(157 days)
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.
| Feature/Requirement | Acceptance Criteria (Implied from text) | Reported Device Performance/Conclusion |
|---|---|---|
| Software Functionality | Software requirements verified against pre-determined performance specifications. | "Software requirements were verified according to pre-determined performance specifications." "Unit, software, regression (system verification), and validation testing were performed to demonstrate the effectiveness of the software and to confirm operation of the machine." |
| System Performance | System requirements verified against pre-determined performance specifications. | "System requirements were verified according to pre-determined performance specifications." |
| Human Factors/Usability | Safe and effective use in accordance with FDA guidance document "Applying Human Factors and Usability Engineering to Medical Devices (February 3, 2016)". | "The VersiHD with GuideMe Software was validated for safe and effective use in accordance with FDA guidance document..." |
| Electrical Safety & EMC | Compliance with IEC 60601-1-2:2014 (4th Edition) and adherence to FDA guidance on EMC. | "Electromagnetic Compatibility testing was performed in accordance with IEC 60601-1-2:2014 (4th Edition)." "Electromagnetic Compatibility information within this submission is provided in accordance with FDA guidance document..." |
| Overall Equivalence | No new concerns with regard to safety or effectiveness compared to the predicate device. Functions as intended. | "Test results demonstrate that the differences between the proposed and the predicate devices do not raise any new concerns with regard to safety or effectiveness." "The information provided in this submission demonstrates the VersiHD with GuideMe Software functions as intended and supports the determination of substantial equivalence to the predicate device." |
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.
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”