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The MD 420-490 series reverse osmosis system is intended to purify water for hemodialysis when used as a component of a complete water purification system.

The MD 420-490 Series is a Reverse Osmosis Machine used in purifying water. The MD 420-490 series features an advanced electronic package including a PLC with software and validation procedures and a Touch-screen. The new advanced system has the capability to monitor both the pre-treatment and posttreatment of the water room. The data can be printed for a daily log or modem to a remote location. The machine is now simpler, quieter, and easier to maintain, run, and service compared to the MD 400 A-F. The PLC can monitor all aspects of the water room including the RO, pre-treatment, storage tank, line and loop pressures, temperatures, and flows. The system will display membrane % rejection and % recovery. All of this data is sent back to the RO where it is displayed. The data also has the capability to be modemed to a remote location. The hydraulic design of the machine remains unchanged for the original 510(k) application, however, we now use SCH 80 PVC pipe and 316L Stainless Steel piping in place of the tubing originally used of the HD- MD series.

The provided document describes a 510(k) submission for a medical device, the MD 420/440/460/470/480/490 Multi-Patient Reverse Osmosis (RO) Machine. However, it does not include information about acceptance criteria or a study that proves the device meets specific performance metrics in the way that would typically be presented for a diagnostic or AI-driven device.

Instead, this document is a summary of the substantial equivalence determination for a modified RO machine for hemodialysis water purification. The "study" here is essentially the comparison to a predicate device and a discussion of non-clinical tests to determine substantial equivalence.

Here's an analysis based on the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in terms of numerical performance thresholds (e.g., sensitivity, specificity, accuracy). The acceptance criteria implicitly revolve around maintaining the safety and effectiveness of the predicate device while incorporating new electronic and design features.

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

• Sample Size for Test Set: Not applicable. This submission is not based on a clinical trial with a "test set" of patients or data in the way a diagnostic device would be. It's an engineering and design modification approval.
• Data Provenance: The "data" primarily consists of engineering specifications, design comparisons, and the rationale for modifications. It's not based on patient data from a specific country or collected retrospectively/prospectively from a clinical population. It's an internal design and safety/effectiveness assessment by the manufacturer, reviewed by the FDA.

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

Not applicable. "Ground truth" in the context of this document refers to the established safety and effectiveness of the predicate device and the engineering assessment that the modifications do not negatively impact these aspects. This would involve internal engineering expertise from Isopure Corporation and regulatory review by the FDA (specifically, the Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices). No external medical experts are mentioned as establishing "ground truth" for a specific test set.

4. Adjudication Method for the Test Set:

Not applicable. There is no specific test set requiring adjudication in the context of this 510(k) submission. The FDA's substantial equivalence review process serves as the "adjudication" of the overall submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images or data. This device is a water purification system, not a diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

No. This device is an electromechanical system, not an algorithm. Its "performance" is its ability to purify water, not to interpret data in an autonomous way.

7. The Type of Ground Truth Used:

The "ground truth" in this context is the established safety and effectiveness of the predicate device (MD 400 Series Multi-Patient Reverse Osmosis (RO) Water Treatment System) and the engineering and regulatory assessment that the modified device (MD 420-490 Series) maintains this level of safety and effectiveness despite design changes and the addition of features like a PLC. It's based on technical specifications, regulatory standards, and the intended use of water purification for hemodialysis.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that is "trained" on a dataset.

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

Not applicable, as it's not an AI/ML device with a training set.

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