(388 days)
The NxStage System One 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 indicated for hemodialysis with or without ultrafiltration in the home.
The NxStage System One is also indicated for Therapeutic Plasma Exchange in a clinical environment.
All treatments must be administered under a physician's prescription, and must be observed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.
The NxStage System One with Therapeutic Plasma Exchange Cartridge provides therapeutic plasma exchange therapy when used with a commercially available TPE filter. The machine that controls the therapy is called the Cycler. The blood tubing set is the NxStage TPE Cartridge. The TPE Cartridge is a single use extracorporeal blood circuit and fluid management device without a pre-attached filter. Therapeutic plasma exchange requires the use of a commercially available therapeutic plasma exchange filter such as the Asahi Plasmaflo.
The provided text describes the NxStage System One with Therapeutic Plasma Exchange Cartridge. While it details the device's indications, substantial equivalence, and general performance claims, it does not include specific acceptance criteria or the study details to prove those criteria were met in a structured format.
The document states:
"Perfication and validation testing was conducted to characterize performance of the proposed device and the predetermined acceptance criteria was met. Results of this testing have documented that the proposed NxStage System One with TPE Cartidge is substantially equivalent to the predicate devices and is suitable for the labeled indications for use."
However, it does not enumerate what those "predetermined acceptance criteria" were or provide any specifics about the "verification and validation testing" such as sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot populate the requested table and answer many of the specific questions about the study design because that information is not present in the provided text.
Based on the provided text, here's what can be extracted and what remains unknown:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in text | The device "met" predetermined acceptance criteria. |
| Not specified in text | The device is "substantially equivalent" to predicate devices. |
| Not specified in text | The device is "suitable for the labeled indications for use." |
2. Sample size used for the test set and the data provenance: Not specified in the text. The document refers to "verification and validation testing" but does not give details about "test sets" or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the text.
4. Adjudication method for the test set: Not specified in the text.
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: Not applicable. The device described is a medical system for therapeutic plasma exchange, not an AI-assisted diagnostic device requiring human reader performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical system, not an algorithm in the traditional sense for standalone performance evaluation against a ground truth in diagnostic imaging, for example.
7. The type of ground truth used: Not specified in the text. The testing appears to be primarily bench testing for characterizing device performance, rather than clinical ground truth for diagnostic accuracy.
8. The sample size for the training set: Not applicable/Not specified. This is a medical device, not a machine learning algorithm that typically uses a "training set" in the context of AI.
9. How the ground truth for the training set was established: Not applicable/Not specified.
In summary, the provided text confirms that "verification and validation testing" was performed and that "predetermined acceptance criteria" were met, leading to a determination of substantial equivalence. However, the specific details of these criteria and the methodology of the testing (including sample sizes, ground truth, and expert involvement) are not elaborated upon.
§ 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.”