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The IDEMSA Hemophan Hollow Fiber Dialyzers 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 IDEMSA Hemophan Dialyzer has been designed for use in hemodialysis and associated forms of treatment for chronic or acute kidney failure.

The IDEMSA Hemophan Dialyzers are a family of hollow fiber dialyzers that provide safe and effective hemodialysis over ranges of dialyzer patient treatment requirements. The membrane used in the device is Hemophan which is substantially equivalent to the Hemophan membranes utilized in the Haidylena Cuprophan and Hemophan Hollow Fiber dialyzers (cleared for marketing in the United States under 510(k) # K982337). The Hemophan membranes utilized in both IDEMSA Hemophan dialyzers and Haidylena Cuprophan and Hemophan Hollow Fiber dialyzers are manufactured by Membrana GmbH (formerly Akzo (Enka AG)) of Germany. Hemophan® is a modified cellulose membrane that was developed by ENKA to improve the blood compatibility of the regenerated cellulose membrane Cuprophan®. Cuprophan® membranes utilized in both Cobe CentrySystem 160E dialyzers and Baxter CF25 are also manufactured by the former Akzo (Enka AG). The Terumo Clirans T175 series dialyzers also use a cellulose membrane.

Blood enters a blood inlet port where it is distributed to the Hemophan membrane. The fibers used in the proposed device are substantially equivalent in design to the previously cleared Haidylena and Cobe CentrySystem dialyzers. Each hollow fiber has an inner diameter of 200 microns and a wall thickness of 8 microns. The wall thickness of the Hemophan and Cuprophan fibers in the Haidylena, Cobe CentrySystem 160E, Baxter CF25, and the proposed device is 8 microns. The inner diameter of Hemophan and Cuprophan in the Haidylena, Baxter CF25 dialyzer and the proposed device is 200 microns.

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

This 510(k) summary describes a conventional dialyzer, a device that performs a physical function (filtration) rather than an AI/ML-driven diagnostic or therapeutic function. Therefore, many of the requested fields related to AI/ML device performance, such as sensitivity, specificity, MRMC studies, and ground truth establishment for a training set, are not applicable.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the IDEMSA Hemophan Dialyzers are based on demonstrating substantial equivalence to predicate devices (Haidylena Cuprophan and Hemophan Hollow Fiber, Cobe CentrySystem 160E, Baxter CF25, and Terumo Clirans T175 dialyzers) in terms of construction, design, intended use, and function. Specific performance parameters were evaluated in vitro.

Note on Technological Equivalence: The document emphasizes that the Hemophan membrane in the proposed device is the same as in the Haidylena predicate, and manufactured by the same entity. Other predicates use Cuprophan or other cellulose membranes, which are described as being functionally similar or having slightly different properties (e.g., Hemophan developed to improve blood compatibility of Cuprophan).

2. 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 a "test set" sample size in the context of typical AI/ML validation. The in-vitro performance testing was conducted on samples of the proposed device. The number of units tested for each in-vitro parameter (ultrafiltration coefficient, pressure drop, clearance rates) is not specified.

Data provenance is not explicitly stated beyond "In vitro testing was performed on the proposed device." This suggests the testing was conducted prospectively on newly manufactured devices. The manufacturer is based in Segovia, Spain.

3. 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 for this type of device. "Ground truth" in this context refers to established engineering and physiological performance standards rather than expert consensus on medical images or patient outcomes. The substantial equivalence argument relies on comparing the device's measured physical and performance characteristics against those of legally marketed predicate devices, which are already accepted as safe and effective.

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

Not applicable. The performance metrics are objectively measured physical properties and clearance rates against established benchmarks or predicate device specifications, not subjective assessments requiring adjudication.

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 is not an AI/ML diagnostic or assistive device. It is a conventional medical device whose function does not involve human "readers" or "AI assistance."

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

Not applicable. This is not an algorithm-only device. It is a physical medical device. The "performance" described is the device's physical function.

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

The "ground truth" for this device's performance is based on established engineering specifications, material properties, and the known performance characteristics of legally marketed predicate devices. For clearance parameters, these are objective measurements (e.g., amount of urea removed per unit time) against expected or benchmark values for effective dialysis.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a "training set."

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

Not applicable.

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