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Medcomp's Hemo-Cath® silicone double lumen catheter can be utilitized for long term implantation as well as temporary access for hemodialysis, hemoperfusion, or apheresis therapy.

It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient.

Alternative insertion sites include subclavian vein as required.

• 12.5French double lumen design with cuff for long-term implant.
• Variety of lumen lengths: 15cm, 18cm, 24cm, 32cm, 32cm and 40cm.
• 12.5F with a pre-curved lumen in a 28cm and 32cm length.
• Radiopaque silicone material
• Lumen is connected to the extension via a soft pliable hub with a suture winq .
• Red and blue clamps and red and blue luers 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.

This document describes the Hemo-Cath® catheter, a medical device. The provided text is a 510(k) summary, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of filing does not typically include detailed clinical studies with acceptance criteria in the same way a new drug or novel high-risk device might.

Therefore, many of the requested categories for acceptance criteria and study data are not applicable or not explicitly detailed in this type of regulatory submission. The focus here is on demonstrating equivalence through non-clinical performance testing and comparison to existing devices.

Here's a breakdown based on the provided text, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) summary for a medical device (hemodialysis catheter) demonstrating substantial equivalence, the "acceptance criteria" are primarily defined by the international standards listed and the successful outcome of the performance tests. The specific numerical targets for each test are not explicitly stated in this summary document, nor are precise performance metrics beyond a statement of "acceptable safety and performance outcomes."

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

• Sample Size: The document does not specify the sample size for the performance tests conducted. These are typically benchtop or in-vitro tests, not human clinical trials.
• Data Provenance: The data provenance is internal to MEDCOMP, derived from controlled laboratory testing as described by the listed international standards. It is not patient data (e.g., country of origin, retrospective/prospective).

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

• Not Applicable. For a medical device like a catheter, "ground truth" is established through engineering specifications, international testing standards (e.g., ISO, ASTM), and design validation, rather than an expert consensus based on clinical observations or images. The "experts" involved would be engineers, materials scientists, and quality assurance personnel responsible for conducting and validating the tests according to established protocols.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1 or 3+1) are typically used for medical image interpretation or clinical outcomes in human studies where there's subjectivity or disagreement among experts. For device performance testing against engineering standards, the results are typically quantitative and assessed against predefined specifications, often following a pass/fail criterion.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with/without AI Assistance

• Not Applicable. This device is a hemodialysis catheter, not an AI-powered diagnostic tool. Therefore, an MRMC study or evaluation of human readers with/without AI assistance is irrelevant to this submission.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not Applicable. This is a hardware medical device, not a software algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• The "ground truth" for this device's performance is based on engineering specifications and established international standards (ISO). Performance is measured against these objective, quantifiable benchmarks. These are not human-centric ground truths like pathology or clinical outcomes in the context of this 510(k) summary. Clinical outcomes are typically assessed during post-market surveillance or more extensive clinical trials, which are not usually required for 510(k) submissions of substantially equivalent devices.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set."

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

• Not Applicable. As there is no training set for a physical device, this question is not relevant.

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