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Gambro PrismaSate solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.

Gambro PrismaSATE solutions are sterile dialysate solutions for use in Continuous Renal Replacement Therapy (CRRT) for the treatment of acute renal failure and in other cases necessitating fluid or solute removal, such as in the case of drug poisoning with dialyzable or filterable substances. The solutions are intended to be used in commercially available continuous renal replacement therapy machines as dialysate. A physician prescribes the chemical composition of the solution to be used. The solutions are sterile, and packaged in flexible bags.

The provided text is a 510(k) summary for a medical device (PrismaSATE Dialysis Solutions). It describes the device, its intended use, and a comparison to predicate devices to establish substantial equivalence. However, it does not contain information about acceptance criteria or a study proving that the device meets such criteria in the way typically expected for a diagnostic or machine learning-based device.

The "Testing, and Recognized Standards" section mentions:

• Expiration Dating: Stability studies were performed and results provided.
• Sterilization: Validation methods followed ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 11138-3.
• Biocompatibility: Primary packaging material was tested per Gambro's procedure for physico-chemical and biological evaluation.

These are compliance activities related to manufacturing and material safety, not performance criteria for a diagnostic or AI-driven system. The core of this 510(k) is based on substantial equivalence to predicate devices due to having the same intended use, indication for use, chemical concentration range, and packaging characteristics, with "no significant technological changes."

Therefore, I cannot populate the requested table and study information because the provided text does not contain a performance study with acceptance criteria for a device that would typically involve such metrics (like sensitivity, specificity, AUC, etc.). The "performance" here is demonstrating chemical and physical equivalence and safety.

Here's a breakdown of why the requested information cannot be extracted:

1. A table of acceptance criteria and the reported device performance: Not provided. The document focuses on chemical composition, packaging, and safety/sterilization standards rather than a quantifiable performance metric (e.g., accuracy for a diagnostic).
2. Sample size used for the test set and the data provenance: Not applicable in the context of this submission. The "tests" mentioned are for stability, sterilization validation, and biocompatibility, not for a "test set" of patient data for a diagnostic algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for an AI/diagnostic device is not discussed.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI-assisted diagnostic 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: Not applicable. The "ground truth" here is adherence to specified chemical concentrations, sterility, and biocompatibility standards.
8. The sample size for the training set: Not applicable. There is no "training set" for an AI/ML algorithm mentioned.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a medical device (dialysis solutions) that is a consumable and is cleared based on substantial equivalence to existing products, as well as adherence to manufacturing and safety standards. It is not a diagnostic device or an AI-powered system that would typically undergo the kind of performance study outlined in your request.

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