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The SOFIA Distal Access Catheter is intended for general intravascular use, including the neuro and peripheral vasculature. It can be used to facilitate the introduction of diagnostic agents. It is not intended for use in coronary arteries.

The SOFIA™ Distal Access Catheter is a single-lumen, flexible catheter designed with coil and braid reinforcement. The distal segment is steam-shapeable and it has a hydrophilic coating for navigation through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. An introducer sheath and shaping mandrel are also provided.

The provided document describes the SOFIA Distal Access Catheter and compares it to a predicate device (K131482). The submission aims to demonstrate substantial equivalence, not to prove clinical effectiveness or diagnostic accuracy in specific use cases as is common for AI/ML devices. Therefore, many of the requested criteria are not applicable, as this is a traditional medical device submission focused on bench testing and biocompatibility.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as pass/fail thresholds in a single table, but rather implied by the "Results" and "Conclusions" for each bench test and biocompatibility assessment. The reported device performance is outlined in the "Results" column.

Regarding the other requested information (2-9), most are not applicable because this is a 510(k) premarket notification for a traditional medical device, not an AI/ML diagnostic or prognostic device. The study presented is a technical verification and validation study against established standards and a predicate device, rather than a clinical effectiveness study.

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: Not explicitly stated for each test, but it would be a reasonable number for bench testing (e.g., 3-10 samples per test, as per common medical device testing practices). The thrombogenicity study in dogs used "two out of two test sites and two out of two control sites" which implies 2 animals for the test and 2 for the control for that specific test.
• Data Provenance: The document does not specify the country of origin for the test data for the proposed device. For many tests, it explicitly states "(Prior test data from predicate device)" or "Biocompatibility was prior test data from predicate device," indicating the data was generated previously for the predicate device. This is a retrospective use of existing data for the current submission. The origin of those previous tests isn't detailed.

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 is not a study requiring expert consensus or ground truth in the context of diagnostic accuracy. The "ground truth" for these tests comes from engineering specifications, ISO standards, and comparison to the predicate device's performance.

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

• Not Applicable. No adjudication method is described as this is not a diagnostic performance 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/ML device, and no MRMC study was performed.

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

• Not Applicable. This is not an AI/ML device.

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

• Not Applicable in the traditional sense. The "ground truth" for the tests performed are primarily:
  • Engineering Specifications: Internal design requirements for dimensions, strength, flow rate, etc.
  • International Standards: e.g., ISO 594-2 for luer connectors, ISO 10993 series for biocompatibility, ISO 10555-1 for sterile single-use intravascular catheters. These standards define acceptance criteria.
  • Predicate Device Performance: Direct comparison of the proposed device's performance to that of the predicate device (K131482) to demonstrate substantial equivalence.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device; there is no training set.

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

• Not Applicable. This is not an AI/ML device; there is no training set.

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The SOFIA Distal Access Catheter is intended for general intravascular use, including The GOT IA Dicture al vasculature. It can be used to facilitate the introduction of the nours and therapeutic agents. It is not intended for use in coronary arteries.

The SOFIA Distal Access Catheter is a single-lumen, flexible catheter designed with coil and braid reinforcement. The distal segment is steam-shapeable and it has a hydrophilic coating for navigation through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy. An introducer sheath and shaping mandrel are also provided.

The provided text describes a medical device, the SOFIA™ Distal Access Catheter, and its verification testing for 510(k) clearance. This submission does not include information about AI/ML models, therefore, many of the requested fields related to AI/ML studies cannot be answered. The information pertains to traditional medical device testing.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document presents internal acceptance criteria implicitly through the "Results" and "Conclusions" sections of the verification tests. The "Conclusions" often state that the device "met established specifications" or "performs as intended," implying these were the acceptance criteria.

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

The document does not specify exact sample sizes for each test in terms of "N" or "number of unique cases/patients." It refers to "test articles," implying a number of device units were subjected to each test. For some tests, it mentions "two out of two test sites" or "test articles."
Data provenance is not provided in terms of country of origin or retrospective/prospective clinical data, as these are bench and biocompatibility tests, not clinical studies involving patient data.

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

N/A. This is a medical device performance and safety (bench and biocompatibility) study, not an AI/ML diagnostic accuracy study requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

N/A. Not applicable for bench and biocompatibility testing. Ground truth for these tests is based on physical measurements, chemical analyses, and biological responses according to established standards.

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

No. This document does not mention any MRMC comparative effectiveness study, nor does it involve human readers or AI assistance.

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

No. This document is for a physical medical device, not an algorithm or AI model.

7. The Type of Ground Truth Used

For the bench testing, the "ground truth" is based on:

• Physical measurements: E.g., dimensions (OD, ID, length), force at break, unscrewing torque, flow rates, burst pressures. These are measured objectively against defined specifications.
• Qualitative assessments: E.g., presence/absence of kinks, visibility under fluoroscopy, ease of assembly, presence of stress cracks, evaluation of surface contaminants. These are typically assessed by trained technicians against defined criteria.
• Performance metrics: E.g., successful tracking, minimal resistance, non-overriding threads. These are observed outcomes during simulated use or specific tests.

For biocompatibility testing, the "ground truth" is based on:

• Standardized biological assays: E.g., MEM elution assay for cytotoxicity, Kligman Maximization Test for sensitization, rabbit blood tests for hemocompatibility, rabbit pyrogen test, dog thrombogenicity study. These tests produce quantitative or semi-quantitative results that are interpreted against established acceptance criteria defined in ISO 10993 series of standards.
• Pathology/Histology: For the thrombogenicity study, "minimal thrombosis observed" would be a histological assessment.

8. The Sample Size for the Training Set

N/A. This is not an AI/ML study, so there is no training set.

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

N/A. This is not an AI/ML study, so there is no training set or ground truth for one.

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