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The Rex Medical Hemo-Stream™ Hemodialysis Catheter is a 16F chronic, multilumen, radiopaque, polyurethane catheter with a polyester cuff and two female luer locking adapters. The cuff promotes tissue in-growth for fixation of the catheter in a subcutaneous tunnel. The luer locking adapters, as well as the tubing clamps, are colored to differentiate the arterial and venous lumens. Four arterial intake lumens are located 360º around a central venous lumen. The catheter intended purpose is identical to the predicate device with the exception that the Hemo-Stream™ Catheter does not facilitate the use of a tear-away sheath during the insertion procedure. The catheter will be manufactured in useable lengths, or the length from the distal catheter tip to the hub junction, of 24cm, 28cm, 32cm, 36cm, and 40cm.

AI/ML Overview

This looks like a medical device submission, specifically a 510(k) premarket notification for a hemodialysis catheter. The document describes the device, compares it to a predicate device, and lists non-clinical tests performed.

Crucially, this document explicitly states in section 8: "Discussion of Clinical Tests Performed: Not applicable, as there are no new indications for use which must be supported by clinical data."

Therefore, a study demonstrating the device meets acceptance criteria through clinical performance (like an AI algorithm would require) was not performed, nor was it required for this type of device submission.

However, I can extract the information related to the non-clinical testing and general equivalency which serves as the "proof" for this particular device submission.

Here's the breakdown based on the provided text, with many fields being "Not Applicable" due to the nature of the device and submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence	Performance comparable to predicate device (Vaxcel Dialysis Catheter)	"Comparative Functional testing to the predicate was performed based on ISO 10555-1 and the FDA's Reviewer Guidance for Long Term and Short Term Intravascular Catheters."
	Adequate offset distance to reduce arterial/venous blood recirculation	"adequate offset distance on the distal tip between the arterial intake lumen and the venous return lumen to reduce the effects of arterial/venous blood re-circulation."
	Color-coded luer adapters for arterial/venous differentiation	"Both Catheters offer a color-coded female luer adapter, red for arterial and blue for venous..."
	Luer priming volume ensures proper heparin lock	"The female luers for both catheters offer the corresponding lumen primina volume to insure the catheter receives the proper heparin lock between treatments."
Material Safety	Biocompatibility	"Material Testing also included ISO 10993 Biocompatibility Testing."
Structural Integrity	Tissue in-growth facilitation for fixation and infection barrier	"Both catheters offer a fixed polyester felt cuff located on the catheter lumen to stimulate tissue in-growth which will anchor the catheter in place as well as form an infection barrier."
	Secure integration of hub, catheter tubing, and extension tubing junctions	"Proximal to the catheter lumens for both catheters is an integrated hub that encapsulates the catheter tubing and extension tubing junctions."
	Ability to anchor catheter to patient (suture wing)	"On this hub is a rotating suture wing that may be used to anchor the catheter to the patient until the tissue in-growth around the catheter cuff is matured."
Overall Equivalence	No new questions of safety and effectiveness compared to predicate device	"Testing results revealed the subject device to be substantially equivalent to the predicate device." "no differences in their technological characteristics, thereby not raising any new questions of safety and effectiveness."

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

Sample Size for Test Set: Not applicable. No clinical test set was used because the submission relies on demonstrating substantial equivalence through non-clinical testing and comparison to a legally marketed predicate device.
Data Provenance: Not applicable for a clinical test set. Non-clinical testing was performed (likely in a controlled laboratory environment).

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

Number of Experts: Not applicable. No clinical test set with human ground truth was used. Non-clinical tests would be evaluated against established standards by qualified laboratory personnel.
Qualifications of Experts: Not applicable in the context of clinical ground truth.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No clinical test set requiring human adjudication was performed.

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

MRMC Study: No, not applicable. This is a medical device, not an AI diagnostic algorithm.

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

Standalone Performance: No, not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: For the non-clinical tests, the "ground truth" would be established engineering specifications, material properties, and performance benchmarks derived from ISO standards (ISO 10555-1 and ISO 10993) and FDA guidance documents. Direct clinical "ground truth" (e.g., pathology, outcomes data) was not used because clinical trials were not conducted.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. As this is not an AI/ML algorithm requiring a training set.

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

Ground Truth for Training Set: Not applicable. As this is not an AI/ML algorithm.

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