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Intended for use as a dialysis solution in Continuous Renal Replacement Therapy.

The HBiofluids HMB32 is a bicarbonate-based dialysis solution packaged in a ready to mix, sterile, non-pyrogenic, two-chambered solution container system. One chamber contains the acidic solution and one chamber contains the basic solution. At the point of use, the membrane between the two chambers is opened, and the acidic and basic solutions are mixed to form the final ionic composition of the solution to be used in the Continuous Renal Replacement Therapy (CRRT) treatment. This solution is delivered to the patient while undergoing CRRT treatment in a healthcare facility.

The HBiofluids HMB32 solution will be offered in one formulation, in two different volumes: 500 mL +4500mL and 500mL +1500mL.

The provided text is a 510(k) Premarket Notification from the FDA to Haemopharm Biofluids S.r.l. regarding their HMB32 Dialysis Solution.

This document does not describe acceptance criteria and a study that proves a device meets those criteria in the context of an AI/ML medical device. Instead, it is a declaration of substantial equivalence for a dialysis solution, which is a medical device and not an AI/ML algorithm.

Therefore, I cannot provide the requested information based on the input text. The information requested (acceptance criteria table, sample sizes, expert ground truth, MRMC study, standalone performance, training set details) is specific to the validation of AI/ML algorithms, which is not applicable to the HMB32 Dialysis Solution as described in this FDA clearance letter.

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Intended for use as a dialysis solution in Continuous Renal Replacement Therapy.

The HBiofluids HMB32 is a bicarbonate based dialysis solution packaged in a ready to mix, sterile, non-pyrogenic, two-chambered solution container system. One chamber contains the acidic solution and one chamber contains the basic solution. At the point of use, the membrane between the two chambers is broken, and the acidic and basic solutions are mixed to form the final ionic composition of the solution to be used in the Continuous Renal Replacement Therapy (CRRT) treatment.

The HBiofluids HMB32 solution will be offered in one formulation, in two different volumes: 500+4500 ml and 500+1500 ml.

The provided text describes the HBiofluids HMB32 dialysis solution and its substantial equivalence to a predicate device (Accusol, K041428) for use in Continuous Renal Replacement Therapy. This is a medical device submission based on substantial equivalence, not typically one that relies on clinical performance studies with specific accuracy metrics in the way AI/ML devices do. Therefore, many of the questions regarding acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable to this type of submission.

However, I can extract information related to the device's characteristics and the nonclinical testing performed to establish its safety and effectiveness.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a submission for a dialysis solution based on substantial equivalence, the "acceptance criteria" are primarily established by demonstrating similarity to a legally marketed predicate device and meeting relevant standards for manufacturing, biocompatibility, and sterility. There are no specific performance metrics like sensitivity, specificity, or AUC that would be generated from a clinical study for this type of device.

Instead, the comparison focuses on key parameters and chemical composition.

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

• Sample Size for Test Set: Not applicable. This device is a dialysis solution, and its performance is evaluated primarily through chemical composition analysis, material testing (biocompatibility, sterility), and stability studies, rather than a "test set" of patient data or images.
• Data Provenance: Not applicable in the context of clinical "data" for a test set. The validation is based on laboratory testing of the solution and its components, and comparison to the predicate device's established characteristics.

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

• Not applicable. There is no concept of "ground truth" derived from expert consensus in the context of chemical composition, sterility, or biocompatibility testing for a dialysis solution.

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

• Not applicable.

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 not an AI/ML diagnostic or therapeutic device.

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

• Not applicable.

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

• Not applicable in the conventional sense. The "ground truth" for this device's safety and effectiveness is established by:
  • Chemical Analysis: Direct measurement of ionic composition and osmolarity.
  • International Standards: Compliance with ISO 10993-1, USP Class VI, European Pharmacopeia 8.0, and EN ISO 17665-1 for biocompatibility, material safety, and sterilization.
  • Material Science: Testing of container/closure materials.
  • Stability Studies: Experimental data from real-time aging.

8. The sample size for the training set:

• Not applicable. This device does not use machine learning, so there is no training set.

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

• Not applicable.

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