(156 days)
The Fresenius 2008T is indicated for acute and chronic dialysis therapy.
The optional CDX modification incorporates a standard Windows/Linux capable computer (PC board) into the 2008T giving clinics the option to load data management software into the machine. With data management software on the machine the user may then interface with the program, using the machines preexisting alphanumeric keyboard, then transfer treatment data directly from the 2008T machine to their In-center medical information system. Additionally, the selection of Citrasate® (K000792) and DRYalvsate® (K980659) acid concentrates have been added to the selection of acid concentrates available to our customers on the 2008T hemodialysis machine. The user interface has been changed to allow the user to select Citrasate/DRYalysate from the dialysis screen of the 2008T hemodialysis machine and to display the proper constituents of the concentrate.
The provided text describes modifications to the Fresenius 2008T Hemodialysis Machine, not a diagnostic AI device. Therefore, the requested information categories (acceptance criteria, sample sizes, expert ground truth, MRMC study, standalone performance, training set details) are largely not applicable in the context of this medical device (a hemodialysis machine) and the information available in this 510(k) summary.
However, I can extract information related to acceptance criteria and "studies" as presented in the document, interpreting them in the context of a non-AI medical device submission.
Here's an attempt to answer based on the provided text, noting where the requested AI-specific information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Software Functionality | Acceptance Criteria: Modifications to the 2008T hemodialysis functions as intended and modifications did not negatively impact the overall 2008T hemodialysis machine system. |
| Reported Performance: Full system validation and software regression testing were performed. "The results from the testing demonstrated that all modifications functioned as intended and met pre-determined acceptance criteria." (Specific details of acceptance criteria for software were not provided beyond successful functioning and no negative impact). | |
| Electromagnetic Compatibility (EMC) | Acceptance Criteria: Compliance with IEC 60601-1-2 (2007) Class A. |
| Reported Performance: EMC testing was conducted according to IEC 60601-1-2 (2007) Class A. "The modified 2008T hemodialysis machine... met the requirements for IEC 60601-1-2 devices." | |
| Electrical Safety | Acceptance Criteria: Compliance with UL 60601-1, 1st Edition, 2006-04-26, and CAN/CSA-C22.2 No. 601.1-M90, 2005. |
| Reported Performance: Electrical safety testing was conducted according to the specified standards. "The modified 2008T hemodialysis machine was found to comply with the above standards." | |
| System Performance (with Citrasate®) | Acceptance Criteria: Function as intended when using Citrasate® acid concentrate and meet pre-determined acceptance criteria (specific criteria not detailed). |
| Reported Performance: "System performance testing using Citrasate® acid concentrate" was performed. "The results from the testing demonstrated that all modifications functioned as intended and met pre-determined acceptance criteria." (Specific details of acceptance criteria for system performance were not provided beyond successful functioning). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of data for an AI algorithm. The testing described (software validation, EMC, electrical safety, system performance) would typically involve physical units of the device and simulation/testing environments rather than a "data set." Therefore, information on sample size for an AI test set or data provenance (country, retrospective/prospective) is not applicable/not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/not provided as the submission is for a physical medical device (hemodialysis machine) with minor modifications, not an AI algorithm requiring expert-established ground truth on data.
4. Adjudication Method for the Test Set
This information is not applicable/not provided as the submission is for a physical medical device.
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
This information is not applicable/not provided. This is not an AI-assisted diagnostic or decision support device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable/not provided. This is not an AI algorithm.
7. The Type of Ground Truth Used
The concept of "ground truth" as it relates to expert consensus, pathology, or outcomes data for an AI algorithm is not applicable here. The "truth" in this context is the successful and compliant operation of the physical device according to engineering standards and regulatory requirements.
8. The Sample Size for the Training Set
This information is not applicable/not provided. This is not an AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided. There is no "training set" or corresponding ground truth establishment for an AI algorithm in this submission.
§ 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.”