described in the provided text. The device is an intravascular catheter designed for delivering agents, not for diagnosis or image interpretation.

Instead, the acceptance criteria and performance evaluation for this device revolve around engineering and physical performance tests, and a comparative animal study against a predicate device.

Here's the information that can be extracted and inferred from the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Surefire Spark Infusion System are implicitly defined by meeting the same performance specifications as its predicate device and demonstrating comparable performance in various physical and functional tests. The study demonstrates that the device met these criteria.

Study Details (Based on available information)

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

   • Test Set Sample Size: Not explicitly stated for each bench test. For the animal study, the sample size is not specified beyond "An animal study was performed."
   • Data Provenance: The bench tests and animal study were performed by the manufacturer to support the 510(k) submission. No country of origin is specified for the data, but the manufacturer is based in Westminster, CO, USA. The study would be considered prospective for the purpose of demonstrating equivalence for this specific device.

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

   • Bench Tests: Not applicable in the sense of expert review for ground truth on performance specifications. These are objective engineering measurements against defined criteria.
   • Animal Study: The acute performance was "defined by physicians in a simulated clinical environment." The number and qualifications of these "physicians" are not specified. Their role was to assess performance, not establish ground truth in a diagnostic sense.

3. Adjudication method for the test set:

   • Not applicable as the tests involve objective measurements (bench tests) or physician assessment (animal study) rather than diagnostic interpretation requiring adjudication.

4. 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 MRMC study was done. This device is an intravascular catheter for substance delivery, not an AI-powered diagnostic tool, so such a study is not relevant to its regulatory approval in this context.

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

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

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

   • For the bench tests, the "ground truth" is defined by established engineering and material performance specifications which the device must meet or perform comparably to the predicate.
   • For the animal study, the "ground truth" for acute performance was based on "user needs" defined by physicians in a simulated clinical environment and comparison to the predicate device's performance.

7. The sample size for the training set:

   • Not applicable. This device does not involve a training set as it is not an AI/machine learning device.

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

   • Not applicable as there is no training set mentioned or implied.

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The Surefire Precision Infusion System is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

The Surefire Precision Infusion Systems are coaxial microcatheters with a female luer lock hub at the proximal end, and the Surefire Expandable Tip at the distal end that is sized for use in various sized vessels. The Surefire Precision Infusion System, serves as the conduit for physician-specified agents such as contrast agents, flush solutions, and embolic beads. It is compatible with standard guide wires up to 0.018", and embolic hydrogel particles ≤500μm, and glass microspheres ≤110μm (0.021" lumen) or <150um (0.025" lumen). The Surefire Precision Infusion System has a Teflon inner liner to provide a lubricious surface for passage of physician-specified agents and other accessory devices. The device is hydrophilically coated. The Surefire Precision Infusion System has an outer sheath to facilitate expanding and collapsing the Surefire Expandable Tip. There are three radiopaque markers located just proximal and distal to the Surefire Expandable Tip. The Tip can be expanded or collapsed for re-positioning during an interventional procedure by simply retracting or advancing the inner microcatheter while holding the outer sheath stationary. When expanded, the Expandable Tip is designed to improve infusion efficiency of compatible embolic agents while maintaining antegrade flow in the vessel. The Surefire Precision Infusion System is provided sterile (EtO) for single patient use.

The Surefire Precision Infusion System is a medical device and the provided text describes its 510(k) summary, focusing on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" and "device performance" are not presented in the context of a diagnostic AI algorithm with specific metrics like accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" are the performance specifications and the "device performance" refers to the results of the verification and validation tests, which show the device meets these specifications and performs comparably to the predicate.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a medical device (intravascular catheter) and not an AI algorithm, the "acceptance criteria" refer to established performance specifications for device function, and "reported device performance" refers to the successful demonstration that the device met these specifications during testing. The document does not provide a quantitative table of specific numerical acceptance criteria and their corresponding results but rather states that the device "meets the same performance specifications and acceptance criteria as the predicate device" and that "performance is comparable to the predicate device."

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

• Test Set Description: The "test set" here refers to the samples used in the performance testing and animal study for the physical device, not a dataset for an AI model.
• Sample Size: The document does not specify the exact numerical sample sizes for each performance test (e.g., number of catheters tested for burst pressure). It only generically states that various tests were performed. For the animal study, the sample size (number of animals) is not disclosed.
• Data Provenance: The biocompatibility testing was conducted by NAMSA (Northwood, OH), indicating US-based data. The performance testing (bench testing) was likely conducted in-house or by a contracted lab. The animal study was also performed to assess comparative acute performance. The general provenance is therefore related to device manufacturing and testing processes, not patient data from a specific country or whether it was retrospective/prospective in the AI sense.

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

This question is not directly applicable in the context of this traditional medical device submission. Ground truth, in the sense of expert consensus on diagnostic imaging, is not relevant here. The "ground truth" for the device's performance is established by objective engineering and biological testing against predefined specifications and comparison to the predicate device's established performance.

However, for the animal study, it notes that the performance was "as defined by physicians in a simulated clinical environment." This implies that physicians (experts) observed and evaluated the device's performance in the animal model. The number and qualifications of these physicians are not specified.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in AI studies where disagreements among experts need to be resolved. This is not applicable to a traditional medical device's performance testing. Device performance is determined by objective measurements and observations against acceptance criteria.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI algorithm on human reader performance, which is not the subject of this 510(k) submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, this question is not applicable as the Surefire Precision Infusion System is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" is defined by:

• Objective Performance Specifications: These are engineering standards and safety requirements that the device must meet (e.g., tensile strength, burst pressure, coating durability).
• Predicate Device Performance: The "ground truth" for comparative performance is the established safe and effective performance of the legally marketed predicate device. The new device must demonstrate comparable performance.
• Biocompatibility Standards: Compliance with ISO 10993 series standards establishes the biological "ground truth" for material safety.
• Physician Assessment (Animal Study): In the animal study, the "ground truth" for acceptability and comparability was a qualitative assessment by physicians based on "defined user needs" in a simulated clinical environment.

8. The Sample Size for the Training Set

This question is not applicable as the Surefire Precision Infusion System is a physical medical device and does not involve AI model training.

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

This question is not applicable as the Surefire Precision Infusion System is a physical medical device and does not involve AI model training or a training set.

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The Surefire Guiding Catheter is intended to provide a pathway through which therapeutic devices are introduced. The Surefire Guiding Catheter is intended to be used in the peripheral vascular system.

The Surefire Guiding Catheter provides a pathway to introduce and facilitate the advancement of devices into the peripheral vascular system.

The Surefire Guiding Catheter is a single-lumen 5F catheter with a soft distal tip and a Luer-Lock hub and strain relief. The Surefire Guiding Catheter has a three-layer construction, consisting of a Teflon inner liner, metal mid-layer, and a polymer outer shaft jacket. The polymer is filled with a radiopacifier agent, to provide visibility of the catheter under fluoroscopy.

The Surefire Guiding Catheter is available in 65 cm and 80 cm lengths with a variety of pre-shaped tip designs (including but not limited to Axis and Sim1) to accommodate access and positioning in a range of peripheral vascular anatomies.

The Surefire Guiding Catheter is compatible with standard 0.038" OD guide wires, Luer-Lock infusion syringes, rotating hemostatic valves (RHV), and 5F catheter sheath introducers.

The Surefire Guiding Catheter is provided sterile (EtO) for single patient use.

The provided text describes a 510(k) summary for the Surefire Guiding Catheter, which is seeking substantial equivalence to a predicate device. This submission focuses on engineering and biocompatibility testing for a modified device, rather than a study on an AI/ML algorithm's performance meeting acceptance criteria. Therefore, most of the information requested in your prompt (1-9) about AI device performance and ground truth establishment is not available in the given document.

The document does describe acceptance criteria and performance data for the catheter device itself. I will provide the available information based on the document, noting where the requested AI-specific information is not present.

Acceptance Criteria and Device Performance (for the physical device, not AI):

The document states that the design verification/validation tests performed on the modified Surefire Guiding Catheter demonstrated that it "meets the same performance specifications and acceptance criteria as the predicate device." This implies a direct comparison to the previously cleared predicate device's established performance. The specific quantitative acceptance criteria and their corresponding reported device performance values are not explicitly listed in a table, but rather implied by statements of "meeting" or "comparable" performance.

Detailed Breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• For Biocompatibility: The document refers to "testing" and "studies" but does not explicitly state sample sizes for each test type (e.g., number of cells for cytotoxicity, number of animals for sensitization/irritation). The "previously completed biocompatibility testing" was leveraged from the predicate device (K140034).
• For Performance Testing (Bench Tests): No specific sample sizes for each bench test are provided. It states these tests were performed and results demonstrate the device meets criteria.
• For Animal Testing: A "GLP animal study was performed," but the number of animals used is not specified.
• Data Provenance: The biocompatibility testing was conducted by NAMSA (Northwood, OH) and Toxicon (Bedford MA). The animal study was also a GLP study; the location is not specified, but it's implied to be a controlled environment for generating data for regulatory submission. All data would be prospective for the purpose of this submission, though some biocompatibility data was leveraged from previous testing of the predicate device.

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

• Not Applicable. This information is relevant for AI/ML device studies where experts define the "correct" diagnostic or classification outcome. For this physical catheter device, "ground truth" relates to objective physical and biological properties measured via standardized tests and potentially assessed by "a physician" in the animal study. The qualifications of the "physician" are not detailed.

4. Adjudication method for the test set:

• Not Applicable. Again, this is typically for AI/ML studies involving human interpretation disagreements. For this device, standard testing protocols are followed, and performance is measured against established specifications or comparison to a predicate device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. This is an AI/ML specific question. No MRMC study was conducted as this is a physical medical device (guiding catheter).

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

• Not Applicable. This is an AI/ML specific question. No algorithm is involved in this device.

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

• For Biocompatibility: Ground truth is established by adherence to ISO 10993 standards and observation of biological reactions (e.g., no significant cytotoxicity, no sensitization, no irritation, no systemic toxicity, acceptable hemocompatibility). This is essentially data derived from standard biological assays.
• For Performance Testing (Bench Tests): Ground truth is based on engineering specifications and direct physical measurements (e.g., visual inspection, dimensional checks, force measurements for pull strength, burst pressure).
• For Animal Study: Ground truth involves "acceptable performance" as defined by a physician's assessment in a clinical environment during the study, and comparison to the predicate device. This is a form of expert assessment of device function in vivo.

8. The sample size for the training set:

• Not Applicable. There is no training set for a physical catheter device. This is an AI/ML specific question.

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

• Not Applicable. There is no training set for a physical catheter device. This is an AI/ML specific question.

In summary, the provided document describes a regulatory submission for a physical medical device (Surefire Guiding Catheter) and focuses on demonstrating substantial equivalence to a predicate device through engineering (bench) tests, biocompatibility testing, and an animal study. It does not involve an AI/ML algorithm, and therefore the details requested about AI performance, ground truth, and study design for AI are not present.

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The Surefire Guiding Catheter is intended to provide a pathway through which therapeutic devices are introduced. The Surefire Guiding Catheter is intended to be used in the peripheral vascular system.

The Surefire Guiding Catheter provides a pathway to introduce and facilitate the advancement of devices into the peripheral vascular system.

The Surefire Guiding Catheter is a single-lumen, braided, fixed-length 5F catheter with a soft distal tip and a proximal Luer-Lock hub and strain relief. The Pebax extruded polymer is filled with a radiopacifier to provide visibility of the Surefire Guiding Catheter under fluoroscopy.

The Surefire Guiding Catheters are 65 and 80 cm in length with a variety of pre-shaped tip designs (including but not limited to Axis, Simmons I and Cobra) to accommodate access and positioning in a range of peripheral vascular anatomies. The distal tip is rounded for atraumatic tracking.

The Surefire Guiding Catheter is compatible with standard 0.038" OD guide wires, Luer-Lock infusion syringes, rotating hemostatic valves (RHV), and 5F catheter sheath introducers.

The Surefire Guiding Catheter is provided sterile (EtO) for single patient use

This document describes the Surefire Guiding Catheter, a medical device, and its acceptance criteria as demonstrated through various studies.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text details various tests performed to demonstrate the safety and effectiveness of the Surefire Guiding Catheter and its equivalence to a predicate device. The acceptance criteria are implicitly met by the successful completion of these tests and the determination of substantial equivalence.

Study that Proves the Device Meets the Acceptance Criteria:

The document describes a series of studies rather than a single unifying study, all aimed at demonstrating the safety, effectiveness, and substantial equivalence of the Surefire Guiding Catheter to its predicate device. This approach is typical for 510(k) submissions.

Summary of Studies:

1. Biocompatibility Testing: Performed per ISO 10993-1, leveraging data from other Surefire products with similar materials. This included various in-vitro tests for cytotoxicity, sensitization, irritation, systemic toxicity, and hemocompatibility.
2. Performance Testing (Bench Studies): Design verification tests including visual/dimensional inspection, particulates, kink, tensile strength, torque, trackability/device compatibility, high pressure injection, and flow/pressure generation.
3. Animal Testing (GLP): A comparative acute performance study against the predicate device.

Detailed Information Regarding the Studies:

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

• Biocompatibility Testing: The specific sample sizes for each in-vitro test (Elution, Maximization, Intracutaneous, Systemic Toxicity, Hemolysis, Complement Assays, Coagulation) are not explicitly stated in the provided text.
  • Data Provenance: The tests were performed by NAMSA (Northwood, OH). This suggests in-vitro laboratory testing. The leveraging of data from other Surefire devices implies the materials were sourced from the manufacturer for these devices.
• Performance Testing (Bench Studies): Sample sizes for the various bench tests (visual/dimensional, kink, tensile, torque, etc.) are not explicitly stated in the provided text.
  • Data Provenance: These were likely performed at a manufacturing or testing facility, but the specific location is not mentioned.
• Animal Testing: The number of animals used for the GLP animal study is not explicitly stated.
  • Data Provenance: The study was a "GLP animal study," meaning it followed Good Laboratory Practices. The location and type of animal are not specified, nor is the country of origin. This would be a prospective study.

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

• Biocompatibility Testing: Not applicable. Ground truth for these in-vitro tests is adherence to established international standards (ISO 10993) and scientific principles of toxicology and material science. The tests were performed by NAMSA.
• Performance Testing (Bench Studies): Not applicable. Ground truth for these engineering tests is meeting predefined specifications and equivalence to the predicate device's performance.
• Animal Testing: The text mentions the study assessed performance "as defined by a physician in a clinical environment." This implies at least one, and likely more, physician experts were involved in defining the performance criteria and potentially assessing the outcomes during the animal study. Their specific qualifications (e.g., years of experience, specialization) are not explicitly stated.

4. Adjudication Method for the Test Set

• Biocompatibility Testing: Not applicable in the sense of expert adjudication. The results are interpreted against established acceptance criteria defined by ISO standards.
• Performance Testing (Bench Studies): Not applicable in the sense of expert adjudication. Results are compared against specifications and predicate device performance.
• Animal Testing: The method for "defining" acceptable and comparable performance by the physician(s) is not detailed. It's possible there was an internal review panel or a sole physician's assessment, but no formal adjudication method (e.g., 2+1, 3+1) is described.

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 MRMC study was done. This device is a guiding catheter, not an AI-powered diagnostic or assistive tool for human readers. Therefore, this question is not applicable.

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

• No standalone algorithm performance study was done. This device is a physical medical instrument, not an algorithm. Therefore, this question is not applicable.

7. The Type of Ground Truth Used

• Biocompatibility Testing: The ground truth is derived from established international standards (ISO 10993 series) for biological evaluation of medical devices. The "ground truth" is that the materials are not biologically reactive, cytotoxic, sensitizing, irritating, systematically toxic, or highly thrombogenic.
• Performance Testing (Bench Studies): The ground truth is based on engineering specifications and comparative performance data from the predicate device. The "ground truth" is that the device can withstand specific forces, pressures, and demonstrates appropriate mechanical behavior for its intended use, comparable to the predicate.
• Animal Testing: The ground truth is based on direct observation and assessment of the device's acute performance and safety within a living biological system (animal model), as evaluated by a physician. This is a form of outcomes data (observed physiological responses, device functionality in-vivo) within a controlled experimental setting, benchmarked against a predicate device.

8. The Sample Size for the Training Set

• Not applicable. This device is hardware and does not involve AI or machine learning models that require training sets. The "training" for this device would be its design, manufacturing, and preclinical testing phases.

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

• Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for a training set does not apply here. The "ground truth" for the device's design and manufacturing is established through quality systems, design controls, material specifications, and regulatory standards.

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The Surefire® Hi-Flow Microcatheter is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

The Surefire® Hi-Flow Microcatheter is an 0.027" lumen microcatheter with the Surefire Expandable Tip at the distal end. It has an outer sheath to facilitate deployment and retraction of the Surefire Expandable Tip. The infusion catheter serves as the conduit for physician-specified agents such as contrast agents, flush solutions, and embolic beads. It is compatible with standard 0.018" guide wires, infusion syringes, rotating hemostatic valves (RHVs), and embolic particles 700µm or less in size. The proximal end of the device features a female luer lock hub. The microcatheter has a Teflon inner liner to provide a lubricious surface for passage of physician-specified agents and other accessory devices. The outer sheath is hydrophilically coated. The usable length of the device is 120cm. The distal soft, pliable, funnel-shaped Surefire Expandable Tip is available in two tip sizes, targeted to treat vessels of 3.0 - 4.5 mm and 4.0 - 6.0 mm.

The Surefire® Hi-Flow Microcatheter is intended for use in angiographic procedures, delivering radiopaque media and therapeutic agents to selected sites in the peripheral vascular system. The provided document details the performance testing and verification conducted to demonstrate the device's substantial equivalence to a predicate device, the Surefire Infusion Catheter System (K110459).

1. Acceptance Criteria and Reported Device Performance

The document states that a "battery of tests was performed according to protocols based on the requirements of recognized standards and was shown to meet the acceptance criteria that were determined to be applicable to the safety and efficacy of the device." While specific numerical acceptance criteria values are not explicitly given in the provided text, the list of tests performed and the overall conclusion of substantial equivalence serve as the reported performance.

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 exact sample sizes used for each individual performance and biocompatibility test. It mentions that "test data provided in bench tests demonstrate that the device is as safe, as effective, and performs at least as safely and effectively as the predicate device."

The tests are described as "bench tests," indicating they were conducted in a laboratory setting rather than involving human or animal subjects. The data provenance is industrial/laboratory testing conducted by the manufacturer, Surefire Medical, Inc. The country of origin for the data is not explicitly stated, but the manufacturer has addresses in Westminster, CO, and Miami, FL, implying the testing was done in the USA. The nature of these tests (bench tests) means they are prospective for the purpose of regulatory clearance.

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 section is not applicable (N/A) for this device and study. The Surefire® Hi-Flow Microcatheter is a medical device, not an AI/software device that requires expert human interpretation to establish ground truth for image analysis or similar diagnostic tasks. The "ground truth" for this device is established by meeting engineering specifications, biocompatibility standards, and demonstrating functional performance through objective physical tests, rather than expert consensus on diagnostic images or clinical outcomes.

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

This section is N/A for this device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in diagnoses or interpretations. The tests described for the microcatheter are objective physical and chemical tests, not involving human interpretation that would require 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

This section is N/A. The Surefire® Hi-Flow Microcatheter is a physical medical device, not an AI system. Therefore, no MRMC study or assessment of human reader improvement with or without AI assistance was conducted or is relevant.

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

This section is N/A. The device is a physical microcatheter, not an algorithm or AI system. Its performance is inherent in its design and manufacturing, tested objectively through bench tests.

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

The "ground truth" for the Surefire® Hi-Flow Microcatheter is established by objective engineering performance specifications, recognized industry standards (e.g., ISO, ASTM, USP), and regulatory requirements. For example:

• Mechanical Integrity: Ground truth is defined by the physical limits the device must withstand (e.g., pull strength, high pressure injection) without failure, as per engineering design and relevant standards.
• Biocompatibility: Ground truth is defined by the absence of toxic, irritating, sensitizing, or thrombogenic reactions when tested against established biological safety standards (e.g., ISO 10993 series, ASTM, USP).
• Functional Performance: Ground truth for infusion efficiency and antegrade flow is defined by the device's ability to perform its intended function within specified parameters, typically benchmarked against predicate device performance or clinical needs.

8. The sample size for the training set

This section is N/A. The device is a physical medical device, not a machine learning model, and therefore does not have a "training set" in the context of AI or algorithm development.

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

This section is N/A, as there is no training set for this physical device.

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