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Each 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 pressurement is useful in determining transvalvular, intravascular and intraventricular pressure gradients.

The Langston dual lumen catheters have two lumens, both with distal sideholes, to allow simultaneous pressure measurements from two sites. The high-pressure inner lumen, which extends the entire length of the catheter, can be used for pressurement and rapid delivery of contrast medium. The outer lumen ends proximal to the distal end of the catheter and is used for pressure measurement only. A side port fitted with an extension tube and a stopcock assembly is used for fluid flow and pressure measurement within the outer lumen. The Langston dual lumen catheter will accommodate a standard ≤ 0.038" diameter guidewire and is supplied with a single use pigtail straightener. The Langston dual lumen catheter is sterilized with ethylene oxide.

This document describes the FDA's 510(k) clearance for the Langston dual lumen catheter (K221470). It's a medical device submission, not a study proving the device meets acceptance criteria for an AI or diagnostic algorithm. Therefore, the questions related to AI/algorithm performance, ground truth, expert consensus, and comparative effectiveness studies are not applicable to this document.

However, I can extract the acceptance criteria and performance data for the physical device based on the provided text.

Here's the breakdown of what can be found and what cannot:

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

Study that proves the device meets the acceptance criteria:

The study was a series of bench tests and biocompatibility evaluation to demonstrate substantial equivalence to a predicate device, focusing on a design modification to the strain relief to hub bond.

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

• Sample Size: Not specified in the document for any of the bench tests.
• Data Provenance: The tests were performed internally by Vascular Solutions LLC ("Performance Data" section). The country of origin and retrospective/prospective nature of data collection for these specific tests are not detailed, but they are generally considered prospective bench tests performed for regulatory submission.

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

• Not Applicable. This document concerns a physical medical device (catheter) and its design validation via bench testing and biocompatibility, not an AI or diagnostic algorithm requiring expert "ground truth" for interpretative accuracy.

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

• Not Applicable. As above, this is about physical device performance, not diagnostic interpretations requiring adjudication.

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-assisted diagnostic device.

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

• Not Applicable. This is not an algorithm.

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

• For Bench Testing: The "ground truth" was defined by the specified acceptance criteria for each individual physical performance test (e.g., a minimum tensile strength, a maximum leak rate). These criteria are objective measurements, not subjective expert interpretations or biological outcomes.
• For Biocompatibility: Compliance with ISO 10993-1 is the standard used, which involves a series of tests to assess biological safety.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. There is no "training set."

In summary, this document is a regulatory clearance for a physical medical device. The "acceptance criteria" and "performance data" provided relate to the manufacturing and physical characteristics of the catheter, not to the diagnostic accuracy of an algorithm or the improvement of human readers with AI assistance.

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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 pressurement is useful in determining transvalvular, intravascular, and intraventricular pressure gradients.

The Langston dual lumen catheter consists of a coaxial tube (outer lumen) mounted over a braided catheter shaft (inner lumen) and an extension line with a 3-way stopcock. The extension line with stopcock connects to the outer lumen. The outer lumen, and extension line are joined by an over molded manifold. The manifold also includes a luer that connects to the inner lumen. The manifold is printed with the Langston catheter length, French size, maximum guidewire diameter, and product logo ("Langston"). The Langston dual lumen catheter tip terminates in either a pigtail or multipurpose tip configuration.

The provided text describes a medical device, the Langston Dual Lumen Catheter, and its substantial equivalence to predicate devices, but it does not contain details about acceptance criteria or a study designed to prove the device meets specific performance criteria in the context of an AI/ML model for diagnosis or prediction.

The document is a 510(k) summary for a medical device (a catheter) seeking FDA clearance, demonstrating substantial equivalence to already cleared predicate devices. The "studies" mentioned are bench tests and biocompatibility tests to show that the new device's modifications (e.g., in manufacturing, materials) do not negatively impact its safety and performance compared to the previously cleared versions. These are not clinical studies in the sense of evaluating diagnostic accuracy or predictive performance through human reader evaluations or ground truth comparisons.

Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML model's performance, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for training sets, because this information is not present in the provided text.

The closest relevant information from the document is related to the performance verification of the physical medical device, not an AI component.

Here's a breakdown of what is available in the document, framed in the context of device performance, but noting its irrelevance to AI/ML model evaluation:

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

The document broadly states: "The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues." It does not provide a table with specific quantitative acceptance criteria or detailed reported performance figures for each test. Instead, it lists the types of tests performed.

The following points are explicitly NOT present in the provided text, as they relate to AI/ML model evaluation, which is not the subject of this 510(k) summary:

2. Sample size used for the test set and the data provenance: Not applicable, no AI/ML test set mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no AI/ML ground truth mentioned.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: "Clinical testing was not performed to validate the performance of the subject device." Therefore, no MRMC study for AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, no algorithm.
7. The type of ground truth used: Not applicable, no AI/ML ground truth mentioned.
8. The sample size for the training set: Not applicable, no AI/ML training set mentioned.
9. How the ground truth for the training set was established: Not applicable, no AI/ML training set mentioned.

In summary, the provided document details the regulatory clearance process for a physical medical catheter through non-clinical bench and biocompatibility testing, not the evaluation of an AI-powered diagnostic or predictive device.

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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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