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The HemoGlide®Star scries and HemoGlide®Star series 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, external jugular vein, subclavian vein, or femoral vein.

Catheters greater than 40 cm are intended for femoral vein insertion.

HemoGlide Star series and HemoGlide Star series XK are dual lumen long-term hemodialysis catheters. The catheters have a dual lumen, double-D cross-sectional design with a staggered distal tip. The formed venous lumen tip is designed with smooth tapered tip transitions and a guide wire passage/hole to facilitate easy over-the-wire (sheathless) placement. The molded bifurcation has an integral suture wing that is suitable for use with StatLock® securement devices. Individual arterial and venous lumen extension legs have an atraumatic occlusion clamp, which closes the access to the lumen. The clamps have integral tags with the priming volumes of the individual lumen printed on them. Red and blue color-coded luer connectors identify the arterial and venous lumens, respectively.

The provided text describes a 510(k) premarket notification for the HemoGlide® Star series and HemoGlide® Star series XK Long-Term Hemodialysis Catheters. The study conducted was a bench test to demonstrate substantial equivalence to predicate devices, not a clinical trial evaluating human performance or diagnostic accuracy.

Therefore, many of the requested fields are not applicable to this type of submission. Below is the information that can be extracted or inferred from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Bench testing was based on the above referenced guidance document and standards and the HemoGlide Star series and HemoGlide Star series XK catheters met the predetermined acceptance criteria." and "The HemoGlide Star series and HemoGlide Star series XK Long-Term Hemodialysis Catheters met all predetermined performance acceptance and validation requirements as specified by test protocols and/or user needs...".

However, the specific acceptance criteria and detailed performance metrics are not explicitly provided in the given text. It only confirms that the devices met them. The testing was based on the following standards and guidance:

• Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95
• ISO 10555-1:1997, Sterile, single-use intravascular catheters, Part 1. General requirements
• ISO 10555-1:1997, Sterile, single-use intravascular catheters, Part 1. General requirements. Amendment 1.
• ISO 10555-3:1997, Sterile, single-use intravascular catheters, Part 3. Central venous catheters
• AAMI/ANSI/ISO I 1135:1994, Medical devices – Validation and routine control of ethylene oxide sterilization

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

• Sample size: Not specified in the provided text.
• Data provenance: Bench testing results. The country of origin for the data is not specified, but the submitter is Bard Access Systems, Inc. in Salt Lake City, UT, USA. The data is prospective in the sense that it was generated for this specific submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This was a bench test involving physical attributes and performance metrics of a medical device, not a diagnostic accuracy study requiring expert human interpretation for ground truth.

4. Adjudication method for the test set

• Not applicable. See point 3. Testing involved objective measurements against established standards, not interpretation or adjudication of human performance or diagnostic findings.

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. This was a 510(k) submission for a long-term hemodialysis catheter based on bench testing for substantial equivalence, not an AI or diagnostic imaging device.

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

• Not applicable. See point 5.

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

• Not applicable in the context of diagnostic "ground truth." For this device, the "ground truth" was established by the specified engineering and performance standards (ISO and FDA guidance documents) against which the device's physical and functional properties were objectively measured.

8. The sample size for the training set

• Not applicable. This was not a machine learning or AI-driven device requiring a training set.

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

• Not applicable. See point 8.

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