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The SORB+ and HISORB+ Cartridges are to be used only with Renal Solutions' REDY Sorbant Dialysis systems for the treatment of acute and chronic uremic patients where hemodialysis is prescribed by the physician.

Sorbent (or regenerative) dialysis systems use the chemical action of a sorbent cartridge to remove urea and other waste materials from the dialysate and return the fresh dialysate to the dialysate holding tank. This fresh dialysate then passes through a dialyzer, removes additional waste material, and re-circulates through the sorbent cartridge to continue the process. This contrasts to traditional "single pass" dialysis, which uses purified water passing across the dialysate side of a dializer membrane in a single flow-through system to remove urea and other waste materials from the dialysis patient's bloodstream. Wastewater is routed to a drain and not recirculated. By re-circulating and refreshing the dialysate, the Renal Solutions' REDY System uses 6L of water per dialysis treatment. A traditional single pass dialysis system uses at least 120L of purified water during the typical 4 hour dialysis session.

The SORB+ and HISORB+ Cartridges are intended to be used in a Renal Solutions REDY Sorbent Hemodialysis System as the chemical agents that absorb the urea and other waste material from the dialysate stream.

Here's an analysis of the provided text to extract the acceptance criteria and study information:

Acceptance Criteria and Device Performance Study for SORB+ and HISORB+ Cartridges

This document describes the 510(k) summary for the SORB+ and HISORB+ Cartridges, which are sorbent-regenerated dialysate delivery systems for hemodialysis. The focus is on demonstrating substantial equivalence to predicate devices (K811170 - SORB 3160 and K812869 - HISORB 3260).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" with quantitative targets for each test, but rather states that the device "Pass"ed the tests by conforming to specified standards or predicate device performance. The de facto acceptance criterion for each test was a "Pass" result, indicating conformance.

2. Sample Size for the Test Set and Data Provenance

The document does not specify exact sample sizes for the "test set" (i.e., the number of cartridges tested for each validation). It mentions "various weights [of REDY Chem™ dialysate] used individually and in combination" which hints at a testing regime, but no specific numbers.

The studies were in-vitro testing and "simulated patient use conditions." This suggests the tests were laboratory-based, not involving human patients directly. The provenance is not explicitly stated as retrospective or prospective due to the nature of the in-vitro testing. It would be considered prospective for the specific in-vitro tests conducted. There's no indication of country of origin for the data provided in this summary, but the submitter's address is in Oklahoma City, USA.

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

This type of information is generally not applicable to the validation of a medical device like a sorbent cartridge, which relies on chemical and physical performance measurements rather than expert interpretation of images or clinical outcomes. The "ground truth" would be established by objective measurements against predefined chemical and physical standards or specifications, rather than expert consensus.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation or clinical events requiring consensus. For these device performance tests, the outcome is objective (e.g., meeting a chemical purity threshold, acceptable biocompatibility levels). Therefore, no adjudication method as described would be relevant or used in these validation tests. The results would be a direct measurement against a standard.

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

No MRMC comparative effectiveness study was done as this device is not an AI diagnostic tool and does not involve human readers for interpretation. The device's performance is measured directly (e.g., chemical capacity, purification levels).

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

This question is not applicable in the context of this device. The device itself is a cartridge, not an algorithm. Its performance is inherently standalone (i.e., the cartridge's chemical and physical function) in that it performs its intended function independently of direct human intervention during the purification process. The "human-in-the-loop" would be the physician prescribing its use and monitoring the patient, but not directly interacting with the cartridge's internal chemical processes. The validation tests (e.g., capacity, biocompatibility) directly assessed the cartridge's standalone performance.

7. The Type of Ground Truth Used

The ground truth used for these tests was primarily:

• Objective Chemical and Physical Standards: Conformance to AAMI/ANSI standards for water purity, endotoxin/bacteria removal.
• Biocompatibility Standards: Conformance to ISO 10993.
• Manufacturer's Published Specifications: Sorb Technologies' published capacity specifications for urea-nitrogen removal.
• Predicate Device Performance: Comparison to the performance of the previously cleared SORB and HISORB Cartridges.

8. The Sample Size for the Training Set

This concept is not applicable. The device is a physical product (sorbent cartridge), not a machine learning model that requires a "training set." The development of the cartridges would have involved R&D, but the validation described herein does not fit the training/testing paradigm of AI/ML.

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

As noted above, the concept of a "training set" is not applicable for this type of device.

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