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The GlidePath™ 7.5F Long-Term Hemodialysis Catheter is indicated for use in attaining short-term or long-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, subclavian vein, or femoral vein.

The GlidePath™ 7.5F 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 secures to the blood intake on the dialysis machine and the venous (blue) luer connector secures 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 over-the-guidewire placement. The symmetrical catheter tip contains holes that aid in the distribution of blood flow or aid in over-the-guidewire placement. The dialysis catheter is 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 smaller lumen diameter and shorter lengths, 8 cm to 19 cm, tip to cuff measurement. Additionally, GlidePath™ 7.5F Long-Term Hemodialysis Catheters have 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 a 510(k) premarket notification for the GlidePath™ 7.5F Long-Term Hemodialysis Catheter. The document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a human-in-the-loop study for a device that meets acceptance criteria for an AI/ML based device.

Therefore, based solely on the provided text, I cannot provide the information requested in your prompt regarding acceptance criteria and a study proving an AI/ML device meets those criteria. The document describes a medical device (a catheter) and its non-clinical performance testing.

Here's what I can extract and address from your prompt based on the provided text, and what I cannot address:

Information NOT Found in the Provided Text (relevant to AI/ML device studies):

• A table of acceptance criteria and the reported device performance for an AI/ML device. The document lists performance tests for a physical catheter, not acceptance criteria for an AI/ML algorithm.
• Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective). This is specific to data used for AI/ML model validation, which is not discussed.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts. Not applicable to a physical catheter.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set. Not applicable.
• 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 mention of human readers or AI assistance.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done. No mention of an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc). Not applicable to a physical catheter.
• The sample size for the training set. Not applicable.
• How the ground truth for the training set was established. Not applicable.

What CAN be stated from the provided text (related to the physical catheter):

The document states:
"The subject device, the GlidePath™ 7.5F Long-Term Hemodialysis Catheter, meets all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."

This indicates that prior to the 510(k) submission, the manufacturer established and met certain acceptance criteria for the physical device's performance. However, the document does not detail these specific criteria in a table or provide the raw results against them. It only lists the types of in-vitro tests performed to demonstrate substantial equivalence.

List of In-Vitro Performance Tests Performed for the GlidePath™ 7.5F Long-Term Hemodialysis Catheter (as a proxy for components of the "study"):

The following in-vitro tests were performed based on FDA Guidance Documents and internal Risk Assessment procedures:

• Catheter Tip (Damage After Flexure)
• Tip Tensile
• Tunneler (Shaft to Tunneler Tensile)
• Catheter Tip Stiffness
• Surface Inspection
• Catheter Insertion Over Split Sheath Introducer
• Assembly Leak Resistance
• Flow Rates
• Catheter Collapse
• Catheter Tensile (Shaft to Bifurcation)
• Catheter Tensile (Extension Leg to Bifurcation)
• Catheter Tensile (Extension Leg to Connector)
• Cuff Securement
• Burst
• Recirculation
• Mechanical Hemolysis
• Catheter Shaft Stiffness
• Catheter Radiopacity
• Thumb Clamps
• Extension Legs (Knitting, Flow)

Conclusion regarding your query:

The provided FDA 510(k) clearance letter and summary concern a physical medical device (a catheter), not an AI/ML-based device. Therefore, the specific details requested about an AI/ML device's acceptance criteria, test set characteristics (sample size, provenance, expert ground truth, adjudication), MRMC studies, standalone performance, and training set information are not present in this document. The document confirms that the physical catheter met its predetermined acceptance criteria for design verification and validation through in-vitro testing.

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