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channeling blood during Haemodialysis Treatement.

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The provided documents are a 510(k) clearance letter and an "Indications for Use" statement for a medical device. This type of regulatory submission does not contain the detailed study information, acceptance criteria, or performance data that would be found in a clinical study report or a more comprehensive premarket application (like a PMA).

Therefore, based only on the provided text, I cannot answer most of your specific questions. I can only infer very limited information.

Here's a breakdown of what can and cannot be answered from the provided text:

Information that CANNOT be extracted from the provided text:

• 1. A table of acceptance criteria and the reported device performance: This information is not present. A 510(k) clearance letter confirms substantial equivalence, but doesn't detail performance metrics or acceptance criteria unless specifically included in the "Indications for Use" which it isn't here.
• 2. Sample sized used for the test set and the data provenance: Not available.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/available for this type of document.
• 4. Adjudication method: Not applicable/available.
• 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: Not applicable. This device is an "Extracorporeal Blood Circuit," not an AI-powered diagnostic device involving human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm/AI device.
• 7. The type of ground truth used: Not applicable/available.
• 8. The sample size for the training set: Not applicable/available (not an AI device).
• 9. How the ground truth for the training set was established: Not applicable/available (not an AI device).

What can be extracted/inferred:

• Device Name: Extracorporeal Blood Circuit
• Intended Use: "channeling blood during Haemodialysis Treatement."
• Regulatory Class: II
• Product Code: 78 FJK
• Submission Type: 510(k) Premarket Notification
• Manufacturer: Haidylena Medical
• Date Cleared: Apr 30, 1999
• Substantial Equivalence: The device was found substantially equivalent to predicate devices. This implies that its performance (safety and efficacy) is considered on par with existing, legally marketed devices for the same intended use, but the specific performance data is not detailed in these documents.

Conclusion:

The provided documents are regulatory clearance letters and an "indications for use" statement. They do not contain the specific performance study details (acceptance criteria, sample sizes, ground truth methods, expert qualifications, etc.) that would typically be required to answer your questions. These details would be found in the full 510(k) submission summary or associated testing reports, which are not included here.

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The Haidylena Cuprophan and Hemophan Hollow Fiber Dialyzer are indicated for use whenever a patient is in acute or chronic renal failure and a physician prescribes hemodialysis. Therefore, use of this device should be only on the direction of a physician who has evaluated all of the aspects of the patient's illness. The indication statement is essentially the same as the indication statement of the predicate devices.

The Haidylena Cuprophan and Hemophan Hollow Fiber Dialyzer are a family of hemodialyzers developed to provide safe and effective hemodialysis over ranges of dialyzer patient treatment requirements. The membrane used in the device is Cuprophan which is substantially equivalence to the Cuprophan membranes utilized in the cobe centry System 160E and Baxter CF25 Dialyzers, which have been previously approved for marketing in the United States. The Cobe Cnetry System 160E was approved under a 510(k) Notification (K864831). The Cuprpohan membranes utilzed in both Haidylena Cuprophan and Hemophan Hollow Fiber Dialyzer and Cobe Centry System 160E Dialyzers are manufactured by Akzo (Enka) of Germany. Cuprophan membrane is also utilized in Baxter CF25 Dialyzers. Hemophan membrane is also manufactured by Akzo (Enka) and is also cellulose membrane but derivative from Cuprophan membrane.

Blood enters a blood inlet port where it is distributed to Cuprophan and Hemophan membrane. Each hollow fiber has an inner diameter of 200 microns and a wall thickness of 8 microns. The fibers used in this device are substantially equivalence in design to the previously approved Cobe Centry System. The wall thickness of the Cuprophan and Hemophan fibers in Cobe Centry System 160E Dialyzers, Baxter CF25 Dialyzers and the proposed device is 8 microns. The inner diameter o Cuprophan and Hemophan in both Baxter CF25 Dialyzer and the proposed device is 200 microns.

Blood is bumped via a roller pump from the artery of the patient into the arterial end of the dialvzer. The blood travels down through the dialyzer fibers where waste products pass through the membrane of the dialyzer into the dialysate, which is constantly circulating through the dilayzer on the outside of the hollow fibers. Blood then exits the venous end of the dilayzer back to the patient.

The provided text describes the acceptance criteria and a study for the Haidylena Cuprophan and Hemophan Hollow Fiber Dialyzer.

Here's the breakdown:

Acceptance Criteria and Reported Device Performance

Study Information

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

   • The document does not specify the exact sample size for the "in vitro performance" testing. It presents consolidated results for multiple models of the Haidylena dialyzer (Cuprophan HL 100, 120, 130 and Hemophan HL 100H, 120H, 130H).
   • The data provenance is from "in vitro testing" performed on the proposed devices. No country of origin for this specific test data is mentioned, but the submitter is Haidylena Medical, located in Cairo, Egypt. It is not specified if the data is retrospective or prospective, but in vitro tests are typically prospective.

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

   • This information is not provided in the document. The ground truth for in vitro performance data is typically based on standardized testing protocols and measurements, not expert consensus in the way a diagnostic image might be.

3. Adjudication method for the test set:

   • This information is not applicable/provided for the type of in vitro performance study described. Adjudication methods like "2+1" or "3+1" are relevant for subjective assessments, primarily in clinical or image-based studies.

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, an MRMC comparative effectiveness study was not done. This type of study is for evaluating human performance, often with AI assistance, usually in a diagnostic context. The provided study is an in vitro performance assessment of a medical device (a dialyzer), not an AI-assisted diagnostic tool.

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

   • Yes, a form of standalone performance assessment was done. The study evaluates the device's intrinsic physical and clearance performance (Urea, Creatinine, Phosphate, Vitamin B12 clearance, and ultrafiltration coefficient) in a laboratory setting ("In Vitro Performance") without human interaction influencing the core measurement results. It is important to note that this is not an "algorithm" in the sense of AI, but rather the performance of the physical device itself.

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

   • The ground truth for the in-vitro performance testing is based on direct physical and chemical measurements of the dialyzer's function in a controlled laboratory environment. This includes quantitative measurements of:
     • Blood priming volume
     • Effective surface area
     • Wall thickness
     • Clearance rates for specific solutes (Urea, Creatinine, Phosphate, Vitamin B12)
     • Ultrafiltration rate
     • Maximum Transmembrane Pressure (TMP)
   • Sterilization efficacy is based on standardized validation protocols (BS EN 550 and AAMI guidelines) to achieve a specified Sterility Assurance Level (SAL).

7. The sample size for the training set:

   • This study does not involve a training set. The described study is an in vitro performance test of a physical medical device (blood dialyzer), not a machine learning or AI model that requires training data.

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

   • This question is not applicable as there is no training set for this type of device and study.

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