(40 days)
Indicated for use with the Prisma Control Unit in providing continuous fluid management and renal replacement therapies for patients who have acute renal failure, fluid overload, or both.
The Prisma Disposable Sets are sterile disposable extracorporeal circuits containing an AN 69 HF hemofilter/dialyzer and fluid circuit for use with the Prisma Control Unit. These Prisma Disposable Sets allow the following fluid management and renal replacement therapies to be performed: SCUF - Slow Continuous Ultrafiltration CVVH - Continuous Venovenous Hemofiltration CVVHD - Continuous Venovenous Hemodialysis CVVHDF - Continuous Venovenous Hemodiafiltration
The provided text is a 510(k) summary for the Gambro Prisma M60/M100 Sets, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove performance against those criteria in the context of advanced AI/ML device evaluations.
Therefore, many of the requested categories are not applicable or cannot be extracted from this document, as the submission predates the common methodologies and requirements for AI/ML device evaluations.
Here's the information that can be extracted or deduced from the provided document, with notes on what is not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in a dedicated table format, nor does it present specific performance metrics like sensitivity, specificity, or AUC as would be found in an AI/ML device study. Instead, it relies on demonstrating "substantial equivalence" through "in vitro testing" to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintain performance comparable to predicate devices in design, function, composition, and operation. | "The results of the in vitro testing demonstrate that the proposed configurations are substantially equivalent to the predicate configurations and are suitable for the intended use." |
2. Sample sized used for the test set and the data provenance
- Sample Size (Test Set): Not specified. The document only mentions "in vitro testing" without details on the number of tests or specific test runs.
- Data Provenance (e.g. country of origin of the data, retrospective or prospective): Not specified. The testing was "in vitro," implying laboratory-based testing rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. The "ground truth" for this type of device (hemofilter and blood tubing set) would be established through engineering specifications, material properties, and functional performance benchmarks rather than expert clinical consensus on diagnostic images or patient outcomes.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for human-reviewed data, typically in diagnostic imaging or clinical assessment, to establish a consensus ground truth. This is not relevant for in vitro functional performance testing of 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
- MRMC Study: No, this type of study was not done. MRMC studies are specific to evaluating AI's impact on human diagnostic performance, which is not relevant for a hemofilter and blood tubing set.
- Effect Size of Human Reader Improvement: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. The device is not an algorithm and does not have a "standalone" performance in the sense of AI/ML evaluation. Its performance is inherent to its physical design and function. The "in vitro testing" assesses the physical device's performance directly.
7. The type of ground truth used
- Type of Ground Truth: For "in vitro testing" of a physical device like this, the 'ground truth' would be defined by established engineering and medical standards, performance specifications for flow rates, filtration efficiency, material compatibility, and sterility, as measured by standard laboratory equipment and protocols. It is not expert consensus, pathology, or outcomes data in the usual sense.
8. The sample size for the training set
- Sample Size (Training Set): Not applicable. This document describes a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set for this 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.”