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The GlidePath™ 13F 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 longer than 34 cm are intended for femoral vein insertion.

The GlidePath™ 13F Long-Term Hemodialysis Catheter is a vascular access device, intended for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy and features a dual-lumen, optimized double-D cross-sectional catheter shaft with a fixed symmetrical tip design. The catheter has separate arterial and venous lumens, a molded bifurcation and, extending from the bifurcation, arterial (red) luer and venous (blue) luer and extension legs which connect to an external dialysis machine or blood cleansing device. Each extension leg has an atraumatic occlusion clamp which closes access to the lumen. The symmetrical catheter tip contains holes that aid in the distribution of blood flow and aid in overthe-guidewire placement. The GlidePath™ 13F Long-Term Hemodialysis Catheters are packaged in a tray with legally marketed accessories intended for use during catheter placement. The device is intended for single patient use only.

The provided text describes a 510(k) premarket notification for a medical device, the GlidePath™ 13F Long-Term Hemodialysis Catheter. This submission aims to demonstrate substantial equivalence to a legally marketed predicate device, the GlidePath™ Long-Term Hemodialysis Catheter (K190527).

The document details various performance tests conducted to support this claim, but it does not describe a study involving an AI/Machine Learning algorithm or human reader improvement with AI assistance. Therefore, many of the requested items related to AI device performance and clinical studies are not applicable or cannot be answered from the provided text.

The acceptance criteria mentioned are general ("met all predetermined acceptance criteria for design verification activities as specified by applicable standards, guidance, test protocols and/or customer inputs") rather than specific quantitative metrics for an AI model's performance.

Here's an analysis based on the provided text, addressing the applicable points:

Acceptance Criteria and Device Performance

The document states that the device "met all predetermined acceptance criteria for design verification activities as specified by applicable standards, guidance, test protocols and/or customer inputs." However, a specific table of quantitative acceptance criteria and reported numerical performance values is not provided in the text. The performance data section lists the types of tests conducted:

Note: The text explicitly states that "The results from these tests performed in accordance with standards and FDA guidance, demonstrate that the technical characteristics and performance criteria of the GlidePath™ 13F Long-Term Hemodialysis Catheter is substantially equivalent to the predicate..."

Study Details (Applicable to Non-AI Device Testing)

This document describes a submission for a traditional medical device (a catheter), not specifically an AI/Machine Learning device. Therefore, many of the questions related to AI study design (like training/test sets, ground truth establishment for AI, expert consensus for AI interpretation, MRMC studies) are not directly applicable to this premarket notification. The "performance data" refers to physical and functional performance testing of the catheter itself, not diagnostic or clinical accuracy.

1. Sample sizes used for the test set and the data provenance: The document does not specify the number of units tested for each characteristic (e.g., how many catheters were subjected to tensile testing). It also does not discuss "data provenance" in the context of clinical data for an AI model, as this is a physical device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would be objective physical measurements or established engineering standards, not expert clinical interpretation.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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-powered device under review.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI-powered device under review.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance tests listed, the "ground truth" would be the established engineering and medical device standards (e.g., ISO standards, FDA guidance on non-clinical testing) against which the catheter's physical/functional properties were measured.
7. The sample size for the training set: Not applicable, as this is not an AI device that requires a training set.
8. How the ground truth for the training set was established: Not applicable, as this is not an AI device.

In summary, the provided document is a 510(k) premarket notification for a physical medical device (a hemodialysis catheter) and details its engineering and physical performance testing to demonstrate substantial equivalence to a predicate device, rather than the performance of an AI/ML algorithm.

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