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Diasol-BiCarb Schutions are indicated for use in acute and chronic hemodialysis and have to be used in conjunction with Diasol acid concentrate or any other commercially available concentrate in the correct proportioning and AAMI standard water as Dialysate solution for hemodialysis .For use in 3 stream dialysis machines calibrated for use with acid and bicarbonate concentrate.

Sodium Bicarbonate is part of the dialysate concentrate for hemodialysis. When mixed with AAM standard water and Acid Concentrate, it creates a dialysate solution for use in renal dialysis therapy. read diarysis therepy . Diasol-BiCarb solution is in a ready to use form that is convenient for use in chronic care dialysis unit as well as acute care, dialysis thin as well as noter care. Sodium bicarbonate Hemodialysis grade, a white, water soluble powder is mixed with South block one of the case your Chloride USP (for 36.83 proportioning) in adequate proportions to provide the bicarbonate part of the dialysate. proportions to provide the breat benefits plastic container (HDPE) similar to the predicate. The solution is non-sterile, non-pyrogenic. Finished product is gamma radiated. The southout is non-centions have been taken to assure that the finished product does not promote bacterial growth.

This document describes a 510(k) premarket notification for the DIASOL-BiCarb, a liquid sodium bicarbonate solution for hemodialysis. As such, the submission focuses on demonstrating "substantial equivalence" to a predicate device rather than conducting a full clinical study with acceptance criteria and a detailed study report as would be typical for novel devices.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit "acceptance criteria" for performance metrics are provided in the document in the way one would see for a diagnostic or therapeutic device with measurable outcomes (e.g., sensitivity, specificity, accuracy). The acceptance criteria for this 510(k) submission are implicit in demonstrating substantial equivalence to predicate devices. This means proving that the new device is as safe and effective as a legally marketed device.

The "reported device performance" is essentially that the DIASOL-BiCarb is substantially equivalent to the predicate devices (RENOSOL K792213 and K781967, and STERILYTE K971053) based on its intended use, composition, raw materials, manufacturing processes, and packaging.

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

This is not a clinical study involving a "test set" of patients or biological samples in the traditional sense. The "test set" here refers to the manufacturing and quality control data of the DIASOL-BiCarb product itself, compared against the known characteristics and standards of the predicate devices.

• Sample Size: Not specified as a number of "cases." Instead, it refers to "all batches" of the manufactured product on which LAL and microbiological cultures are performed.
• Data Provenance: The data comes from the manufacturing and quality control processes of Diasol Inc. for the DIASOL-BiCarb. There is no information about country of origin of patient data or whether it's retrospective/prospective, as this is a materials/process equivalence submission, not a patient outcome study.

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

This type of submission typically does not involve medical experts establishing "ground truth" derived from patient data. The "ground truth" for chemical composition, sterility, and adherence to AAMI standards would be established by:

• Internal experts within Diasol Inc.: Quality control specialists, chemists, microbiologists, and manufacturing engineers who ensure compliance with specified formulations, raw material quality, and AAMI standards. Their qualifications would include relevant scientific degrees and experience in pharmaceutical/medical device manufacturing and quality control.
• Regulatory Experts at FDA: The FDA reviewers who assess the 510(k) submission act as experts in determining if the provided data is sufficient to establish substantial equivalence.

No specific number of experts or detailed qualifications are provided in the public summary.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" needing expert adjudication in the context of clinical outcomes. Quality control tests (like LAL, microbiological cultures) have predefined pass/fail criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not a diagnostic imaging or human-in-the-loop AI device, so MRMC studies are not relevant.

6. Standalone Performance (Algorithm Only without Human-in-the-loop Performance)

Not applicable. This device is a chemical solution used in a hemodialysis system, not a software algorithm or AI.

7. Type of Ground Truth Used

The "ground truth" employed for this device is based on:

• Chemical composition and purity standards: Ensuring the ingredients (Sodium Bicarbonate, Sodium Chloride USP, water) meet required grades and proportions.
• Microbiological standards: Adherence to AAMI microbiological standards, confirmed through LAL and microbiological cultures.
• Manufacturing process controls: Ensuring the production methods consistently yield a product meeting specifications.
• Predicate device characteristics: The known specifications, safety profile, and effectiveness of the legally marketed predicate devices (RENOSOL and STERILYTE) serve as the benchmark for "ground truth" in demonstrating equivalence.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a "training set."

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

Not applicable, as there is no training set for this device.

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