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The Langston™ Dual Lumen Catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressure measurement is useful in determining transvalvular, intravascular and intraventricular pressure gradients.

The Vascular Solutions Langston™ Dual Lumen Catheter is intended for use as a pressure measurement catheter and for delivery of contrast media during angiographic studies. The Langston catheter consists of the Merit Medical Softouch Diagnostic Intravascular Catheter (K943739) as the inner lumen and an extruded outer lumen designed by Vascular Solutions. The inner lumen and hub assembly are purchased from Merit Medical in a non-sterile state. The pigtail catheter and outer lumen are joined together using an adapter junction placed near the proximal end of the pigtail catheter. The adapter junction incorporates a side port fitted with a stopcock/tube assembly for fluid flow and pressure measurement within the outer tube. The distal end of each lumen is perforated with side holes to allow pressurement simultaneously. The Langston catheter is deployed through standard guide catheters and will accommodate standard 0.038" diameter guidewires.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Langston™ Dual Lumen Catheter:

Summary of Acceptance Criteria and Study Details:

The provided 510(k) summary for the Langston™ Dual Lumen Catheter does not present specific, quantifiable acceptance criteria or a dedicated study designed to prove the device meets those criteria in the traditional sense of a clinical trial or a detailed performance validation study.

Instead, the submission relies on the concept of substantial equivalence to predicate devices. The "study" referenced is largely a summary of non-clinical testing that confirmed physical properties and suitability for intended use, as well as a comparison to the predicate devices.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Not explicitly defined as quantifiable criteria. The overall "acceptance criteria" appear to be implicit in demonstrating substantial equivalence to predicate devices and suitability for intended use through non-clinical testing.	"The results of the tests confirmed the suitability of the device for its intended use." "The Langston 7F outer lumen and 5F inner lumen is substantially equivalent to the currently marketed Langston catheters, based on a comparison of the indications for use, construction materials, catheter dimensions, injection pressure ratings, and sterilization methods."

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. The document mentions "non-clinical testing" without detailing sample sizes for physical property tests or comparisons.
   • Data Provenance: Not specified, but implied to be from internal lab testing conducted by the manufacturer (Vascular Solutions, Inc. in Minneapolis, Minnesota, USA). The testing is non-clinical, so concepts like retrospective/prospective clinical data do not apply.

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. The non-clinical testing for this device would involve engineering and quality control personnel, not medical experts establishing ground truth for diagnostic or clinical performance in this context. The "ground truth" for physical properties would be engineering specifications and established test methods.

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

   • Not applicable. Adjudication methods are typically used in clinical studies or studies involving expert interpretation of medical images/data. This submission focuses on non-clinical engineering and comparison studies.

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. This type of study (MRMC, AI assistance) is not relevant to an intravascular diagnostic catheter that performs physical measurements and delivers contrast. The device itself is not an AI diagnostic tool.

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

   • Not applicable. This device is a physical medical instrument, not an algorithm, and intrinsically requires human operation.

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

   • For Non-Clinical Testing: The "ground truth" would be engineering specifications, material standards, and established physical performance benchmarks (e.g., pressure ratings, flow rates, dimensional tolerances).
   • For Substantial Equivalence: The "ground truth" is the performance and characteristics of the legally marketed predicate devices (Langston 8F/5F, 7F/4F, and 6F/4F dual lumen catheters).

8. The sample size for the training set:

   • Not applicable. This is a physical device, not an AI/machine learning model that requires a "training set."

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

   • Not applicable for the same reason as above.

In summary: The 510(k) submission for the Langston™ Dual Lumen Catheter focuses on demonstrating substantial equivalence to existing predicate devices already on the market. The "study" mentioned is a "Summary of Non-Clinical Testing" which assessed physical properties and confirmed the device's suitability for its intended use, rather than a clinical effectiveness study or an AI performance study with strict, quantifiable acceptance criteria. The acceptance criteria are implicitly met by demonstrating that the new device is fundamentally similar in function, materials, dimensions, and performance characteristics to the already-approved predicate devices.

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