(510 days)
The Centrysystem 14 PES Gamma can be used whenever hemodialysis is indicated. This dialyzer can be used for long term chronic hemodialysis as well as for acute hemodialysis. In hemodialysis therapy, monitoring of patient vital signs, the dialysate delivery system, heparin administration, and clotting times should be performed under the direction of a physician.
The membrane used in this device is polyether sulfone which is substantially equivalent to the polysulfone membrane utilized in the Fresenius F80A dialyzers and the polyether sulfone membrane utilized in the Gambro HC 14 R Hemoconcentrators. Both devices have been previously approved for marketing in the United States under 510K Notifications. The polyether sulfone membrane is manufactured by Gambro.
Blood enters a blood inlet port where it is distributed to polyether sulfone hollow fiber has an inner diameter of approximately 215 microns and a wall thickness of 50 microns. The effective length of the fibers is 267 mm. The fibers used in this device are substantially equivalent in design to the previously approved Gambro HC 14R Hemoconcentrator. The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port.
By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the Polyether sulfone membrane, plasma water along with certain lower molecular weight solutes of plasma water pass through the membrane and into the dialysate Removal of uremic toxins and waste products are removed from the compartment of the devices. patient's blood in this device by means of both diffusion and convection through the Polyether sufone membrane into the counter current flowing dialysis solution. The dialysate exits the devices via a dialysate outlet port.
The provided text describes a 510K Notification for a medical device, the Cobe Centrysystem 14 PES Gamma hemodialyzer. This document details the device's characteristics, intended use, and a comparison to predicate devices, along with summaries of non-clinical and clinical tests. However, it does not contain the specific information required to complete the detailed table and answer all the questions about acceptance criteria and a study proving the device meets them, particularly in the context of an AI/algorithm-based device.
The document discusses performance criteria for a hemodialyzer, which are physical and physiological measurements, not typical "acceptance criteria" for an AI model's performance. The "study" described is a clinical test of a physical medical device, not a study validating an algorithm's performance.
Therefore, I can only extract limited information, mainly regarding the clinical test performed.
Here's a breakdown based on the provided text and the limitations:
Acceptance Criteria and Reported Device Performance (as far as can be inferred for a physical device):
The document states: "It can be concluded from the results of the investigation that the Cobe Centrysystem 14 PES Gamma Hemodialyzer fulfills the performance criteria stated by Gambro." However, the specific numerical acceptance criteria and the corresponding reported performance values are not explicitly listed in a table format with thresholds. Instead, it lists parameters that were studied.
| Acceptance Criteria (Inferred/Studied Parameters) | Reported Device Performance |
|---|---|
| Fulfills Gambro's performance criteria | Fulfilled |
| Blood side priming volume | Satisfactory (implied) |
| Dialysate side priming volume | Satisfactory (implied) |
| Dialysate and blood flow resistance | Satisfactory (implied) |
| Ultrafiltration coefficient | Satisfactory (implied) |
| Urea clearance (at varying blood flows) | Satisfactory (implied) |
| Creatinine clearance (at varying blood flows) | Satisfactory (implied) |
| Phosphate clearance (at varying blood flows) | Satisfactory (implied) |
| Vitamin B12 clearance (at varying blood flows) | Satisfactory (implied) |
| Pressure drops (blood compart., dialysate compart.) | Satisfactory (implied) |
| Blood flows | Satisfactory (implied) |
| Transmembrane pressures | Satisfactory (implied) |
| Ultrafiltration rates | Satisfactory (implied) |
| Beta 2 microglobulin clearances | Satisfactory (implied) |
| Residual blood volumes | Satisfactory (implied) |
| Handling and safety evaluations | Satisfactory (implied) |
Detailed Information about the Study:
The document describes a clinical test for a physical medical device. It does not describe a study for an AI/algorithm. Therefore, many of the requested points are not applicable or cannot be answered from the provided text.
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Sample size used for the test set and the data provenance:
- Sample Size: 24 Cobe Centrysystem 14 PES Hemodialyzers used in six patients.
- Data Provenance: Not specified (e.g., country of origin, specific demographics), but it's a clinical test performed on human subjects with the device. It is a prospective clinical test, as indicated by "Clinical testing was performed utilizing... in six patients."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to a physical device clinical study determining physiological parameters. "Ground truth" here would be the actual measurements and observed patient outcomes, not expert labeling of data. The "direction of a physician" is mentioned for monitoring vital signs, heparin, etc., but not for establishing ground truth of the device's physical performance parameters.
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Adjudication method for the test set:
- Not applicable for a physical device performance study in this context. The study is measuring physical parameters directly.
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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:
- No. This is a study of a physical hemodialyzer, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a study of a physical hemodialyzer, not an algorithm.
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The type of ground truth used:
- For the physical device, the "ground truth" implicitly refers to physiological measurements and clinical observations (e.g., actual ultrafiltration rates, clearance values, pressure drops, observed safety, and handling).
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The sample size for the training set:
- Not applicable. This is a physical device, not an AI algorithm requiring a training set.
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How the ground truth for the training set was established:
- Not applicable. This is a physical device, not an AI algorithm.
§ 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.”