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• The Hemodialysis Catheter is indicated for use in attaining short-term or long-term vascular access for Hemodialysis therapy and apheresis.

• It may be inserted percutaneously and is primarily placed in the internal jugular vein of an patient.
• Alternate insertion sites include subclavian vein as required.
• Catheters greater than 40 cm are intended for femoral vein insertion.
• The curved Hemodialysis Catheter is intended for internal jugular vein insertion.
• 8-10Fr Hemodialysis Catheters can be used in pediatric patients.

The Hemodialysis Catheter is indicated for use in attaining vascular access for Hemodialysis and Apheresis therapy. The catheter tubing is made of radiopaque polyurethane with a dual D cross-sectional design, providing independent arterial and venous lumens. The proximal end of the catheter features two luer connectors. The luer connectors are connected to extension legs. The extension legs are made of silicone material. Each extension leg has a catheter clamp, which is durable and can effectively ensure timely closure of the extension leg. The lumen with the red catheter clamp, which is called arterial lumen, is used for blood outflow; The lumen with the blue catheter clamp, which is called venous lumen, is used for blood return. The arterial and venous lumen priming volumes are printed directly on the ID ring of the clamp. Catheters range from approximately 13-55 cm long and are offered in straight or curved catheter configurations with cuff for long-term implantation. The Hemodialysis Catheter is packaged in a tray with legally marketed accessories intended for use during catheter placement. The Hemodialysis Catheter Kit is provided sterile, single use.

The provided FDA 510(k) clearance letter and associated documentation for the Hemodialysis Catheter (K241581) primarily detail the regulatory approval process, comparison to predicate devices, and non-clinical performance testing. It does not contain information about acceptance criteria for device performance based on clinical study data, nor does it describe a study that validates the device performance against such criteria in a clinical setting.

The document specifically states: "Clinical test: Clinical testing is not required." This indicates that the clearance was based on non-clinical performance data and substantial equivalence to legally marketed predicate devices, not on direct clinical evidence of the device's performance in patients.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance from a clinical study.
• Sample sizes used for the test set and data provenance from a clinical study.
• Number of experts used to establish ground truth and their qualifications from a clinical study.
• Adjudication method for a clinical study.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only without human-in-the-loop performance) study.
• Type of ground truth used in a clinical study.
• Sample size for the training set from a clinical study.
• How ground truth for the training set was established in a clinical study.

The provided document focuses on the following types of performance data, which are non-clinical in nature:

1. Acceptance Criteria and Reported Device Performance (Non-Clinical)

While not presented in a table with specific pass/fail metrics, the document implies that the device met the requirements of the following standards and guidance:

• FDA guidance "Implanted Blood Access Devices for Hemodialysis, issued on January 21, 2016"
• ISO 10555-1:2013 (Sterile, single-use intravascular catheters - Part 1: General requirements)

The following non-clinical tests were performed to demonstrate compliance:

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

• Not Applicable for Clinical Data: The document explicitly states "Clinical testing is not required."
• For Non-Clinical Data: Specific sample sizes for each non-clinical test (e.g., tensile testing, leakage testing) are not detailed in this summary document. Data provenance is implied to be from internal lab testing conducted by Haolang Medical USA Corporation, in compliance with the cited ISO standards and FDA guidance.

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

• Not applicable as clinical testing with expert-established ground truth was not performed or required for this 510(k) clearance.

4. Adjudication Method for the Test Set

• Not applicable as clinical testing with an adjudication method was not performed or required.

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

• Not applicable. This type of study is typically for AI/imaging device performance evaluation, not for a physical device like a hemodialysis catheter, and certainly not for a clearance that states "Clinical testing is not required."

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

• Not applicable. This is not a software/AI device.

7. The Type of Ground Truth Used

• For Non-Clinical Testing: The "ground truth" for the non-clinical tests is adherence to the specified performance requirements as outlined in the referenced ISO standards (e.g., ISO 10555-1) and FDA guidance documents for hemodialysis catheters (e.g., "Implanted Blood Access Devices for Hemodialysis"). This involves objective, measurable physical, mechanical, and biological properties.

8. The Sample Size for the Training Set

• Not applicable. This refers to training data for AI/ML algorithms, which is not relevant to this device's clearance.

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

• Not applicable.

In summary, the FDA 510(k) clearance for the Hemodialysis Catheter (K241581) was granted based on a substantial equivalence determination supported by comprehensive non-clinical performance testing (physical, mechanical, biocompatibility, sterilization, and shelf-life) against recognized industry standards and FDA guidance, rather than a clinical study with patient data and expert-derived ground truth.

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The Arterial Catheter permits access to the peripheral arterial circulation.

The Arterial Catheter is a lumen peripherally inserted catheter assembly designed to perform short term access to the peripheral arterial circulatory system for less than 7 days, it is also intended to be used for pressure monitoring. It consists of an introducer needle or catheter-over-needle assembly, spring guide wire, and a catheter assembly that incorporates an extension tubing segment with a slide clamp and a flex tube end cap. These components are used together for catheter insertion using the "Seldinger" catheter-over-guide-wire insertion technique, which divided into three types according to structure: Standard Seedinger; Modified Seedinger-Integrated; Modified Seedinger-Sleeve. The Arterial Catheter is available in 18 ga, 20 ga, 21 ga, 22 ga and 24 ga, the corresponding diameter of guide wire is 0.025", 0.018", 0.015", 0.012". Configurations with usable lengths of 2.5 cm to 23 cm. The catheters are attached to an injection molded polyurethane hub with Luer lock fittings for access attachment. The Arterial Catheter is provided sterile.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Arterial Catheter, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria (e.g., "flow rate must be > X mL/min"). Instead, it lists the types of performance tests conducted and generally states that the device "comply with" standards and that "performance is acceptable."

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

The document does not specify the sample sizes used for any of the non-clinical performance tests. It also does not provide information on data provenance (e.g., country of origin, retrospective/prospective) for these tests, as they appear to be laboratory-based engineering performance evaluations rather than clinical data involving human subjects.

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

This information is not applicable and not provided. The "ground truth" for these tests would be established by the physical and chemical properties of the device and its direct performance against defined engineering standards, not by expert interpretation.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies for interpretation of results or image assessment, not for direct engineering performance tests.

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 MRMC comparative effectiveness study was mentioned. The device is an arterial catheter, a physical medical device, not an AI-powered diagnostic tool. Therefore, human reader improvement with/without AI assistance is not relevant or applicable.

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

This is not applicable, as the device is a physical medical instrument and not an algorithm or AI system.

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

The "ground truth" for the non-clinical performance tests (e.g., flow rate, tensile strength, leakage) is established by adherence to recognized engineering standards (e.g., ISO 10555-1, ISO 10993-1, ISO 11607-1, ISO 11135) and the physical properties and measured performance of the device against predefined specifications derived from those standards. For biocompatibility, it's based on the material's interaction with biological systems as assessed by specific tests.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical instrument, not a learning algorithm that requires a training set.

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

This is not applicable, as there is no training set for a physical medical device like this catheter.

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UMBILICAL VESSELS CATHETER is intended for short-term vascular access via umbilical vessels in neonatal patients:

Via the umbilical artery:

--- sampling of blood,

---measurement of intravascular arterial pressure.

Via the umbilical vein:

--- infusion (simultaneous infusion of several medicinal products for the dual lumen catheter).

The UMBILICAL VESSELS CATHETER has catheters in single lumen and dual lumen. The catheters tube is made of radiopaque polyurethane which is insert molded to a polyurethane hub. The insertion tip of the catheter has been heat melted to form a smooth, rounded tip to reduce tissue trauma upon insertion.

Placement of the device is facilitated by depth markings, which are printed on the catheter at 1 cm intervals, beginning at 5 cm from the insertion tip and continuing to 40 cm from the tip. Catheter placement must be confirmed by x-ray.

The UMBILICAL VESSELS CATHETER has 17 primary configurations: Catheters in 2 Fr., 2.5 Fr., 2.8 Fr., 3 Fr., 3.5 Fr., 4 Fr., 5 Fr., 6 Fr., 6.5 Fr. and 7 Fr. for Single lumen; 2.8 Fr., 3 Fr., 3.5 Fr., 4 Fr., 5 Fr., 6 Fr. and 6.5 Fr. for dual lumen. Each device will continue to be packaged in a Tyvek pouches are packaged in a carton. The UMBILICAL VESSELS CATHETER does not contain DEHP and is Ethylene Oxide sterilized. The product and packaging are not made of natural rubber latex.

The provided text describes a 510(k) premarket notification for an Umbilical Vessels Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance criteria through extensive clinical studies involving AI. Therefore, most of the requested information regarding AI performance metrics, sample sizes for training/test sets, ground truth establishment, expert adjudication, and MRMC studies is not applicable to this document.

However, I can extract information related to the device's functional performance and equivalence.

Here's a breakdown of what can be extracted based on your request:

1. Table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative sense for the device's functional performance beyond complying with established standards. Instead, it demonstrates compliance with recognized industry standards. The "reported device performance" is a statement of "Pass" for each test, indicating that the device met the requirements of the specified standards.

2. Sample size used for the test set and the data provenance:
The document refers to "nonclinical testing" performed according to applicable standards. It does not specify the sample size for these tests. Data provenance is implied to be laboratory testing as part of the manufacturing and submission process, likely conducted in China where the correspondent is located. This is not retrospective clinical data from a specific country, but rather prospective bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. For this type of device and submission, "ground truth" related to expert consensus or clinical judgment on a test set (as would be relevant for an AI device) is not established. The ground truth here is adherence to engineering and biocompatibility standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are relevant for subjective assessments, particularly in clinical image interpretations or similar AI-assisted diagnoses. Here, the tests are objective measurements against established 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 medical catheter, not an AI-powered diagnostic or assistive tool. There are no "human readers" interpreting data with or without AI assistance in the context of this submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:
For the non-clinical testing, the "ground truth" is defined by the requirements and specifications within the referenced international and national standards (e.g., ISO 11135, ASTM F88, ISO 10993 series for biocompatibility, ISO 10555-1 for intravascular catheters). The tests determine if the device meets these objective, pre-defined standards.

8. The sample size for the training set:
Not applicable. There is no AI model or "training set" for this device.

9. How the ground truth for the training set was established:
Not applicable, as there is no training set.

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