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THE MEDCOMP SPLIT CATH® II CATHETER 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.

The Medcomp Split Cath® II is a polyurethane, double lumen catheter used to remove and return blood through two-segregated lumen passages. Both lumens are "D" shaped, tapered at the distal tip, with three side holes on each tip. The distal venous lumen extends beyond the arterial lumen to reduce recirculation. The fixed polyester cuff allows for tissue ingrowth for long term placement. The arterial and venous lumens are designed to be split, or peeled apart, prior to insertion to provide two free-floating lumens within the vessel. The side holes are orientated to allow 360-degree arterial uptake and venous return. The lumens are connected to the extensions via a soft pliable hub with suture wing. Red and blue luer connectors and clamps identify the arterial and venous extensions. Priming volume information is printed an identification ring housed within the extension line clamp.

The provided text is a 510(k) summary for the Medcomp Split Cath® II Hemodialysis Catheter. This document describes the device, its intended use, and its comparison to a predicate device for regulatory clearance. It is not a study that provides detailed performance data, acceptance criteria, or an analysis of how the device meets those criteria.

Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, training set details) cannot be extracted from this document, as this type of information is typically found in detailed scientific studies, not regulatory summaries focused on substantial equivalence.

However, I can extract information regarding the type of performance data submitted and how the ground truth was "established" in the context of this regulatory submission.

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

This document does not specify formal acceptance criteria with numerical targets. Instead, it relies on the concept of "substantial equivalence" to a predicate device. The performance data presented are qualitative statements about the device's similarity to the predicate and the types of tests performed.

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

• Sample Size: Not specified for any "test set" in the traditional sense. The document refers to "in vitro performance data" and "numerous published clinical papers."
• Data Provenance:
  • In Vitro Data: Likely conducted by the manufacturer, Medcomp, or their contracted labs. No country of origin is specified.
  • Clinical Data: Based on "numerous published clinical papers." These are likely retrospective reviews of existing literature. No specific country of origin is mentioned, but such papers would typically originate from various medical institutions globally.

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 document relies on in vitro laboratory tests and published clinical literature. There is no mention of a "test set" for which experts established ground truth in the context of this 510(k) submission.

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

Not applicable. There was no "test set" and expert adjudication in the manner described.

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 device is a medical catheter, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a medical catheter, not a software algorithm.

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

The "ground truth" for this regulatory submission is established through:

• Comparison to the predicate device: The fundamental "ground truth" for 510(k) clearance is that the device is "substantially equivalent" to a legally marketed predicate device. This implies that the predicate's established safety and effectiveness serve as the benchmark.
• Established laboratory testing standards: For in vitro performance, the ground truth is against standard material and device performance tests (tensile strength, leakage, flow, biocompatibility per ISO 10993).
• Published clinical literature/outcomes data: For the translumbar indication, the ground truth leans on "numerous published clinical papers" which "stress that this technique is for a very small patient population as an absolute last resort when all other traditional access sites have been exhausted" and that "Properly inserted catheters via the translumbar technique do not have a detrimental affect on the clinical outcome as to catheter function." This refers to established clinical practice and observed patient outcomes from the medical community.

8. The sample size for the training set

Not applicable. There is no "training set" for this type of device.

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

Not applicable. There is no "training set."

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The Medcomp® Split-Cath® II is indicated for use in attaining chronic (longthe wousehip access for hemodialysis and apheresis. It may be inserted tonni/ vaceusly and is ideally placed in the internal jugular vein of an adult patient. Alternate insertion site includes the subclavian vein as required.

The Medcomp Split-Cath II is a polycarbonate/polyurethane, double lumen catheter used to remove and return blood through two-segregated lumen passages. Both lumens are "D" shaped, tapered at the distal tip, with eight side holes. The distal venous lumen extends beyond the arterial lumen to reduce recirculation. The fixed polyester cuff allows for tissue ingrowth for long term placement.

The arterial and venous lumens are designed to be split, or peeled apart, prior to insertion to provide two free-floating lumens within the vessel. The side holes are orientated to allow 360-degree arterial uptake and venous return. The lumens are connected to the extensions via a soft pliable hub with suture wing. Red and blue luer connectors and clamps identify the arterial and venous extensions. Priming volume information is printed an identification ring housed within the extension line clamp.

The provided document is a 510(k) premarket notification for the Medcomp® Split-Cath® II Hemodialysis Catheter. It seeks to demonstrate substantial equivalence to predicate devices, rather than establishing de novo safety and effectiveness. Therefore, the information typically found in a study proving a device meets acceptance criteria for new devices (like detailed performance metrics against specific acceptance criteria, sample sizes for test and training sets, expert qualifications for ground truth, MRMC studies, or standalone algorithm performance) is largely absent.

However, based on the provided text, here's an attempt to answer the questions within the context of a substantial equivalence submission:

Acceptance Criteria and Study to Prove Device Meets Criteria for Medcomp® Split-Cath® II Hemodialysis Catheter

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance metrics against pre-defined acceptance criteria for a new device. The "acceptance criteria" here are implicitly tied to the performance of the predicate device and the general safety/effectiveness standards for such devices.

• Intended use
• Insertion method
• Anatomical location
• Design
• Performance
• Labeling
• Manufacturing process
• Method of sterilization |
  | II. Physical and Functional Performance (In Vitro): | Met: In Vitro performance data for the Medcomp Split Cath II demonstrated substantial equivalence to the legally marketed Ash Split-Cath II catheter for:
• Tensile strength
• Joint strength
• Leakage
• Recirculation
• Flow performance
• Flexural
• Lumen peel |
  | III. Biocompatibility: | Met: Biocompatibility testing on the Split-Cath II demonstrates the lumen materials meet the requirements of USP XXII for a permanent contact device. Substantial equivalence for lumen material formulation to the predicate device (polyurethane) is also noted, with the only difference being a second vendor for the material. |
  | IV. Regulatory Compliance (e.g., GMP, Labeling, Sterilization): | Met (Implied): The FDA letter instructs the submitter to comply with all Act's requirements, including annual registration, listing of devices, good manufacturing practice (QSR), and labeling, implying these are expected for market entry. The submission likely contained documentation to support compliance with manufacturing and sterilization processes, as these were mentioned in the substantial equivalence comparison. |

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

The document does not explicitly state a "test set" sample size in the traditional sense of a clinical trial. The performance data provided is in vitro, focusing on engineering characteristics. The "test set" for demonstrating substantial equivalence primarily refers to the Medcomp Split Cath II samples used in the specified in vitro tests. The document does not specify the number of devices or components tested for each in vitro performance measure.

Data Provenance: The in vitro data was generated specifically for this 510(k) submission, likely at Medcomp's facilities or an accredited testing lab. No country of origin for the data is specified, but the submitter is based in Harleysville, PA, USA. The data is prospective in the sense that it was generated for the purpose of this submission and to evaluate the new device against the predicate.

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

This information is not applicable and not provided in the document. For a 510(k) submission based on substantial equivalence and in vitro testing, there isn't typically a ground truth established by medical experts in the same way there would be for a diagnostic or AI device that requires expert adjudication. The "ground truth" for in vitro performance tests would be the established engineering and materials science principles and the performance of the legally marketed predicate device.

4. Adjudication Method for the Test Set

Not applicable and not provided. As the primary performance data discussed is in vitro and focused on mechanical and material characteristics, there is no expert adjudication method like "2+1" typically used for clinical endpoints or image interpretation.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical data was not deemed necessary since substantial equivalence is addressed by way of comparison to a legally marketed device." Therefore, there is no information on human reader improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

Not applicable. This device is a medical catheter, not an AI algorithm or an imaging device.

7. The Type of Ground Truth Used

The "ground truth" for this submission is:

• Predicate Device Performance: The established performance characteristics of the legally marketed predicate device(s), particularly the Ash Split-Cath II catheter, as demonstrated through in vitro testing.
• Industry Standards/Regulations: Compliance with relevant standards like USP XXII for biocompatibility.
• Design Specifications: The documented design specifications of the proposed device being identical to the predicate (Ash Split-Cath II) except for the lumen material vendor.

8. The Sample Size for the Training Set

Not applicable. This submission is for a physical medical device (catheter) and does not involve AI algorithms that require training sets in the typical sense.

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

Not applicable. As above, no training set for an AI algorithm is involved.

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