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The Hemo-Stream™ True Over the Wire Dialysis Catheter is designed for chronic hemodialysis and apheresis.

The Rex Medical Hemo-Stream™ True Over the Wire Dialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressures. The Hemo-Stream™ True Over the Wire Dialysis Catheter will be available in lengths of 24, 28, 32, 36 and 40cm. The device is used in exactly the same manner as the predicate devices and other substantially equivalent 510(k) cleared devices.

The provided text describes a Special 510(k): Device Modification for the Hemo-Stream Hemodialysis Catheter. This type of submission is for modifications to a previously cleared device, asserting substantial equivalence to predicate devices, rather than establishing de novo performance criteria against a disease or condition. Therefore, the traditional concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" as it would apply to a diagnostic or AI-driven device with performance metrics (like sensitivity, specificity, etc.) is not directly applicable here.

Instead, the acceptance criteria for this type of submission are based on demonstrating substantial equivalence to predicate devices in terms of intended use, technological characteristics, and safety and effectiveness. The "study" in this context is a series of non-clinical (bench) tests and material testing to show that the modified device performs comparably to its predicates and does not raise new questions of safety or effectiveness.

Here's how the information aligns with your request:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally that the modified device's performance in relevant non-clinical tests is comparable to or better than that of the predicate devices, and that its technological characteristics do not introduce new safety or effectiveness concerns.

Details Regarding the "Study" (Non-Clinical Testing)

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • The document does not explicitly state the sample sizes for the non-clinical tests. Non-clinical tests typically involve a defined number of device units tested according to standardized methods, but these numbers are not disclosed here.
   • The data provenance is from non-clinical (bench) testing performed by the manufacturer, Rex Medical, LP, in the United States (Conshohocken, PA). This is implicitly prospective testing, as it was performed to support the 510(k) submission for the device modification.

2. 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):

   • Not applicable. As this is a non-clinical (bench) study, "experts" in the context of clinical ground truth (like radiologists) are not involved in the test execution or data interpretation. The ground truth for such tests is typically established by engineering specifications, validated test methods, and comparison against established predicate device performance or industry standards.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving interpretation of medical data by multiple experts. For non-clinical bench testing, results are objective measurements against defined standards.

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:

   • No. This is a medical device modification involving a physical catheter, not an AI or diagnostic imaging device. Therefore, MRMC studies are not relevant.

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

   • No. This relates to AI/software performance, which is not applicable to a physical hemodialysis catheter.

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

   • The "ground truth" for this submission is based on engineering specifications, performance against established industry standards (ISO 10555-1, ISO 10993), and direct comparison to the performance of the legally marketed predicate devices in non-clinical tests.

7. The sample size for the training set:

   • Not applicable. There is no AI algorithm being "trained" in this context. The "training" for a physical device involves its design, manufacturing processes, and testing against known performance benchmarks.

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

   • Not applicable. There is no training set as this is not an AI/machine learning device.

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The Hemo-Stream™ Hemodialysis Catheter Set is designed for chronic hemodialysis and apheresis.

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.

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

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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