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The 091 Balloon Guide Catheter is infacilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.

The 091 Balloon Guide Catheter is a coaxial-lumen, coil-reinforced, variable stiffness catheter with a balloon at the distal end. A radiopaque marker is included at the distal end of the distal tip of the catheter) for fluoroscopic visualization. A compliant balloon is flush mounted on the catheter to provide temporary vascular occlusion during angiographic procedures. A bifurcated luer hub on the proximal end of the catheter allows attachments for flushing, and aspiration. This catheter is designed for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The dimensions and maximum recommended balloon inflation volume for the 091 Balloon Guide Catheter are indicated on the product label. A peel-away introducer, dilator, and one-way luer valve accessory are included within the packaging. A similar dilator was cleared as part of the reference device under K172468. The 091 Balloon Guide Catheter is supplied sterile, non- pyrogenic, and is intended for single use only.

The provided text is a 510(k) Summary for a medical device called the "091 Balloon Guide Catheter". It describes the device, its indications for use, and how its substantial equivalence to a predicate device was established through various performance tests.

However, the questions posed (acceptance criteria, study details, sample sizes, expert involvement, ground truth, MRMC studies, etc.) are typically associated with the evaluation of AI/ML-enabled medical devices where performance is measured in terms of diagnostic accuracy, sensitivity, specificity, or other clinically relevant metrics based on analyzing data (images, signals, etc.).

The "091 Balloon Guide Catheter" is a physical medical device, not an AI/ML diagnostic or therapeutic device. The "performance data" section (Table 6.2) refers to engineering verification and validation tests for physical properties such as tensile strength, burst pressure, particulate matter, and dimensions, not AI model performance metrics.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies for an AI model does not apply to this medical device submission.

Here's why and what can be extracted from the document:

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

  • Acceptance Criteria (Implicit): For a physical device, the acceptance criteria are implicit in the "Pass" results listed in Table 6.2. For instance, "The catheter must meet tensile strength specifications" is the acceptance criterion, and "Pass" is the reported performance. The specific numerical thresholds for these specifications are not disclosed in this summary but would be in the full design verification and validation reports.
  • Reported Device Performance:

    Test performed	Test Summary	Reported Performance
    Catheter Tensile Strength	The catheter must meet tensile strength specifications.	Pass
    Catheter Burst	The catheter must meet catheter burst specification.	Pass
    Particulate	The catheters were tested in comparison to the predicate device for all particle sizes including the large particles to establish substantial equivalence to the predicate device.	Pass
    Dilator Working Length	The dilator must meet working length specification.	Pass
    Dilator Inner Diameter (ID)	The dilator must meet inner diameter (ID) specification.	Pass
    Dilator Outer Diameter (OD)	The dilator must meet outer diameter (OD) specification.	Pass
    Dilator Hub Compatibility	The hub luer shall meet the applicable criteria for each test as defined by ISO 594-1 and ISO 594-2.	Pass
    Dilator Radiopacity	The dilator shall be visible under fluoroscopic imaging.	Pass
    Dilator Tensile Strength	The dilator must meet tensile strength specifications.	Pass
    Dilator Visual Inspection	Samples were visually inspected under 2.5X magnification to ensure acceptance criteria were met.	Pass
    Label Content	The label and directions for use (DFU) must meet content specifications.	Pass
    Usability - Simulated Use Testing	Simulated use testing was conducted utilizing all accessory devices expected to be used during a clinical procedure.	Pass

• 2. Sample sized used for the test set and the data provenance: Not applicable in the context of an AI/ML model's test set for diagnostic performance. For physical device testing, samples are typically drawn from manufacturing lots, but the specific number of units tested for each parameter is not disclosed in this summary. The data provenance is testing conducted by the manufacturer. All tests listed are bench tests, not clinical studies, so "country of origin for data" or "retrospective/prospective" don't apply in the sense of patient data.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device is established by engineering measurements and standards, not expert clinical interpretation of data.

• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This relates to expert consensus for image/data interpretation.

• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for AI/ML diagnostic tools.

• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for AI/ML diagnostic tools.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a physical device, the "ground truth" for performance testing is defined by engineering specifications, validated test methods (e.g., ISO standards), and physical measurements. For example, the ground truth for "Dilator Hub Compatibility" is adherence to ISO 594-1 and ISO 594-2.

• 8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.

• 9. How the ground truth for the training set was established: Not applicable.

In summary, this document pertains to a traditional physical medical device (catheter) and its regulatory clearance based on engineering performance tests and substantial equivalence to a predicate device, not an AI/ML-enabled device. Therefore, the detailed questions about AI model testing methodologies do not apply.

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The 091 Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.

The 091 Balloon Guide Catheter is a coaxial-lumen, coil-reinforced, variable stiffness catheter with a compliant balloon at the distal end to provide temporary vascular occlusion during angiographic procedures. A radiopaque marker is included at the distal end of the distal tip of the catheter) for fluoroscopic visualization. A bifurcated luer hub on the proximal end of the catheter allows attachments for flushing, and aspiration. This catheter is designed for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The dimensions and maximum recommended balloon inflation volume for the 091 Balloon Guide Catheter are indicated on the product label. A Peel-Away Introducer accessory is included within the packaging. It is supplied sterile, non-pyrogenic, and is intended for single use only.

This document describes the validation of the 091 Balloon Guide Catheter. Since the provided text focuses on the device's substantial equivalence to a predicate device for regulatory approval, the "acceptance criteria" and "device performance" primarily refer to engineering performance specifications and bench testing results, rather than clinical efficacy metrics for an AI/ML device. There is no mention of an AI/ML component in this premarket notification.

Therefore, the requested information specifically related to AI/ML device validation (e.g., sample sizes for training/test sets, expert ground truth adjudication, MRMC studies, standalone algorithm performance) is not applicable to this document. The document details the testing performed to ensure the device meets safety and performance standards for a medical device.

Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the "Pass" result for each test. The reported device performance is that it met all predetermined acceptance criteria for each test.

Details of the Study:

• 1. A table of acceptance criteria and the reported device performance: Provided above. All tests "Passed," indicating the device met all predetermined acceptance criteria.

• 2. Sample size used for the test set and the data provenance: The document states that "Some of the tests were also conducted on the predicate device to help establish substantial equivalence." However, specific sample sizes for each test are not explicitly detailed in this summary. The data provenance is from bench testing and simulated use, conducted to support a regulatory submission in the United States. It is not patient data, so "retrospective or prospective" is not applicable.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable in the context of an AI/ML device. For the "In-vitro Simulated Use Study – Benchtop," it states "A simulated interventional procedure was performed by physicians." For "Usability Testing," it mentions "Evaluators representative of the intended user population shall review... then attempt to use the catheters and accessories along with the expected compatible products in a simulated use environment, using worst-case neurovascular models." The specific number or qualifications of these physicians/evaluators are not detailed.

• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as this is not an AI/ML device with image interpretation or complex diagnostic outputs requiring expert adjudication. Performance was assessed against pre-defined engineering and functional criteria.

• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical medical device (catheter), not an AI/ML diagnostic or assistive tool.

• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device (catheter), not an AI/ML algorithm.

• 7. The type of ground truth used:

  • Engineering/Performance Specifications: For most tests (e.g., Tensile Strength, Torque Strength, Burst, Leak tests, Dimensional Verification), the "ground truth" is defined by established engineering and materials standards (e.g., ISO 10555-1, USP , ASTM F-1929, ISO 594-1:1986).
  • Simulated Use/Usability: For these tests, the "ground truth" is the successful and safe performance of the device by intended users in a simulated clinical environment, meeting pre-defined operational criteria.
  • Biocompatibility: The "ground truth" is compliance with ISO 10993-1 and specific biological test methodologies (e.g., MEM elution, Magnusson-Kligman Method, ASTM Method for Hemolysis) to ensure the device is not harmful to biological systems.

• 8. The sample size for the training set: Not applicable. This is a physical medical device, not an AI/ML device trained on data.

• 9. How the ground truth for the training set was established: Not applicable.

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