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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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The Vascular Solutions Langston™ Dual Lumen Pressure Monitoring 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 Pressure Monitoring catheter is intended for use as a pressure measurement catheter and for delivery of contrast media during angiographic studies. The DLP 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 Merit Softouch catheter and outer lumen are joined together using an adapter junction placed near the proximal end of the Merit Softouch 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 the outer tube is perforated with side holes to allow pressure measurement simultaneously with the sideholes at the tip of the catheter. The dual lumen catheter is deployed through standard guide catheters and will accommodate standard 0.038'' diameter guidewires.

The provided text describes a 510(k) submission for the Langston™ Dual Lumen Pressure Monitoring Catheter. This device is an Intravascular Diagnostic Catheter and is an unclassified device. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing a study that assesses its performance against specific acceptance criteria in a clinical setting.

Therefore, much of the requested information cannot be extracted directly from this document because it outlines a regulatory submission process for a medical device rather than for an AI/machine learning device that would undergo rigorous performance evaluation against established reference standards.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific "acceptance criteria" for device performance (e.g., accuracy, sensitivity, specificity) and corresponding reported performance are provided in the document. The submission focuses on demonstrating substantial equivalence to predicate devices based on design verification and biocompatibility.

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

No test set for evaluating the device's performance (in the context of AI/ML) is mentioned. The document refers to "design verification" non-clinical testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. The document does not describe a study involving expert-established ground truth for device performance evaluation.

4. Adjudication Method:

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was conducted or reported.

6. Standalone Performance:

No standalone (algorithm-only) performance is reported, as this is a physical medical device, not an AI algorithm.

7. Type of Ground Truth Used:

Not applicable in the context of an AI/ML device. For a physical medical device, "ground truth" would refer to its physical and functional characteristics verified through engineering and biocompatibility testing. The text states: "Testing conducted included assessments of the design verification of the Dual Lumen Pressure Monitoring Catheter along with biocompatibility assessments."

8. Sample Size for the Training Set:

Not applicable; no AI/ML model was trained.

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

Not applicable; no AI/ML model was trained.

Summary of Information from the Provided Text:

The document describes a 510(k) premarket notification for a medical device, not an AI/ML product. The regulatory pathway for this device relies on demonstrating substantial equivalence to existing predicate devices, primarily through non-clinical testing (design verification and biocompatibility) rather than clinical performance studies against specific acceptance criteria.

Key points from the document regarding the device's qualification:

• Non-Clinical Testing: "Testing conducted included assessments of the design verification of the Dual Lumen Pressure Monitoring Catheter along with biocompatibility assessments. The results of this battery of tests confirmed the suitability of the Dual Lumen Pressure Monitoring Catheter for its intended use."
• Clinical Testing: "No clinical evaluations of this product have been conducted." (This explicitly states the absence of human clinical trials).
• Predicate Devices: The device is deemed substantially equivalent to:
  • Langston Dual Lumen Pigtail Catheters
  • Cordis Dual Lumen Pressure Monitoring Catheter
  • Merit Medical Softouch Diagnostic Intravascular Catheter
• Conclusion: "The testing performed confirms that the Langston Dual Lumen Pressure Monitoring Catheter will perform as intended." This statement refers to the non-clinical design verification and biocompatibility testing.

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The Vascular Solutions Langston™ Dual Lumen Pressure Monitoring Catheter is indicated for delivery of contrast media 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 Pressure Monitoring catheter is intended for use as a pressure measurement catheter and for delivery of contrast media during angiographic studies. The DLP catheter consists of the Merit Medical Softouch Diagnostic Intravascular Catherer (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 Merit Softouch catheter and outer lumen are joined together using an adapter junction placed near the proximal end of the Merit Softouch catherer. 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 the outer tube is perforated with multiple holes to allow pressure measurement simultaneously with the inner catheter. The dual lumen catheter is deployed through standard introducers and will accommodate standard 0.038'' diameter guidewires.

The provided document, K050168, is a 510(k) Summary of Safety and Effectiveness for the Langston™ Dual Lumen Pressure Monitoring Catheter. This document is a premarket notification for a medical device and, as such, does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner typically seen for performance evaluations of AI/software devices.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It explicitly states that "No clinical evaluations of this product have been conducted." Therefore, the information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable to this submission, as such studies were not performed for this 510(k) clearance.

Here's a breakdown of the provided information in the context of your request:

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

• Acceptance Criteria: Not explicitly stated in terms of performance metrics like sensitivity, specificity, accuracy, or similar quantitative measures for an AI/software device. The implicit acceptance criterion for a 510(k) is "substantial equivalence" to predicate devices, supported by non-clinical testing.
• Reported Device Performance: Instead of performance metrics, the document reports the outcome of non-clinical testing.
  • "Testing conducted included assessments of the design verification of the Dual Lumen Pressure Monitoring Catheter and biocompatibility assessments."
  • "The results of this battery of tests confirmed the suitability of the Dual Lumen Pressure Monitoring Catheter for its intended use."
  • This confirms the device met its design specifications and biocompatibility requirements but doesn't provide specific quantitative performance data in the context of your request.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not Applicable. No clinical or performance test set data is reported. The "testing" refers to bench testing and biocompatibility assessments, not data from a test set of cases.

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. No ground truth establishment by experts for a test set was performed or reported.

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

• Not Applicable. No clinical test set and thus no adjudication method for ground truth.

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 hardware device submission, not an AI/software device. No MRMC study was conducted or reported.

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

• Not Applicable. This is a hardware device.

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

• Not Applicable. No ground truth was established for "performance" as it relates to clinical outcomes or interpretation in the way an AI/software device would be evaluated. The "ground truth" equivalent here would be the engineering specifications and established safety standards met through bench testing.

8. The sample size for the training set:

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

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

• Not Applicable. No training set was used.

In summary: The K050168 document is a traditional medical device 510(k) submission, not for an AI/software device. Its clearance is based on non-clinical testing demonstrating substantial equivalence to pre-existing predicate devices, not on the type of clinical performance studies and ground truth establishment typically required for AI-powered diagnostics.

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The Vascular Solutions Langston™ Dual Lumen Pigtail 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 Pigtail catheter is intended for use as a pressure measurement catheter and for delivery of contrast media during angiographic studies. The DLP 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 a 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 the outer tube is perforated with side holes to allow pressure measurement simultaneously with the sideholes at the tip of the pigtail. The dual lumen pigtail catheter is deployed through standard 8Fr guide catheters and will accommodate standard 0.038" diameter guidewires.

Acceptance criteria and the study proving the device meets them:

This submission is for a K041909 Dual Lumen Pigtail Catheter.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample size for the test set: Not applicable for clinical data. The document explicitly states, "No clinical evaluations of this product have been conducted." For non-clinical testing, specific sample sizes for design verification or biocompatibility testing are not provided in this summary.
• Data provenance: Not applicable for clinical data. For non-clinical data, the provenance is internal testing performed by Vascular Solutions, Inc.

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

• Not applicable, as no clinical evaluations were conducted that would require experts to establish ground truth from patient data. Non-clinical testing would have relied on design specifications and engineering standards.

4. Adjudication method for the test set:

• Not applicable, as no clinical evaluations were conducted that would require adjudication of patient data.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an intravascular diagnostic catheter, not an AI-assisted diagnostic tool.

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

• No, a standalone algorithm-only performance study was not done. This device is a physical medical instrument, not a software algorithm.

7. The type of ground truth used:

• For the non-clinical testing, the "ground truth" would be established by engineering specifications, material standards, and performance benchmarks relevant to physical medical devices (e.g., pressure measurement accuracy based on calibrated instruments, material compatibility based on established biocompatibility standards).
• No clinical ground truth (e.g., expert consensus, pathology, outcomes data) was used, as no clinical studies were performed.

8. The sample size for the training set:

• Not applicable, as this is a physical medical device and not an AI/machine learning model that requires a training set.

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

• Not applicable, as this is a physical medical device and not an AI/machine learning model whose training set would require ground truth establishment.

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