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The GlidePath™ 10F long-term hemodialysis catheter is indicated for use in attaining short-term vascular access in pediatric, adolescent and adult patients for hemodialysis, hemoperfusion or apheresis as determined by the prescribing physician. Access is attained via the internal jugular vein, or femoral vein, Catheters longer than 22 cm are intended for femoral vein insertion, depending on patient anatomy and size.

The Glidepath™ 10F Long-Term Hemodialysis Catheter features a dual-lumen shaft with optimized double-D cross-sectional designs providing separate arterial and venous lumens, a molded bifurcation and, extending from the bifurcation, arterial and venous extension legs that connect to an external dialysis machine or blood cleansing device. The arterial (red) luer connector connects to the blood intake on the dialysis machine and the venous (blue) luer connector connects to the blood return line on the dialysis machine. Each extension leg has an atraumatic occlusion clamp which closes access to the lumen. Long-term dialysis catheters are packaged in a tray with legally marketed accessories intended for use during catheter placement. The symmetrical catheter tip contains holes that aid in the distribution of blood flow or aid in overthe-guidewire placement. The dialysis catheters are offered in various lengths. This line extension of GlidePath™ has been designed with smaller patients in mind and for physicians that may prefer a smaller diameter catheter, so product offerings include the smaller lumen diameter, 10 F, and shorter lengths, 10 cm to 23 cm. Additionally, Glidepath™ 10F Long-Term Hemodialysis Catheter has been designed to reach adequate flow rate requirements for pediatric patients or smaller adult patients for whom a physician desires a smaller catheter size.

The provided text describes the regulatory clearance of a medical device, the GlidePath 10F Long-Term Hemodialysis Catheter, and its substantial equivalence to predicate devices. However, the document does not contain the specific details required to answer all parts of your request regarding acceptance criteria and the study that proves the device meets those criteria, especially in the context of an AI/ML device.

This document is a 510(k) summary for a physical medical catheter, not an AI/ML device. Therefore, questions relating to AI/ML device performance (e.g., test sets, ground truth establishment by experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to the information provided.

The document discusses performance data for the physical catheter, but these tests are related to mechanical and physical properties of the device, not diagnostic accuracy or AI performance.

Here's a breakdown of what can be extracted from the provided text, and what cannot:

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

The document lists various in vitro tests performed to demonstrate substantial equivalence, and states that the "subject device... meets all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." However, it does not provide a table detailing the specific acceptance criteria (e.g., numerical thresholds for flow rates, tensile strength) or the reported numerical performance data for the GlidePath 10F Long-Term Hemodialysis Catheter against those criteria. It only lists the types of tests performed.

Note: The phrase "Met predetermined acceptance criteria" is inferred from the statement "The subject device... meets all predetermined acceptance criteria of design verification and validation." Specific numerical values for the criteria or the device's performance are not provided.

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

The document does not specify sample sizes for the "test set" in the context of diagnostic performance, nor does it describe data provenance for patient data. The "performance data" refers to in vitro mechanical/physical tests on the device itself, not a clinical study on patient data.

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, as this is not an AI/ML device or a diagnostic device relying on expert interpretation for ground truth.

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

Not applicable.

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, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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

For the physical device performance tests, the "ground truth" or reference is established by the specifications in applicable standards, guidance documents, and internal test protocols. For example, a "burst" test would have a specified pressure it must withstand, and the device either passes or fails that engineering specification.

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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