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Intended for temporary occlusion of large vessels, or to expand vascular prostheses.

The Coda Balloon Catheter is a 10.0 French device measuring 120 or 140 cm in usable length. The Coda Balloon Catheter shaft contains two independent lumens. The distal lumen extends the length of the catheter and is used for placement over a 0.035 inch diameter wire guide. The balloon (inflation and deflation) lumen extends from the proximal hub to the inflation ports within the balloon. The maximum inflation diameter is 46 mm, with a corresponding maximum balloon inflation volume of 60 mL. The device will be supplied sterile, intended for one-time use.

Here's an analysis of the provided text regarding the Coda Balloon Catheter, organized according to your requested information:

Coda Balloon Catheter Acceptance Criteria and Study Details

The provided document describes a Special 510(k) Premarket Notification, which typically focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving novel clinical effectiveness. Therefore, the "study" described is a series of engineering and performance tests, not a clinical trial involving human subjects or AI algorithms.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the exact sample sizes for each test in terms of the number of individual catheters or components tested. However, it mentions statistical confidence levels and coverage, implying that a statistically significant number of samples were used for tests like "Balloon Minimum Burst Strength and Compliance," "Occlusion and Migration," and "Inflation/Deflation Time."

• Sample Size: Not explicitly stated as a specific number for each test. Phrases like "99% coverage and 95% confidence," "95% confidence level and with 90% minimum coverage," and "90% of the overall population from which test articles were sampled... with a 95% confidence level" indicate a statistically sound approach was taken to determine the number of samples needed.
• Data Provenance: The tests are described as pre-clinical bench testing and simulated use testing. This is not human clinical data. The location of the testing is not specified, but it can be inferred to be from the manufacturer (Cook Incorporated) or its contracted testing facilities. This is prospective testing conducted to evaluate the modified device before seeking market clearance.

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

This type of testing does not involve "experts" establishing a "ground truth" in the clinical sense (e.g., radiologists interpreting images). The ground truth is defined by the objective physical and mechanical properties and performance standards of the device itself. The "experts" involved would be the engineering and quality assurance personnel who designed, executed, and analyzed these tests, following established engineering standards and protocols. Their qualifications would be in engineering, materials science, and quality assurance, not clinical practice.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where there is subjective assessment (e.g., by human readers). Since these are objective engineering and performance tests, there is no need for such adjudication. The results are quantitative measurements or observations against predefined pass/fail criteria.

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

No, an MRMC comparative effectiveness study was not done. This document pertains to the clearance of a medical device (a balloon catheter) based on its physical characteristics and engineering performance, not the interpretative accuracy of an AI algorithm or human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

No, this is not applicable. This document describes a physical medical device, not an AI algorithm. Therefore, there is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

The ground truth used for these tests is objective, measurable engineering and performance specifications. For example:

• Burst Strength: The maximum pressure the balloon can withstand before rupturing.
• Occlusion: The ability to form a complete seal in a mock vessel without leakage.
• Fatigue: The ability to withstand inflation/deflation cycles without structural damage.
• Inflation/Deflation Time: The time taken to reach full inflation/deflation.
• Usable Length: A precise measurement of the catheter's length.

These are not based on expert consensus, pathology, or outcomes data in the clinical sense, but rather on physical science and engineering principles.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this device clearance. This is not an AI/machine learning device. The design and manufacturing processes are established based on engineering principles and regulatory standards, not on "training data."

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

Not applicable. As there is no training set for an AI algorithm, there is no ground truth established for it. The performance standards and acceptance criteria for the physical device are based on established engineering principles, industry standards, and the performance of the predicate device (K032869).

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The COOK CODA™ BALLOON CATHETER is intended for temporary occlusion of large vessels, or to expand vascular prostheses.

The COOK CODA™ BALLOON CATHETER is a 2-lumen catheter. The distal lumen extends the length of the catheter for use over a ,035 wire quide. The other lumen communicates with the balloon and is used to expand and deflate it. Radiopaque bands are placed at both the distal and proximal aspects of the balloon to assist with positioning of the device under fluoroscopy. The balloon will be provided in diameters ranging from 30 to 40 mm, and in lengths ranging from 100 to 120 cm. The device is packaged in sterile, sealed double pouches.

The provided 510(k) summary for the COOK CODA™ BALLOON CATHETER does not contain detailed information regarding acceptance criteria, specific study designs, or performance metrics in a way that allows for the completion of all requested fields. This document focuses on demonstrating substantial equivalence to predicate devices based on general performance, biocompatibility, and mechanical property testing rather than a detailed clinical or comparative effectiveness study as would be seen for AI/ML-driven devices.

Here's the information that can be extracted from the provided text, and an explanation for the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation for Missing Information:
The 510(k) summary only states that "The device met the test criteria, providing reasonable assurance of device performance for its intended use and supporting substantial equivalence." It does not provide the specific quantitative or qualitative acceptance criteria for these tests, nor does it present the detailed results of these tests.

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

• Sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "testing to assess biocompatibility, mechanical properties, performance characteristics, and safety," which implies laboratory-based testing rather than clinical data from a specific population.

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

• Number of experts: Not applicable.
• Qualifications of experts: Not applicable.

Explanation for Missing Information:
This section is not applicable because the provided 510(k) summary describes a traditional medical device (balloon catheter) undergoing engineering and biocompatibility testing, not an AI/ML device requiring human expert ground truth for image or data interpretation.

4. Adjudication method for the test set

• Adjudication method: Not applicable.

Explanation for Missing Information:
As mentioned above, this type of adjudication is typically relevant for studies involving human interpretation or machine learning models, which is not the case for this device's reported testing.

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

• MRMC study: No.
• Effect size: Not applicable.

Explanation for Missing Information:
An MRMC comparative effectiveness study is not relevant for this type of traditional medical device. This is a common study type for AI-powered diagnostic devices, where the goal is to show the benefit of AI assistance for human readers.

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

• Standalone study: No.

Explanation for Missing Information:
This concept is specific to AI/ML algorithms. The COOK CODA™ BALLOON CATHETER is a physical device, and its performance is evaluated in terms of its physical and material properties, not as a standalone algorithm.

7. The type of ground truth used

• Type of ground truth: Laboratory and engineering test results (e.g., measurements of mechanical properties, results of biocompatibility assays).

Explanation for Missing Information:
The term "ground truth" as typically used in AI/ML studies (expert consensus, pathology, outcome data) does not apply directly here. The "ground truth" for this device's testing would be established by validated test methodologies comparing the device's characteristics against predefined engineering specifications.

8. The sample size for the training set

• Training set sample size: Not applicable.

Explanation for Missing Information:
This device does not involve machine learning; therefore, there is no "training set."

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

• Ground truth establishment: Not applicable.

Explanation for Missing Information:
Since there is no training set, there is no ground truth for a training set to be established.

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