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The Moda-flx Hemodialysis System™ is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute, post-acute, or chronic care facility. Treatments must be administered under a physician's prescription, by a trained person who is considered competent in the use of the device.

Treatment types available include: Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED/ SLEDD), and Prolonged Intermittent Renal Replacement Therapy (PIRRT).

The Moda-flx Hemodialysis System™ Cartridge is a single use, disposable arterial and venous bloodline set, with dialysate tubing, intended to provide extracorporeal access during hemodialysis. The Moda-flx Hemodialysis System™ Cartridge is compatible only with the Moda-flx Hemodialysis System TM.

The Moda-flx Hemodialysis System™ is a transportable hemodialysis system that consists of three parts: Hemodialysis Delivery (HD) Device. Dialysate Generator (DG) Device, and a single use Moda-flx Hemodialysis System™ Cartridge that provides extracorporeal access during hemodialysis. The Moda-flx Hemodialysis System™ Cartridge is only compatible with the Modaflx Hemodialysis System™. The system creates purified water from tap water; from this purified water and chemical concentrates, the system creates dialysate in real time. The chemicals used to create the dialysate are standard 45X concentrates.

Ultrafiltration is achieved by controlling the dialysate going in and coming out of the dialyzer independently, using pumps on the HD Device to control fluid flow from both the inlet and outlet of the dialyzer. An external bag of saline is used to provide solution infusions to combat hypotensive episodes. Saline is also used to prime the Moda-flx Hemodialysis System™ Cartridge prior to use.

Prescribed blood flow rate is generated by a peristaltic pump, while heparin is administered to prevent blood coagulation. All fluid pathways are disposable and easily installed and replaced. Once installed, the device will check the connections of the fluid pathways and the system will automatically prepare itself for treatment.

This document is a 510(k) summary for the Moda-flx Hemodialysis System and Cartridge. It outlines the device's indications for use, its description, and a comparison to predicate devices, but does not provide the acceptance criteria or results of a study designed to prove the device meets specific acceptance criteria related to its clinical performance.

The "Performance Data" section lists various tests conducted, such as biocompatibility, electrical safety, software verification, and bench performance (including clearance, transport, and dialyzer integrity testing). It explicitly states that "no clinical studies were required to support this submission." This indicates that the FDA's substantial equivalence determination for this device was based on non-clinical performance data and comparison to predicate devices, rather than a clinical study demonstrating specific efficacy or clinical performance acceptance criteria.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them, as such a study (specifically a clinical one with performance metrics) is stated as not being required and thus not provided in this document.

However, based on the information provided, here's what can be inferred about the types of performance criteria and tests performed, even if specific numerical acceptance values aren't given:

Inferred Information from the Document:

While specific clinical acceptance criteria are not detailed (as no clinical study was required for this submission), the document does list various performance data provided in support of substantial equivalence. These imply underlying performance criteria for safety and technical functionality.

1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the document for clinical performance. The document only lists categories of tests performed.

2. Sample size used for the test set and the data provenance: This information is not provided in the document for any of the listed performance tests. The provenance (e.g., country of origin, retrospective/prospective) is also not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not applicable/provided, as no clinical study with "ground truth" established by experts is mentioned. For the non-clinical tests (e.g., bench testing, software V&V), the "ground truth" would be the engineering specifications and regulatory standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not applicable/provided, as no clinical study requiring adjudication is described.

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: This information is not applicable/provided. The device is a hemodialysis system, not an AI-assisted diagnostic tool involving 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 device is a medical system, not an AI algorithm in the typical sense of "standalone performance" for diagnostic or predictive tasks. Performance was likely evaluated for the integrated system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests mentioned (biocompatibility, electrical safety, software V&V, bench performance, etc.), the "ground truth" would be established by relevant engineering standards, regulatory requirements, and internal specifications for the device's functional performance. No clinical ground truth (like pathology or outcomes data) was used or required for this submission according to the document.

8. The sample size for the training set: This information is not applicable/provided. As no clinical study requiring "training data" for an AI model is described, this question is not relevant to the provided text.

9. How the ground truth for the training set was established: This information is not applicable/provided for the same reasons as point 8.

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2008T BlueStar Hemodialysis Machine: The 2008T BlueStar Hemodialysis Machine is indicated for acute and chronic dialysis therapy in a healthcare facility.

Additional therapy options for patients receiving hemodialysis include: Isolated Ultrafiltration, Sustained Low Efficiency Dialysis (SLED), and low volume hemodialysis (patients weighing ≥ 20 kg and ≤40 kg). This machine accommodates the use of both low flux and high flux dialyzers. The SLED therapy option is not to be used for patients weighing ≤40 kg. The 2008 BlueStar Hemodialysis Machine is not to be used for plasma replacement therapies, for patients weighing less than 20 kg, or for renal therapies using substitution fluid.

bibag System (Optional): The bibag system is used with three stream proportioning Hemodialysis Machines equipped with the bibag module such as the 2008T BlueStar Hemodialysis Machine and is intended for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription.

Crit-Line Clip Monitor (CLiC) (Optional): The Crit-Line Clip Monitor is used with the 2008T BlueStar Hemodialysis Machine to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume. The CLiC device measures hematocrit, percent change in blood volume and oxygen saturation in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the clinician. Based on the data that the monitor provides, the clinician nurse, under physician direction, intervenes (i.e., increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common complications of dialysis which include nausea, cramping and vomiting.

The 2008T BlueStar Hemodialysis Machine is an electromechanical device. Software controls the machine during hemodialysis treatment, including fluid flow, mixing, heating, and alarms. The 2008T BlueStar Hemodialysis Machine provides hemodialysis treatment by controlling and monitoring both the dialysate circuit and the extracorporeal blood circuit. The machine pumps blood from the patient's body through an extracorporeal circuit, one component of which is the dialyzer. The dialyzer contains a semi-permeable membrane that uses diffusion to transfer toxins and ultrafiltration to transport excess water from the blood into the dialysate circuit. In this separate dialysate circuit, the dialysate concentrates are mixed with purified water, heated, degassed, and delivered to the dialyzer. Balancing chambers control the incoming flow and outgoing flow of the dialysate fluid during ultrafiltration. During hemodialysis, the extracorporeal blood circuit is monitored for venous and arterial blood pressures as well as for the presence of air and blood.

The provided text describes specific acceptance criteria and the studies conducted to verify the performance of the 2008T BlueStar Hemodialysis Machine.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes (number of devices or test cases) used for each specific test mentioned (Biocompatibility, Electrical Safety, Software V&V, Mechanical, Environmental, Ship, Human Factors).
The data provenance (country of origin, retrospective/prospective) is not specified. The testing was conducted "according to existing FMCRTG procedures, protocols, declared performance standards, and guidelines of the quality system regulation (21 CFR §820)."

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 section is not applicable as the document describes the performance testing of a physical medical device (hemodialysis machine) based on engineering specifications and regulatory standards, not the performance of an AI/ML algorithm that requires expert-established ground truth for a test set. Experts would be involved in the design, testing, and regulatory review processes, but their role isn't in establishing a "ground truth" for an AI model's output in the typical sense.

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

This is not applicable for the type of device and testing described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for evaluating subjective interpretations, often in the context of AI models. The testing described here is focused on objective engineering performance verification.

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

This is not applicable. The document describes a hemodialysis machine, which is not an AI-assisted diagnostic or interpretive device that would typically be evaluated with a multi-reader, multi-case study comparing human readers with and without AI assistance.

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

This is not applicable. The device is a hemodialysis machine, a physical piece of medical equipment, not an AI algorithm. Its performance is inherent to its mechanical and software functions, which inherently involve human operation as "human-in-the-loop."

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

For a device like a hemodialysis machine, "ground truth" refers to established engineering specifications, physical laws, and regulatory standards. The performance characteristics (e.g., flow rates, temperatures, pressures, accuracy) are evaluated against these predefined, objective criteria. For instance, the accuracy of blood flow rates is verified against a known, precise measurement reference. The "ground truth" is therefore:

• Established engineering specifications and design requirements.
• International standards (e.g., ISO 10993 for biocompatibility, IEC 60601-1-2:2014 for EMC, IEC 60601-2-16 for dialysate temperature).
• Quality system regulations (21 CFR §820).

8. The sample size for the training set

This is not applicable. The device is a hemodialysis machine, not an AI/ML model that is 'trained' on data.

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

This is not applicable as there is no "training set" for this type of medical device.

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