(138 days)
Hemodialysis with Xenium XPM dialyzers is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.
Xenium XPM dialyzers are Polyethersulfone fiber dialyzers and will be labeled for single use only. The dialyzers are available in six (6) sizes, which are differentiated by membrane surface area.
The provided document is a 510(k) Premarket Notification for the Xenium XPM hemodialyzer. It focuses on demonstrating substantial equivalence to a predicate device and does not contain the detailed information typically found in studies for AI/ML-based devices regarding acceptance criteria, performance metrics, ground truth establishment, or sample sizes in the manner requested.
Here's an analysis of the information that is available in the document, and where the requested details are missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document states, "All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use." However, it does not specify what these quantitative acceptance criteria are (e.g., specific thresholds for clearance rates, ultrafiltration rates, etc.).
- Reported Device Performance: No specific performance metrics or results are reported in this summary. The manufacturer conducted "design verification tests" but the outputs of these tests are not provided. The demonstration of substantial equivalence suggests the performance is similar to the predicate, but no direct performance data is given.
Conclusion for Point 1: No specific acceptance criteria or quantitative device performance data are provided in this 510(k) summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document mentions "design verification tests" and "risk analyses per ISO 14971." These are non-clinical tests.
- Sample Size: No sample size for any test set is mentioned.
- Data Provenance: Not applicable, as this refers to non-clinical, in-vitro testing/design verification, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This device is a hemodialyzer, a physical medical device, not an AI/ML diagnostic or measurement tool. There is no concept of "ground truth" derived from expert consensus in the context of its performance verification as described here. Physical and chemical tests are likely used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This term refers to the process of resolving discrepancies in expert interpretations, which is not relevant for the type of device and verification described.
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 Xenium XPM is a hemodialyzer, not an AI-assisted diagnostic or imaging system. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the AI/ML sense. For a hemodialyzer, "ground truth" for performance would be established by validated physical and chemical measurement methods (e.g., measuring solute clearance, ultrafiltration, pressure drops according to established standards).
8. The sample size for the training set
- Not applicable. This device does not involve an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve an AI/ML algorithm.
Summary of what the study provided in the document focuses on:
The document describes a "Special 510(k) Premarket Notification" for a hemodialyzer, the Xenium XPM. The primary objective of this type of submission is to demonstrate substantial equivalence to an already legally marketed predicate device (in this case, the Baxter Xenium XPH dialyzer, K083778).
The "study" or testing mentioned is non-clinical: "Baxter Healthcare Corporation conducts risk analyses, per ISO 14971, and design verification tests based on the result of these analyses. All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use."
This indicates that standard engineering and regulatory verification tests were performed to ensure the device met its design specifications and safety requirements, likely comparing its physical characteristics and functional performance (e.g., membrane surface area, materials, in-vitro clearance, and ultrafiltration rates) against the predicate device to demonstrate equivalence. The details of these tests, including specific acceptance criteria and detailed quantitative results, are not included in this 510(k) summary, which is typical for such submissions where the focus is on the conclusion of substantial equivalence rather than a full study report.
§ 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.”