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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.

• Visual and Dimensional (Implicitly met comparable dimensions)
• Tensile (Pull) Strengths
• Kink Radius
• Torque Resistance
• Burst Pressure
• Coating Frictional Force
• Base Catheter Insertion/Retraction Force
• Corrosion Resistance
• Hub Solvent Compatibility
• Coating Durability and Uniformity
• Particulates
• Pouch Integrity
• Pouch Seal Strength
  Overall: The test results demonstrate that the Surefire Spark Infusion System meets the same performance specifications and acceptance criteria as the predicate device. |
  | Functional Compatibility | The Surefire Spark Infusion System met the same performance specifications for:
• Diagnostic Agent Compatibility
• Embolic Agent Compatibility
• Hub Aspiration
• Antegrade Flow
• Infusion Efficiency
  Overall: The test results demonstrate that the Surefire Spark Infusion System meets the same performance specifications and acceptance criteria as the predicate device. |
  | Biocompatibility | No direct new biocompatibility testing was performed on the subject device. Testing was leveraged from previously cleared predicate devices (Surefire High Flow Microcatheter K121677, Surefire Guiding Catheter K162359, and Surefire Precision Infusion System K171355), implying that the materials are deemed biocompatible based on prior assessments. |
  | Thrombogenicity | Testing for thrombogenicity was performed on the Surefire Spark Infusion System Catheter as a part of an Animal Study. (Specific results are not detailed, but the overall conclusion of the animal study indicates acceptability). |
  | Sterilization Residuals | EtO Residuals testing was leveraged from previous testing of the predicate device. |
  | Acute Performance (Animal Study) | "An animal study was performed to assess the comparative acute performance of the Surefire Spark Infusion System to the predicate device, as defined by physicians in a simulated clinical environment. The Surefire Spark Infusion System was found to be acceptable in all evaluated categories, met the defined user needs, and performed comparably to the predicate device." |

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

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 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 modified Surefire Infusion System is a 0.027" lumen coaxial microcatheter with the Surefire Expandable Tip at the distal end. The Surefire Infusion System has a female luer lock hub on the proximal end of the catheter and has a catheter shaft length of 150 cm.

The modified Surefire Infusion System 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/Tuohy Borsts), and embolic hydrogel particles 700um or less in size and glass microspheres 190um or less in size. The Surefire Infusion System, serves as the conduit for physician-specified agents such as contrast agents, flush solutions, and embolic beads. The Surefire 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 soft, pliable, funnel-shaped Surefire Expandable Tip is sized for use in vessels of 4 mm to 6 mm.

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

This document is a 510(k) summary for the Surefire Infusion System, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria in the context of AI/diagnostic performance.

Therefore, many of the requested fields are not applicable or cannot be extracted from this type of regulatory document.

However, based on the provided text, I can infer information relevant to performance testing and equivalence for a physical medical device, not an AI system. The "acceptance criteria" here refer to meeting performance specifications for design verification/validation tests, not diagnostic accuracy metrics.

Here's a breakdown of what can be extracted and what cannot:

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

The document does not explicitly present a table of acceptance criteria with corresponding numerical performance metrics. Instead, it states that the device "meets the same performance specifications and acceptance criteria as the predicate device" for a list of tests. It then concludes that "the modified Surefire Infusion System was found to be acceptable in all evaluated categories, met the defined user needs, and performed comparably to the predicate device."

Types of Performance Tests Conducted (without specific numerical acceptance criteria or reported device performance values):

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

• Sample Size for Test Set: Not specified for individual bench tests. For the animal study, the sample size is not explicitly stated, only "An animal study was performed."
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be prospective testing (bench tests and animal study specifically conducted for this submission).

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

Not applicable. This device is a physical catheter, not a diagnostic AI system requiring expert-established ground truth for a diagnostic test set. The animal study was evaluated by "physicians in a simulated clinical environment," but the number or specific qualifications are not provided.

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

Not applicable. This is not a diagnostic AI study.

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 not an AI device.

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

Not applicable. This is a physical medical device.

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

For the performance tests, "ground truth" would be engineering specifications, material properties, and visual/dimensional standards. For biocompatibility, it's established ISO/ASTM standards and biological reaction assessments. For the animal study, it was performance evaluation by physicians against "defined user needs" and comparison to a predicate device.

8. The sample size for the training set

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

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

Not applicable.

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The Surefire Infusion System 021 is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

The Surefire Infusion System 021 is a 0.021" lumen coaxial microcatheter with the Surefire Expandable Tip at the distal end. It has an outer sheath to facilitate expanding and collapsing the Surefire Expandable Tip. The Surefire 021, 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/Tuohy Borsts), and embolic hydrogel particles 500um or less in size and glass microspheres 110um or less in size. The Surefire 021 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 soft, pliable, funnel-shaped Surefire Expandable Tip is sized for use in vessels of 1.5mm to 4 mm.

There are two radiopaque markers located just proximal and distal to the Surefire Expandable Tip. The Tip can be expanded or collapsed up to 3 times for re-positioning 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 various size vessels.

The Surefire Infusion System 021 is provided sterile (EtO) for single patient use.

The document provided is a 510(k) premarket notification letter and summary for the Surefire Infusion System 021. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.

Based on the provided text, the device is the Surefire Infusion System 021, and the study described is a comparison to a predicate device (Surefire Infusion System, K121677) to demonstrate substantial equivalence, rather than a study defining specific acceptance criteria for a novel AI or diagnostic algorithm and its performance against those criteria. Therefore, much of the requested information regarding acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert adjudication, and MRMC studies for an AI/diagnostic device is not directly applicable or available in this document.

However, I can extract the information that is relevant to the performance testing and comparison made in this submission.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal, quantitative table of acceptance criteria with specific thresholds for performance metrics. Instead, it states that the device "meets its specified performance requirements" and "is comparable to the performance of the predicate device."

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

• Test Set Description: The "test set" in this context refers to the samples used for design verification (bench testing) and the animal study.
• Bench Testing: No specific sample sizes are provided for the various bench tests (visual/dimensional inspection, lubricity, wear, particulates, burst pressure, tensile strength, kink resistance, torque resistance, trackability, infusion/embolic agent compatibility, antegrade flow, infusion efficiency). The document only states "Design verification testing was performed."
• Animal Study: The document states "An animal study was performed," but does not provide the number of animals or specifically state the country of origin.
• Data Provenance: Not explicitly stated for either bench or animal testing, beyond "NAMSA (Northwood, OH)" for biocompatibility (which was leveraged from the predicate device). The animal study involved a "simulated clinical environment," suggesting a controlled experimental setting rather than retrospective patient data.

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

• This document does not describe the use of "experts" to establish ground truth in the context of diagnostic performance for a test set. The animal study assessed "comparative acute performance... as defined by physician's in a simulated clinical environment," implying physician observation and assessment, but no specific number or qualifications are given for these "physicians."

4. Adjudication method for the test set

• No adjudication method is described. The performance assessments are generally stated as being "met" or "comparable."

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 comparative effectiveness study was conducted. This device is an infusion system (catheter), not an AI or diagnostic imaging device that would typically involve human readers interpreting cases.

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

• Not applicable. This is a medical device (catheter) and does not involve an algorithm for standalone performance evaluation in the way an AI diagnostic device would.

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

• The "ground truth" for the performance claims comes from:
  • Bench Test Specifications: The device met its internal specified performance requirements.
  • Predicate Device Performance: Performance was compared to that of the predicate device.
  • Animal Study Observations: Physicians' assessments in a simulated clinical environment were used for acute performance.

8. The sample size for the training set

• Not applicable. This is a mechanical device, not an AI or machine learning algorithm. Therefore, there is no "training set."

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

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

In summary: This FDA submission focuses on demonstrating substantial equivalence for a physical medical device (catheter) through bench testing, biocompatibility testing (leveraging existing data), and an animal study. It does not involve the types of testing, acceptance criteria, or ground truth establishment typically associated with AI-powered diagnostic devices or software that require human expert review and large datasets.

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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.

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The SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER is intended for use where angiographic diagnosis is indicated.

The Surefire High Flow Angiographic Catheter (SAC) is used to facilitate advancement of the Surefire High Flow Microcatheter to the target vessel. The SAC is a single lumen, fixed length guide catheter with a Luer Lock Hub. It is compatible with standard 0.038" guide wires, Luer lock infusion syringes, and rotating hemostatic valves (RHVs). The angiographic catheter has an approximate length of 65 cm (usable length). A reinforced proximal section allows for ease of insertion and the barium sulfate filled extrusion provides clear fluoroscopic images of the shaft. A braided tungsten filled shaped tip provides visual feedback for the location of the guide catheter under fluoroscopy. The distal tip is rounded for atraumatic tracking. A shaped tip will assist to deliver the Surefire High Flow Angiographic Catheter to the desired target site. A peel-away Introducer is supplied with the SAC to insert the shaped tip into a catheter sheath introducer. The system is provided sterile (FO) for single patient use. The Angiographic Catheter is packaged in sealed sterile protective pouches and product boxes.

The Surefire® High Flow Angiographic Catheter is intended for angiographic diagnostic use. The study relied on performance and verification testing to establish substantial equivalence to a predicate device, the Angiodynamics Soft-Vu Angiographic Catheter (K112452).

1. Table of Acceptance Criteria and Reported Device Performance

Note: 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." Specific numerical acceptance criteria were not provided in the summary.

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

The information provided specifies bench tests were conducted. Details on the specific sample sizes for each individual test (e.g., number of catheters tested for kink radius, pull strength, etc.) are not explicitly stated in the provided summary. The data provenance is from bench testing, which is performed in a controlled laboratory environment and is not tied to specific countries of origin or retrospective/prospective patient data.

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 study involved bench testing of a medical device's physical and biological properties, not a clinical study involving experts evaluating patient data or images to establish ground truth.

4. Adjudication method for the test set

This information is not applicable for bench testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human reviewers assess data.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This study focuses on the physical and biocompatibility performance of a medical device, not on the effectiveness of human readers assisted by AI.

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

No, a standalone algorithm performance study was not performed. This device is a physical catheter, not an AI algorithm.

7. The type of ground truth used

For the performance and verification testing, the "ground truth" was established by recognized industry standards (ISO 10555-1, ISO 10555-2, ISO 10993 series, ASTM F756, ASTM F2382, USP , USP 788) and internal protocols based on these standards. These standards define the acceptable physical properties, biocompatibility, and safety parameters for such devices.

8. The sample size for the training set

This information is not applicable as this study does not involve machine learning or a "training set."

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

This information is not applicable as there is no training set mentioned or implied in this type of device submission.

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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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The SUREFIRE® GUIDE SHEATH is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

The Surefire® Guide Sheath is designed to act as a conduit for diagnostic agents and facilitates deployment at the desired treatment location. The Guide Sheath is a 0.035" guide wire compatible, single lumen, fixed length catheter body with a luer lock hub.

The document describes the performance testing for the Surefire® Guide Sheath. Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that a "battery of tests was performed according to protocols based on the requirements of the international standards and was shown to meet the acceptance criteria that were determined to be applicable to the safety and efficacy of the device." However, specific numerical acceptance criteria (e.g., "tensile strength must be > X N") and the exact numerical performance results are not detailed in the provided text for most tests.

The document lists various tests under "Performance Testing & Verification Testing" and states that "The following series of tests have been provided in this submission:" and "Testing listed below was provided in the original submission."

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

The document does not specify the sample sizes used for any of the performance or biocompatibility tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective, as these are typically bench-top or lab-based tests for medical devices of this nature, not clinical studies.

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

This information is not applicable to the type of device and testing described. The Surefire® Guide Sheath is an intravascular catheter, and its performance is evaluated through engineering and biocompatibility bench testing, not through human expert assessment of data like in image-based diagnostic AI.

4. Adjudication Method for the Test Set:

This information is not applicable for the reasons stated above. Adjudication methods like 2+1 or 3+1 are used in clinical trials or expert consensus studies, which are not described here.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI algorithms comparing human performance with and without AI assistance. The Surefire® Guide Sheath is a physical medical device (catheter), not an AI diagnostic tool.

6. If a Standalone (Algorithm Only) Performance Study Was Done:

No, a standalone (algorithm only) performance study was not done. This is relevant for AI algorithms without human intervention. The Surefire® Guide Sheath is a physical device that is used by a human operator. Its performance is assessed through bench tests of its physical properties and biocompatibility.

7. The Type of Ground Truth Used:

The "ground truth" for the performance testing of the Surefire® Guide Sheath is primarily defined by international standards and engineering specifications.

• Engineering Specifications: For tests like Kink Testing, Tensile Testing, High-Pressure Injection, Trackability, Torque, and Dimensional Inspection, the ground truth is established by predetermined engineering specifications and functional requirements for the device. For example, a certain force must be withstood in a tensile test, or a specific pressure must be tolerated during injection.
• International Standards (Biocompatibility): For biocompatibility, the ground truth is established by well-defined tests and pass/fail criteria outlined in standards such as ASTM F756, ISO 10993 series, and USP Standards. These standards provide methodologies and acceptable limits for biological responses.

8. The Sample Size for the Training Set:

This information is not applicable. The Surefire® Guide Sheath 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:

This information is not applicable as there is no training set for a physical medical device.

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The SUREFIRE™ INFUSION CATHETER 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™ Infusion Catheter System is a two-part system comprised of an Infusion Microcatheter and a Guide Sheath.

The Surefire™ Infusion Catheter System is a medical device intended for use in angiographic procedures to deliver radiopaque media and therapeutic agents to selected sites in the peripheral vascular system. The provided document is a 510(k) premarket notification summarizing the device's performance testing and substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Surefire™ Infusion Catheter System are based on established international standards and the performance of predicate devices. The study demonstrates the device's performance by showing it meets these acceptance criteria.

The primary study type is an equivalence study, specifically demonstrating substantial equivalence to predicate devices (Terumo Radifocus GLIDECATH for the Guide sheath and EmboCath Plus Infusion Microcatheter by BioSphere Medical for the Microcatheter). This is a common approach for 510(k) submissions where a new device is compared to legally marketed devices.

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

The document does not explicitly state the numerical sample sizes for each specific performance or biocompatibility test. However, it indicates that a "battery of tests were performed" using "protocols based on the requirements of the following standards." This implies that the sample sizes would have been determined by the requirements of the cited standards (e.g., ISO 10555-1, ISO 10555-2, ISO 10993 series, ASTM F756, USP).

The data provenance is the manufacturer's internal testing and is considered prospective as it was conducted specifically for this regulatory submission to demonstrate device performance. The country of origin of the data is implicitly the United States, where Surefire Medical, Inc. is located. The document also mentions "animal study data is submitted in this 510(k) and is on file at Surefire Medical," indicating some pre-clinical animal testing was performed.

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

This submission does not involve a "test set" in the traditional sense of a clinical diagnostic study requiring expert ground truth establishment for patient data (e.g., image interpretation). Instead, the "ground truth" for this device's performance is established by the specified acceptance criteria defined by international standards and validated engineering principles.

Therefore, there were no "experts" in the sense of clinical specialists providing interpretations. The "experts" involved would be engineers, quality assurance specialists, and regulatory professionals who designed the tests, interpreted the results against the standards, and compiled the submission. Their qualifications are inherent in their roles within a medical device company and their adherence to recognized standards.

4. Adjudication Method for the Test Set

Not applicable. As explained above, this submission does not involve a test set requiring adjudication of, for example, diagnostic interpretations or clinical outcomes by multiple experts. The "adjudication" is primarily against pre-defined engineering and biocompatibility specifications.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices to assess human reader performance with and without AI assistance. The Surefire™ Infusion Catheter System is an intravascular catheter, not a diagnostic imaging AI system. The comparison for this device is primarily against established performance benchmarks and predicate devices through physical and chemical testing.

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

No, a standalone performance assessment (in the context of an algorithm's performance without human interaction) was not done. This device is a physical, manually operated catheter system. Its performance evaluation focuses on its mechanical, material, and biological properties, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on:

• Engineering Specifications and Performance Standards: The device's performance (e.g., kink resistance, tensile strength, flow rates, dimensions) is compared against pre-defined, acceptable ranges and thresholds derived from international standards (e.g., ISO 10555-1, ISO 10555-2).
• Biocompatibility Standards: The device's biological safety is assessed against the requirements of ISO 10993 series and USP standards.
• Predicate Device Performance: For substantial equivalence, the device's performance characteristics are compared to those of legally marketed predicate devices to ensure it performs as safely and effectively.
• Risk/Hazard Analysis: Per EN ISO 14971, safety criteria are established based on potential risks, and the device is evaluated against these.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI/machine learning algorithm that requires a "training set" of data.

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

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

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