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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 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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