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The Medcomp® Split Cath® III is indicated for use in attaining long term vascular access for Hemodialysis and Apheresis in the adult patient. It may be inserted percutaneously and is primarily placed in the internal jugular vein. Alternate insertion sites include the subclavian vein and inferior vena cava as required. Catheters greater than 40cm are intended for femoral vein or inferior vena cava insertion. Translumbar insertion via inferior vena cava is indicated when all other access sites are identified as non-viable.

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I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that the device meets such criteria. The document is a 510(k) clearance letter from the FDA for a medical device called "Split Cath III®" and "Split Cath III® (Translumbar Insertion)". It details the regulatory classification, general controls, and indications for use of the device.

To address your request, I would need a different document that describes the performance study conducted for this device, including the acceptance criteria and the results of that study.

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The Medcomp® Split Cath® III is indicated for use in attaining long term vascular access for Hemodialysis and Apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein. Alternate insertion sites include the subclavian vein. Catheters greater than 40cm are intended for femoral vein insertion.

The Medcomp® Split Cath® III is indicated for use in attaining long term vascular access for Hemodialysis and Apheresis in the adult patient. It may be inserted percutaneously and is primarily placed in the internal jugular vein. Alternate insertion sites include the subclavian vein and inferior vena cava as required. Catheters greater than 40cm are intended for femoral vein or inferior vena cava insertion. Translumbar insertion via inferior vena cava is indicated when all other access sites are identified as non-viable.

• 14 French, double "D" Jumen design with cuff for long-term implant.
• Variety of lumen lengths from 20cm to 55cm.
• Soft radiopaque polyurethane material
• Lumen is connected to the extension via a soft pliable hub with a suture wing
• Red and blue clamps and red and blue sleeves are provided on the extension tube to prevent air/fluid communications
• The hub contains the device name and French size, clamp I.D. Rings are printed with the priming volume.

The provided document is a 510(k) Summary for the Medcomp® Split Cath® III, a hemodialysis catheter. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study design with performance metrics for a novel AI device. Therefore, much of the requested information (like acceptance criteria for AI performance, sample sizes for training/test sets in an AI context, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types for AI) is not applicable or present in this document.

The document details safety and performance tests for the physical medical device itself, not for an AI algorithm.

However, I can extract information regarding the device's functional performance and the tests conducted.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for substantial equivalence of a physical medical device, not an AI product, the "acceptance criteria" are implied by meeting the requirements of the standards and demonstrating performance comparable to predicate devices. The document does not explicitly list numerical acceptance criteria for each test, but it states that "Subject product testing has yielded acceptable safety and performance outcomes."

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

The document does not specify sample sizes (e.g., number of catheters tested) for the performance tests. It refers to "Subject product testing" but does not give numerical details. The data provenance is internal to Medcomp, a US-based company. The tests are prospective tests on manufactured devices, not retrospective clinical data analysis.

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

This is not applicable as the document describes physical device testing against engineering standards, not expert-based ground truth for an AI algorithm. The "ground truth" is defined by the international standards themselves.

4. Adjudication method for the test set

Not applicable, as it's not an AI study requiring adjudication of expert opinions. The tests are objective measurements against established engineering standards.

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 510(k) for a physical medical device, not an AI system.

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

Not applicable. This is a 510(k) for a physical medical device designed for human use, not an AI algorithm.

7. The type of ground truth used

For the physical device performance, the "ground truth" is established by adherence to recognized international standards and engineering specifications (e.g., ISO 10555-1, ISO 10555-3, ISO 594-2, ISO 10993-1).

8. The sample size for the training set

Not applicable. There is no AI training set involved.

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

Not applicable. There is no AI training set involved.

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