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The NxStage system is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration, in an acute or chronic care facility.

The system is also indicated for home hemodialysis, including home nocturnal hemodialysis and solo home hemodialysis during waking hours.

All treatments must be administered under a physician's prescription, and must be performed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.

The VersiHD with GuideMe Software is comprised of the NxStage Cycler, an electromechanical control unit and the NxStage Cartridge (disposable) extracorporeal blood and fluid management circuit (with or without a pre-attached high permeability filter) that mounts integrally within the NxStage Cycler.

The combined system is designed to deliver hemofiltration, hemodialysis and/or ultrafiltration in an acute or chronic care facility. It is also indicated for home hemodialysis, including home nocturnal hemodialysis and solo home hemodialysis during waking hours.

Based on the provided text, the device in question is the VersiHD with GuideMe software, which is a modification to an existing hemodialysis system (specifically, a software-only modification to the graphical user interface). This submission is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness from scratch.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within the context of demonstrating safety, effectiveness, and non-inferiority compared to the predicate device, especially regarding the software modification and its human factors.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for performance metrics in a pass/fail table format, nor does it provide numerical "reported device performance" against those criteria in the way one might see for a diagnostic algorithm. Instead, it details that testing was conducted to demonstrate compliance with specifications and equivalence to the predicate.

The closest equivalent to "acceptance criteria" derived from the text are the regulatory and engineering requirements that the device must meet, and the "reported device performance" is indicated by the statement that these requirements were met.

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 terms of patient data or case numbers. The testing described (simulated treatments, software V&V, system V&V, human factors validation) are engineering and usability tests, not clinical performance studies with patient cohorts.
• Data Provenance: Not applicable in the context of patient data. The origin of the testing itself would be the manufacturer (NxStage Medical, Inc.). The simulated treatments were described as "Simulated home hemodialysis treatments were performed in a simulated use environment (dialysis center/clinic or home setting)." This indicates a lab-based simulation rather than real patient data collection. The study specifically states "N/A. No clinical studies were conducted," and "N/A. No animal studies were conducted."

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

This information is not provided in the document. Given that no clinical studies or animal studies were conducted, and the device is a software modification (GUI change) to an existing system, the "ground truth" would likely relate to engineering specifications, safety standards, and usability engineering principles, rather than clinical diagnostic ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not provided in the document. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical imaging studies to establish ground truth from multiple expert reads. Since no clinical studies were performed with patient data, such a method would not be relevant here.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• Was it done?: No. The document explicitly states: "N/A. No clinical studies were conducted." MRMC studies are clinical studies involving human readers interpreting cases.
• Effect Size of Human Readers Improvement with AI vs. without AI assistance: Not applicable, as no MRMC study was performed. The "GuideMe" software appears to be an instructional aid, not an AI for diagnostic interpretation.

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

• Was it done?: This concept isn't directly applicable in the same way it would be for a diagnostic AI algorithm. The "GuideMe" software is described as a "new optional 'Guide Me' feature in which step-by-step instructions are available for users if they press the 'Guide Me' button on the updated user interface." It assists the human operator, rather than performing an independent task that could be evaluated in isolation like a diagnostic algorithm.
• The software's performance was verified and validated as part of the overall system and human factors testing, demonstrating its functionality and safety within the human-in-the-loop context.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" relevant to this submission is primarily:

• Engineering specifications and pre-determined performance specifications: For software and system verification and validation.
• International standards (e.g., IEC 60601 series): For electrical safety and EMC.
• FDA Human Factors guidance: For usability and safe interaction.

There is no mention of clinical ground truth derived from expert consensus, pathology, or outcomes data, as no clinical studies were conducted.

8. The Sample Size for the Training Set

• Not applicable / Not provided. This device is not described as a machine learning or AI model trained on a data set in the typical sense for image interpretation or diagnosis. The "GuideMe" feature is a software modification providing step-by-step instructions. Therefore, there wouldn't be a "training set" like for a deep learning model.

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

• Not applicable / Not provided. As there's no mention of a training set for an AI/ML model, the establishment of ground truth for such a set is irrelevant here. The software's functionality and content (the "Guide Me" instructions) would have been developed based on existing procedural knowledge for operating the hemodialysis system and validated through engineering and human factors testing.

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