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The 2008 Sorbent System is intended for adult acute and chronic uremic patients in the presence of a healthcare practitioner where hemodialysis is prescribed on the order of a physician.

The 2008 Sorbent System consists of two distinct components:

• the 2008 Machine, and .
• . the SORB™ Module.

The SORB Module is a sorbent dialysate regenerative system that attaches to the 2008 Machine and replaces the machine's existing single-pass dialysate delivery system.

During treatment, used dialysate is chemically reprocessed into fresh, new dialysate and sent back to the dialyzer instead of being sent down a drain. By recirculating and regenerating the dialysate, the 2008 Sorbent System uses less than 15 liters of potable tap water per treatment compared to a standard sinqle-pass system that uses at least 120 liters of purified water during a standard 4-hour dialysis treatment.

The provided text describes a Special 510(k) submission for an updated version of a hemodialysis system, the 2008 Sorbent System. This type of submission focuses on demonstrating substantial equivalence to a predicate device (an already legally marketed device) through verification testing for modifications that do not significantly alter the device's fundamental technology, indications for use, or safety and effectiveness.

Here's an analysis based on the provided text, addressing your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative "acceptance criteria" in the traditional sense of a performance study with specific outcome measures and thresholds. Instead, it describes a "verification testing summary" aimed at demonstrating that the modified device meets its design requirements and is substantially equivalent to the predicate device.

The "performance" is implicitly defined by the successful completion of these verification activities, indicating that the modified device functions as intended and safely.

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

• Sample Size: The document does not specify a numerical sample size for "test sets" in the context of a clinical study. The testing described is non-clinical verification testing (e.g., software testing, hardware testing, cartridge performance), not a study involving human patients. Therefore, the "sample size" would refer to the number of test runs, prototypes, or cartridges used to perform the verification, which is not detailed.
• Data Provenance: The data is likely internal to the manufacturer, Renal Solutions, Inc., and represents retrospective (or in-house) testing focusing on engineering and performance verification of the device itself, rather than prospective clinical data from patients. There is no information regarding the country of origin of data, as it's not a clinical data set.

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

This information is not applicable to this submission. The "ground truth" for non-clinical verification testing is typically established by engineering specifications, regulatory standards, and the performance characteristics of the predicate device. The experts involved would be engineers, scientists, and quality assurance personnel within Renal Solutions, Inc., responsible for design, testing, and regulatory affairs. Their specific numbers and qualifications are not detailed here, as this is not a study requiring expert clinical review for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies where multiple human readers assess cases and discrepancies need to be resolved. This submission describes non-clinical verification testing of a device's functionality and performance against engineering requirements and established safety standards.

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

There is no mention of an MRMC comparative effectiveness study, human readers, or AI assistance. This device is a hemodialysis system, not an imaging or diagnostic AI-powered device.

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

This question is not applicable. The device is a hemodialysis machine with a sorbent system. It is a physical medical device for treatment, not an algorithm or AI system for standalone performance evaluation. Its operation still requires a healthcare practitioner ("human-in-the-loop") as stated in its Indications for Use.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Engineering Specifications and Design Requirements: The device was tested to ensure it met its own defined performance parameters.
• Predicate Device Performance: The primary ground truth for demonstrating "substantial equivalence" is the established safety and effectiveness of the legally marketed predicate device (2008 Sorbent System, K093362). The modified device's performance was compared to, and intended to be equivalent to, that of the predicate.
• Regulatory Standards: Implicitly, the verification testing would also adhere to relevant industry standards and regulatory guidance for hemodialysis devices.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical hemodialysis system, not a machine learning model that requires a "training set."

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

This information is not applicable for the same reason as above (not a machine learning model).

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The 2008 Sorbent System is intended for adult acute and chronic uremic patients in the presence of a healthcare practitioner where hemodialysis is prescribed on the order of a physician.

The 2008 Sorbent System is intended for adult acute and chronic uremic patients in the presence of a healthcare practitioner where hemodialysis is prescribed on the order of a physician. The 2008 Sorbent System operates in a similar manner to standard hemodialysis systems currently approved for use; it is substantially equivalent to the Fresenius 2008T hemodialysis machine (K080964) and the Renal Solutions Allient® Sorbent Hemodialysis System (K070739). The significant difference between the 2008 Sorbent System and standard single-pass hemodialysis machines is that the 2008 Sorbent System utilizes a sorbent cartridge to purify dialysate made from potable tap water and then regenerates fresh dialysate from spent dialysate (like the Allient Sorbent Hemodialysis System). The 2008 Sorbent System consists of two distinct components: the 2008 Machine, and the SORB™ Module. The SORB Module is a sorbent dialysate regenerative system that attaches to the 2008 Machine and replaces the machine's existing single-pass dialysate delivery system. During treatment, used dialysate is chemically reprocessed into fresh, new dialysate and sent back to the dialyzer instead of being sent down a drain. By recirculating and regenerating the dialysate, the 2008 Sorbent System uses less than 15 liters of potable tap water per treatment compared to a standard single-pass system that uses at least 120 liters of purified water during a standard 4-hour dialysis treatment.

The provided text describes the 2008 Sorbent Hemodialysis System, focusing on its substantial equivalence to predicate devices and the verification testing performed. However, it does not include the specific details required to fully answer your request regarding acceptance criteria and a study proving the device meets those criteria, particularly for an AI-powered medical device.

The document is a 510(k) summary for a Sorbent Hemodialysis System, which is a medical device for dialysate delivery, not an AI or software-intensive diagnostic device in the sense your questions imply (e.g., test sets, ground truth, expert consensus, MRMC studies). The "software testing" mentioned is to ensure the device's control software meets its design input requirements, not for evaluating an AI algorithm's diagnostic or predictive performance.

Therefore, many of your requested items cannot be extracted from this document as they are not relevant to the type of device being described.

However, I can extract what is available:

1. A table of acceptance criteria and the reported device performance:

The document outlines categories of testing and general objectives, implying acceptance criteria were defined for each. However, it does not explicitly state the quantitative acceptance criteria or the specific numerical performance results. Instead, it refers to "pre-defined acceptance or pass/fail criteria" and states that testing "demonstrates the device meets its performance specifications."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the given text. The testing described is non-clinical verification testing of a physical medical device, not a study involving patient data in the context of AI performance evaluation.

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)

This information is not applicable/provided. The ground truth for this type of device (a hemodialysis system) is established through engineering and performance specifications, adherence to standards, and risk analysis, not expert consensus on diagnostic interpretations.

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

This information is not applicable/provided. Adjudication methods like 2+1 are typically used in clinical studies involving multiple readers or interpretations, which is not what is described here.

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

An MRMC comparative effectiveness study was not done, as this device is a hemodialysis system and not an AI-assisted diagnostic tool for human readers.

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

This information is not applicable/provided. The "software testing" refers to the control software of the device, not a standalone diagnostic algorithm.

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

The "ground truth" for this device is based on engineering specifications, regulatory standards (e.g., IEC, ISO), and performance requirements related to the physical and functional operation of the hemodialysis system. The document lists "pre-defined acceptance or pass/fail criteria" as part of the test protocols.

8. The sample size for the training set

This information is not applicable/provided. This device is a physical medical device, not an AI model trained on a dataset.

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

This information is not applicable/provided. As above, there is no AI model or training set in the context of this device.

In summary, the provided document describes a 510(k) submission for a Sorbent Hemodialysis System, focusing on its functional, safety, and software verification to demonstrate substantial equivalence to predicate devices. It does not contain the detailed information typically associated with the evaluation of AI-powered diagnostic or predictive medical devices.

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