(119 days)
The PRISMA M10 Pre Set is indicated for use with the PRISMA control unit only in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure, fluid overload, or both.
The set is intended for use in the following veno-venous therapies:
- slow continuous ultrafiltration (SCUF)
- continuous veno-venous hemofiltration (CVVH)
- continuous veno-venous hemodialysis (CVVHD)
- continuous veno-venous hemodiafiltration (CVVHDF)
The PRISMA M10 Pre Set is intended for treatment of neonates and infants with a body weight ranging between 2 and 15 kg.
The PRISMA M10 Pre Set is a disposable, extracorporeal circuit for use with the PRISMA control unit. The PRISMA M10 Pre Set consists of a AN 69 hollow fiber hemofiter / dialyzer and tubing lines.
The filter is permanently connected:
- on the blood compartment to an access line (red-striped), a return line (blue-striped) .
- on the dialysate compartment to a dialysate inlet line (green-striped) and to anceff)vent . outlet line (yellow-striped).
Other lines of the set include a replacement solution line (purple-striped) and anticoagulant line.
- A 1-liter bag is connected to the end of the blood access line to collect the priming . liquid.
- A 5-liter bag is connected to the end of the effluent outlet line to collect the ultrafil trate . and/or dialysate.
Pre-dilution: the PRISMA M10 Pre Set is a set provided for addition of replacement solution before blood enters the filter.
The provided text describes a 510(k) premarket notification for the "PRISMA M10 Pre Set" device by Gambro Renal Products. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or performing a study to prove acceptance criteria for an AI/CADe device. Therefore, the information required to answer the prompt is not present in the provided text.
Here's why and what information is missing:
- Device Type: The PRISMA M10 Pre Set is a disposable extracorporeal circuit (a medical device hardware) for renal replacement therapies, not an AI/CADe system. The prompt, with its focus on "multireader multicas study," "human readers improve with AI," and "standalone (algorithm only)" performance, is clearly tailored for AI/CADe devices.
- Acceptance Criteria/Performance Table: The document states that "In vitro performance and clinical testing was performed to establish and compare performance characteristics to the predicate devices." However, it does not explicitly list the acceptance criteria (e.g., sensitivity, specificity, AUC) or the numerical results of these tests for the PRISMA M10 Pre Set. It only concludes that the device performs "as well as the predicate devices."
- Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone): The document mentions "clinical testing" but does not provide any details about the study design, such as sample size, characteristics of the test data (e.g., country of origin, retrospective/prospective), the involvement of experts, adjudication methods, or whether it was a multi-reader multi-case study. These are standard elements for AI/CADe validation but not typically presented in this level of detail for a medical device hardware 510(k) submission.
- Ground Truth: For a hardware device like this, "ground truth" would relate to its physical and functional performance (e.g., ultrafiltration rate, solute clearance), rather than diagnostic accuracy established by expert consensus or pathology, which is relevant for AI/CADe systems. The document implies that the "performance data/specifications" are the "ground truth" for comparison to predicate devices, but no specifics are given.
- Training Set: Since this is not an AI/CADe device, there is no concept of a "training set" in the context of the device itself.
In summary, the provided content is a 510(k) summary for a medical device hardware, and thus does not contain the information requested about acceptance criteria and study data for an AI/CADe device.
§ 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.”