(74 days)
Diacap LO PS (10, 12, 15) and Diacap HI PS (10, 12, 15, 18, 20) Hemodialyzers are designed for single use in acute and chronic hemodialysis.
The Diacap LO PS (10, 12 and 15) and Diacap HI PS (10, 12, 15, 18 and 20) are, respectively, conventional permeability and high permeability hemodialyzers. The hollow, polysulfone membrane is housed within a plastic cylinder with four ports: two ports for blood compartment access and two ports for dialysate access.
The provided text is a 510(k) summary for the B. Braun Medizintechnologie G.m.b.H. Diacap LO PS and HI PS Hemodialyzers. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include detailed acceptance criteria or a study that specifically addresses device performance against stated acceptance criteria in the way typically expected for an AI/ML device where performance metrics (e.g., sensitivity, specificity, AUC) are calculated.
This document describes a medical device (hemodialyzers), not an AI/ML system. Therefore, the questions related to AI/ML device performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment in that context are not applicable.
Instead, the performance evaluation for these hemodialyzers focused on bench and clinical testing to demonstrate performance and safety, primarily in comparison to a predicate device.
Here's how to interpret the available information:
1. Table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative table with thresholds. Instead, it states that the device's performance was evaluated against "expected values" and through "comparison with the predicate device".
| Performance Aspect | Reported Device Performance | Basis for Evaluation (Implicit "Acceptance Criteria") |
|---|---|---|
| Ultrafiltration coefficients | "consistent with expected values" | Consistency with established physiological parameters and performance of predicate device. |
| Clearances (urea, creatinine, phosphate, vitamin B12) | "consistent with expected values" | Consistency with established physiological parameters and performance of predicate device. |
| Hemocompatibility (white cell and platelet counts) | "confirmed" | White cell and platelet counts within acceptable ranges for hemodialysis and comparable to predicate device. |
| Hemocompatibility (complement activation - C3a) | "evaluated" (implied as acceptable) | C3a levels within acceptable ranges for hemodialysis and comparable to predicate device. |
| Hemocompatibility (intrinsic and extrinsic coagulation system - TAT, thrombocyte activation) | "evaluated" (implied as acceptable) | TAT and thrombocyte activation within acceptable ranges for hemodialysis and comparable to predicate device. |
| Hemocompatibility (cell activation - thrombocyte and/or leukocyte adhesion and leukocyte activation) | "evaluated" (implied as acceptable) | Cell activation within acceptable ranges for hemodialysis and comparable to predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample size: Not specified. The document mentions "clinical testing" but does not detail the number of subjects or samples.
- Data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided. Performance evaluation for hemodialyzers does not typically involve "experts establishing ground truth" in the way an AI/ML diagnostic device would. Performance is assessed through direct measurement of physical and physiological parameters.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable and not provided.
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. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth," in the context of a hemodialyzer, would be the direct measurement of its physical properties (e.g., surface area, membrane characteristics) and its performance in clearing solutes and removing fluid in bench and clinical settings, as well as the physiological response of patients (e.g., blood cell counts, inflammatory markers). It's based on direct measurement and observed physiological effects rather than expert consensus on diagnostic images or pathology.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device and thus does not have a "training set" in that sense.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML 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.”