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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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The dual-lumen hemodialysis catheter permits venous access to the central circulation system for rapid fluid administration, temporary or acute hemodialysis and apheresis . It oyoton for rapid have actual an, or femoral veins of children, adolescents and small adults.

The device is a dual-lumen, polyurethane catheter, 8 French in size, with two independent non-communicating lumens, extension lines, Luer hubs and extension line clamps. Each lumen exits at the distal end of the catheter through individual ports spaced at a given distance apart. A soft tip that is more pliable than the catheter body is grafted onto the distal tip of the catheter. At the proximal end of the juncture hub the lumens are connected to clear separate extension lines. Each extension line contains either a red or blue clamp. The colored clamps indicate arterial flow (outflow) or venous flow (inflow). Also, centimeter markings are placed along the length of the indwelling catheter body to facilitate proper positioning. This catheter is identical in appearance and function to the Quinton® manufactured catheter aforementioned in section 3c. Moreover, the ARROW Pediatric Two-Lumen Hemodialysis Catheter is also identical to the ARROW predicate catheter with the exception of French size and length.

An ARROW Pediatric Two-Lumen Hemodialysis Catheterization Kit consists of a dual-lumen catheter packaged with various accessory components that are required during catheterization. These components include combinations of the following: spring wire quides. dilators, introducer needles, catheter over needle assemblies, syringes, pressure transduction probes, scalpels, disposal cups and medication. Moreover, the kit also includes labeling information including instructions for use, contents sheet and various unit package labels. The contents of the kit are contained in the tray and wrapped with a CSR wrap. The wrapped kit is then packaged into another tray and sealed with Tyvek lidstock. The complete trays are placed in corrugated shipping cartons and labeled.

The provided text describes a Special 510(k) submission for a device modification, not a study proving acceptance criteria for a novel device. Therefore, much of the requested information (like expert ground truth, MRMC studies, standalone performance, training set details) is not applicable to this type of submission.

This submission aims to demonstrate substantial equivalence to a predicate device, meaning the modified device is as safe and effective as a device already legally marketed. The primary "study" here is a series of performance tests to show the modified device maintains its safety and effectiveness.

Here's the breakdown of the information that can be extracted or inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document states, "The results of the laboratory tests demonstrated that the device is safe, and as effective as the legally marketed predicate device." However, it does not explicitly list the quantitative acceptance criteria or the specific numerical results for each test. These would typically be detailed in the full submission, not necessarily in the 510(k) summary.

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

• Sample Size: Not explicitly stated. The tests are described as "laboratory tests," suggesting in-vitro testing. The number of units tested for each specific performance test (tensile, flow rate, etc.) is not provided.
• Data Provenance: Not explicitly stated, but it's generated by the manufacturer (ARROW International, Inc.) through internal "laboratory tests." This would be prospective testing on the modified device.

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

• Not Applicable. This is a performance testing submission for a physical medical device, not an AI/diagnostic software. Ground truth in this context refers to engineering and performance specifications, not clinical diagnoses by experts.

4. Adjudication Method for the Test Set

• Not Applicable. As above, this applies to clinical or diagnostic studies, not 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

• Not Applicable. This is not an AI-assisted diagnostic device. It is a physical medical device (catheterization kit).

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 performance tests, the ground truth would be defined by pre-established engineering specifications and performance requirements derived from regulatory standards, internal product design specifications, and comparison data from the predicate device. For example, "tensile strength must exceed X Newtons" or "flow rate must be Y ml/min at Z pressure."

8. The Sample Size for the Training Set

• Not Applicable. This device does not use machine learning or AI, so there is no "training set."

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

• Not Applicable. As above, there is no training set.

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