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The GlidePath™ Long-Term Hemodialysis Catheters are indicated for use in attaining short-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, subclavian vein, or femoral vein. Catheters longer than 40cm are intended for femoral vein insertion.

The HemoStar™ and HemoStar™ XK Long-Term Hemodialysis Catheters are indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, subclavian vein or femoral vein. Catheters greater than 40 cm are intended for femoral vein insertion.

The GlidePath™, HemoStar™, and HemoStar™ XK Long-Term Hemodialysis Catheters feature a dual-lumen shaft with 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. Both the staggered and symmetrical catheter tips contain holes that aid in the distribution of blood flow or aid in over-the-quidewire placement. The dialysis catheters are offered in various lengths in straight or Alphacurve™ configurations. Alphacurve™ configurations feature a pre-formed, ~225 ° curve. Long-term dialysis catheters are tunneled to provide greater distance between the skin and entry site into the vein and provide a physical barrier to the migration of skin organisms.

The HemoStar™ and HemoStar™ XK Long-Term Dialysis Catheters feature a fixed, staggered distal tip. This tip design is identical to that of the predicate devices, HemoGlide™ Star Series and HemoGlide™ Star Series XK Long-Term Dialysis Catheters, cleared August 12, 2005 under K051748.

The GlidePath™ Long-Term Dialysis Catheters, launched in February 2013, are a modification of the HemoStar™ Long-Term Dialysis Catheters. GlidePath™ catheters feature an optimized catheter shaft extrusion profile and a modified tip which is fixed and symmetrical, allowing for reduced luminal pressure during use. The GlidePath™ catheters also include a preloaded stylet for ease of placement. This accessory was previously cleared under K090101. The changes to the catheter were documented via internal note to file prior to launch in 2013.

The provided text describes the 510(k) summary for the Bard Access Systems' GlidePath, HemoStar, and HemoStar XK Long-Term Hemodialysis Catheters. It details performance testing conducted to demonstrate substantial equivalence to predicate devices, but does not provide specific acceptance criteria values or detailed reported device performance in a table format. It also does not include information on sample sizes for test sets, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details as these are not relevant for a medical device clearance focused on physical and fluid dynamics performance instead of AI/software performance.

Therefore, I cannot populate all the requested sections. However, I can summarize the information related to device performance and the study that "proves" the device meets acceptance criteria, based on the provided text.

Acceptance Criteria and Device Performance for GlidePath, HemoStar, and HemoStar XK Long-Term Hemodialysis Catheters

The provided 510(k) summary indicates that the devices underwent a series of bench tests to demonstrate substantial equivalence to predicate devices. The "study" mentioned here refers to these non-clinical bench tests. The report states that the devices met all predetermined acceptance criteria, implying that the performance observed during these tests was within acceptable limits established for each test. However, the specific quantitative acceptance criteria values and the reported device performance measurements are not detailed in this summary document.

1. Table of Acceptance Criteria and Reported Device Performance

Summary of Device Performance:
The document concludes that the subject devices "met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." This statement indicates that all tests listed above were successfully passed according to their respective acceptance criteria.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in the provided summary.
• Data Provenance: The tests were "bench tests" performed by Bard Access Systems, Inc. The data is non-clinical. No country of origin is specified, but the company is located in Utah, USA. The data is non-clinical and would be considered prospective in the context of device development and testing, meaning the tests were designed and executed to evaluate the new/modified devices.

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):

• This is not applicable as the study involves bench testing of physical device characteristics, not interpretation of medical images or patient outcomes. The "ground truth" for these tests is established by engineering specifications, recognized standards, and established test protocols.

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

• This is not applicable for bench testing. Test results are typically objective measurements against predefined specifications.

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:

• This is not applicable. The devices are physical hemodialysis catheters, not AI software or diagnostic imaging aids.

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

• This is not applicable. The devices are physical hemodialysis catheters.

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

• For bench testing, the "ground truth" is defined by engineering specifications, recognized industry standards (e.g., ISO, ASTM relevant to medical devices), and internal test protocols that establish the functional and safety requirements for the catheter's physical properties, fluid dynamics, and material integrity.

8. The sample size for the training set:

• This is not applicable. There is no machine learning or AI component to this device.

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

• This is not applicable. There is no machine learning or AI component to this device.

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